cyrilzakka/clinical-trials huggingface dataset:
The DHA (Docosahexaenoic Acid) Oxford Learning and Behaviour (DOLAB) Study

The purpose of this study is to determine whether DHA (in a daily dose of 600 mg.) will improve the behaviour and learning of normal children aged 7-9 years in mainstream state schools who are underperforming according to nationally standardized tests.

The study has two stages, as its primary aim is to find out whether there is a real link between children's fatty acid status and their reading and behaviour. Previous reviews have stated the importance of objective measures, as did our referees.

We will aim to address this by using well validated tests of reading and behaviour, and comparing results from these with children's fatty acid status as assessed from a pinprick blood sample. In Stage 1 we will primarily aim to establish the degree of association between fatty acid status and reading and behaviour. Secondarily, we will look at whether the children who have a higher DHA status have better sleep, and whether in turn they have better reading and/or behaviour, as previous work has suggested this.

In Stage 2 we aim to carry out a randomised trial where children will be given either DHA or a taste- and appearance-matched dummy capsule for 16 weeks. Neither the children, parents nor the researchers will know which children will get which treatment until the study is over.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 7 - 9 years from mainstream state schools who are underperforming in literacy skills according to nationally standardized assessments of scholastic achievement at age 7 years (Key Stage 1 ). To be eligible, children must score below the 33rd centile for reading/writing, but within the normal range in at least one other domain.
2. English as a first language.

Exclusion Criteria:

1. Major learning disabilities or medical disorders
2. Taking medications expected to affect behaviour and learning
3. Taking fish oils already, or eating fish 2 times or more a week
Benefit of Follicular Flushing During Oocyte Retrieval for Poor Responder Patient in an Assisted Reproductive Technology Program

The object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. The investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) have to be included. All patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, Group A: Oocyte retrieval is performed with a single lumen aspiration needle 17G. Group B: Oocyte retrieval is performed with a double lumen aspiration needle 17G. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20CC of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. First criterion of our comparison is the number of oocyte retrieved. Second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. In Group B the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. Then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing an IVF or ICSI treatment
* long agonist, antagonist or short stimulations protocols
* less than 5 follicles of 14mm or more day of HCG
* Major patients aged under 43 years
* patient within a couple married or can prove a married life of over 2 years

Exclusion Criteria:

* all the cons indication to the oocyte retrieval
* oocyte donor
* Couple supported viral loop
* Patient does not speak French or unable to give informed consent
* Patients major protected
* Patients with biopsy performed on weekends are also excluded due to unavailability of adequate personnel and equipment
* Absence of follicles
Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.


Eligibility Criteria:
Inclusion Criteria:

* Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.

Exclusion Criteria:

* Medical records for the subject are not available for review or tabulation
* Subject did not comply with pre-operative or post-operative instructions.
Analysis of the Sweat Response According to the Pathology in Neurologic Patients

Cardiovascular autonomic neuropathy (CAN) has been shown to be an important risk factor for cardiac diseases, particularly in diabetes.

CAN may be investigated by a battery of laboratory cardiovascular autonomic reflex tests(initially described by Ewing).

First screening for CAN (as proposed in diabetic patients) can be performed by assessing heart rate (HR) response to deep breathing, blood pressure (BP) and HR response to a 5 minutes stand test

Sweat glands are innervated by thin and un myelinated sympathetic C-fibers that can be impaired in neuropathies,especially length-dependent ones. Sweating dysfunction has been shown in several neurological peripheral disorders and it has been suggested that sweating function should be included among the diagnostic tests for the early detection of autonomic neuropathies. Several methods have been developed, but the lack of easy and quick tests to diagnose sweating dysfunction has restricted widespread use in clinical practice. Measurement of electrochemical skin conductance (ESC) using Sudoscan® is a new method for quick, non-invasive and quantitative assessment of sweating. This technique has demonstrated its usefulness in detecting autonomic and small fiber neuropathy, especially in diabetic patients.The aim of this study was to evaluate the performance of the laboratory battery of CV tests and of sweating dysfunction by Sudoscan®, alone or in combination, to differentiate MSA-P from PD. Among the CV tests, the present study particularly looked at those tests already recommended as screening bedside tests in diabetic patients (HR variations with deep breathing and BP variations during stand test) ; these tests are rapid and easy to perform. HR variations with deep breathing depend on parasympathetic tone and BP variations depend on vasomotor sympathetic response.

Eligibility Criteria:
Inclusion Criteria:

* Patients with MSA-P or PD

Exclusion Criteria:

-
Effect of Altered Mechanical Loading in ACLR

Altered loading is a causative factor for the development of knee osteoarthritis following anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an effective intervention to manipulate altered mechanical loading about the knee. The purpose of this study is to 1) determine if ACLR participants are able to acquire and retain various loading patterns using real-time biofeedback, 2) determine the effect of altered loading on lower extremity biomechanics during walking gait, and 3) determine the effect of altered loading on biochemical markers of collagen turnover and inflammation during walking gait.

