cyrilzakka/clinical-trials huggingface dataset:
Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants

To explore the effects of enteral choline and DHA supplementation on plasma choline and DHA-PC concentrations and metabolism, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and choline and DHA supplementation.

After 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels, uptake and distribution of choline and DHA.

This study is designed to inform larger studies evaluating this approach of enteral co-application of choline and DHA on clinical important outcomes.

In utero, there is a constant high supply of choline to the fetus. Preterm delivery disrupts this maternal-fetal choline-transfer. We have shown that choline plasma levels rapidly half after preterm delivery. We also demonstrated that plasma DHA-PC rapidly falls after preterm delivery. DHA supplementation has been evaluated and found safe, however the clinical benefits have been smaller than expected. We speculate that choline deficiency may have contributed to the smaller than expected benefit of DHA supplementation in the past.

This study verifies the hypothesis that concomitant supply of choline and DHA will improve DHA-PC availability and turn-over. This is important because DHA-PC is the transport molecule for the DHA transport to the brain and the retina.

To explore the effects of enteral choline and DHA supplementation on plasma choline and DHA-PC concentrations, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and choline and DHA supplementation.

After 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels, uptake and distribution of choline and DHA.

This study is designed to inform future larger studies evaluating this approach of enteral co-application of choline and DHA on important clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with a gestational age at birth between 24 and 32 weeks
* on almost complete enteral feeding (\>75% of total fluid intake)

Exclusion Criteria:

* insufficient enteral intake,
* gastrointestinal disease,
* missing parental consent
Computer-Assisted Self-Interviews and Health Screening in the Pediatric Emergency Department

The purpose of this study is to determine if an Audio-enhanced Computer-Assisted Self-Interview (ACASI) will lead to increase testing for sexually transmitted infections in youth visiting a pediatric ED

The purpose of this study is to see if computer based health surveys for teenagers and young adults in the emergency department can improve the care we give, even for things that are not related to why they came to the emergency department.

Topics that are important in this age range include depression, violence, sexual behavior, physical activity and nutrition, though we are not asking about all of these.

WHAT WILL HAPPEN DURING THIS STUDY?

We wish to respect the privacy of everyone takes this survey. In order to do this, we are asking all relatives including your parents or guardians to respect several things so that you may participate:

* We cannot tell family or friends the exact questions on the survey
* You must be given complete privacy to answer the questions
* The answers will only be shown to the healthcare team taking care of them today and the people running the study - family members will not be shown the answers
* Family and friends will not pressure you to discuss the survey or their answers after you are done
* You will be given privacy to discuss their answers with the healthcare team

If you do not feel your friends and family can respect these requests, then you cannot take the survey and cannot enroll in the study.

If you agree to these requests, we will use a private area and allow you to use a computer to do the following:

* Explain in more detail what types of questions we will ask and why they are important
* Tell you how we will use your answers to improve their health care
* Give you a chance to answer any questions you have about the study
* Answer a series of questions about yourself and your health

You are allowed to skip any questions you do not want to answer and can stop at any time.

After you have completed the survey, a summary of your answers will become part of your medical record from today and be shown to the doctors and nurses taking care of you today.

Most participants will be asked to review their answers in private with the doctors and nurses taking care of them. If you do, your family and friends will be asked to step out of the room while you review the answers with the doctors and nurses.

Some participants may have additional testing or services done as part of their visit today based on their answers

Eligibility Criteria:
Inclusion Criteria:

* Patient in the St. Louis Children's Hospital Emergency Department
* 15-21 years old

Exclusion Criteria:

* Evaluation of abuse or sexual assault
* Activation of the trauma system,
* Level 1 or 2 triage scores (highest severity)
* Disabilities preventing independent computer use
* Psychiatric chief complaints
* Inability to speak English
Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study

