cyrilzakka/clinical-trials huggingface dataset:
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.

Mild vitamin B12 deficiency is highly prevalent in old age. Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin B12. In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. In both healthy and cognitively impaired elderly people, associations between vitamin B12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment.

We investigated whether daily oral supplementation with 1,000 μg vitamin B12 or 1,000 μg vitamin B12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.

Eligibility Criteria:
Inclusion Criteria:

* Mild vitamin B12 deficiency:

  * Low plasma vitamin B12 concentration (100 \< B12 \< 300 pmol/L)
  * Elevated methylmalonic acid (MMA) concentration (\> 0.32 umol/L)
  * Creatinine concentration \< 120 umol/L

Exclusion Criteria:

* Severe cognitive impairment
* Anemia
* Gastrointestinal surgery or diseases
* Use of vitamin B12 injections or supplements containing \> 25 ug vitamin B12 and/or 200 ug folic acid
* \< 90% compliance during a 2 week placebo run in period
* No written informed consent
* Participation in other research studies
Breath Analysis in in Adults With Cystic Fibrosis (CF)

Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients with age and gender-matched healthy adults in order to identify a disease-specific exhaled breath pattern as well as to gain insight into pathophysiological and microbial contributions to exhaled breath composition.

Although there is some evidence that breath composition reflects aspects of CF pathology, so far a disease-specific molecular breath profile has not been identified. Real-time, whole breath analysis incorporating all of the thousands of potentially relevant volatile compounds is needed in order to identify reliable CF-specific breath patterns. These may be used in future clinical applications to greatly enhance cost-effectiveness and simplicity of diagnostic testing for CF.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cystic fibrosis (for CF-patients)
* Age ≥ 18 years

Exclusion Criteria:

* Previous lung transplantation (for CF-patients)
* Pulmonary exacerbation within the preceding 6 weeks (for CF-patients)
* Moribund or severe disease prohibiting protocol adherence (for CF-patients)
* Respiratory illness requiring physician consultation within the preceding 6 weeks (for controls)
* Chronic respiratory illness (for controls)
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnancy
Contribution of PET (Positron Emission Tomography) Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN

Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions.

The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18 and under 50
* Patient with symptomatic endometriosis with indication for surgery
* Showing at least one typical endometriosis lesion on MRI, greater than 5mm
* Accepting surgical management
* Having signed an informed consent after information
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient who has received an injection with GnRH (gonadotropin-releasing hormone ) analogues for less than 3 months (because it induces the quiescence of the disease which is no longer stimulated by estrogen secretion)
* Patient with a history of heavy abdominopelvic surgery
* Diabetic patient
* Patient unable to understand the interest of the study
* Patient already included in another therapeutic trial with an experimental molecule.
* Persons referred to in articles L1121-5 to L1121-8 of the PHC (public health code) (corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person making the subject to a legal protection measure: guardianship or curators)
* Contraindications to PET Scanner (major claustrophobia, contraindication or hypersensitivity to 18-FDG or one of its excipients, contraindication or hypersensitivity to Ultravist® or one of its excipients, etc.)
* Contraindication to surgery or anesthesia
The 5-FU Holter Study

To assess the feasibility of using ambulatory ECG monitoring (Holter monitor) for patients receiving 5-FU chemotherapy

5-fluorouracil (5-FU) is the key chemotherapy component in systemic treatment of colorectal cancer. However, 5-FU treatment is also associated with cardiotoxicity which can have devastating consequences.

Cardiotoxicity can be both symptomatic (e.g. chest pain, myocardial infarction (heart attack) and/or sudden death) as well as asymptomatic ('silent myocardial ischemia', which is only detectable by ECG). Data suggests that asymptomatic cardiotoxicity may be relatively common (\~30% of patients).

About 69% of the cardiac events are seen during or within the first 72 hours of the first cycle of 5-FU.

The development of cardiotoxicity requires permanent discontinuation of 5-FU chemotherapy. There are no PHARMAC funded alternatives for patients who discontinue 5-FU due to cardiotoxicity. Discontinuation of 5-FU is likely to lead to a worse oncological outcome (survival time) for the patient.

