cyrilzakka/clinical-trials huggingface dataset:
Application of New Technologies and Tools to Nutrition Research

The overall objective of the research is to develop new methods for studying the link between diet, health and disease.

The enquiry consists of two part. A metabolomic biomarker discovery study followed by a randomised controlled trial of moderate dietary induced weight loss.

A cohort of moderately overweight men and women will undergo a metabolomic study follow by randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week period. This intervention will improve the volunteer's body composition and reduce their risk of developing diabetes.

Extensive tests will be conducted before and after the dietary intervention using emerging technologies with current state-of-the-art methods. These tests will monitor the numerous physiological adaptations that have occurred on a gene, cell, organ and organismic level.

The study will, therefore, aim for a scientific breakthrough by developing a series of novel biological "markers" that can accurately determine an individual's health status.

Eligibility Criteria:
Inclusion Criteria:

* Healthy overweight volunteers (body mass index (BMI) of 25-30 kg/m2)
* Age between 50-65 years

Exclusion Criteria:

* Weight change of ≥ 3kg in the preceding 3 months
* Current smokers
* Substance abuse
* Excess alcohol intake
* Pregnancy
* Diabetes
* Cardiovascular disease
* Cancer
* Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
* Kidney disease
* Liver disease
* Pancreatitis
* Have any metallic or magnetic implants such as pacemakers
* Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
Iron Mediated Vascular Disease in Sickle Cell Anemia Patients

The purpose of this research study is to determine the frequency and severity of iron overload in patients with Sickle Cell Anemia and its relationship to blood vessel function. The investigators hypothesize that intermittent transfusions that these patients receive during hospitalizations produces significant iron overload and impairs blood vessel relaxation.

Patients with sickle cell anemia often require blood transfusion as part of the treatment for their disease. Each teaspoon of transfused blood contains about 5 mg of iron and the levels of iron in sickle cell patients increase rapidly with each transfusion. While iron is necessary for many bodily functions, too much iron damages blood vessels, liver, hormone producing glands (pancreas, pituitary and thyroid) and the heart. It is important to know how iron damages blood vessels because most of the problems experienced by sickle cell anemia patients (stroke, kidney failure, pulmonary hypertension, heart disease) result from blood vessel damage. In this trial, iron in the liver, pancreas, and kidney will be measured noninvasively by MRI while vascular function will be measured by ultrasound and tissue Doppler. Patients will be recruited primarily from the greater Los Angeles area, although patients from greater distances will be allowed to participate.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 13 years
* Documented diagnosis of sickle cell anemia (SS, SC, Sß0, Sß+)
* Transfused no more than 8 times in a year.

Exclusion Criteria:

* Cardiac pacemaker, implantable neurostimulator or other MRI incompatible device.
* History of extreme claustrophobia in MRI machine or other reason for inability to do MRI without sedation.
* Inability to be positioned on the MRI table for sufficient time to complete the MRI exams.
* Any medical or psychological condition that, in the opinion of the local investigator, would make it unsafe or ill-advised for the subject to participate.
* Currently not receiving chronic transfusion therapy, defined as greater than 8 transfusions per year.
Pulsatile Pressure Waveform to Confirm Correct Placement of the Epidural in Laboring Patients

Epidural analgesia is highly effective for labor pain relief and is widely chosen by pregnant patients. However, placement of the epidural needle can be challenging in pregnant patients due to lax tissue ligaments and edema so that the traditional loss of resistance method (LOR) used to find the space may be subtle leading to retries which may delay onset of analgesia as well as increase the risk of complications. The ability to transduce a pulsatile pressure waveform from epidural needles placed in non-laboring patients correlates highly with successful placement of the epidural needle. We wish to evaluate the efficacy of obtaining a pulsatile pressure waveform with correct epidural needle placement in laboring women.

