cyrilzakka/clinical-trials huggingface dataset:
Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis

Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.

Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with age above 18 years old
* Patient with diagnosis of ulcerative colitis for at least 6 months.
* Patient with mayo endoscopic score ≥ 1
* Patient with mild to moderate disease activity (3 \< SCCI \< 12)
* Ongoing treatment by mesalamine, steroids, thiopurines or Tumor Necrosis Factor antagonist at stable dose.
* Patients who have given written informed consent.

Exclusion Criteria:

* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
* Psychiatric disease that alter the judgment
* Stoma
* Proctocolectomy
* Severe disease (SCCI \>12, acute severe colitis)
* Steroid dose \> 10 mg/j or introduction of steroid (topic or oral) within 4 weeks
* Introduction or dose optimization of TNF antagonist within 4 months
* Introduction or dose optimization of thiopurine
* Hemoglobin level \< 11,5 g/dL, Platelets \> 400000/mm3, Leukocytosis \> 10 000/mm3
* Intolerant to lactose
* Disease extent limited to the rectum
* Mayo endoscopic subscore of 3
The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration

The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Eligibility Criteria:
Inclusion Criteria:

* patients aged five to eight years at the time of dental treatment,
* patients attending follow-up appointments
* patients with compomer restoration and Hall restoration in their teeth
* patients with matching the extent of caries in the two groups

Exclusion Criteria:

* patients not attending follow-up appointments
* patients without both treatment
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.

Eligibility Criteria:
Inclusion Criteria:

* Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
* Able and willing to give written informed consent.

Exclusion Criteria:

* None
RAdiology Consultation Effectiveness

Performing a consultation with the radiologist before a spinal invasive procedure serves to foster a trusting physician-patient relationship. It also provides an opportunity for the comprehensive explanation of the procedure, its aftermath, and any patient inquiries. We believe that this proactive approach has the potential to alleviate pre-procedure anxiety, thereby contributing to an enhanced overall experience of the intervention and its outcomes. Despite these potential benefits, it is noteworthy that such consultations are not systematically implemented, and their impact on the intervention effictness remains unexplored in existing literature.

The hypothesis is grounded in the belief that patients who perform a consultation preceding their spinal intervention are likely to witness improvements in both the overall experience of the procedure and its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older
* Referred to the imaging department for a peri-spinal injection under CT guidance.
* Low back pain, dorsal pain, or neck pain with an average pain intensity of ≥ 5/10 on NPRS.

Exclusion Criteria:

* Patient unable to read and/or write French
* Patient unable to condut a teleconsultation (no phone, no internet connection)
* Current pregnancy, breastfeeding, or lack of effective contraception for women of childbearing age
* Lack of consent
* Legally protected population:

  * Adults protected by law (guardianship, curatorship, or judicial protection)
  * Non-emancipated minors
  * Individuals unable to express consent (research conducted in emergency situations)
  * Individuals deprived of liberty (by judicial or administrative decision, or involuntary hospitalization)
* Not affiliated with a social security scheme or not benefiting from such a scheme
* Participation in another research study with an ongoing exclusion period
Experiencing Transplant With Stories From Survivors

Allograft transplants are offered to people with haematological cancers sometimes as the best chance of a cure. However, the survival rates for these procedures can be quite poor, as the transplant, in itself, can be lifethreatening.

In addition, these procedures usually involve a period of lengthy hospitalisation accompanied by a host of debilitating conditions which patients must cope with in isolation due to their increased risk of serious infection. Perhaps unsurprisingly, there is considerable evidence that mood plays a role in the way people recover.

I wish to investigate the psychological impact of providing testimonies from survivors of transplants to patients undergoing the procedure.

The plan is initially to collect about 10-15 testimonials from past transplant patients using a videotaped structured interview then to collate these testimonials into a booklet format and DVD.

This booklet and DVD would be used as an intervention where 40 consecutive patients who are going ahead for transplant are invited to receive the testimonial intervention.

Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test (LOT), and a questionnaire about expectations of treatment in clinic once a decision to proceed to transplant has been made. Patients will receive the testimonies upon admittance to the transplant unit and then receive the HADS and a structured interview within the first week of being admitted to the transplant ward (just prior to receiving the transplant) and within the first two weeks following the transplant.

