cyrilzakka/clinical-trials huggingface dataset:
Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula

The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula).

75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months.

Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.

This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Approximately 75 partipants of 30 days old will be enrolled from a study site, 50 of whom will be randomized 1:1 to receive an mask labelled investigational formula or a control formula for 3 months of feeding. The remaining approximately 25 partipants will be enrolled as a breastfeeding reference group. Parents will be instructed to exclusively feed the study formula (formula groups) or exclusively human milk (breastfeeding group) during the study. The study will consist of 4 study visits, on baseline day, and every 30 days. At each visit, all relevant clinical data of partipants will be captured and recorded into CTMS (Clinical Trial Management System). The data will be exported, analyzed and reported upon the study completion.

Eligibility Criteria:
Inclusion Criteria:

* 30 days of age at randomization and enrollment, inclusive (day of birth is considered day 0)
* Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
* Singleton birth
* Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
* Birth weight of 2490g to 4200g
* Signed informed consent obtained for infant's and mother's participation in the study

Exclusion Criteria:

* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
* Infants with a known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
* Weight at randomization is \<90% of birth weight \[(weight at Visit 1÷birth weight) x 100 \<90%\]
* Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
* Known head/brain disease/injury such as microcephaly, macrocephaly or others.
* Enrollment in another interventional clinical research study while participating in this study
Specific Genotypes/Phenotypes of Pneumocystis Jirovecii in Solid Organ Transplant Recipients: Potential Involvement of Mycophenolic Acid

To determine the presence of IMDPH mutants of Pneumocystis jirovecii in solid organ transplant recipient with prior exposition to mycophenolic acid.

Mycophenolic acid (MPA) targets inosine 5'-monophosphate dehydrogenase (IMPDH) of human lymphocytes. It is used as an immunosuppressant to prevent rejection in solid organ transplant (SOT) recipients who are otherwise at risk for Pneumocystis pneumonia (PCP). We recently hypothesized that MPA exerts selective pressure on Pneumocystis given the in vitro antifungal activity of this drug on other fungi. In a single center study, we identified a missense mutation G1020A in the impdh gene, corresponding to an amino acid change Ala261Thr in IMPDH protein, among Pneumocystis isolates from MPA-treated SOT recipients. Considering that the IMPDH of MPA-resistant Candida albicans isolates harbors Thr at the analogous position, this mutation was considered to be a marker of Pneumocystis strain selection related to MPA exposure.

The aim of this study is to strengthen these preliminary results with data from a large multicenter study.

The study will be conducted in 26 centers in France. About one hundred patients with PCP will be enrolled. Pneumocystis isolates from SOT recipients exposed to MPA and from control patients (non-SOT recipients, not exposed to MPA) will be examined.The analysis of the impdh gene was combined with a multilocus sequence typing (MLST) method (mtLSUrRNA, cytochrome b and superoxide dismutase genes) characterized by a high discriminatory power.

The expected results may show the presence of the G1020A mutation (Ala261Thr) in SOT recipients exposed to MPA and in none of the control patients not exposed to MPA. This mutation will be significantly associated with MPA exposure. It could also be associated with a specific multilocus genotype in SOT patients and none of the control patients.

The study will confirm that the G1020A mutation (Ala261Thr) represents the signature of MPA exposure. The results of the analysis of the impdh gene combined with the MLST will highlight the selection under MPA pressure of specific strains of Pneumocystis, which circulate in the population of SOT recipients.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years old with PCP diagnoses, organ transplant recipient or not, acceptation to participate

Exclusion Criteria:

* \< 18 years old, no acceptation to participate
Retrospective Study on the Evolution of CIN 1 to 3 in Per and Postpartum in Nancy From 2014 to 2022

In France, the screening rate for cervical cancer remains too low. Screening is simple and non-invasive.

Pregnant patients are most of the time young and are part of the target population for screening, and for many women, it is the first encounter with a gynecologist.

The cervical smear is therefore an important step of the first consultation during pregnancy In the case of pathological results, colposcopies with biopsies are performed, frequently finding CIN 1 to 3. (cervical intraepithelial neoplasia) These CIN lesions evolve slowly and most of the time, treatment can be withheld until the end of the pregnancy.

Several studies suggest a higher regression rate in pregnant patients. Our study will evaluate the rate of regression, progression or persistence of these lesions in per and post partum patients in Nancy, between 2014 and 2022.

To obtain our results, we will compare the results of per and post partum biopsies in each patient.

