cyrilzakka/clinical-trials huggingface dataset:
Glycemic Control, Brain Structure and Cognition in Youth With Type 1 Diabetes (T1DM)

LO5 study: The investigators are inviting a new group of youth (ages 7-16) who have been recently diagnosed with type 1 diabetes and their non-diabetic siblings. These youth will complete cognitive tests and a MRI scan of the brain. This scan uses strong magnets to obtain pictures and does not involve any radiation or injections. The investigators will recruit patients within three months of their diagnosis date. The study entails 1 study visit that lasts 3.5 hours. Evening and weekend times are available. The investigators plan to enroll 135 participants.

HY5 study: The investigators are inviting a cohort of youth and young adults (ages 9-21) with type 1 diabetes and their non-diabetic siblings for a follow-up to a study they have already completed. This group of people will complete several memory and thinking tests along with several MRI scans of their brain, just as they did at their previous visits. The investigators plan to enroll 150 participants.


Eligibility Criteria:
LO5:

Inclusion Criteria for Participants with Type 1 Diabetes:

* Between the ages of 7 and 16
* Diagnosed with type 1 diabetes within 3 months

Inclusion Criteria for Participants without Type 1 Diabetes:

* Between the ages of 7 and 16

Exclusion Criteria for Participants with Type 1 Diabetes:

* Pregnant or lactating
* Chronic disease other than T1DM, well-controlled asthma, or Hashimoto's thyroiditis
* Other current serious medical illness
* Psychiatric illness
* Psychoactive drug dependence
* Neurological illness (except T1DM-related): stroke, seizure, major loss of consciousness, head injuries, encephalitis, or hydrocephalus, blindness, deafness
* Use of psychoactive medications or exposure to neuroleptics (except that exposures of less than 1 month, occurring more than 5 years ago, will be allowed)
* Use of dopamine depleting agents or stimulants such as Ritalin, Cylert, Adderall
* Pre-maturity at birth of more than 4 wks early with complications (e.g. on respirator at NICU)
* Inability to complete MRI scan (e.g. claustrophobia, metal implants)
* Full set (top and bottom) of orthodontic braces (Half set braces, fillings, and retainers are OK)

Exclusion Criteria for Participants without Type 1 Diabetes:

* Same as above (except cannot have type 1 diabetes)

HY5: Must have been a participant in our earlier study.
Testing the Effectiveness of Integrating Relationship Education Into an Existing Workforce Readiness Program

The project will test the strategy of integrating 25 hours of relationship education into an existing employment program for low-income individuals ages 18-30. It will use a 2-arm randomized controlled trial to test the effect of this full package of services on participants' employment outcomes and relationship outcomes.

The study will examine the programming by FWCA, which currently offers the Career Pathways Bridge program in three locations in St. Louis County in Missouri. The evaluation will test the strategy of integrating relationship education into an existing workforce readiness program. FWCA plans to add approximately 17 hours of content from the Within My Reach relationship education curriculum to the two-week job readiness workshop it offers as part of the Career Pathways Bridge program. Second, FWCA will add up to eight additional one-hour relationship skills education sessions that customers can attend in the five weeks after completing the initial two-week job readiness workshop.

The evaluation will use a 2-arm randomized controlled trial to test the effect of this full package of services on participants' employment outcomes and relationship outcomes. The target population will be low-income individuals ages 18-30 living in St. Louis County, Missouri. The study will aim to enroll 1000 individuals over 2 years. The Metropolitan Employment and Training (MET) Center will be the primary recruitment and service location.

Eligibility Criteria:
Inclusion Criteria:

* disconnected from workforce

Exclusion Criteria:

-
Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients

The objective of this randomized, controlled pilot study is to determine the efficacy of Deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.