Participants will attend 4 testing sessions. Lower extremity biomechanical outcomes and blood samples will be taken before and following the participant walking at a self-selected speed for 20 minutes. During the 20 minutes of treadmill walking real-time biofeedback will be displayed in an attempt to alter mechanical loading. Participants will complete a control, overloading, under-loading, average loading testing session. Order of loading condition will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Have a history of a primary, unilateral ACLR using either a hamstring or patellar tendon autograft, cleared by a physical for full return to physical activity with no limitations, and participate in at least 30 minutes of physical activity 3 times per week

Exclusion Criteria:

* History of injury to either leg, other than ACLR (e.g. ankle sprain, muscle strain), within 6 months prior to participation in the study, history of lower extremity surgery other than ACLR, history of osteoarthritis or current symptoms related to knee osteoarthritis (e.g. pain, swelling, stiffness), currently pregnant, or planning to become pregnant while enrolled in the study, cardiovascular restrictions that limit the participant's ability to participate in physical activity.
Investigation of the Effect of I-PRF Application on Pain in Alveolitis

Literature review showed that there are no studies on the use of i-PRF in alveolitis cases. The aim of this study was to investigate the effect of i-PRF on the treatment of alveolitis. The hypothesis of the study was that i-PRF applied to alveolitis patients would reduce pain.

The present study will include 60 healthy patients over 18 years of age with alveolitis. 60 patients will be randomly divided into two groups: Control and I-PRF. After irrigation of the sockets, no substance will be applied to the control group, and I-PRF will be applied to the study group. Postoperative pain will be measured on the 3rd and 7th days.

Eligibility Criteria:
Inclusion Criteria:

Healthy individuals without systemic disease Patients with complete data and attending their appointments

Exclusion Criteria:

Patients who smoke Pregnant or breastfeeding female patients with bleeding disorders and diabetics Patients currently or previously using bisphosphonates or receiving radiotherapy to the jaw Patients unable to consent to participate in the study
A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed adenocarcinoma of the colon or rectum. Participants must have recurrent, unresectable or metastatic disease
* Be diagnosed to have KRAS, NRAS, and BRAF wild-type (WT) tumor as determined by local testing
* Must agree to the submission of fresh or archival tumor tissue post-progression from the most recent therapy, if clinically feasible
* Have measurable disease according to RECIST v1.1
* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
* Participant must have received 1 line of systemic therapy (fluoropyrimidine-based and oxaliplatin-based) for metastatic colorectal cancer (mCRC), with documented radiographic disease progression on or after this line of therapy

Exclusion Criteria:

* Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: amivantamab, cetuximab or bevacizumab or any component of FOLFIRI
* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status who has not received immunotherapy treatments
* Participant with known human epidermal growth factor receptor 2 (HER2)- positive/amplified tumor
* Has prior exposure to irinotecan, any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19

Multicenter observational/registry study of the clinical features and outcomes of critically ill patients with COVID-19.

The goals of this project are to determine the independent risk factors for hospital mortality and acute organ injury, and to identify treatment strategies associated with improved survival. Additionally, we will assess outcomes according to differences in geographic and institutional parameters.

Eligibility Criteria:
Inclusion Criteria (each of the following):

1. Adults (aged ≥18 years)
2. Laboratory-confirmed diagnosis of COVID-19
3. Hospitalized in the ICU for illness related to COVID-19

Exclusion Criteria:

-None
Atkins Diet and Prostate Cancer Clinical Trial

This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).

Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer. While a very effective anti-cancer treatment, ADT is associated with significant toxicity including but not limited to major metabolic disturbances including impaired glucose tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates within the diet will prevent or at least minimize these consequences.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate
2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
3. Overweight or obese (body mass index ≥ 25 kg/m2)

Exclusion Criteria:

1. Symptomatic metastatic disease
2. Myocardial infarction within 6 months
3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
4. Patient consuming a low-carbohydrate diet
5. Medical conditions or co-morbidities that preclude participation in the protocol
6. Vegetarians
Clinical Trial to Evaluate the Effect of a Probiotic Product on Weight

The study of the intestinal microbiota and its relationship with health and disease, as well as the use of probiotics as effective alternative treatments to improve people's well-being is a field of growing research in recent years.

Overweight and obesity are increasingly common due to the current lifestyle, but this is not incompatible with the growing interest of the population in taking care of themselves, both physically and psychologically, and, in general, the interest in food supplements, including those based on probiotics, is increasingly common.

The objective of the clinical trial is to evaluate the effectiveness of a food supplement based on probiotics to reduce body weight in 104 volunteers with overweight and type I obesity (BMI 25 - 34.9 kg/m2).