In a second step, we will study the risk factors of aggravation or on the contrary the protective factors, allowing a faster regression of the lesions


Eligibility Criteria:
Inclusion Criteria:

* women who have a CIN lesion during pregnancy
* in Nancy, France, MRUN Center
* between 2014 and 2022

Exclusion Criteria:

* lost of follow up women
Interventions to Facilitate Working While Depressed and Anxious

The study compares the effects of two add-on interventions in primary care rehabilitation, on work ability and psychological health, in workers with common mental disorders. One intervention consists of a person-centered plan using work-directed treatment modules of occupational therapy and physical therapy, during 8 weeks. The other intervention consists of supported physical activity during 8 weeks. The primary outcome is work ability, measured by the work ability index and days on sick leave.

Common mental disorders (CMD), including mild to moderate depression, anxiety disorders and exhaustion disorder, are a major cause of sick leave and work disability. Compared to other disorders, work-related problems associated with CMD is sparsely explored. While recommended treatments, such as antidepressants or cognitive behavioral therapy have effects on psychiatric symptoms, the effect on work capacity is unclear, suggesting a need for alternative interventions.

The aim of this study is to evaluate the effects of an add-on work-directed intervention in primary care rehabilitation, compared to a physical activity control, for persons with CMD.

The goal of the experimental condition is to enhance the participant's ability to work by creating an individually tailored plan for self-management, supported by occupational and physical therapy techniques, such as structuring daily activities, stress management or body awareness techniques. Enhancing self-management is the core of this intervention and also a new approach compared to earlier efforts to promote work capacity.

Eligibility Criteria:
Inclusion Criteria:

* Unipolar depression or anxiety disorder according to the Mini Neuropsychiatric Interview (DSM-5 criteria).
* Currently working to some extent, part time sick leave is accepted.

Exclusion Criteria:

* Substance abuse according to the Mini interview
* High suicide risk according to the Mini interview
* Psychotic symptoms according to the Mini interview
The Value of Dual-parametric Magnetic Resonance Combined with Regional Saturation Biopsy in Patients with Suspected Prostate Cancer

The aim of this study was to investigate the value of dual-parameter magnetic resonance imaging(bpMRI) combined with regional saturation biopsy in the diagnosis of prostate cancer by means of a prospective randomized controlled study.

The main questions it aims to answer are:

Can bpMRI guide the timing of prostate puncture and avoid unnecessary prostate biopsy? Effectiveness of focal saturation biopsy versus systemic biopsy + targeted biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years of age or older.
2. Compliance with clinical guidelines for indications for prostate puncture:

   * suspicious prostate nodule detected on rectal palpation;
   * suspicious lesion detected by transrectal ultrasound or magnetic resonance;
   * tPSA \> 10 ng/mL;
   * tPSA 4-10 ng/mL with f/t \< 0.16 or PSAD \> 0.15.
3. Complete sequence of bpMRI of the prostate at our institution;

Exclusion Criteria:

1. tPSA \>50ng/mL;
2. Presence of contraindications to prostate puncture and inability to tolerate prostate puncture;
3. reatment with radiotherapy, chemotherapy and surgery before prostate puncture;
4. History of prostate cancer;
5. Prostate multiparametric magnetic resonance images of poor quality or some sequences are missing.
Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients

The aim of this study is to monitor the effect of intraoral topical high fluoride application on the development of white spot lesions (WSL) after orthodontic treatment with multibracket appliances and to compare it to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthy volunteers (≥11 years) scheduled for bracket removal
* ≥ 1 WSL with a modified score 1 or 2 (Gorelick et al. 1982) on UFT at debonding

Exclusion Criteria:

* Known hypersensitivity or allergy to study products and standard toothpaste ingredients and/or dental material used in the present study
* Known hypersensitivity or allergy to placebo gel ingredients
* Alterations in the teeth's enamel, e.g. hypoplasia, fluorosis
* Any illness/condition potentially affecting the study outcome at investigator's discretion
* Known pregnancy or breast feeding during the course of the study
ICU Triage Practices in a Cancer Hospital

The primary objective of this study is aimed at analyzing the ICU triage practices of clinicians at a cancer hospital with and without the use of an algorithm-based triage tool, and to assess whether or not the triage tool improves the consensus amongst practioners on the prioritization of patients for ICU admission. Secondary objectives include assessment of whether or not triage practices based on guidelines correlate with what is done in actual practice.

