cyrilzakka/clinical-trials huggingface dataset:
Diabetic Cardiomyopathy and Heart Failure

This study will demonstrate the beneficial effects of ketone bodies in type 1 diabetes (T1D) patients and will have significant translational applications to prevent serious metabolic conditions such as T1D induced diabetic cardiomyopathy (DCM).

T1D remains the primary cause of DCM. The long-term goal is to understand the mechanism of T1D leading to DCM. Proprotein convertase subtilisin/kexin type 9 (PCSK9) plays an important role in degrading the low-density lipoprotein receptors (LDLRs) and that increases the circulating LDL cholesterol (LDL-C). Further, PCSK9 increases duringT1D and that, in turn, decreases mitochondrial bioenergetics, transcription factor- mitochondrial (TFAM), and the mitochondrial numbers thus creates an oxidative stress. These changes lead to oxidation of high-density lipoprotein paraoxonase-1 (HDL-Pon1). Because Pon1 hydrolyzes homocysteine (Hcy), the oxidized Pon1 thus causes accumulation of Hcy (i.e. hyperhomocysteinemia; HHcy). Also, the 'metabolic memory' is associated with epigenetic modification (methylation) of genes encoding proteins such as thioredoxin interacting protein (TXNIP). Since methylation/epigenetics inhibits genes, this phenomenon generates even more amounts of Hcy. Investigators have shown that HHcy decreases G-protein coupled receptor (GPCR) Gαs subunit, protein kinase-B (AKT), focal adhesion kinase (FAK) but increases calpain-1, inflammasome and oxidative stress. The central hypothesis is that an increase in PCSK9 causes oxidative stress and decreases TXNIP thus causing oxidation of HDL-Pon1 and subsequent accumulation of Hcy. These alterations lead to decrease in Gαs, AKT, FAK and concomitant increase in PCSK9 and calpain-1 causing metabolic, diastolic, and systolic cardiac dysfunction. Treatment with ketone bodies (the food for mitochondria) will mitigate these changes.

Eligibility Criteria:
Inclusion Criteria:

-Diabetic subjects with high blood glucose levels

Exclusion Criteria:

- Comorbidities affecting glucose levels and cardiac function
Milk Types and Fish Oil in 9- to 12-Month-Old Infants

The objective of this intervention study is to examine the effect of whole cow's milk versus infant formula as primary milk sources with or without supplements of n-3 LCPUFA for growth, nutritional status, development, risk factors for later diseases and the impact on the intestinal microbiota and inflammation in 9 - 12 months old infants.


Eligibility Criteria:
Inclusion Criteria:

* Singleton infants
* Born \>= 37 wk of gestation
* Birth weight \> 2500g
* \>= 5th percentile for gestational age
* A 5-min Apgar score \>= 7
* Daily consumption of cow's milk or formula

Exclusion Criteria:

* No major complications at birth or in fetal life
* No chronic diseases
Lactation Outcomes Among Survivors of Pediatric Cancer

While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes.

Participants will complete a cross-sectional survey. Responses will be compared with a national sample of healthy women from Project First (Infant Feeding Practices Survey II).

Primary Objective:

* To describe breastfeeding outcomes (intention, initiation, duration, and weaning) among female SJLIFE protocol participants 18 years of age and older who reported a live birth.

Secondary Objective:

* To compare breastfeeding outcomes between childhood cancer survivors and healthy mothers.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.
* Female
* 18 years of age or older
* At least one reported live birth after childhood cancer diagnosis and treatment.

Exclusion Criteria:

* Unable to read and write.
* Unable to read and understand English.
Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain

Lifestyle intervention and certain medications have been shown to be effective for antipsychotic-induced weight gain, but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain.

The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention.128 patients were randomized to one of four 12-week individual treatments: metformin (750mg/day), placebo, lifestyle intervention plus metformin (750mg/day) or lifestyle intervention plus placebo. Medications were provided in double-blind fashion.The assessments include body weight, body mass index, waist circumference, fasting glucose, fasting insulin and insulin resistance index.

Eligibility Criteria:
Inclusion Criteria:

* All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia27.
* Participants were required to get weight gain more than 10% of their predrug body weight during less than 12 months of treatment with a targeted antipsychotic agent- clozapine, olanzapine, risperidone or sulpiride.
* The duration of illness for all participants was less than 12 months.
* Participants could be taking only one antipsychotic, whose dose had not changed by changed by more than 25% over the past 3 months.
* All patients were stable outpatient.
* The total score of Positive and Negative Syndrome Scale (PANSS) for all patients could be ≤60.
* All participants were ensured that they could be carefully taken care of by one of their parents or guardians during the trial.

