cyrilzakka/clinical-trials huggingface dataset:
Tregocel® as a Dietary Supplement in Mild Knee Osteoarthritis

This study is an assessment of the overall performance of participants with symptomatic mild knee OA taking Tregocel® as a dietary supplement in addition to standard of care treatment.

Tregocel® is a combination herbal product which as a dietary supplementation may help maintain proper performance of joints. Although some studies have reported beneficial effects for individual components of Tregocel®, there have been no clinical assessments of supplementation with Tregocel® as a finished product. This study will involve collection of data on Tregocel® supplementation in participants with symptomatic mild knee osteoarthritis (OA) who are already receiving standard pharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

* Compliance with all study procedures
* Fulfilment of consent process
* Documented diagnosis of radiologically confirmed mild knee osteoarthritis with stable pain management (including patello-femoral joint, Kellgren-Lawrence classification ≤2 and clinical symptoms lasting more than 6 months prior to screening)
* Maximal pain score ≥30 on a 100 mm VAS at screening and confirmed at baseline, with PRN use of analgesics during run-in
* Completed patient diary during run-in
* Ambulant with ECOG score \<2

Exclusion Criteria:

* pregnancy or breastfeeding (women)
* body mass index less than 18.5 kg/m\^2 or more than 35.0 kg/m\^2.
* secondary knee OA
* clinically apparent tense effusion of the target knee
* valgus/varus knee/foot deformities, ligament laxity, or meniscal instability
* changes in regular OA therapy during screening
* chronic diseases which may require treatment with systemic steroids
* progressive serious medical conditions
* severe organ dysfunction
* cardiac insufficiency
* history of gastrointestinal ulcer or bleeding.
* any significant medical conditions that may interfere with the study procedures, safety, compliance or overall participation in the study
* allergies or intolerance to any of the dietary supplement ingredients
Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.

The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.

Group B streptococci (Streptococcus agalactiae) are found in the vaginal microbiota in 10-30% of women without showing signs of infection. However, during delivery, it can be transmitted to the baby and, although in most cases it does not lead to disease, in a percentage of 5% of babies it causes serious infections that can trigger the death of the baby. In order to avoid this risk, a protocol of intra-partum preventive administration of antibiotics was implanted decades ago in women with a positive vaginal culture for this species in the weeks before birth. Taking into account the high percentage of women who show positive culture, this represents a high percentage of women who receive preventive antibiotic treatment with the consequences that this has for the mother's and baby's microbiota, as well as contributing to the generation of antibiotic resistance, a serious problem for today's society.

The fecal microbiota is considered a source of bacteria for the vaginal microbiota. In fact, women who present S. agalactiae in the vaginal microbiota also have it in stool. Given the demonstrated ability of Lactobacillus to control certain bacterial populations, the ability of a battery of Lactobacillus strains to inhibit the growth of S. agalactiae in the context of the fecal microbiota was analyzed. From these tests the strain Lactobacillus BSL_PS71 was selected for its antibacterial capacity against S. agalactiae.

Eligibility Criteria:
Inclusion Criteria:

* Test positive for S. agalactiae in vaginal exudate
* Accept freely to participate in the study and sign the informed consent document

Exclusion Criteria:

* Consumption of probiotic supplements
* Antibiotic use in the period of 2 weeks before the start of the study
* Being pregnant or intending to get pregnant in the next 8 weeks
* Being allergic to any group of antibiotics
The Comparison of the Two Simulators for ACLS Training

Compared two different training simulators(the computer screen-based simulator versus the full-scale mannequin-based simulator) with respect to training effectiveness in ACLS training.At the same time,evaluate the effectiveness of combination of these two simulators(screen-based simulation followed by mannequin-based simulation),so that to find out a new simulation format for ACLS training.

A prospective,single-blinded,randomized controlled study was used.30 first-year residents were randomized to Computer screen-based simulator group(C group),full scale Mannequin-based group(M group) and screen+Mannequin combing group(SM group).After a 30min ACLS lecture and 30min integrated CPR hands-on training,all groups received a pretest.The C group was exposed to two ACLS computer scenarions,M group was exposed to two ACLS mannequin scenario.Each scenario took 10min and followed by 20min debriefing with simulation educator.After the training session,each participant completed by modified'megacode'checklist.

Eligibility Criteria:
Inclusion Criteria:

- training doctors,intern Exclusion Criteria:Standardized training of doctors，Medical students

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Identification of Molecular Defects in Idiopathic Cytopenia of Undetermined Significance

The project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may be a precursor of MDS