Comparative analyses of the measures between the three time points would be performed and qualitative analysis of the structured interview data.

Around 80 people undergo transplant each year, it is estimated that the project will be completed by September 2016. The intention would be to publish following completion.


Eligibility Criteria:
Inclusion Criteria:

* For the testimonial part all patients attending bone marrow transplant follow-up clinic who have had an allogenic transplant and who have capacity to consent to the study and who are fluent in English will be eligible.

For the intervention part all patients going forward for allogenic transplant at St James's Institute for Oncology who have capacity to consent to the study and who are fluent in English will be eligible.

Exclusion Criteria:

* Patients without capacity to consent will not be eligible for participation Patients who are not fluent in English will not be eligible for participation Patients who are not going forward for allogenic transplant will not be eligible
Effect of Tub Bathing on Skin and Bilirubin Levels in Infants Undergoing Tunnel and LED of Phototherapy

The study was conducted as a randomized controlled study to determine effect of tube bathing on skin and bilirubin levels in infants undergoing tunnel and LED of phototherapy. The population of the study consisted of term babies with the diagnosis of hyperbilirubinemia in Gaziantep Cengiz Gökçek Maternity and Pediatrics Hospital and Kilis State Hospital Neonatal Intensive Care Units (NICU) among November 2019-September 2020. The sample size was composed of a total of 140 babies, which were determined according to Power Analysis and met the case selection criteria. Accordingly, Thirty-five babies were randomly assigned to each group (Tunnel Group = experiment and control; LED Group = experiment and control). The babies in the experimental groups were given a tube bath at 6 and 12 hours after phototherapy started. On the other hand, the babies in the control groups were given routine cares in the units. Data were gathered 'Information and Registration Form', Neonatal Skin Risk Assessment Scale (NSRAS) and Neonatal Skin Condition Score (NSCS).


Eligibility Criteria:
Inclusion Criteria:

* The baby is receiving phototherapy due to physiological hyperbilirubinemia,
* Being a term newborn,
* Monitoring of the LED group in the incubator and the tunnel group in the tunnel phototherapy device,
* Parents' consent to participate in the study.

Exclusion Criteria:

* Rh incompatibility between mother and baby,
* Finding ABO non-compliance,
* Positive direct Coombs test,
* Presence of congenital anomaly or syndrome,
* Any surgical intervention has been or will be made,
* Having any skin lesions,
* The need for mechanical ventilation.
A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.

The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).

This is a Phase 1b, randomized, double blind, placebo-controlled study and will be conducted in participants with established ASCVD and CKD with persistent inflammation (High-sensitivity C-reactive protein \[hsCRP\] \> 2 mg/L and eGlomerular filtration rate \[eGFR\] ≥ 30 to \< 60 mL/min/1.73m2). The participants will be randomized in the 1:1 ratio to either receive treatment with AZD4144 or placebo.

The study will be comprised of:

* A screening period of 28 days
* Treatment period where each participant will either receive oral dose of AZD4144 or placebo for 28 days.
* A follow-up visit (Day 35 ±1) and a Final Follow-up (on Day 56±1) post first dose administration.

The total duration of the study will be approximately 12 weeks.

Eligibility Criteria:
Key Inclusion Criteria:

* Participants with established ASCVD history of one or more of the following

  1. Prior Myocardial infarction (MI) (\>60 days from index event) or coronary revascularization procedure like coronary stenting or Coronary artery bypass graft (CABG)
  2. Prior ischemic stroke (\>60 days from index event)
  3. Symptomatic Peripheral Arterial Disease
* Chronic kidney disease defined as eGlomular filtration rate (eGFR) ≥ 30 to \< 60 mL/min/1.73 m2
* Serum hsCRP \> 2 mg/L
* Body mass index ≥ 18 to ≤ 45 kg/m2
* All females must have a negative pregnancy test at the Screening Visit and at the randomization visit

  1. Sexually active male participants with partner of childbearing potential must adhere to the contraception methods
  2. Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception
  3. Females of non-childbearing potential must be confirmed at the Screening visit

Key Exclusion Criteria:

* History of malignancy within the last 5 years
* History of MI, coronary revascularization, stroke or revascularization for peripheral arterial disease in the 60 days prior to Screening
* Active systemic infection within 30 days
* Clinically significant active and chronic infections within 60 days prior to randomization
* Clinically significant recurrent infection (≥ 2× during the last 12-month period).
* Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury in the past 12 month
Prognosis and Therapeutic Biomarkers for Glioblastoma Patients

The purpose of this study is to investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (GBM).