Exclusion Criteria:

* Participants were excluded from the study if they had evidence of liver or renal diseases, pregnant or lactating women, cardiovascular diseases, hypertension or diabetes mellitus, specific systemic diseases, or conditions that limited their ability to perform the lifestyle modifications, such as arthritis, pulmonary diseases, neurological or dietary restrictions.
Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)

This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy
* Having received oral and written information about the survey and not objecting to having his/her data computerized

Exclusion Criteria:

- Participating in a clinical trial assessing an anticancer treatment
A-EYE: A Mixed Quantitative and Qualitative Study to Develop and Evaluate the Application of Artificial Intelligence (AI) Methods Using Retinal Imaging for the Identification of Adverse Retinal Changes Associated With Cancer Therapies.

This is a data collection study involving the gathering of clinical data and OCT (optical coherence tomography) scans from 350 patients.

The purpose of this study is to gather data to help develop an AI algorithm to detect eye abnormalities specifically those related to certain cancer treatments.

At the end of the study interviews will be held with expert ophthalmologists to assess the acceptability of implementing AI into clinical practice.

Many cancer patients will access new treatments through clinical trials. These treatments have often never been tested in humans and therefore, are likely to have unknown side effects. Some of these side effects include changes to the eye, such as blindness.

Ahead of patients taking part in these trials there is often little planning done to manage potential side effects on the eye. Additionally, accessing the expertise of eye specialists is not always available and often referral to a specialist is only given when eye symptoms have become advanced. These delays in identifying side effects on the eye also delays treatment and follow-up management. Providing patients access to this expertise would help in the detection and management of treatment side effects, however, due to demands on resources this access is not always readily available.

The aim of this study is to create an artificial intelligence (AI) program that can detect changes to the eye related to disease, which, in the future, can be specifically used in cancer patient care. Additionally, developing an AI program to detect cancer related side effects to the eye will go a significant way in easing the burden on the health care system and improve side effects from new cancer treatments.

This study will involve the collection of eye scans and medical data from participants at the Manchester Royal Eye Hospital. These will then be used to develop AI methods to detect changes in the eye related to those seen by patients on cancer treatment. The AI will then be compared with the assessments of eye specialists to assess if they give similar results.

Eligibility Criteria:
Inclusion Criteria:

Patients are eligible for the study if all inclusion criteria are met:

1. Voluntary informed consent.
2. Aged at least 18 years.
3. Fully registered patient attending the Manchester Royal Eye Hospital
4. Patients are having an optical diagnostic imaging as part of their standard of care.

Exclusion Criteria:

Patients are excluded from the study if any of the following criteria apply:

1. Patient who are deemed clinically unable to be scanned by healthcare professional.
Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants

Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.


Eligibility Criteria:
Inclusion Criteria:

* \<1501 g weight at birth

Exclusion Criteria:

* chromosomal anomalies
* congenital heart disease
* congenital disorders known to impair neurodevelopment
Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance

Increased intestinal permeability can represent compromise of the epithelium's integrity and is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune response. In this study, the investigators propose to use a novel, minimally invasive technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium. The primary aim of this study is to identify if there is a difference in duodenal mucosal impedance between CeD and control patients.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for endoscopy as part of routine care with or without suspected Celiac Disease based upon at least 1 positive serologic marker of CeD
* consuming gluten at time of endoscopy

Exclusion Criteria:

* Already on a gluten free diet or unwilling to undergo a gluten challenge
* Undergoing upper endoscopy for an urgent indication such as unstable gastrointestinal bleed or food impaction
* Patients with inflammatory bowel disease
* Patients on blood thinners other than aspirin at time of endoscopy
* Patient unable to give informed consent
* Patient less than 18 years old
Mobile Sleep and Growth Study

The purpose of this research study is to see if we can help parents to get their children to go to bed earlier. This may help children to improve their sleep. The study will use a web-based study platform and an activity monitor.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 10 to 12 years.
2. Speak, read and write in English.
3. Parental/guardian permission (informed consent) and child assent.
4. Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
5. Typically spend 8-9 hours in bed at night (e.g. 8 hour time in bed: go to bed at 10pm \& get out of bed at 6am).

Exclusion Criteria:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).
2. Syndromic obesity.
3. Diagnosed with a psychiatric disorder \[e.g. Attention-deficit/hyperactivity disorder (ADHD), depression, anxiety\].
4. Diagnosed with an eating disorder.
5. Musculoskeletal or neurological disorder that limits physical movement and activity.
6. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
Modified Dosage for Severe Acute Malnutrition

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-59 months
2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
3. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
4. Pass appetite test conducted at the time of enrollment
5. Consent for randomization into the study given by mother, father, and/or other primary caregiver
6. Mid-upper arm circumference less than 115 mm and/or nutritional edema
7. Weight-for-height Z-score (WHZ) less than -3

Exclusion Criteria:

1. Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
3. Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.


