cyrilzakka/clinical-trials huggingface dataset:
Synergy Between Choline and DHA

The purpose of this study is to determine whether choline supplementation influences the availability of docosahexaenoic acid throughout pregnancy.

Metabolic synergy exists between choline, phospholipid, and polyunsaturated fatty acid metabolism. Previous evidence from our laboratory has shown that higher dietary choline intakes increase the amount of docosahexaenoic acid (DHA) incorporated into phosphatidylcholine (PC), as measured by PC-DHA concentrations in circulating erythrocytes. PC-DHA results from the production of PC through the phosphatidyl N-ethanolamine methyltransferase (PEMT) pathway and is critical for exporting fat from the liver to peripheral tissues. We are expanding this work to pregnant women, for whom DHA intake is critical to support the developing infant's growth, by undertaking a double blind, randomized controlled trial of choline supplementation (500mg) throughout the 2nd and 3rd trimesters of pregnancy. All women will consume 200mg of docosahexaenoic acid (DHA), a prenatal vitamin, and 25-50mg of deuterated choline (choline d9) daily throughout the duration of the trial. The use of a stable isotope will allow for modeling of choline dynamics throughout the 2nd and 3rd trimester of pregnancy, and calculate the activity of PEMT in pregnant women. Consenting participants will provide a baseline blood draw, followed by 2 additional blood draws throughout their pregnancies, and maternal/cord blood at birth, in addition to the placenta. This trial will test the hypothesis that choline supplementation increases the amount of PC-DHA in the blood of pregnant women and increase its supply to the developing fetus.

Eligibility Criteria:
Inclusion Criteria:

* healthy, singleton pregnant women gestational weeks 12-16, ages 21-40, willingness to comply with the study protocol

Exclusion Criteria:

* Habitually high choline/DHA intake
* Pre-pregnancy BMI \>32
* Pregnancy complications and comorbidities (at baseline and throughout the study)
* Current smokers, drinkers, or drug users
Epirubicin Versus Docetaxel Plus Cyclophosphamide in Lymph Node Negative, ER-positive, Her2-negative Breast Cancer

The purpose of this study is to compare the safety and efficacy of epirubicin plus cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node negative, estrogen receptor (ER) positive, human epithelial growth factor receptor 2 (HER2) negative breast cancer patients as adjuvant chemotherapy.

This is a non-inferiority study. According to previous study results, the investigators hypothesize the incidence of grade 3-4 neutropenia is 40%, with a α of 0.05 and β of 0.8, a sample size of 264 cases if needed.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18 years and \< 70 years with life expectancy \> 12 months
2. Have finished radical operation, pathologically verified no lymph node involvement
3. Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be with ER positive, Her2 negative tumor.
4. Adequate bone marrow function
5. Adequate liver and renal function
6. Has Eastern Cooperative Oncology Group (ECOG0 Performance Score 0-1;
7. Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study;
8. Written informed consent according to the local ethics committee requirements.

Exclusion Criteria:

1. Prior systemic or loco-regional treatment of breast cancer, including chemotherapy;
2. Metastatic breast cancer;
3. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma;
4. Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease;
5. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive;
6. History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension;
7. Has peripheral neuropathy ≥ grade 1;
8. Patient is pregnant or breast feeding;
9. Known severe hypersensitivity to any drugs in this study;
10. Treatment with any investigational drugs within 30 days before the beginning of study treatment.
Evaluation of the Functional Impact of Adenotonsilectomy

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery

Spirometric assessment of respiratory function before and after adenotonsillectomy surgery Study site at CHUPorto: Department of Otorhinolaryngology at CHUPorto, Portugal.

Study design: Institutional, observational, cohort, prospective. Classification of studies according to the law of clinical investigation (Dec. Law No. 21/2014): Clinical study without intervention. Main objective of the study: To collect a database referring to pediatric patients enrolled for surgery in an outpatient setting, in order to compare vital, spirometric and clinical parameters at two different times: pre and post surgical intervention.

Secondary objectives of the study: Based on validated indices, to assess the impact of surgical intervention on the child's respiratory and cardiovascular system. Participants: Patients undergoing surgery in the field of Pediatric Otorhinolaryngology at CHUPorto, a tertiary referral Hospital in Portugal.

Eligibility Criteria:
Inclusion Criteria:

* Age between 4-14 years;
* Patients with surgical indication for any combination of:

  * tonsillectomy
  * adenoidectomy
  * turbinoplasty
  * myringotomy;
* naive children (not submitted to previous ENT surgery);
* signature of informed consent by the parent entity.