Dairy products consumption is widely recommended in a healthy diet not only for bone growth and maintenance, but also as a protein, calcium and magnesium sources for an adequate diet. However, dairy products are a major dietary source of saturated fat that is associated with increased risk of coronary heart disease. ln this context, dietary guidelines still advocate a restriction in dietary saturated fat for optimal heart health. Nevertheless, the association between saturated fat and the risk of heart disease remains highly controversial within the scientific community. There is also emerging evidence that the impact of dietary saturated fat will be significantly influenced by the food matrix through which it is provided. Recent studies indicate that cheese could have a major influence on intestinal fat absorption and the magnitude of the after meal release of fat in blood circulation. This is of interest because substantial evidence exists indicating that elevated levels of the after meal fat levels are associated with increased cardiovascular risk. Therefore, the improvement of the after meal fat levels produced by cheese consumption could well be part of novel therapeutic approaches contributing to improve cardiovascular risk.

The general objective of the proposed research is to investigate how cheese consumption affects the after meal release of fat in blood circulation in healthy subjects. Our hypothesis is that, compared to butter, cheese consumption will have a beneficial impact on the after meal fat levels in healthy subjects. Favourable results from the proposed study will provide novel and much warranted evidence on the importance of considering changes in the after meal fat levels, not only bad cholesterol, as part of the on-going saturated fat-heart disease debate and that cheese should indeed be part of a healthy diet.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years (men and women)

Exclusion Criteria:

* Smokers (more than 1 cigarette/d)
* Body weight variation more than 10% during the last 6 months prior to the study baseline
* BMI more than 35 kg/m2
* Previous history of cardiovascular disease
* Subjects with type 2 diabetes
* Subjects with monogenic dyslipidemia
* Subjects taking anti-inflammatory drugs
* Subjects with endocrine or gastrointestinal disease
* Allergy/intolerance to dairy
* Clinical use of vitamin D and calcium supplements
* Vegetarians
* Subjects who are in situation or have a condition that, in the opinion of the investigators, may interfere with optimal participation in the study
Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?

Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled trial.

Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous phototherapy in extremely low birth weight (ELBW) infants without the risks that have been associated with continuous phototherapy.

Phototherapy (PT) is widely used and assumed to be safe as well as effective in reducing total bilirubin (TB) levels. Our recent NICHD Network Trial showed that aggressive use of phototherapy reduces neurodevelopmental impairment (NDI), but may increase deaths among ELBW infants. Among ventilator treated infants \<750 g birth weight (BW) (n =696), conservative Bayesian analyses (using a neutral prior probability) identified a 99% (posterior) probability that aggressive phototherapy reduced profound NDI but a 99% probability that it increased deaths relative to conservative phototherapy. The possibility that PT increases deaths among high risk infants is also suggested by the Collaborative Phototherapy trial (performed in the 1970s), the only large RCT in which LBW infants were randomly assigned to receive PT or no PT. The relative risk for death among those randomized to PT relative to those randomized to no PT was 1.32 (0.9-1.82) among all LBW infants and 1.49 (0.93-2.40) among ELBW infants. These findings are consistent with a major increase in mortality but have been ignored because the p was \>0.05, an error often made in ignoring important potential treatment hazards when power is limited.

Multiple studies, most performed decades ago in larger infants, found that short on/off cycles of PT (e.g. 15 min on/60 min off, 1 h on/3 h off, or 1 h on/1 h off ) are as effective as uninterrupted PT to reduce TSB. (Cycles with \>6 h off PT do not appear to be as effective as uninterrupted PT). The clinical use of uninterrupted rather than cycled PT appears to be based largely on the assumption that PT is safe for all infants.

