cyrilzakka/clinical-trials huggingface dataset:
Research of Diagnostic Value for BMJ Infants

Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus. Which can cause long-term dysfunction in infants. But for a long time, BMJ diagnosis has relied on clinical exclusive methods, lack of objective and reliable laboratory indicators. Which leads to misdiag. This project is a single-center, prospective nested case-control study. It is planned to establish a neonatal BMJ cohort. According to the admission criteria, 100 cases of early-onset BMJ and late-onset BMJ will be completed, and 100 healthy controls collected during the same period. , Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis, and try to find the feasibility and practical value of diagnostic markers for feces in infants with BMJ.

This project is a single-center, prospective nested case-control study to investigate feasibility and practical value of diagnostic markers in infants with BMJ.

According to the admission criteria, 100 cases of early-onset BMJ, 100 late-onset BMJ and 100 healthy controls will be selected. Their feces, peripheral venous blood and mothers' breast milk were collected for further testing. Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis.

This study is to find the objective and reliable laboratory indicators to diagnose BMJ.

Eligibility Criteria:
Inclusion Criteria:

* All the following conditions must be met

  1. Term newborns admitted to hospital with "neonatal hyperbilirubinemia"
  2. Exclusive breastfeeding or mainly breastfeeding
  3. Exclude perinatal infection, G-6P-D deficiency, homoimmune hemolysis, polycythemia, scalp hematoma, intracranial hemorrhage, cholestasis, hypoglycemia, hypothyroidism, hypothermia, neonatal asphyxia, fetus Pathological jaundice factors such as delayed stool excretion.

Exclusion Criteria:

* As long as any one of the following conditions should be excluded

  1. During the follow-up period, breastfeeding was terminated or the daily milk powder intake exceeded 200 ml.
  2. Other pathological jaundice was diagnosed during the follow-up period.
  3. Take probiotics during the sampling period.
  4. The guardian asked to withdraw from the study halfway.
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic

This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.


Eligibility Criteria:
Inclusion criteria:

* infants diagnosed with colic,
* with 0-90 days of age,
* who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study.

Exclusion criteria:

* infants diagnosed with any sort of pathological illness, allergies or food intolerance
* who have suffered any intracranial hemorrhages or skull fractures.
Biologic National Registry

BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists

BINAR is a Tunisian, descriptive, non-interventional, multicenter and prospective clinical study performed in rheumatology consultations, of both public and liberal sectors. Eligible patients are recruited by successive inclusions until the end of the recruitment period, set at one year. A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project and a Data Review Committee supervises the management of the data and carries out all the missions of audit and control of validity of the collected data, as well as the planning of statistical analysis.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient followed for rheumatoid arthritis according to ACR EULAR criteria or spondylitis including all disorders (axial, peripheral, enthesitis).
* Patient on biological treatment at the time of inclusion
* First biological treatment initiated ≤ 2 years
* Informed consent, read and signed

Exclusion Criteria:

* Evolutionary neoplasia at the time of inclusion
* Other associated systemic diseases, except Sjögren's Syndrome
* Consent not obtained
* Pregnant or lactating woman
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients

OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile.

The study takes place during a single visit, at the time of patient enrollment in the study


Eligibility Criteria:
Inclusion Criteria:

* Patient with severe haemophilia A defined as residual factor VIII activity \< 1%
* or Patient with moderate haemophilia A (residual factor VIII activity \>1% and \<5%) with severe clinical profile
* Patient treated in prevention with the same plasma or recombinant factor VIII for at least 6 months
* Patient whose inclusion visit is performed during a routine visit including a measurement of plasma residual factor VIII :c level
* In the medical file (retrospective data) the pharmacokinetic parameters are available and have been obtained from a PK analysis of factor VIII level performed with the same anti haemophilic factor than the one used on the inclusion day

Exclusion Criteria:

* Patients with haemophilia B
Physical Literacy and Rehabilitation

With the aging population, the prevalence of chronic conditions continues to rise, affecting 1/3 of Canadians. The promotion of physical literacy, defined as "the motivation, confidence, physical competence and knowledge, to take responsibility for engagement in physical activity for life", has emerged as a promising strategy to increase movement for children. However, little is known about how physical literacy can impact aging adults. A working definition of physical literacy for adults focusing on mobility, function and self-monitoring provides opportunity to guide public health programs in addressing the rehabilitation needs of persons living with multiple chronic conditions.

The objectives of this three stage mixed methods study is to:

1. Develop a new physical literacy framework, with the help of health professionals and end-users that promotes optimal physical functioning for adults.
2. Develop a population-based health intervention using rehabilitation strategies that are delivered virtually to increase physical literacy for adults.

The first 2 qualitative studies will be used to inform the third quantitative intervention.

First, an on-line consensus approach with physiotherapy leaders, rehabilitation researchers and public health experts will be used to identify a new physical literacy framework as it relates to adults.

Second, virtual semi-structured interviews with working adults who are living with 2 or more chronic conditions will determine how aging adults frame physical literacy in their life, specifically with the management of chronic conditions.

