cyrilzakka/clinical-trials huggingface dataset:
Late Metabolic Effects of Metformin Therapy in Gestational Diabetes

Metformin in widely used as the treatment of gestational diabetes. However, it is not known whether exposure to metformin in utero has late metabolic effects on the child.

In this study the investigators investigate metabolism (oral glucose tolerance test, insulin, plasma lipoproteins, inflammation markers as well as body composition by DEXA (dual energy X-ray absorption) and MRI) in 9 year-old children whose mothers used either metformin of insulin during pregnancy.

Gestational diabetes is usually managed with diet and insulin, if needed. However, oral metformin therapy has been also used to treat gestational diabetes and the short-term studies have shown that it is effective and also safe for the child. However, long-term studies of its effects are lacking.

Previously, several years ago, 217 pregnant women with gestational diabetes in Turku and 100 such women in Oulu, Finland, were randomised to either insulin or metformin therapy to treat gestational diabetes. In those studies, the metformin therapy proved to be safe in the short-term.

Now these children are 5-9 years old. In the present study these children (as well as their mothers) are investigated when the children are 9 years old. The aim is to study whether the metformin given during the pregnancy has any metabolic effects on the child at 9 years of age. To do this these families are contacted by mail and asked to participate into the study.

At 9 years of age, the following investigations will be made (after consent from the child and family): oral glucose tolerance test+insulin+c-peptide, plasma lipoproteins, adiponectin, PAI-1 (plasminogen activator inhibitor-1), IL-6 (interleukin-6), HS CRP (high-sensitivity C-reactive protein), p-metabolomics, DEXA, abdominal MRI, WISC IV (Wechsler intelligence scale for children IV)cognitive testing, BRIEF questionnaire, questionnaire about diet and health habits. The study subjects will also be clinically examined and measured and blood pressure will be taken.

All analyses are performed at the University hospital laboratory and radiology facilities using modern techniques. The amount of blood taken is limited and also radiation dose from DEXA is very small. The data are kept behind lock and key. Statistical analyses will be performed to study whether children exposed to metformin during pregnancy have any differences in their metabolism and well-being than those exposed to insulin. This study involves no new medical treatments to the study subjects.

Eligibility Criteria:
Inclusion Criteria:

* all children whose mothers used either metformin or insulin to treat gestational diabetes and were involved in the previous metformin study in Turku or Oulu, Finland

Exclusion Criteria:

* severe congenital malformations
PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR Mutations

This is PART B of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. PART B will assess subjects who do not have CNVs in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity.


Eligibility Criteria:
Inclusion Criteria:

1. Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
2. Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).
3. Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements prior to administration of investigational product (IP).
4. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based upon DSM 5 criteria.
5. Subject has a minimum score of ≥28 on the ADHD-RS-5 at the Baseline Visit (Visit 2).
6. Subject has been genotyped previously and has their identity confirmed (if required).

Exclusion Criteria:

1. Subject or parent/LAR is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit (Visit 1) which could interfere with the conduct of study evaluations.
2. Subject has a current, controlled or uncontrolled, co-morbid major psychiatric diagnosis (aside from ADHD), including an anxiety disorder, major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability. Mild anxiety and/or depressive symptoms that do not meet diagnostic criteria for an anxiety disorder or major depression and/or do not require treatment are not exclusionary.
3. Subject has autism spectrum disorder to include a DSM-IV diagnosis of autistic disorder, Asperger's disorder, or pervasive developmental disorder.
4. Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
5. Subject has a known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, or other serious cardiac problems.
6. Subject has any clinically significant abnormality on 12-lead ECG performed at the Screening Visit (Visit 1) and/or the Baseline Visit (Visit 2) such as serious arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
Contraceptive Choice at the Time of Uterine Evacuation

The goal of this project is to investigate whether a pre-visit telephone intervention could increase awareness of long-acting reversible contraception (LARC) availability at the time of uterine evacuation.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Scheduled for uterine evacuation
* Speaks English proficiently in order to understand the telephone conversation and the survey questions.