The objective of this proposed study is to determine the expression levels of a panel of markers including CD133, CD44, ABCC3, TNFRSF1A, AKT1, IDH2, and MGMT in GBM tissues and the CSF, blood, and saliva from patients with GBM receiving different types of treatment (Optune only or Optune with TMZ) and the non-brain tumor patients (controls). Our aims are: 1) To compare the differences of CD44 between the control group and the combined cancer groups at baseline; and 2) To compare the levels of CD44 and other markers among the 3 different groups such as control vs. GBM patients and Optune vs. Optune + TMZ after 8 weeks of treatment. Exploratory analysis of all other markers will be performed.

Eligibility Criteria:
Inclusion Criteria:

* 22 years old
* Control Group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture)
* Non-Control Group - Diagnosed with GBM (Glioblastoma)

Exclusion Criteria:

* Pregnancy
* Infectious Disease to include cold, flu, HIV, etc.
* Blood Disorder (example:low platelets, anemia, thrombosis)
* Vascular Malformations
Effects of Insulin on Hypotension and Sarcopenia

In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia

Diabetes is common in the elderly. By the age of 70, approximately 25% of the population has diabetes and another 25% is at risk for diabetes. Elderly patients with diabetes are at increased risk for disability and reduction in their instrumental and basic activities of daily living. The prevalence of frailty is higher in people with diabetes that with age matched controls without diabetes. One of the major contributing factors to frailty is sarcopenia.

Insulin is an important anabolic hormone that prevents protein breakdown and to a lesser extent stimulates protein synthesis. There is some evidence that the ability of insulin to stimulate anabolic processes may be reduced in diabetes.

Insulin has cardiovascular properties, resulting in simultaneous adrenergic and vasodilatory responses that have opposing influences on blood pressure. Epidemiological studies have demonstrated that the use of insulin is a risk factor for syncope.

The investigators will study 30 older adults age 65 and older with type 2 diabetes who have never taken insulin to manage their diabetes but now need insulin to manage their diabetes. Data will be compared pre insulin start and 3 and 6 months after starting insulin.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* Type 2 diabetes for at least 5 years
* Insulin naive
* now needs insulin to manage diabetes

Exclusion Criteria:

* anemia as defined by serum hematocrit
* abnormal liver function tests
* elevated serum creatinine
* smoked within last 5 years
* musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals
* aortic stenosis
Intelligent Activity-based Client-centred Training

The purpose of this study is to determine whether additional therapy with i-ACT system is effective in the training of functional skills in persons with central neurological diseases (e.g. multiple sclerosis, stroke, spinal cord injury, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of central nervous system disease (e.g. multiple sclerosis, stroke, spinal cord, etc.)
* Be able to understand and respond to questions in Dutch
* Actively involved in a rehabilitation programme in the participating rehabilitation centres
* Have a dysfunction in upper and/or lower limb and/or core stability
* Specifically for multiple sclerosis: min. of one month without corticosteroids
* Specifically for stroke and spinal cord: min. 3 months post injury

Exclusion Criteria:

* Severe spasticity which prevent performing basic functional exercises
* Severe cognitive and communicative impairment which prevent the person to understand and respond to Dutch instructions
* Severe visual impairment, e.g. blindness, cataract, etc.
* Pregnancy
* Persons who use an electrical wheelchair, who can not transfer safely into a normal chair and perform the exercises
Safety and Efficacy of KRT-232 in Combination With Acalabrutinib in Subjects With R/R DLBCL or R/R CLL

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, combined with acalabrutinib for the treatment of adults with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia. Participants must be relapsed/refractory (having failed prior therapy)


Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Confirmed diagnosis of TP53wt DLBCL (WHO); R/R DLBCL after at least 2 prior lines of treatment or 1 prior for patients who are ineligible for stem cell transplant
* Cohort 2: Confirmed diagnosis of TP53wt CLL (iwCLL); R/R CLL after at least 1 prior line of treatment
* ECOG 0 to 2
* Adequate hematologic, hepatic, and renal functions.