Eligibility Criteria:
Inclusion Criteria

1. Age ≥ 18 years
2. Index Anterior wall STEMI
3. Emergency coronary angiogram with primary PCI

Exclusion Criteria

1. Prior history of MI / PCI / coronary artery bypass graft (CABG) within previous 1 year
2. Patients with previous history of left ventricular ejection fraction (LVEF) \< 40%
3. Use of investigational drugs or devices 30 days prior to randomization
4. Known allergy or contra-indication to gadolinium/contrast agents
5. eGFR \< 30 ml/kg/min
6. Any contraindication against cardiac MRI (such as metal implants)
7. Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test prior to randomization
8. Body weight \> 140 kg (or 309 lbs.)
9. Absolute neutrophil count - ANC \< 1.5 k/cumm
10. History of Chronic Liver Disease
11. Elevated hepatic enzymes (BOTH ALT and AST) \> 2 times of upper normal limit
12. Patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators
13. Any clinically significant abnormality identified prior to randomization that in the judgment of the Sponsor-Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone.
14. Life expectancy of less than 1 year due to non-cardiac pathology
Vaccination Perception in Inflammatory Conditions - Flu, Pneumonia and COVID-19

People with inflammatory diseases are often treated with medications that act to suppress the immune-system, increasing the risk of catching infections. Consequently, vaccination with the pneumonia and seasonal flu vaccines is recommended for them. They were also prioritised to receive the COVID-19 vaccines early in the national rollout.

However, the uptake of the pneumonia and seasonal flu vaccines among this group is lower than ideal. There may be many reasons why they do or do not seek to be vaccinated for these infections, such as the belief it may cause their disease to flare up or lack of knowledge of vaccines effectiveness. Anecdotally there was a high uptake of COVID-19 vaccines in adults with inflammatory conditions, however, concerns about vaccine-induced disease flare-ups and reports of complications deterred some from being vaccinated. A better understanding of why people do and do not seek vaccination may result in more targeted messaging for patients to help overcome vaccine hesitancy for these infectious diseases.

This study aims to explore the drivers and barriers to being vaccinated among adults with common inflammatory conditions and on immune-suppressing medication. They will be invited to participate in a single, semi-structured interview. Interviews will be face-to-face, by telephone or video-call, last up to one hour, and digitally audio-recorded. They will explore participants' understanding of pneumonia, seasonal flu and COVID-19 and the risk they pose to their health, their understanding of vaccinations, beliefs of the benefits and risks of vaccinations for these infections, and reasons for seeking or not seeking vaccination.

Findings will inform messaging about being vaccinated for these infections in patient education leaflets, such as those by patient charities regularly provided at speciality clinics. They will also be disseminated to healthcare professionals to help them better understand the drivers and barriers to vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Age at-least 18 years,
* Diagnosed with either rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, vasculitis (small or large vessel), or reactive arthritis, and
* At-least one prescription of either methotrexate, azathioprine, 5-mercaptopurine, sulfasalazine, mycophenolate mofetil, leflunomide, ciclosporin, tacrolimus, or sirolimus, biologic agents (such as anti-TNF, anti-CD 20 etc).
* Ability to give informed consent

Exclusion Criteria:

* Age \< 18 years
* Dementia: making it impossible to give informed consent and to comply with interview
Treatment of Androgenetic Alopecia in Males With Theradome™ LH80 PRO

This is a prospective, randomized double-blind, multi-center study to evaluate the efficacy of low level laser therapy over-the-counter at home device Theradome LH80 PRO, compared to SHAM for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability study to assess subject ability to self-assess hair loss and understanding use of the device.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be diagnosed with androgenetic alopecia with Norwood Hamilton hair loss scale of IIa, III vertex, IV and V.
* Subject must have Fitzpatrick skin type scale I to IV.
* Subject must be able to visit clinic site for baseline, 13 week and 26 week study visits and attend 2 visits by phone ( 6 and 19).
* Hair must be at least 1 inch in length. The hairstyle and length shall be the same for each site visit. Subjects are instructed to have their hair cut/styled 1-5 days in advance of a site visit.
* Be willing to undergo all study procedures including consent for global photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site along the indicated transition area of the scalp between the hairline and the balding area of the vertex.
* Be willing to avoid use of wigs, hairpieces, and/or hair extensions during the study period.
* Ability to communicate effectively with study personnel.
* Agrees to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study