One proposed mechanism for 5-FU cardiotoxicity involves fluoro-beta-alanine (FBAL), which is a metabolite formed when 5-FU is catalysed by the enzyme dihydropyrimidine dehydrogenase (DPD). The rationale for this feasibility study is to provide preliminary information required to develop a prospective pharmacokinetic study exploring plasma clearance of FBAL and 5-FU cardiotoxicity.

This study aims to determine i) whether the use of continuous ECG monitoring (ambulatory Holter monitoring) in real life conditions (over two days, while at home receiving infusional 5-FU chemotherapy), is able to appropriately assess these types of silent heart attacks (ST changes) and ii) the acceptability of this study to both patients and clinicians iii) the excretion rate of FBAL over the 48 hour time period \& interpatient pharmacokinetic variability in FBAL excretion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of gastrointestinal malignancy
* Planned to receive either FOLFOX chemotherapy with any treatment intent
* Aged ≥ 18 years at time of signing informed consent form

Exclusion Criteria:

• ECG with left bundle branch block or left ventricular hypertrophy with strain
Molecular Markers of Prognosis in Colorectal Cancer Patients

To correlate the molecular profile of a series of defined CRCs with prognosis and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* All patients participating in the RMHNHST study of infusional versus bolus 5FU (Saini et al. 2003).
Predictive Analytics in Lower Respiratory Tract Infections (VA-LRTIs)

To determine the accuracy and generalizability of VA-LRTI algorithm to detect and predict three high-incidence and high-impact VAEs from electronic health records data: 1) ventilator-associated event, 2) ventilator-associated pneumonia, and 3) ventilator-associated tracheobronchitis.


Eligibility Criteria:
All invasively ventilated ICU patient (aged 18 or over)
The Role of Endothelin 1 as a Marker of Renal Impairment in Sickle Cell Disease

Sickle cell disease (SCD) refers to a group of hemoglobinopathies that include mutations in the gene encoding the beta subunit of hemoglobin. Within the umbrella of SCD, many subgroups exist, namely sickle cell anemia (SCA), hemoglobin SC disease (HbSC), and hemoglobin sickle-beta-thalassemia (beta-thalassemia positive or beta-thalassemia negative). Several other minor variants within the group of SCDs also, albeit not as common as the varieties mentioned above. It is essential to mention the sickle cell trait (HbAS), which carries a heterozygous mutation and seldom presents clinical signs or symptoms. Sickle cell anemia is the most common form of SCD


Eligibility Criteria:
Inclusion Criteria:

* The patients fulfilling all the following criteria will be included:
* Patients with sickle cell disease in the age range of 1-18years.

Exclusion Criteria:

* Patients diagnosed to have coexistent renal disease before the study
Graded Exercise Hypoxia Testing

The purpose of this study is to develop a single, standardized test to determine how individuals tolerate acute hypoxia in a stepwise fashion. We aim to evaluate the association between multiple factors, such as ventilatory compensation, heart rate response, acid-base changes, sex, pulmonary function, etc, which may explain why some individuals tolerate exercise in hypoxia better than others. Identifying these factors of association will inform future pharmacological and non-pharmacological attempts to combat acute hypoxic exercise.


Eligibility Criteria:
Inclusion Criteria:

• Physically active (≥150 minutes of moderate physical activity per week)

Exclusion Criteria:

* Contraindications to exercise testing
* Currently pregnant
* Musculoskeletal or metabolic disease
* Allergies to lidocaine
* Body-mass index ≤18 or ≥35 kg·m-2
* Pacemaker
* No confounding cardiorespiratory disease
* Persistent tobacco use (\>15 pack years)
Oxytocin and Emotion Processing

The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.

An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies. However, in humans, effects seem more complex.

The rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
* MRI contraindication
Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients

The purpose of this study is to verify the equivalence in clinical efficacy of fluconazole and micafungin for the treatment of Candida bloodstream infection in non-neutropenic patients.