The project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may be a precursor of MDS. To this end, high-throughput exon sequencing (using next-generation sequencing (NGS)) will be used to target the genes known to be mutated in MDS. This study is important for two reasons. Firstly, it will help to optimise the clinical monitoring of patients with molecular defects and considered to be at risk of progression. Secondly, it will provide a better understanding of the fundamental molecular mechanisms underlying the progression of ICUS to MDS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over.
* Haemoglobin \<11 g/dl and/or a polynuclear neutrophil count \<1.5.109/L and/or a platelet count \<100.109/L
* Full clinical biochemistry/haematological profiling: complete blood count, blood smear, reticulocyte count, iron status, folates, B12, TSH, creatinine, liver enzymes, ANAs, rheumatoid factor, anticardiolipin antibodies, Coombs test, EPO assay, serological tests for HIV, HVB and HVC.
* Availability of a bone marrow differential cell count and an evaluation of myelopoiesis disorders (number of lineages, percentage of cells affected, etc.) plus Perls staining.
* Availability of a cytogenetic analysis.
* Voluntary provision of written, informed consent
* Life expectancy \>6 months
* Social security coverage

Exclusion Criteria:

* An obvious cause of anaemia (if isolated): iron deficiency, chronic kidney failure (clearance \<60 ml/min), regenerative anaemia (reticulocytes \>150G/L)
* Vitamin B12 or B9 deficiency
* Hepatomegaly, or clinical and/or ultrasound signs of portal hypertension
* Clinical and/or ultrasound signs of splenomegaly
* Abnormal liver enzyme levels: total bilirubin, alkaline phosphatases or transaminases \> 1.5N; gammaGT \> 2N. A history of (or diagnostic criteria during screening) auto-immune diseases such as systemic erythematous lupus, antiphospholipid syndrome or Evans syndrome.
* An abnormal bone marrow differential cell count
* A bone marrow karyotype revealing MDS
* Medical, psychological or social conditions that prevent the participant from correctly understanding the study procedures.
* Legal guardianship and incarceration.
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis

The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.


Eligibility Criteria:
Inclusion Criteria:

* The subject is over 18 years old.
* Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care.

Exclusion Criteria:

* The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
* The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
* The subject is pregnant.
* The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
* The subject manifests thyrotoxicosis or is on dialysis.
Occult Gastrointestinal Bleeding in Non-pulsatile Left Ventricular Assist Device(VAD)Patients

The purpose of this study is to estimate the proportion of Ventricular Assist Device (VAD) patients with abnormal gastrointestinal bleeding as assessed by HemoQuant fecal occult blood test. Also, in patients with gastrointestinal bleeding present, to summarize the extent of gastrointestinal bleeding; to examine the behavior of HemoQuant fecal occult blood test over time by estimating the proportion of VAD patients with a positive test prior to implantation; at one week, one month, three months, six months and one year post implantation, and after explantation of the VAD and to evaluate whether presence of any abnormal fecal HemoQuant test is predictive of a future major bleeding event.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 - cross sectional study. Patients with implanted non-pulsatile ventricular assist devices of any type and at any time after implantation
* Group 2 - prospective study. Patients with usual VAD indications will be invited to participate, when, in the opinion of their treating physician a VAD will be highly likely within one month.

Exclusion Criteria:

* Unwillingness to provide stool samples for study
* Unwillingness to be followed for study endpoints.
* Unwillingness to follow dietary restrictions necessary for accurate HemaQuant measurement
Implementing Precision Medicine in cOmmunity HospiTALs

This is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting

Patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy).

All tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. Triple negative breast cancer and Hormone receptor positive, Her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study.

A plasma sample will be collected at baseline and after the first radiologic assessment after treatment start. Plasma samples obtained at baseline will be tested for a large panel of gene and MSI status using Next Generation Sequencing (NGS) (cf table). Plasma samples obtained during treatment will be tested for the concentration of circulating DNA.

Results will be discussed within a Molecular Tumor Board (MTB) with all declared centers.

Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if they meet all of the following criteria:

1. Age ≥ 18 years
2. Histology: solid malignant tumor
3. Locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for RH+/HER2- breast cancer: prior treatment with endocrine therapy plus anti-CDK4/6 inhibitor)
4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2
5. Measurable disease as per RECIST criteria
6. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code)
7. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

1. Radiological evidence of symptomatic or progressive brain metastases
2. Previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer
3. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol
4. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
5. Minors (Age \< 18 years)
6. Pregnant or breast-feeding women
7. Previous enrollment in the present study.
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida

A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.

The study's goals involve understanding how transcutaneous stimulation affects motor deficits across three dimensions; weakness, coordination, and spasticity. This will be investigated by an electrophysiological characterization lower-extremity deficits, using TS to interrogate neuromotor topography and connectivity of the spinal cord to specific muscles. These evaluations will enable a unique patient-specific understanding of the electrophysiological mechanisms underlying motor deficits. Furthermore, these evaluations will assess the therapeutic potential of a novel closed-loop TS plasticity induction protocol to strengthen weakened muscles in a pediatric SB population.

Eligibility Criteria:
Inclusion Criteria

* Congenital diagnosis of myelomeningocele (MMC)
* Able to follow verbal commands or instructions.
* If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation.