Eligibility Criteria:
Inclusion Criteria:

* birth weight 401-1000 grams
* age less than or equal to 24 hours

Exclusion Criteria:

* hemolytic disease
* major anomaly
* overt nonbacterial infection
Triple Therapy for Postoperative Nausea and Vomiting in Laparoscopic Gastrointestinal Surgery

Postoperative nausea and vomiting (PONV) are common in patients, especially in patients at high risk. PONV may result in prolonged hospital stay and threaten patients' life. Because the etiology of PONV is very complex, there is an increasing focus on combining antiemetics from different classes for PONV prophylaxis. Fosaprepitant is a neurokinin-1 (NK-1) receptor antagonist to prevent PONV. Palonosetron is a 5-HT3 receptor antagonist with high efficacy and sustained action for PONV prophylaxis. Dexamethasone belongs to corticosteroid and also has the ability to reduce the incident of PONV. This study aims to use the combination of these three drugs in high-risk patients to test whether triple therapy is better than combination of palonosetron and dexamethasone to prevent PONV.

This trial is a prospective, randomized controlled study with blinded participant, care provider, investigator, and outcomes assessor. 1154 patients aged 18 to 75 years undergoing laparoscopic gastrointestinal surgery will be enrolled.Triple therapy of palonosetron and dexamethasone plus fosaprepitant will be administered in the intervention group, and double therapy of palonosetron and dexamethasone will be used in the control group. The anxiety of patients will be evaluated. The primary outcome is proportion of participants with PONV during the first 24 postoperative hours. Secondary outcomes are as follow: proportion of participants with PONV,emetic episodes, nausea, with rescue antiemetic medication; the scores of QOR-15; pain scores;time to first flatus after surgery; time to first defecation after surgery; recovery time; health related quality of life; proportion of participants with adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and Age ≤75 years;
* Scheduled for laparoscopic gastrointestinal surgical procedure with general anesthesia ;
* The score evaluated by Apfel simplified PONV risk assessment systems is ≥3.

Exclusion Criteria:

* The American Society of Anesthesiologists (ASA) rating is \>3;
* Severe hepatic dysfunction(the score of Child-Pugh is \>9);
* With contraindications for using fosaprepitant, 5-HT3 receptor antagonist or dexamethasone ;
* Take medications with known antiemetic properties preoperatively ;
* With mental disorder, or not be able to communicate ;
* Pregnant women or nursing mothers.
Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis

To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.

This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis.

Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
* Patients range from 15-90 years of age.
* Female patients not pregnant or lactating.
* Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
* Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
* Patients with adequate renal function, creatinine ≤ 1.5 mg/dl.
* Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT \<1.5×control.

Exclusion Criteria:

* Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
* Signs and symptoms of clinically significant cardiac disease.
* Diagnosis of a transient ischemic attack in the 6 months prior to screening,
* Known allergy to anesthetic or any other components of study.
* Patients infected with hepatitis B, C or HIV.
* Patients with Body Mass Index (BMI) \> 39kg/m2 .
* Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.
Long-term Follow-up of Bivalent Human Papillomavirus (HPV) Vaccine Study in Women

This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. No additional vaccine doses will be given. Cervical samples will be obtained for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. If applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. Blood samples will be drawn from an immunology subset for antibody testing.The study includes data collection from multiple sites across China to assess the vaccine's long-term efficacy in preventing HPV-related cervical diseases and its durability over time.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand and provide informed consent by signing the informed consent form (non-illiterate).
* Have the ability to comply with protocol requirements, such as attending scheduled visits and responding to follow-up phone calls.
* Prior enrollment in the 311-HPV-1003 study, with at least one dose of the study vaccine administered.
* At least one documented gynecological visit between 6 and 48 months during the previous 311-HPV-1003 study.
* Refrain from vaginal intercourse for 48 hours and avoid behaviors such as vaginal douching or using vaginal medications that could interfere with gynecological examinations or sample collection for 72 hours prior to each gynecological visit.

Exclusion Criteria:

* Participants who received another HPV vaccine during the prior 311-HPV-1003 study or between the end of that study and enrollment in this extension study.
* Participants diagnosed with HPV 16- or 18-related CIN2+ by an independent pathology expert panel during the prior 311-HPV-1003 study, or who were definitively diagnosed with HPV 16- or 18-related CIN2+ through external testing after the prior study ended.
* Participants who, at baseline in the 311-HPV-1003 study, tested positive for both HPV 16 and 18 antibodies, or were positive for both HPV 16 and 18 (by Cobas 4800), or whose cytology was not normal or of low-grade changes.
* Participants who are pregnant at the time of gynecological visits or within three months prior to the visit.
* Participants with any other factors deemed unsuitable for participation in the clinical trial, as determined by the investigator.
Dacarbazine and Carmustine in Metastatic Melanoma

The purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.