This is a prospective study designed to evaluate the ICU triage practices of clinicians at MD Anderson Cancer Center using the standard Society of Critical Care Medicine Prioritization Model (SCCMP) versus a uniquely designed flowchart-based triage tool created specifically for the oncologic setting.

Study participants will initially receive either an email explaining the study and asking if they would agree to participate in the survey, or a hard copy of an identical letter. Their participation will remain anonymous, and will strictly be on a volunteer basis. If the participant wishes to participate, they will be given either a link to the survey using an institutionally improved electronic survey tool, or alternatively a hard copy of the survey with identical instructions.

The survey consists of 15 fictional patient case scenarios, and participants will be asked to use the modified SCCMP to prioritize each patient scenario into one of the 5-point likert-scale categories for admission. The participants will be randomized with 1:1 ratio to use either a) the standard SCCMP or b) the SCCMP in addition to a newly designed flowchart-based triage guide to prioritize each patient case scenario into one of the 5-point likert-scale categories.

Eligibility Criteria:
Inclusion Criteria:

1) Study participant must be a health care provider who frequently refers or accepts oncologic patients to the ICU

Exclusion Criteria:

1) none
16SRDNA Sequencing of 30 Samples of Human Oral Microbial Samples by Tianjin Medical University

Study Objective:

To explore suitable sampling sites and methods for oral epidemiological surveys in large populations, we aim to compare the distribution of the oral core microbiome at different sites and using different sampling methods in a small sample of healthy individuals.

Main Question:

What is the distribution of the oral core microbiome at different sampling sites and using different sampling methods in orally healthy individuals?

Study Design:

Participants will be randomly selected from a population of orally healthy individuals. After explaining the study to the participants and obtaining informed consent, they will complete a consent form and be informed of the precautions. Samples will be collected using cotton swabs and curettes from the buccal surface of the lower right first molar and using cotton swabs from the left and right buccal mucosa. The samples will be placed in pre-numbered test tubes and sent to the laboratory for microbiome analysis.


Eligibility Criteria:
Inclusion Criteria:

* (1) People who had no oral diseases particularly caries, periodontitis, and oral mucosal diseases. (2) Teeth without previous restorations.

Exclusion Criteria:

* (1) People who are pregnant. (2) People who suffer from severe systematic diseases, such as diabetes, immune system diseases, and genetic diseases. (3) People who have taken antibiotics within two weeks before sampling.(4) People who have had or currently receiving radiotherapy or chemotherapy. (5) People with complete or incomplete absence of dentition. (6) Individuals who smoke or have smoked within the past six months
Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.


Eligibility Criteria:
Inclusion criteria:

1. Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
2. Three month history of reversible (12% with 200 mL) asthma according to \[Global Initiative for Asthma (GINA)\] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
4. Diagnosis of asthma prior to 40 years.
5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.
6. Male or female, 18 to 65 years.
7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
8. Able to perform pulmonary function test (PFT).

Exclusion criteria:

1. Significant diseases other than asthma or allergic rhinitis.
2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
3. Hospitalizations for asthma or asthma related intubation within 3 months.
4. Uncontrolled asthma on ICS + another controller.
5. Respiratory tract infection or exacerbation within 4 weeks.
6. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more than two consecutive days or asthma exacerbation during the run-in period.
7. Participation in another interventional study.
8. Pregnant or nursing women.
9. Women of child bearing potential nor using appropriate methods of birth control as defined by protocol.
Holter and ECG Changes After Trancatheter Closure Of ASD In Children

Atrial septal defects (ASD) account for 10% of all congenital heart defects . Hemodynamic consequences of an ASD are dilatation of the right atrium and right ventricle (RV) because of the volume overload due to the left-to-right shunt through the ASD.For several decades, surgical closure has been considered the standard method of repairing a secundum ASD . Surgical repair, albeit enjoying a high success rate, negligible mortality, and good long-term outcome, is associated with morbidity, discomfort, and thoracotomy scars. That is why the transcatheter closure of the ASD has more recently become an alternative to the surgical procedure . During the last decade , ASD device closure , has finally replaced surgical ASD repair in most patients as the standard method of repair for the secundum ASD Cardiac arrhythmias and right chamber enlargement are well known long-term sequelae of atrial septal defect (ASD) . Therefore, many authors suggest ASD closure before adulthood . Classical ECG findings for a significant ASD are prolongation of the PR interval, prolongation of the QRS duration and right axis deviation of the QRS .