Eligibility Criteria:
Inclusion Criteria:

* Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
* Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
* A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
* Age \>= 18 years
* The patient has signed the consent form

Exclusion Criteria:

* Known with allergic reactions against human plasma or plasma products
* Having an ongoing progressive disease, including HIV infection
* Pregnancy or lactation
* Known with insufficiency of coronary or cerebral circulation
* Having renal insufficiency (plasma creatinin \> 115µmol/L)
* Having IgA deficiency and anti-IgA antibodies have been detected
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

The purpose of this study was to evaluate the safety and efficacy of linaclotide for the treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment for chronic non-cancer pain that has been present for a minimum of 3 months.

This study included up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients meeting the entry criteria were randomized to 1 of 2 doses of linaclotide or placebo once per day for 8 weeks. This 8-week study assessed the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of OIC.


Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic non-cancer pain that has been present for a minimum of 3 months
* Patient has been receiving a stable oral dose of a full-opioid agonist for at least 4 days per week during the 8 consecutive weeks
* Patient meets protocol criteria for Opioid-Induced Constipation (OIC): \< 3 spontaneous bowel movements (SBMs) per week and reports one of the following symptoms for at least 4 weeks:

  1. Straining during \> 25% of BMs
  2. Lumpy or hard stools during \> 25% of BMs
  3. Sensation of incomplete evacuation during \> 25% of BMs
* Patient meets the colonoscopy requirements defined by the American Gastroenterological Association guidelines
* Patient has successfully completed protocol procedures (with no clinically significant findings)
* Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting
* Patient has a total of \< 6 SBMs in IVRS during the 14 days before and up to the time of Randomization
* Patient has adequate relief and well-controlled pain with current dose of opioid

Exclusion Criteria:

* Patient has been using opioids for abdominal pain
* Patient has symptoms of or been diagnosed with chronic constipation or chronic idiopathic constipation prior to initiation of opioid treatment
* Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior to initiation of opioid treatment
* Patient has a history of loose or watery stools for \> 25% of BMs during the 3 months before the Screening in the absence of laxatives, suppositories, or enemas
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments
A Comparison Between Orthodontic and Non-orthodontic Patients on Oral Indexes and Salivary pH and Quality

This study aims to assess the caries susceptibility in pediatric patients aged 6-14 years old using Saliva-Check Buffer salivary tests. A total of 40 patients will be enrolled, divided into two groups:

1. Group A (Pre-Orthodontic Treatment): this group will include pediatric patients who have completed dental treatments (mechanical debridement, fillings, extractions) and have not yet started orthodontic treatment.
2. Group B (Orthodontic Treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months.

This study aims to assess the caries susceptibility in pediatric patients aged 6-14 years old using Saliva-Check Buffer salivary tests. A total of 40 patients will be enrolled, divided into two groups:

1. Group A (Pre-Orthodontic Treatment): this group will include pediatric patients who have completed dental treatments (mechanical debridement, fillings, extractions) and have not yet started orthodontic treatment.
2. Group B (Orthodontic Treatment): this group will consist of pediatric patients who have been undergoing orthodontic treatment for at least 6 months.

Ethical Considerations: the study will be conducted in accordance with the Declaration of Helsinki and the norms of the Good Clinical Practice.

Patient Enrollment: patients meeting the inclusion criteria will be identified from the dental clinic's patient records. Parents or legal guardians will be approached to obtain informed consent for participation in the study.

Baseline Assessment: baseline dental examinations will be conducted to assess the dental health status of each patient, recording the following indexes: DMFT (Decayed, Missing, Filled Teeth), DMFS, PCR. Then, saliva collection and testing will be performed with Saliva-Check Buffer.

Data Analysis: data will be statistically analysed. Normality test will be performed, and a parametric or non-parametric test will be performed to compare the two groups for all the variables tested. Significance threshold will be predefined for p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients about to begin orthodontic treatment or already undergoing orthodontic therapy
* Willingness to undergo Saliva-Check Buffer salivary tests.
* Parental or legal guardian consent for participation in the study.

Exclusion Criteria:

* Patients with systemic medical conditions that may affect the results of salivary tests.
* Patients unwilling or unable to cooperate for saliva sample collection required for the tests.
* Patients who have taken antibiotics or other medications that could influence saliva composition in the weeks prior to testing.
* Patients with oral anomalies that may interfere with data collection or affect test results.