Exclusion Criteria:

* History of taking Propecia or any other hair growth supplements for 12 months prior to enrollment.
* History of using Rogaine for 6 months prior to enrollment.
* Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
* Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata.
* Currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc).
* Subject has a sensitivity or allergy to tattoo ink.
* Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
* Employed by sponsor, clinic site, or entity associated with the conduct of the study.
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis

The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation in atherosclerotic plaque


Eligibility Criteria:
Inclusion Criteria:

* History of documented atherosclerosis
* LDL between 70 and 130 mg/dL
* Patients receiving stable low- to moderate-dose statin
* BMI 18-37 kg/m²
* Must be able to swallow tablets
* Must be able to medically tolerate the procedures, contrast medium, and medications involved

Exclusion Criteria:

* Statin intolerance
* Renal impairment (serum creatinine \> 1.5 mg/dL)
* History of chronic viral hepatitis or other liver dysfunction
* Major infection requiring hospitalization or receipt of IV antibiotics due to an infection within 2 months prior to initiation of study treatment
EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)

To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.


Eligibility Criteria:
Inclusion Criteria:

* age: 18-80;
* ischemic stroke confirmed by brain CT or MRI
* the time from onset to treatment: 4.5-6 hours
* NIHSS≥4
* prestroke mRS≤1
* signed informed consent

Exclusion Criteria:

* prestroke mRS≥2
* planned endovascular treatment
* planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion
* any contraindiction of intravenous thrombolysis
* other unsuitable conditions judged by investigator
Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback.

The study hypotheses include:

* Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF
* Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
* PFC activation will positively correlate with CR ability


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of interference or distress due to the lowered chances of encountering anxiety-provoking stimuli during the study period
* Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
* Medically and physically able to consent
* Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:

  1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
  2. The same oral hormonal contraceptive for at least 3 months
* For females, not currently pregnant or actively trying to become pregnant
* Ability to tolerate small, enclosed spaces without anxiety
* No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (per protocol)
* Size compatible with scanner gantry (per protocol)

Exclusion Criteria:

* Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
* Current substance abuse or dependence (past 6 months)
* Active suicidality with plan or intent
* Current psychosis
* History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
* History of closed head injury, e.g., loss of consciousness greater (\>) approximately (\~) 5 minutes, hospitalization, neurological sequela
Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects

Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion and mass balance of parent compound and radioactivity at steady-state; to isolate, identify and quantify major metabolites of tipranavir in plasma, urine and feces


Eligibility Criteria:
Inclusion Criteria:

1. Healthy HIV-negative male subjects as determined by results of screening. Healthiness was determined by medical history, laboratory testing and 12-lead ECG
2. Signed written informed consent in accordance with Good Clinical Practice (GCP)
3. Age \>18 and \<=60 years
4. Subjects within 20% of the normal height: weight range defined by the Metropolitan Life Insurance Company Tables
5. Ability to swallow numerous large capsules
6. Willingness to abstain from smoking, ingesting methylxanthine containing drinks or food (coffee, tea, cola, chocolate, etc.), or ingesting alcohol, St. John's Wort, milk thistle, garlic supplements, Seville oranges, and grapefruit or grapefruit juice for the duration of the study

Exclusion Criteria:

1. Any finding of the medical examination (including blood pressure, pulse rate, and ECG) deviating from normal and of clinical relevance
2. History of clinically significant disease including metabolic, endocrinologic, immunological, hepatic, renal, gastrointestinal, respiratory, cardiovascular, psychiatric or neurological
3. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator and/or the sponsor
4. Subjects with a history of drug abuse or alcoholism
5. Chronic or relevant acute (within 2 weeks of screening) infections
6. Subjects who have taken prescription medications, over-the-counter drugs, or herbal preparations within 2 weeks of the start of the trial
7. Participation in another trial with an investigational drug (in the 30 days prior to screening)
8. Blood donation \>400 mL (within 1 month prior to treatment administration or during the trial)
9. Any laboratory value that represents a Division of DAIDS (DAIDS) toxicity Grade \>1
10. Positive urine drug screen, positive HIV antibody, positive Hepatitis C Ribonucleic acid (RNA), or positive Hepatitis B surface antigen
11. History of any familial bleeding disorder
Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism

The aim of the study is to determine the factors affecting the bioavailability of iron and folic acid during the simultaneous use of iron supplements and folic acid supplements in non-pregnant women of childbearing age.

Scientists in the field of nutrition and gynecology and obstetrics have been paying attention to the need of use iron and folate supplements in women of childbearing age. Increased intake of micronutrients in the diet or the use of supplementation does not always bring the expected results, what depends on factors that affect the bioavailability of minerals and vitamins. On the one hand these factors are related to the properties of food intake, e.g. to the presence of other nutrients that can increase or decrease the absorption of folates and iron (eg vitamin C, phytates), and on the other hand the functioning of the body itself, which to a certain extent is determined by genetic factors (e.g., genetically determined reduced activity of methylenetetrahydrofolate reductase \[MTHFR\], which reduces the bioavailability of folic acid).

The study aims:

* assessment of the effect of simultaneous supplementation with iron and folate on:

  * parameters of the iron metabolism
  * parameters of the folate metabolism
* the estimation of gene polymorphisms encoding proteins transporting iron and folate
* obtaining information whether the polymorphism of genes encoding proteins transporting iron and folate is related to the effectiveness of the iron and folic acid supplementation used in non-pregnant women of childbearing age.

In 200 non-pregnant women of childbearing age a blood level of iron and folic acid will be determined. Subjects with low level of blood iron and folic acid will be supplemented with oral iron and folic acid for 3 months. Subjects with proper level of blood iron and folic acid will be a control group. At baseline and at completion of the study (after 3 months) fasting blood will be collected and abovementioned parameters will be estimated.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 35 years
* stable body weight (\< 3 kg self-reported change during the previous three months)
* written informed consent to participate in the study,
* regular menstrual period;
* regular diet

Exclusion Criteria:

* history of use of any dietary supplements within the one month prior to the study containing iron or folic acid
* clinically relevant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
* simultaneous participation in a study that affects body weight or use of diet / medication / nutritional behaviors affecting body weight;
* a history of infection in the month prior to the study
* nicotine, drug or alcohol abuse
* vegetarian diet;
* pregnancy or lactation
* other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results
A Study of LCAR-AIO in Subjects with Relapsed/Refractory Autoimmune Diseases

This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.

This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily participate in clinical research.
2. Age 18-65 years.
3. Adequate organ function at screening.
4. Clinical laboratory values meet criteria at screening.

SLE:

* Have been diagnosed of SLE at least 6 months before screening.
* At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
* Fulfill relapsed/refractory SLE conditions.

AAV:

* Have been diagnosed of AAV before screening.
* Positive test for anti-PR3 or anti-MPO antibodies at screening.
* Fulfill relapsed/refractory AAV conditions.

SSc:

* Have been diagnosed of SSc before screening.
* At screening, mRSS is higher than 10.
* Fulfill relapsed/refractory SSc conditions.

IIM:

* Have been diagnosed of IIM before screening.
* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
* Fulfill relapsed/refractory IIM conditions.

Exclusion Criteria:

1. Active infections such as hepatitis and tuberculosis.
2. Other autoimmune diseases.
3. Serious underlying diseases such as tumor, uncontrolled diabetes.
4. Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
5. Participated in other clinical trials within 4 weeks.