Percutaneous ASD closure is an ideal situation to study changes of RV dimensions and their impact on ECG as interferences from cardiopulmonary bypass, cardiac incisions and sutures on the right atrium and on the interatrial septum are excluded


Eligibility Criteria:
Inclusion Criteria:

* All children under the age of 18 years diagnosed with ASD , that will undergo transcatheter secundum ASD device closure during the period of the study .

Exclusion Criteria:

* Failure to obtain informed consent .
Evaluation of the Bone Structure Surrounding Photofunctionalized Implants

Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.

Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044\<0.05) and the bone fractal score increased.

Bacground: Implant failure may necessitate the need for another surgical procedure to improve implant survival. Photofunctionalization with UV is a practice that can positively affect dental implant success and osseointegration. The aim of this study is to evaluate the effect of the photofunctionalization process on the bone quality around the implant.

Methods: In the study, 42 implants were evaluated using the Fractal Analysis method from the panoramic radiographs taken before and after the implant. The analysis of the data was done with the SPSS 26 program and worked with a 95% confidence level. In the test group, there was a statistically significant difference between the 1st panoramic measurement and the 2nd panoramic measurement (p=0.044\<0.05) and the bone fractal score increased.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Having bilateral edentulous areas in the posterior mandibular region

Exclusion Criteria:

* Individuals with any systemic disease,
* Individuals using drugs that affect bone metabolism,
* Patients with findings that could affect the study results such as bone cysts, tumors, lesions or fractures
Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy

In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate whether there is a difference in terms of postoperative results between those with and without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron replacement and those who did not, according to the hemoglobin value in their preoperative examinations.


Eligibility Criteria:
Inclusion Criteria:

* thoracotomy patients

Exclusion Criteria:

* emergency cases
Determination of Cell Population in Solution-Induced Corneal Staining (SICS) and Symptomatic Versus Asymptomatic Lens Wearers

The purpose of the study is to investigate the corneal epithelial cell response associated with lens wear that results in solution-induced corneal staining (Phase1) and to determine the cell appearance in symptomatic and asymptomatic contact lens wearers (Phase 2).

This study consisted of 2 phases. In Phase 1, participants wore contact lenses pre-soaked overnight in contact lens solution for 2 hours and 4 hours, separate days. A minimum of 7 days separated the wear periods. Ocular surface cells were collected after both wear periods. In Phase 2, participants wore their habitual contact lenses on a daily wear basis for 4 weeks with habitual lens care. Ocular surface cells were collected after Day 1 and Day 28. Phase 2 included eligible participants who completed Phase 1 and new participants. A participant was considered to be asymptomatic if he/she can typically wear contact lenses comfortably for at least 10 hours/day a minimum of 5 days/week, and symptomatic if he/she typically wears contact lenses for a minimum of 3 days/week and experiences ocular discomfort after less than 6 hours of wear. Phase 1 participants not eligible to participate in Phase 2 or uninterested in continuing into Phase 2 were exited from the study.

Eligibility Criteria:
Inclusion Criteria (Phase 1):

* Full legal capacity to volunteer.
* Read and sign an informed consent form.
* Willing and able to follow instructions and maintain the appointment schedule.
* Current or previous contact lens wearer and competent to insert and remove contact lenses.
* Up-to-date spectacles.
* Other protocol-defined inclusion criteria may apply.

Inclusion Criteria (Phase 2):

* Full legal capacity to volunteer.
* Read and sign an informed consent form.
* Willing and able to follow instructions and maintain the appointment schedule.
* Up-to-date spectacles.
* Wears single vision silicone hydrogel contact lenses, following a monthly replacement schedule.
* Has worn the same lens type for a minimum of 2 months, with the exception of the 2 periods of lens wear for participants who were also in Phase 1.
* Has used the same type of cleaning solution for a minimum of 2 months.
* Currently wears brand name contact lenses and uses brand name cleaning solutions that are commercially available in Canada (no private labels).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria (Phase 1 and 2):

* Any ocular disease.
* Systemic condition that may affect a study outcome variable.
* Use of any systemic or topical medications that may affect ocular health.
* Known sensitivity to the diagnostic pharmaceuticals to be used in the study.
* Presents with significant amounts of corneal staining.
* Current use of artificial tears and/or rewetting drops.
* Wears contact lenses on an extended (overnight) or continuous wear schedule.
* Other protocol-defined exclusion criteria may apply.