Exclusion Criteria:

* Previous participation in this study
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)

The hyperglycemic response to surgery and the added effect of low-dose steroids (dexamethasone 4 to 8mg), and whether these differ in diabetics and nondiabetics remain unclear. Therefore, we prospectively evaluate the intraoperative and postoperative serum glucose concentrations in diabetics and nondiabetics that received intravenous steroid administration. This multicentre study include \> 250 patients.Primary endpoiunt was glucose concentration at H6 after surgery. Secondary endpoints were glucose concentration at H12 and at H24 and effect of anesthesia (regional anesthesia)


Eligibility Criteria:
Inclusion Criteria:

* elective surgery under anesthesia

Exclusion Criteria:

* \< 50 kg
* emergency
* insulin therapy
* cardiac surgery
* refusal
* hyperglycemia\> 2g/L
Interactive Stepping Exercise on Executive Function and Gait Variability

The present study is to examine the effects of interactive stepping exercise on executive function and gait variability in community-dwelling older adults

This is a single blinded, randomized controlled trial. 40 community-dwelling older adults will be recruited and randomly assigned to either experimental group (n=20) or control group (n=20). The 12-week intervention comprises of 1-hour exercise per day and 3 days per week. The experimental group will receive interactive stepping exercise while the control group will be put under home exercise program. Primary outcome measures are executive function and gait variability. Secondary outcome measures include community walking test and other gait parameters (gait velocity, stride length and stride time). The participants will receive assessment at pre- and post-intervention

Eligibility Criteria:
Inclusion Criteria:

* community-dwelling older adults
* age ≥ 65 years old
* able to walk independently outdoor without an assistive device
* Mini-mental state examination ≥ 24
* use an exercise pre-participation health screening form by the American College of Sports Medicine to recruit those participants that are suitable to join the training session

Exclusion Criteria:

* diagnosed of any psychiatric and neurologic disorders such as schizophrenia, stroke, Parkinson, Alzheimer disease, etc.
* any comorbidity or disability that would preclude training
Horizons Chronic Graft-Versus-Host-Disease Study

This research is being done to evaluate the feasibility of the Horizons Program, a group-based behavioral intervention, to enhance quality of life in patients with chronic graft-versus-host disease.


Eligibility Criteria:
Inclusion Criteria:

* underwent allogeneic hematopoietic stem cell transplant
* have moderate to severe chronic graft versus host disease
* currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
* able to participate in a group intervention in English or Spanish language

Exclusion Criteria:

* comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
* vulnerable patients, defined here as prisoners and pregnant women
Characterization of the Inflammatory Profile of Patients With Macrophage Activation Syndrome Secondary to Bacterial Sepsis

The pathophysiology of macrophage activation syndrome has been mainly studied in pediatric genetic primary forms. There is little data in secondary forms related to bacterial sepsis. Because of the seriousness of this entity (43% of deaths in intensive care in the largest cohort published so far by the medical resuscitation team of Rouen University Hospital), it is necessary to better understand the physiopathological mechanisms to be able to propose a suitable therapy. For now, the management of this syndrome is far from consensual. Some authors advocate a single etiological treatment, while others suggest the need for intensive management of anti-inflammatory and immunosuppressive type. The fragility of resuscitation patients does not allow intensive immunosuppressive therapies as proposed by some authors. In the era of immunotherapy, the precise knowledge of physiopathological data would make it possible to propose a targeted therapy with little risk of adverse effects. Recent work has indeed shown excellent tolerance of immunotherapy during sepsis and could be applied eventually in patients with macrophage activation syndrome.


Eligibility Criteria:
Inclusion Criteria:

Patient hospitalized in intensive care for macrophage activation syndrome secondary to sepsis / bacterial septic shock with a strong clinical probability score (defined by a HScore\> 80% cf appendix 4) (experimental population) or Patient hospitalized in intensive care for sepsis or septic shock (control population)

* Age ≥ 18 years
* Person affiliated with a social security scheme or beneficiary of such a scheme
* Trusted person or informed patient who has signed the consent to participate in the research. (If the patient is unable to sign his / her consent (emergencies) the consent will be signed by the person of trust, and consent to further study will be requested from the patient).
* Effective contraception in women of childbearing potential (negative pregnancy test). For postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Person deprived of liberty by an administrative or judicial decision
* Protected major subject, under tutorship or curatorship
* Patient participating in another interventional clinical trial with the same primary objective
Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery

The purpose of this study is to analyze the changes in cardiac performance before and after milrinone administration in order to find out whether milrinone improves LV performance in patients undergoing coronary artery bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* patient agree and provide written informed consent.
* patient undergoing elective coronary artery bypass graft surgery
* preoperative LV EF\>50% (TTE)

Exclusion Criteria:

* preoperative cardiac dysrhythmia
* preoperative IABP
* use of other inotropic agents
Modulation Effect of tACS on Chronic Low Back Pain

Investigating the modulation effect of tACS

Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain

Eligibility Criteria:
Inclusion Criteria:

1. Volunteers 18-60 years of age
2. Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months)
3. At least 4/10 clinical pain on the 0-10 LBP NRS
4. At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures
5. Meeting the MRI / MEG / EEG screening criteria

Exclusion Criteria:

1. Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections)
2. Complicated back problems (eg, prior back surgery, medicolegal issues)
3. The intent to undergo surgery during the time of involvement in the study
4. History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome (for example: asthma or claustrophobia)
5. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner)
6. Concomitant autoimmune, chronic, inflammatory, neoplastic, and psychiatric diseases
7. Pregnant or lactating
8. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1)
9. Active substance abuse disorders (based on subject self-report and drug test)
10. Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents
11. Any medical conditions, such as peripheral neuropathy, that could affect the results of QST
12. Current use of psychotropic medication
Adaptive Strategies for Resilient Intrinsic Self-Regulation in Extremes (RISE)

The purpose of this study is to assess the efficacy of a resilience intervention in Veterans with chronic pain compared to wait list control.