Patients requesting epidural labor analgesia will be eligible for recruitment. After written informed consent is obtained, placement of monitors and aseptic technique, the 17G epidural needle will be placed using the loss of resistance (LOR) technique to air or saline at the lumbar level chosen by the anesthesiologist. When LOR occurs, the needle will then be filled with 2 mL NaCl 0.9% from that syringe and the pressure monitoring accessory will be connected to the needle. The second investigator will then connect the high pressure tubing to the acessory without touching it, and the pressure will be zeroed at level of the needle insertion. Pressure will then be transduced and the waveform, recorded. An epidural catheter (SIMS Portex) will then be passed through the needle and advanced 5 cm beyond the tip of the epidural needle. After securing the epidural catheter in place, the patient will be placed on the lateral position. The catheter will then be filled NaCl 0.9% from a syringe and a high-pressure tubing extension leveled at the spine level will be connected to the catheter and the pressure will be transduced and recorded. Data recorded will include 2 parameters: 1) The presence or absence of a pulsatile waveform, and 2) The actual pressure read at the epidural space, in mmHg. Those readings will be obtained in 2 distinct moments: at a " rest" state, meaning during an interval between contractions, and at an "active" state, during the first contraction after the epidural catheter is placed. A test dose of 3 mL of 2% lidocaine with epinephrine1:200.000 will then be given to exclude potential spinal or intravascular injection. After 3 minutes, a loading dose of 10mL of 0,125% bupivacaine will be given for labor analgesia and the presence or absence of a bilateral sensorial block at T10 or higher at 30 min will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Female Patients
* ASA I-III
* Term Pregnancy (\>37 weeks)
* 18 years or older
* Early Labour (\<6 cm of cervical dilation)
* BMI\<40

Exclusion Criteria:

* Any contraindication to epidural analgesia placement (coagulopathy, sepsis, infection at site, increased ICP, hypovolemia, unstable ischemic heart disease, unstable neurologic disease, severe aortic stenosis, prior spinal surgery, LA allergy)
* Serious concern for maternal or fetal wellfare.
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
* Body mass index between 18.5-34.9 kg/sqm (both inclusive)
* Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration
* Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment
Moxifloxacin vs. Polytrim for Conjunctivitis

The purpose of the study is to compare the effect of Polytrim Ophthalmic Solution and Moxifloxacin Ophthalmic Solution in treating your child's pink eye. Both these medications are approved by the Food and Drug Administration, for treatment of conjunctivitis. This study will investigate if both of the medications are equally good.


Eligibility Criteria:
Inclusion Criteria:

* 1 - 18 years of age with presumed bacterial conjunctivitis.

Exclusion Criteria:

* Previous antibiotics or to receive systemic antibiotic.
A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety in Asian subjects with type 2 diabetes mellitus.

This is a multi-center, active-controlled, double-blind, double-dummy, parallel-group comparative study. After a screening period followed by a placebo run-in period under the single-blind condition, subjects will be randomized to either the ASP1941 or the acarbose group. Subjects will take the study drug under the double-blind condition in the treatment period. After completion of the study drug administration, a follow-up period will be provided.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
* stable diet and exercise program for at least 6 weeks before the study
* for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
* BMI of 20.0 to 45.0 kg/m2
* for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
* for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period

Exclusion Criteria:

* type 1 diabetes mellitus
* proliferative diabetic retinopathy
* receiving insulin within 12 weeks prior to the study
* history of clinically significant renal disease(s)
* significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
* urinary tract infection or genital infection
* continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
* history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
* severe infection, serious trauma, or perioperative subject
* known or suspected hypersensitivity to ASP1941, acarbose or other alpha-GI
* history of treatment with ASP1941
* participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
* serum creatinine value exceeding the upper limit of normal range
* urinary microalbumin/urinary creatinine ratio \>300 mg/g
Motor Imagery Ability After Stroke

Individuals with stroke may experience sensory-motor deficit and/or neglect, with possible reduction in motor imagery ability (MI). To our knowledge, no study completely investigated MI ability in one individual whereas MI practice can be performed using visual or kinesthetic modalities (respectively visualizing with mind's eyes or imagining movement using sensation) and internal or external perspectives (performing action as spectator or as actor). This study aims to investigate MI ability in patients with stroke as compared to aged-matched healthy individuals. The investigators will assess explicit MI ability using 3 questionnaires (Movement Imagery Questionnaire-RS - MIQ-RS, Kinesthetic and Visual Imagery Questionnaire-20 - KVIQ-20, Vividness of Movement Imagery Questionnaire-2 - VMIQ-2) and 2 tests (imagined Time Up and Go - iTUG, imagined Box and Block test - iBBT). Outcome parameters will be i) the composite score of vividness measured for all tests using Likert scales, ii) the temporal equivalence between MI and Physical practice (PP - where MI/PP ratio equal to 1 indicate good MI ability and respect of temporal equivalence between MI and PP) and iii) the amplitude of electrodermal activity. The investigators will also study implicit MI ability using a hand laterality judgment task. Outcomes parameters will be response time (i.e. the duration to identify the hand laterality) and the percentage of correct responses.