Lastly, working adults with 2 or more chronic conditions will participate in a 5-week physical literacy program. Multifaceted knowledge translation strategies including; "walk and talk" with a neighbour or friend, podcasts and on-line mobility challenges will be utilized.

It is anticipated the intervention will improve important physical literacy outcomes such as; physical competence, function, mobility, motivation, awareness, and self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be screened by the primary researcher for the following inclusion criteria:

  1. Diagnosed from a physician with 2 or more chronic conditions and have lived with the conditions for ≥1 year
  2. Able to speak English
  3. Employed full time as a teacher in the Hamilton-Wentworth School Board, Ontario between the ages of 45 and 65 years.
  4. Describe themselves as moderately physically active or inactive over the past 12 months

Exclusion Criteria:

* Advised by physician not to participate in physical activity
Surveillance Endoscopy After Proximal Gastriectomy With Double Tract Reconstruction.

The primary purpose of surveillance endoscopy after gastric cancer surgery is to detect malignancy recurrence in the remnant stomach. This study aims to analyze the rate of proper remnant stomach observation following proximal gastrectomy(PG) with double tract reconstruction (DTR). Data from patients who underwent PG with DTR for gastric cancer at six institutions in South Korea from 2011 to 2023 were included. Clinicopathological and serial endoscopic data were retrospectively reviewed and analyzed. Successful surveillance endoscopy was defined as obtaining an endoscopic image of the pyloric antrum. Factors associated with successful endoscopy were analyzed using a mixed-effects logistic regression model. A total of 634 surveillance endoscopies were performed on 160 patients after PG with DTR. The median duration from surgery to the endoscopy was 17.5 months (range, 0-137 months). The success rate of the endoscopies was 75.6%, with a mean time of 271.7±300.5 seconds to reach the pyloric antrum. The average total procedure time for successful endoscopic examinations was 439.4±336.0 seconds, compared to 373.7±326.0 seconds for failed examinations. (p=0.033). Among patients who underwent the procedure twice or more, 6.5% had all endoscopic examinations fail, while 2.8% of those who underwent the procedure three times or more experienced failure in all examinations. Factors associated with successful endoscopy included longer procedure time (OR 1.32, 95% CI 1.01-1.72), endoscopy performed by a non-surgeon (OR 0.19, 95% CI 0.11-0.36), longer duration after surgery (OR 1.33, 95% CI 1.02-1.72) and younger age (OR 0.70, 95% CI 0.49-0.97). Understanding the anatomic alterations after PG with DTR is crucial for the success of surveillance endoscopy. Additionally, the duration from surgery to endoscopy is associated with the success of the examination, and the rate of failure across all serial endoscopies is very low. Therefore, clinicians should perform endoscopies with sufficient procedure time and conduct endoscopies regardless of the failure of previous examinations.


Eligibility Criteria:
Inclusion Criteria:

Patients who underwent proximal gastrectomy with double tract reconstruction and had at least one postoperative surveillance endoscopy.

Exclusion Criteria:

Patients who did not undergo postoperative surveillance endoscopy.
Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.

Primary Objective:

Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).

Secondary Objectives:

* Assess effectiveness in achieving glycemic goal measured by HbA1c;
* Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
* Assess requirement for intensification of therapy by additional antidiabetics.
* Assess incidence of hypoglycemia;
* Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
* Assess change in body weight.

Patients will be observed for one year

Eligibility Criteria:
Inclusion criteria :

* Signed patient informed consent;
* Type 2 diabetes mellitus;
* Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months;
* Hemoglobin A1c (HbA1c) \>7.0 % and ≤11% within 3 months of study baseline;
* Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen

Exclusion criteria:

* Diabetes mellitus other than type 2;
* Contraindication to insulin glargine U300 according to local product labelling;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
LifeVest Trends Validation Protocol

This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).

This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
* Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
* Ejection fraction of 35% or less at the start of WCD use
* Anticipated to need a WCD for three months or more
* At least 18 years of age (over the legal age of providing consent)

Exclusion Criteria:

* Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
* Need for an assistive device for ambulation (wheelchair, walker, or cane)
* Use of a unipolar pacemaker
* Physical or mental conditions that prevent interaction with or wearing of the device
* Advanced directive prohibiting resuscitation
* Pregnancy
Network-based rTMS in Alzheimer's Disease

Severe alterations of brain networks connectivity have been described in Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained evidence as an effective tool to modulate brain networks connectivity, leading to a recovery or reorganization of both local and remote brain regions functionally connected to the stimulated area. The investogators propose an innovative tailored network-based rTMS treatment to ameliorate cognitive symptoms in mild AD, through the boosting of connectivity within brain networks affected by AD pathophysiology. The combination of the proposed intervention with an integrated multi-modal imaging approach will allow to evaluate the neural mechanisms underlying the clinical response to the treatment and to define quantitative markers of clinical impact on AD. If successful, the present proposal would immediately impact on patient's quality of life, with important implications for the time and costs of delivery of rehabilitative services.