Candida bloodstream infection occurs in patients with poor general conditions and has poor prognosis with attributable mortality of more than 30%. Clinical efficacy of fluconazole for the treatment of Candida bloodstream infection has been reported in clinical studies, since 1985 when it placed on the market. Fluconazole has established a position as the first-line drug up to date. However, possibly associated with the increased use of fluconazole, increased frequency of Candida species or strains with low susceptibility to fluconazole has been pointed out. Micafungin, an antifungal echinocandin with a different antifungal mechanism from fluconazole, has been reported to show good in vitro activity to various Candida species and strains with fluconazole resistance, and has comparative clinical efficacy with fluconazole for esophageal candidiasis, while it has relatively low in vitro activity to certain Candida species. There is no comparative study of fluconazole versus micafungin against Candida bloodstream infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients in whom Candida species have been isolated from blood culture.
* Patients accompanied by systemic infectious symptoms during the period from 24 hours (h) before collection of blood culture showing a positive result.
* Patients aged 20 years or older on the date of registration.
* Patients who have not received systemic administration of antifungal agents or who have started such administration within 48 h.
* Patients in whom a central venous (CV) catheter has been removed during the period from 24 h before collection of blood culture showing a positive result to registration, or a CV catheter can be removed within 72 h after registration.
* Patients with no verified undrainable abscess with a diameter of at least 3 cm, or impassable occlusive lesions, which are possibly attributable to Candida species.
* Patients from whom written informed consent to participate in this study has been obtained (or from their legally acceptable representatives).
* Patients who have adequate neutrophil count and hepatic/renal function in the blood test performed within 72 h before registration.

Exclusion Criteria:

* Patients with a history of adverse reactions associated with fluconazole or micafungin.
* Patients who have been treated with fluconazole or micafungin for at least 1 week within 12 weeks.
* Patients with a history of detection of fluconazole non-susceptible Candida species within 12 weeks.
* Patients in whom the neutrophil count is predicted to decrease to below 500/mL.
* Patients who are not treated with terfenadine, triazolam, cisapride, and ergotamine, which are contraindicated for concomitant use with fluconazole.
* Patients who are determined to be ineligible by the investigator.
The Flapless Approach in Periodontal Regeneration

The present investigation is designed in order to compare the radiographic and clinical effectiveness of flapless procedure performed alone or in combination with enamel matrix derivatives in the periodontal regenerative treatment of deep intrabony defects in patients with moderate or severe periodontitis. The study will have a follow-up of 12 months.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of periodontitis stage III or IV;
* presence of at least one tooth with ≥6 mm associated with a radiographic intrabony defect ≥3 mm at least 2 months after the completion of non-surgical therapy;
* a full-mouth plaque score and full-mouth bleeding score \<15% at the time of the experimental procedure;
* signed informed consent.

Exclusion Criteria:

* relevant medical disorders contraindicating periodontal surgery or detrimental to periodontal healing;
* consumption of drugs known to affect periodontal status;
* pregnancy and lactation;
* third molars, teeth with furcation involvement or inadequate endodontic treatment and/or prosthetic restoration;
* heavy smokers \>10 cigarettes per day.
A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With PNH

This is a Phase IIa, open-label, multiple dose, study in patients with PNH who have not received eculizumab (Soliris ®) in the past. A single cohort of subjects is planned for evaluation.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old (inclusive)
* Diagnosed with PNH (white blood cell (WBC) clone \>10%)
* Lactose dehydrogenase (LD) ≥2 times the upper limit of normal
* Screening Ferritin ≥ normal and Total Iron Binding Capacity (TIBC) \< LLN based on central lab reference ranges. If a subject is receiving iron supplements at screening, the investigator must ensure that his/her dose has been stable for 8 weeks prior to enrolment and must be maintained throughout the study
* Last transfusion within 12 months prior to screening
* Platelet count of \>30,000/mm3 at the screening visit
* Absolute neutrophil count \>500/ mm3 at the screening visit
* Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study
* Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study
* Vaccination against Neisseria meningitides types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day 1 dosing, or within 14 days after starting treatment with pegcetacoplan. Unless documented evidence exists that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits
* Willing and able to give informed consent