This randomized, double-blind and placebo-controlled clinical trial has a 12-week intervention period, during which subjects have to take a daily dose of the product (probiotic or placebo).

In this trial, anthropometric clinical data, the effect of the intervention on blood parameters and the composition of the intestinal microbiota will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years.
* Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I).
* Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study.
* Signing of informed consent.

Exclusion Criteria:

* Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain.
* Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study.
* Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months.
* Treatment with antibiotics in the previous 4 weeks.
* Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks.
* Consumption of products containing probiotics in the previous 2 months.
* Contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients.
* In the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.
Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay

This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.


Eligibility Criteria:
Inclusion Criteria:

* The subject is chronically infected with HBV.The subject is treatment naïve and is initiating HBV antiviral therapy with either entecavir or tenofovir as indicated in the FDA approved label
* The subject will be considered treatment naïve if he/she had \<12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
* The subject is at least 18 years of age at the time of enrollment
* Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
* The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)

Exclusion Criteria:

* Subject is in one of the following patient populations:

  * Acute HBV infection
  * Patients who are HBV immune tolerant
  * Human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) co-infection
  * Solid organ or bone marrow transplant recipients
  * Renal failure or dialysis
  * Evidence or history of hepatic decompensation
  * Evidence or history of hepatocellular carcinoma
* Underlying liver disease other than HBV
* Receiving chemotherapy, immunosuppressive agents
* Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
* Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study
A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children

The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery.

The POPSICLE study is a multi-centre, international research study that will investigate the prevalence, risk factors and consequences of chronic post-surgical pain (CPSP) in children 0-16 years undergoing the following common paediatric surgeries: laparoscopic appendicectomy, scrotal exploration, orchidopexy, hypospadias repair and circumcisions. CPSP as well as risk factors and their association with chronic pain, including parent and child anxiety, pre-existing pain, peri-operative pain experience and acute post-operative management, will be assessed through a series of longitudinal questionnaires at 6 timepoints from pre-surgery to 10-12 months post-surgery. Baseline measures will be completed pre-operatively and post-surgery measures of pain and function will be undertaken at Day 2, 3-4 weeks, 3-4 months and 10-12 months post-operatively.

Chronic pain has a significant effect on children's quality of life, negatively impacting their physical, emotional and social health as well as schooling. Additionally, adolescent chronic pain is associated with higher rates of depression, anxiety, feeling of helplessness and lack of autonomy compared to healthy children. Therefore, evidence-based knowledge from this research will inform perioperative practice minimising the risk of a child going on to develop chronic post-surgical pain. This will benefit the child, their family and the healthcare system by aiding in the formulation of practice guidelines to follow high risk children more closely to treat any potential persistent pain earlier to avoid the development of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

The patient is undergoing a surgical procedure in either group elective (circumcision, hypospadias, orchidopexy, laparoscopic appendicectomy) or group emergency (laparoscopic appendicectomy, scrotal exploration)

Exclusion Criteria:

The parent and child have inadequate English language skills to understand the questionnaires

Children with significant/severe developmental or cognitive delay based on a formal diagnosis.

Families that are unable to complete the long-term follow up surveys.
Comparing Efficacy and Safety of Thrice Daily Versus Twice Daily NovoMix® 30 (Biphasic Insulin Aspart 30) in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

This trial is conducted in Asia. The aim of the trial is to compare efficacy and safety of thrice daily versus twice daily NovoMix® 30 (Biphasic insulin aspart 30) in subjects with type 2 diabetes inadequately controlled with basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing informed consent. For Algeria only: age at least 19 years at the time of signing informed consent
* Type 2 diabetes subjects clinically diagnosed for at least 12 months prior to the day of screening (Visit 1)
* Treated with basal insulin for at least 90 days prior to the day of screening (Visit 1). The following basal insulin are allowed : insulin analogue once daily (OD) Neutral Protamine Hagedorn (NPH) OD or BID (twice daily)
* Treatment with metformin with or without one additional OAD (oral antidiabetic drug) for at least 90 days prior to the day of screening (Visit 1) Metformin must be at a stable dose of at least 1500 mg daily or maximum tolerated dose for at least 60 days prior to screening (Visit 1) One additional OAD:Sulphonylurea/Glinides/ a-glucosidase inhibitors/Dipeptidyl-peptidase-4 inhibitors/Sodium glucose co-transporter 2 (SGLT2) inhibitors (if applicable)
* HbA1c (glycosylated haemoglobin) 7.5%-10.0% (both inclusive) by central laboratory analysis at screening (Visit 1)
* Able and willing to intake three main meals daily (breakfast, lunch and main evening meal) throughout the trial. Definition of main meal as judged by the investigator

Exclusion Criteria:

* Previous insulin intensification regimen for more than 14 days: premixed insulin thrice daily, basal-bolus regimen or continuous subcutaneous insulin infusion (CSII). Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days
* Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, systemic corticosteroids)
* Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit at screening (Visit 1)