Currently, no effective cure is available for Alzheimer's disease (AD). Repetitive Transcranial Magnetic Stimulation (rTMS) has gained increasing attention as a potential treatment for various neurological and psychiatric disorders, but available rTMS studies are flawed by inaccurate anatomical targeting, inadequate sample size, unsatisfactory controls and lacking blindness. To date, the elective target area of rTMS interventions in AD has been the dorsolateral prefrontal cortex (DLPFC), a core area of the Central Executive network (CEN), which plays a key role in regulating executive functions, attention and working memory. While the CEN has recently been described as dysfunctional in AD, AD pathophysiology has been mainly associated with the breakdown of the Default Mode network (DMN) and with structural disconnection of its parietal nodes. The DMN plays a crucial role in episodic memory retrieval and incorporates various brain regions, among which parietal areas are highly connected with the rest of the brain. The present multicenter, double-blind, randomized and placebo-controlled study has the ambition to provide evidence of the efficacy of two tailored network-based rTMS treatments in mild AD, through the enhancement of connectivity of CEN and DMN. Innovative integrated multi-modal imaging investigations will further enrich this proposal allowing to identify quantifiable markers underlying the clinical impact of rTMS on AD.

Eligibility Criteria:
Inclusion Criteria:

* Mini-Mental State Examination score \>=16, \<=24
* Anti-cholinesterase treatment for at least 3 months prior the start date

Exclusion Criteria:

* Enrollment in other clinical and pharmacological trials
* Previous evidence of any other CNS disorder (e.g. epilepsy, infectious diseases, frontotemporal, Parkinson or Pick's disease)
* History of major psychiatric disorders
* History of alchol or substance abuse
* Stress-related skin problems
* Current consumption of psychiatric medication
* Presence of metal implants or any implanted electronics
Back-on-Track Studying Early Quality Care

This study is a randomized controlled trial conducted at two clinical sites. The purpose of this study is to determine whether patients with musculoskeletal injuries do better by seeing a primary care provider first versus seeing a physical therapist first. Target enrollment is 150 subjects.

Physical therapists have an important role as initial contact providers for individuals with musculoskeletal disorders. Health care expenditures are on the rise each year in the U.S. and a large proportion is due to musculoskeletal disorders. Despite the rise in spending, there has not been an improvement in outcomes for individuals with musculoskeletal disorders. Furthermore, increased medical spending and utilization could expose patients to iatrogenic harm. Comparative effectiveness studies of different portals of entry would help to determine the most effective pathways for individuals with musculoskeletal disorders to seek care. The purpose of this study is to determine whether patients with musculoskeletal injuries do better by seeing a primary care provider first versus seeing a physical therapist first. Subjects will be enrolled from two sites (Temple University, Philadelphia, PA and Brooke Army Medical Center, San Antonio, TX). Patient self-reported outcomes measures will be collected at baseline and 6 weeks. At 6 months, healthcare utilization will be assessed. The investigators plan to enroll a target sample size of 75 subjects per site (150 total). Descriptive statistics will be computed to characterize the 2 treatment groups with ANCOVA being used to assess differences between treatment groups at 6 weeks, adjusting for baseline values, evaluating the assumption of parallel slopes. The investigators will further investigate sources of systematic differences in response to treatment using methods such as generalized estimating equations and linear mixed effects models. This research will be the first multi-site study to compare effectiveness of these two pathways for individuals with musculoskeletal pain in the U.S. With a growing older adult population, the percentage of individuals who have musculoskeletal pain in the U.S. will only increase over time. This research study is timely and could meet the need for identifying the most effective pathway for individuals with musculoskeletal pain to seek care.

Eligibility Criteria:
Inclusion Criteria:

1. A patient at Temple University Employee Health, OR, Brooke Army Medical Center.
2. Able to speak English sufficiently to understand informed consent
3. A patient with a musculoskeletal condition as their primary complaint
4. Greater than 18 years old
5. Within 90 days (3 months) of either initial musculoskeletal onset or repeat acute recurrence of a previous episode

Exclusion Criteria:

1. Patients have already sought care from provider for their presenting condition for this current episode
2. Patients have an insurance plan that requires them to see an outside provider prior to seeing the study providers
Effect of Specific Immunotherapy to Dust Mites in Children With Asthma

The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms, reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.

Specific immunotherapy is the only one causal treatment method of atopic diseases including bronchial asthma in children.

The aim of the study is to assess the effect of specific immunotherapy (SIT) to dust mites on clinical symptoms,reliever drugs usage, inhaled glucocorticosteroid usage, quality of life, lung function, chosen markers of inflammation, induction of regulatory lymphocytes, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SIT in children with asthma.

Eligibility Criteria:
Inclusion Criteria:

* patients allergic to house dust mites
* patients with moderate bronchial asthma
* patients with controlled asthma
* patients who were qualified for immunotherapy and gave written informed consent for immunotherapy (active treatment group)
* patients who were qualified for immunotherapy and did not agree with this kind of treatment - did not give written informed consent for immunotherapy (control group)

Exclusion Criteria:

* patients allergic for other perennial and seasonal allergens
* patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
* medications that resulted in patient exclusion included:anti-parasites or oral corticosteroids within 6 months before the first visit.