Exclusion Criteria:

* Prior eculizumab (Soliris®) treatment
* Active bacterial infection
* Hereditary complement deficiency
* History of bone marrow transplantation
* Concurrent severe aplastic anemia (SAA), defined as currently receiving immunosuppressive therapy for SAA including but not limited to cyclosporin A, tacrolimus, mycophenolate mofetil or anti-thymocyte globulin
* Participation in any other investigational drug trial or exposure to another investigational agent, device or procedure within 30 days
* Evidence of QTcF prolongation defined as \>450 ms for males and \>470 ms for females at screening
* Breast-feeding women
* History of meningococcal disease
Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism

In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.

It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.

To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.


Eligibility Criteria:
Patients with hypopituitarism

Inclusion Criteria:

* Age 18-75 years
* Complete insufficiency of the anterior pituitary
* Stable hormone substitution for at least 3 months

Exclusion Criteria:

* Hormone excess in the past
* Sleep disorder, e.g. sleep apnea syndrome

Healthy controls

Inclusion Criteria:

* Age 18-75 years

Exclusion Criteria:

* Any medication during 6 week prior to study entry
* Shift work
Gait Speeds and Demands in Chronic Stroke Patients: A Multi-dimensional Investigation

This study investigated the effect of treadmill walking training with and without random speed changes in persons in the chronic stage of stroke. It was hypothesized that random speed change group will show less attention and balance demands for speed change in level walking.

This study includes chronic stroke patients who will be randomly assigned to blocked or random walking speed change group to receive 30 min per session, 3 sessions per week for 2 weeks' walking training on a treadmill. The outcome measures include gait characteristics under 3 tasks x 3 speed conditions x 2 attention conditions on an obstacle-free walk way. The three tasks are normal walking, narrow based walking and obstacle crossing. The three speed conditions are constant (preferred) speed, speeding up (preferred to maximum speed), and slowing down (maximum to preferred speed). The two attention conditions are none and serial subtraction of 3 during walking. Clinical sensorimotor function assessment, including hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and Fugl-Meyer lower extremity motor scale will be conducted for subject characterization.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with first stroke for at least 6 months
* Able to walk for at least 20 minutes independently without exhaustion
* Residual gait deficits
* Resting blood pressure is lower than 150/90 mmHg

Exclusion Criteria:

* Unable to follow experimental instructions during the process
* Any pain, inflammation, or other neuromuscular or musculoskeletal conditions in the lower limbs that affect walking ability
* Unstable health problems
Saliva-based COVID-19 DNA Aptamer Test

This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess initial accuracy by validating with the patient's PCR test results.

RT-PCR has several limitations that need to be considered in its role as a COVID-19 diagnostic modality, especially in areas with limited health infrastructure. Potential diagnostic tests are needed that are capable of detecting results that are fast to read, can be carried out in service locations with limited infrastructure, and have high accuracy. The DNA Aptamers-based diagnostic test has the potential to meet these criteria, as it allows the detection of infection quickly and without invasive procedures, where the examination is only on a person's saliva.

The development of diagnostic tools must be well planned including the usability and internal validation of the tools to be studied before they can be used in clinical trial settings or diagnostic accuracy tests by involving patients in health services. This study aims to conduct formative usability and internal validation of the DNA aptamer-based COVID-19 rapid diagnostic test, involving 200 patients and also laboratory personnel to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for testing in clinical trials, and also assess early indications of instrument accuracy by validating with the patient's PCR test data.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-59 years old
* Undertaking PCR swab test for screening, or
* In-patients undertaking PCR swab test

Exclusion Criteria:

* Unable to produce saliva
* Refusing to participate
Longitudinal Study of Neurodegenerative Disorders

The purpose of this study is to understand the course of rare genetic disorders that affect the brain. This data is being analyzed to gain a better understanding of the progression of the rare neurodegenerative disorders and the effects of interventions.

Patients would be evaluated by a multidisciplinary team at specific time points every 3 months the first year, every 6 months the second year and once a year thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a genetic neurodegenerative disorder

Exclusion Criteria:

* none