In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and carmustine commonly used in this cancer, but given using a schedule that might theoretically improve on this combination. Patients on this study will be assessed in terms of toxicity, response rate, median duration of response, median time to disease progression, and median survival.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma which has progressed on at least one prior systemic therapy.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months.
3. Patients must be felt to have recovered from effects of prior cancer therapy, such as past expected leukocyte nadir for chemotherapy (\> 2 weeks).
4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl; platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and AST must be less than 3 times the upper limit of normal; creatinine must be less than or equal to 1.8 mg/dl.
5. Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
6. Patient consent must be obtained prior to entrance onto study.
7. Patients must have no evidence of significant cardiovascular disease including history of recent (\< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina or cerebrovascular accident.

Exclusion Criteria:

1. Evidence of significant cardiovascular disease including history of recent (\< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina, or cerebrovascular accident.
2. Prior history of psychiatric disorder that could be exacerbated by or which could preclude completion of this therapy.
3. Pregnancy or lactation.
4. Prior chemotherapy with carmustine
Specialist Conferences Between General Practitioners and Endocrinologists

To support the primary care sector in delivering high-quality Type 2-diabetes (T2D), literature reviews emphasize the need for implementing models of collaboration that in a simple and effective way facilitate clinical dialogue between general practitioners (GPs) and endocrinologists. The overall aim of the project is to study if an intervention consisting of structured cross-sectoral and virtual conferences between GPs and endocrinologists about T2D improves diabetes care and increases diabetes competencies and management in general practice. This aim will be studied in a pragmatic randomized controlled trial design. This potential is yet to be fully tapped because of methodological limitations. Studies have also not yet systematically evaluated virtual conferences in the context of chronic care using a high-quality research design.

The overall aim is to study if cross-sectoral and virtual specialist conferences improves diabetes care and increases diabetes competencies and management in general practice. The expectation is that the intervention will:

at the patient level:

* improve adherence to international recommendations on diabetes medication for patients with Type 2-diabetes (T2D)
* improve the risk profile of patients with T2D with a reduction in glycated haemoglobin, blood pressure and cholesterol

at the general practice level:

- improve the self-reported competence and confidence in management of patients with T2D among general practitioners and practice staff

The intervention consists of four virtual and thematic conferences: (1) T2D and cardiovascular disease and heart failure, (2) T2D and lipids, (3) T2D and kidney disease and blood pressure, and (4) T2D and a free topic selected by the general practitioner (GP). Before having the first virtual conference, an introductory webinar is held to learn GPs about how to use the electronic "Diabetes Overview" to identify and manage patients with T2D. Each general practice is assigned to an endocrinologist who they meet at all four conferences. The intervention was developed using the Medical Research Framework for developing complex interventions.

All general practices located in the Municipality of Aarhus, Denmark are invited (n = 100). Block randomization is performed at the general practice level, and general practices will be randomized in a 1:1 ratio to either the intervention or the control group.

Eligibility Criteria:
Inclusion Criteria:

* General practices are eligible for inclusion if licensed and located in the municipality of Aarhus.
* GPs must consent to participate in the intervention and collect the data needed to measure patient and general practice outcomes.
* GPs must agree to bring patient cases to the virtual conferences who are ≥18 years, diagnosed with T2D and who they would like to discuss with the endocrinologist.

Exclusion Criteria:

* None
A Study to Compare Two Paracetamol Tablets

This is a single dose pharmacoscintigraphic study investigating the differences in paracetamol absorption between two formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects who are in good general health
* Have not exceeded the limits of total radiation exposure (5mSv) allowed in any 12 month period