Exclusion Criteria:

* Age under 4 years and over 14 years;
* surgery: myringotomy+TT placement exclusively;
* associated co-morbidities:

  * asthma/other obstructive lung diseases
  * congenital facial or thoracic dysmorphism
  * neurological disease with cognitive impairment
  * cardiopulmonary disease
* patients without surgical indication
* other causes of nasal obstruction (severe septum deviation or polyps).
COVID-19 and Psycological Well-being in Healthcare Workers

Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.

After signing informed consent and privacy informed consent subject are asked to complete questionaries presented as google modules.

No personal data are required.

Well-being of healthcare workers is assessed by specific questionaries validated for resilience, depression, anxiety, coping strategies and fear for COVID-19.

Data will be analysed to investigate levels of resilience in healthworkers that have been in contact with patients or relatives with COVID-19.

Intervention strategies engaged by subjects are monitored to understand unmet feedings to promote well-being.

Eligibility Criteria:
Inclusion Criteria:

* Healthworkers of San Raffaele Institution
* age\>18

Exclusion Criteria:

* all those who do not agree
A PK and Safety Study in Subjects With Hepatic Impairment

Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.

Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe hepatic impairment or matched control
* BMI between 18.0 and 40.0 kg/m2

Exclusion Criteria:

* Evidence of acute deterioration of hepatic function within 8 weeks
* ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes
* Total bilirubin \> 5 mg/dl for moderates; no upper limit for severes
* Hemoglobin \< 10g/dl for moderates; Hemoglobin \< 9g/dl for severes
Role of Apfel's Score in Predicting Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

The goal of this observational study is to assess the role of Apfel's score in predicting postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in patients with symptomatic cholelithiasis. The main questions it aims to answer are:

1. Does Apfel's score accurately predict the occurrence of PONV after laparoscopic cholecystectomy?
2. Which components of Apfel's score are most strongly associated with PONV?

Participants will undergo laparoscopic cholecystectomy under general anesthesia. Researchers will calculate each participant's Apfel score preoperatively, and postoperative outcomes, such as nausea and vomiting, will be monitored for 24 to 48 hours. Researchers will compare PONV incidence among patients with varying Apfel scores to determine if higher scores correlate with a higher risk of PONV.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 90 years.
* Patient scheduled for elective laparoscopic cholecystectomy for symptomatic cholelithiasis.
* Patients who provided written informed consent to participate in the study.

Exclusion Criteria:

* Patients receiving prophylactic antiemetic medications prior to surgery.
* Patients on opioid analgesics for reasons other than the surgical procedure.
* Pregnant women.
* Patients whose laparoscopic cholecystectomy was converted to open cholecystectomy during the operation.
Implementation of an Enhanced Rehabilitation Protocol After Liver Transplantation: Feasibility and Analysis of Results

Currently, there are no expert recommendations regarding enhanced rehabilitation after liver transplantation. The development of Enhanced Rehabilitation After Surgery (ERAS) protocols in major surgery, particularly cardiothoracic surgery, has motivated some anesthesia teams to extubate liver transplant patients earlier who meet predefined criteria (young patient, absence of comorbidities, absence of intraoperative transfusion) in order to limit the occurrence of complications of mechanical ventilation (pneumopathies, tracheal wound, muscle loss, etc.) On the other hand, improved rehabilitation in this case was often synonymous with early extubation in the operating room. Few studies, on the other hand, relate the implementation of a complete rehabilitation protocol including pre-, intra- and postoperative guidelines.


Eligibility Criteria:
Inclusion criteria:

* Major subject operated at HUS for a liver transplant whose management was scheduled in the Surgical Intensive Care Unit fbetween December 01, 2018 and August 31, 2020
* Subject who does not question, after information, the reuse of his data for the purpose of this research

Exclusion criteria:

* Subject having expressed his opposition to participate in the study
* Liver transplant patient hospitalized in the Medical Intensive Care Unit before or after the surgery
Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial

This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children \<2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.

This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children \<2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.

Eligibility Criteria:
Inclusion Criteria:

* admission to inpatient pediatrics
* clinical diagnosis of bronchiolitis
* BASS score of moderate or severe

Exclusion Criteria:

* non-english speakers
* patients with urgent need for CPAP, BIPAP or intubation
the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures

Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.