Exclusion Criteria

* Severe cognitive deficits demonstrating inability to communicate needs
* Gaping, weeping, or unhealed open wounds
* Unhealed fractures on load bearing bones
* History of osteoporosis
* History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.)
* Pregnancy
* Epilepsy
* History of seizure
* Ongoing infections (currently being treated or are symptomatic)
* Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Trial of Vitamin D in HIV Progression, Birth Outcomes, and Child Health

The purpose of this study to assess the effect of maternal vitamin D3 (cholecalciferol) supplementation on maternal HIV progression, small-for-gestational age infants, and infant stunting at 12 months postpartum for HIV-infected Tanzanian pregnant women who are receiving highly active antiretroviral therapy (HAART).

The study is a randomized, double-blind, placebo-controlled trial of maternal vitamin D3 (cholecalciferol) supplementation starting in the second trimester (12-27 weeks gestation) and continuing until 12 months postpartum among HIV-infected Tanzanian pregnant women who are receiving HAART. Eligible individuals are randomized to receive a) a vitamin D3 regimen consisting 3,000 IU of vitamin D3 taken orally once daily starting in the second trimester and continuing until 12 months postpartum or b) a placebo regimen taken orally once daily starting in the second trimester and continuing until 12 months postpartum. Mothers will be followed at study visits during pregnancy and mother/infant pairs will attend study visits from birth until trial discharge at 12 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥18 years old
* HIV-positive
* Receiving HAART
* Pregnant and of 12-27 weeks gestation (Second Trimester)
* Calcium levels in the normal physiologic range (≤2.6 mmol/L)

Exclusion Criteria:

* Enrolled in any other clinical trial
Echo-Doppler Assessment of the Occurrence of Asymptomatic DVT in Orthopedic Replacement Surgery Under Enoxaparin

The objectives of the study are:

o Objective ultrasound: Determine the presence or absence of subclinical DVT in practicing ultrasound-Doppler Day7 and Day35, patients who underwent TKA or THA

o Clinical objective To evaluate the efficacy and tolerability clinical Enox ® in these patients compared with the original drug Lovenox ®.


Eligibility Criteria:
Inclusion Criteria:

* man or woman aged over 18 years, admitted to undergo orthopedic total knee or total hip prosthesis requiring the use of enoxaparin 4000 IU for the Prophylaxis.

Exclusion Criteria:

* Patient participating in another study.
* hypersensitivity to enoxaparin sodium, heparin unfractionated heparin or other low molecular weight.
* Patients at risk of major bleeding or uncontrolled including patients with recent stroke
* Pregnant
Taltz in Combination With Enstilar for Psoriasis

Enstilar in combination with Taltz for plaque psoriasis.

A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult ≥ 18 years of age;
* Diagnosis of chronic plaque-type
* Body Surface Area between 3%-8%.
* Patient has been treated with Taltz for a minimum of 24 weeks
* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
* Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination
* Able and willing to give written informed consent prior to performance of any study-related procedures.

Exclusion Criteria

-˂3% or \>8% BSA

* Patient not receiving Taltz, or receiving Taltz \<24 weeks
* Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
* Pregnant or breast feeding, or considering becoming pregnant during the study.
* Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
* Use of oral systemic medications for the treatment of psoriasis within 4 weeks.
* Patient used other topical therapies to treat within 2 weeks of the Baseline Visit.
* Patient received UVB phototherapy within 2 weeks of Baseline.
* Patient received PUVA phototherapy within 4 weeks of Baseline.
* Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
* Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
* The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
* Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.

Exclusion Criteria:

* Have had more than one TNF-inhibitor prior to the enrolment visit.
* Have had biological treatment other than TNF-inhibitors.
* Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).
Epidemiology of Roller Hockey Related Injuries.

Roller Hockey is a sport played on a 40\*20 metres rink characterized by combined periods of high intensity and short breaks, there´s a lack of epidemiological studies in this field. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. This way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.

A retrospective study was performed in male Roller Hockey players. 275 players will be recruited. Data of all injury along a whole season will be collected. Patients' information, including age, number of years playing, skill level and injured body part, will be analysed.

Eligibility Criteria:
Inclusion Criteria: Being a roller hockey player, play for one of the teams who participated in the 2020-2021 season third division league (Ok Liga Bronce). Play in at least one match in the season.

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Exclusion Criteria: Being unable to understand the questionaire, do not accept on participating in the study.

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Clinical Deterioration in Cerebral Venous Thrombosis: A Predictive Study

The objective of this retrospective, prospective, multicenter cohort study is to determine the risk factors for deterioration of CVT patients after admission and establish a scoring model for risk stratification of patients. This study included two stages, the first stage was to enroll CVT patients from a single center from 2017 to 2022 for modeling, and the second stage was to enroll CVT patients from three centers in 2023 for external validation


Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years old
* Patients were diagnosed with cerebral venous thrombosis (CVT) through imaging techniques such as Computed Tomography Venography (CTV), Magnetic Resonance Venography (MRV), or Digital Subtraction Angiography (DSA)
* The diagnostic algorithm for CVT conformed to the current guideline criteria

Exclusion Criteria:

* Patients who had performed endovascular treatment (EVT) or decompressive craniectomy (DC) before admission and those whose primary treatment was EVT or DC rather than conservative treatment after admission
* Patients with severe hepatic or renal insufficiency
* Patients with intracranial tumors
* Patients with other cerebrovascular diseases