After being consented and screened for eligibility, participants completed baseline assessments and then were randomized to either the study intervention or wait list control. Participants who were randomized to the study intervention completed post testing assessment measures within two weeks of the final treatment. Participants who were randomized to waitlist conditions completed post testing assessment measures within 2 weeks of the end of the waitlist condition and then subsequently received the study intervention.

Eligibility Criteria:
Inclusion Criteria:

1.18-80 years of age 2. United States Veterans from the conflicts of OEF/OIF to Vietnam era 3. Self-identified chronic pain or chart diagnosis of chronic pain

Exclusion Criteria:

1. Active suicidality of suicidal intent requiring a greater than outpatient level of care (Columbia Suicidality Rating Scale screen, C-SSRS)
2. Active alcohol abuse (Alcohol Use Disorder Identification Test, AUDIT-C)
3. Active psychosis (Psychosis Screener)
4. Current severe disabling illness
5. Inability to participate in a small group interactive setting
6. Inability to meet attendance requirement
7. Neurocognitive conditions other than TBI (e.g. dementia, Parkinsons, stroke)
8. Concurrently receiving Exposure Therapy, Cognitive Behavior Therapy, Acceptance and Commitment Therapy
Valproate Versus Propranolol in Migraine

Investigators aim to compare the effect of valproate versus propranolol in migraine by assessing the absolute reduction in MMD in each group and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

Investigators will enrol 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 500-1000 mg valproate daily, and the second group will receive propranolol 160 mg per day. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.

Eligibility Criteria:
Inclusion Criteria:

Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,

Exclusion Criteria:

* Patients with major neurological disorders such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumours, and patients with essential tremors.
* Patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.
* Patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or HbA1C more than 6.5.
* patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure
* patients who received prophylactic treatment for migraine,
* patients with any contraindications to drugs used in the study
* patients with bronchial asthma, chronic obstructive pulmonary disease
Clinical Trial to Compare the Pharmacokinetics of DP-R208

A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* BMI 17.5\~30.5
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 60 days or component blood within 14 days
* Clinically significant allergic disease
* Taken IP in other trial within 90 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

To compare myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR

Coronavirus disease 2019 (COVID-19) is a global pandemic affecting 185 countries and \>3 000 000 patients worldwide as of April 28, 2020. COVID-19 is caused by severe acute respiratory syndrome coronavirus 2,. Among patients with COVID-19, there is a high prevalence of cardiovascular disease, and \>7% of patients experience myocardial injury from the infection (22% of critically ill patients). Although angiotensin-converting enzyme 2 serves as the portal for infection, the role of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers requires further investigation.

However, much like any other respiratory tract infection, pre-existing cardiovascular disease (CVD) and CV risk factors enhance vulnerability to COVID-19. Further, COVID-19 can worsen underly- ing CVD and even precipitate de novo cardiac complications.

Preliminary reports suggest that haemostatic abnormalities, including disseminated intravascular coagulation (DIC), occur in patients affected by COVID-19. Additionally, the severe inflammatory response, critical illness, and underlying traditional risk factors may all predispose to thrombotic events, similar to prior virulent zoonotic coronavirus outbreaks CMR is the reference non-invasive standard for cardiac function and tissue characterization and may offer an effective and efficient diagnostic imaging choice to obtain critical information for clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with symptoms and ECG indicative of acute MI (both STEMI \& NSTEMI) AND confirmed COVID-19.
2. Patients admitted with acute MI (both STEMI \& NSTEMI) who develop COVID-19 symptoms during hospital admission \& are confirmed by RT-PCR to have COVID-19

Exclusion Criteria:

1. History of previous diagnosis of STEMI or myocarditis.
2. History of previous PCI in infarcted related artery or NSTEMI
3. Severe respiratory distress that precludes lying supine in the CMR scanner.
4. Acute kidney injury with rapidly declining GFR or GFR that is persistently below 30 ml/min/1.73 m2 (contraindication for Gadopentetate dimeglumine contrast).