The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs)
* Affiliation to a social security scheme or beneficiary of such a scheme.
* Patient having signed the free and informed consent

Exclusion Criteria:

* Dementia
* Language barrier
* Claustrophobia
* Nausea
* History of intolerance to Virtual Reality
* Patient with epilepsy
* Refusal to participate in the study
* Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Unstable patient (state of shock, respiratory or neurological distress)
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation

This study is to evaluate whether the dynamic Medial Patellofemoral Ligament (MPFL) reconstruction as described by Becher is a successful operation technique to prevent patella instability and restore quality of life. It is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction

The recurrent dislocation rate of conservatively treated chronic patellar instability is high, therefore, it is recommended to manage it surgically. A frequently used surgical technique is static medial patellofemoral ligament (MPFL) reconstruction (e.g. Schöttle-technique). A novel dynamic surgical technique according to Becher was developed, addressing the most common complications occurring in static reconstruction, which are malpositioning and overtensioning of the graft. This study is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with isolated dynamic (operation procedure according to Becher et al.using the gracilis tendon) or static MPFL plastic (operation procedure according to Schöttle et al. using the gracilis tendon). MPFL reconstruction will be performed in patients with preceding patella dislocation with: 1) a Patella-Instability-Severity (PIS) score ≤ 3 with concomitant flake fracture or 2) a PIS score ≥ 4 with clinical asymptomatic trochlea dysplasia (patella stability between 30°-60° knee flexion) without other clinically relevant static risk factors.
* Closed growth plates

Exclusion Criteria:

* Combined procedures with trochleoplasty (high grade trochlea dysplasia, type Dejour C,D with clinical instability between 30° and 60° of knee flexion)
* combined procedures with cartilage transplantation
* High grade patellofemoral arthritis (Kellgren Lawrence score ≥3)
* combined procedures with femoral or tibial osteotomy
* Clinically eminent valgus axis (\>15° valgus)
* Femoral internal rotation \>20°, tibial external rotation \>40°
* Instability of the cruciate or collateral ligaments
* Known significant musculoskeletal disease
* Cognitive impairment
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase

1a and Phase 1b. Phase 1a has 2 stages, skin/subcutaneous lesions stage, deep (visceral) lesions stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18-75
* Patients with malignant solid tumors that have been diagnosed by pathology and/or cytology
* Patients who have progressed on or who cannot tolerate available therapies or for whom curative therapy does not exist
* Patients with at least one non-injected measurable tumor lesion per RECIST v1.1
* Patients with lesions suitable for intratumoral injection (the lesion length is at least 10mm and not exceeding 80mm)
* Patients enrolled in the Skin/subcutaneous lesions and deep （visceral） lesions stages of Phase Ia must agree to provide pre- and post-treatment tumor biopsy tissues
* Patients must have adequate organ and marrow functions
* Patients with treated brain metastases are eligible if meeting protocol's requirement
* Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C), hormonal, biological, targeted agents, other investigational therapy or radiotherapy

Exclusion Criteria:

* Patients who have received prior IL-12 either alone or as part of a treatment regimen
* Patients who have received prior therapy with an immuno-oncology agent and were discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE)
* Patients requiring therapeutic doses of anticoagulation
* Patients with tumors that impinge on major airways, blood vessels, or nerve bundles
* Patients with a history of autoimmune disease that has the possibility of recurrence or active autoimmune disease that requires immunosuppressive medications
* Patients who had a major surgical procedure within 4 weeks prior to the first dose of study treatment
* Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of study treatment
* Patient with history of solid organ or allogenic bone marrow transplantation
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents


Eligibility Criteria:
Inclusion Criteria:

* Healthy adolescents 11-18 years of age
* virgins (both male and female) with no intention of becoming sexually active during the study period
* who have been properly vaccinated against diphtheria, tetanus, pertussis

Exclusion Criteria:

* who had a previous confirmed or suspected disease caused by N. meningitidis;
* who have previously been immunized with a meningococcal vaccine
* who have received prior human papillomavirus (HPV) vaccine;
* who have any serious acute, chronic or progressive disease
* who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired
* who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
* who have Down's syndrome or other known cytogenic disorders;
Effect of Acupuncture on Patients With Crohn's Disease in Remission

To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

1. Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD
2. Effect of acupuncture on brain functional activity of CD

Eligibility Criteria:
Inclusion Criteria:

1. aged 16-70;
2. patients in remission (CDAI \< 150);
3. patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
4. those who did not use TNF alpha and other preparations within 3 months before entering the study;
5. those who have never experienced acupuncture;
6. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;
2. patients with serious organic diseases;
3. patients diagnosed as psychosis;
4. patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.