Exclusion Criteria:

* Prior treatment with any MDM2 inhibitor
* Prior treatment with any BTK inhibitor
Prospective Clinical Trials to Assess Performance and Safety of EyeSwift Pro

EyeSwift Pro assessment of visual function parameters as measured by psychophysics

The following assessments and procedures will be carried out in this trial:

* Baseline assessments will include the following: age, gender, ethnicity, race, education, clinical ocular diagnosis, and general health and use of any concomitant medications.
* Visual and ocular assessment will include unitary testing methods, using the EyeSwift Pro system and the reference method (if applicable).

Eligibility Criteria:
Inclusion Criteria:

* ≥4 years
* Have visual acuity better than 6/60
* Diagnosed as having either Orthophoria or/and Heterophoria or/and Orthotropia or/and heterotopia (group A only)
* Normal vision or visual impermeant (group C and E only)
* Normal or deficient vergence (group D only)
* Normal or deficient reading disabilities (group F only)
* 8 years and older or third grade (group F only)
* Subject in general good health and able, as per investigator decision, to comply with study visits and protocol procedures
* Signed and dated informed consent form
* Parent and participant understand and are willing to comply with

Exclusion Criteria:

* Anophthalmic
* Photosensitive epilepsy or susceptible to epileptic seizures
* Pre-existing concomitant pathology such as congenital cataracts or glaucoma (not including group E)
* Severe developmental delay that would interfere with testing (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded
* Extraocular muscle (EOM) paralysis (groups A and B only)
* Nystagmus
* Any ocular pathology or anomalies which can interfere with eye-tracking
* Any ocular pathology or anomalies (i.e., age-related macular degeneration (AMD), diabetic retinopathy etc.) (relevant for groups A-F, group E can include such anomalies)
Second Echelon Node Study With Methylene Blue

The investigators plan to study the ability to identify the lymph nodes beyond the sentinel lymph node that may harbor cancer using methylene blue dye.

After lymphatic mapping of the SLN with Tc-99 sulfur colloid only, the second-echelon lymphatic mapping was then performed with methylene blue dye by injecting the SLN with 0.05-0.10 cc non dilute methylene blue and tracing via the efferent lymphatic channel to the second echelon lymph node (Figure 1). For our initial patients a 27 gauge needle and 3cc syringe was utilized but this was modified over the study to a 30 gauge needle and 1cc syringe. The blue efferent lymphatic was traced with minimal spreading of the surrounding tissue to visualize its drainage into the next lymph node(s). A second echelon lymph node was considered any blue lymph node or any lymph node with blue dye leading directly into it. The number of second echelon lymph nodes was recorded. The second-echelon lymph node(s) was not removed.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary cutaneous melanoma located on the extremity or trunk
* Patients with clinically stage I-II melanoma
* Histologically confirmed invasive ductal or lobular carcinoma
* Patient undergoing surgical treatment of breast primary and sentinel lymph node biopsy- clinically node negative

Exclusion Criteria:

* Melanoma located on the head or neck, uveal or mucosal
* Previous surgery or radiation in or near the sentinel lymph node biopsy nodal basin
* Preoperative biopsy proven regional lymph node involvement
* Failure of lymphatic mapping with radioactive colloid
* Women who are pregnant or nursing
* Prior ipsilateral axillary surgery or radiation
* Inflammatory breast cancer
* No lymph node identified in the ipsilateral breast during pathologic review of the mastectomy specimen
* Stage IV breast cancer
Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate

A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.

The remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, weight, BMI, abdominal circumference, blood pressure, Hba1c , average daily insulin requirements, lipid profile, TSH, 24h urine creatinine clearance and the SF-36 Quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* adult (\>18 years)
* stage IV and V chronic renal disease (glomerular filtration rate \< 30 ml/min,
* body mass index (BMI) of greater than 40 kg/m2 or \> 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes

Exclusion Criteria:

* medically unfit for surgical intervention
* previous gastric or intestinal surgery
* active gastric disease
* pregnancy or lactation
* known intolerance to tacrolimus or mycophenolic acid
* awaiting potential multi-organ transplantation
* active infection