Eligibility Criteria:
Inclusion Criteria:

For both groups:

* be more than 18 years old
* be less than 75 years old
* benefit from social security

For experimental group:

* patient admitted in Henry Gabrielle hospital for rehabilitation
* patient with one single episode of stroke

Exclusion Criteria:

For patients:

* sign of cognitive decline (MMSE score under 27/30)
* evolutionary pathology associated

For healthy subjects:

- neurological or orthopaedical history
Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)

A clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.


Eligibility Criteria:
Inclusion Criteria:

* Patient has type 2 diabetes mellitus
* Male
* Female that is highly unlikely to become pregnant
* Patient is not on an antihyperglycemic agent (AHA) (hemoglobin A1c \[A1C\] 7-10%) or on oral single AHA or low-dose combination therapy (A1C 6.5-9.0%)

Exclusion Criteria:

* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
* Patient has required insulin therapy within the past 12 weeks
* Patient is on or has been taking a Peroxisome Proliferator-Activated Receptor-gamma (PPAR -gamma) agent (i.e. Thiazolidinediones \[TZDs\]) within the prior 12 weeks of the screening visit.
Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

In stage 3 NSCLC, treatment and follow-up are generally performed in a 'one-size-fits-all' manner. In the setting of metastatic lung cancer there has been considerable success identifying biomarkers, which allow treatments to be tailored and lead to more personalised medicine. In patients with stage 3 disease there exists a significant unmet clinical need for equivalent biomarkers to guide treatment decisions such as to identify poor responders, predict benefit from treatment and diagnose relapse before standard of care imaging. Recent advances have made it possible to detect and quantify circulating-tumour DNA in peripheral blood of patients with stage 3 NSCLC, a promising prognostic biomarker and a measure of minimal residual disease. In addition, the information contained in routine medical images and electronic patient reported outcome measure (ePROM) questionnaires can add further predictive power to circulating tumour DNA and other clinical factors to determine patient's outcome. There is scope to integrate biomarkers in treatment decision algorithms aiming to make personalised treatment modifications (e.g. decision to treat with immunotherapy or not). VIGILANCE is a highly exploratory observational study to understand how these biomarkers might inform a future hypothesis driven interventional study.


Eligibility Criteria:
Inclusion criteria:

* Histological or cytologically confirmed NSCLC.
* Unsuitable for surgery due to tumour or patient factors.
* Stage 3 A, B or C (TNM version 8).
* Planned to receive radical radiotherapy OR sequential chemoradiotherapy OR concurrent chemoradiotherapy +/- consolidation immunotherapy.
* Predicted life expectancy \>12 weeks.
* Ability to provide written informed consent.
* Willingness to comply with study procedures.

Exclusion criteria:

* Mixed non-small cell and small cell tumours.
* Adjuvant radiotherapy post-surgery.
* Participation in a study of an interventional study as part of lung cancer treatment.
* Recent/active malignant disease which might impact study results.
* Psychotic disorders/cognitive impairment.
Study of Edecesertib in Participants With Cutaneous Lupus Erythematosus (CLE)

The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in participants with CLE. Information on what is happening in the body relating to CLE, how the body processes, is affected by and responds to the study drug, and any study drug side effects will also be collected in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Either fulfill European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 classification criteria for systemic lupus erythematosus (SLE) and/or have biopsy confirmed Cutaneous Lupus Erythematosus (CLE) at any time.
* Must have active CLE at screening and Day 1. Individuals with acute CLE (ACLE) must have involvement of 2 distinct body areas.
* Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening.
* Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points.
* Must have documented prior intolerance or inadequate response at any time (per investigator judgement) to protocol-specified treatments.

  * Topical corticosteroids or topical calcineurin inhibitors.
  * Oral corticosteroids.
  * Any other nonbiologic standard-of-care therapy, including, but not limited to: chloroquine, quinacrine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
* Individuals willing to comply with all study visits and assessments.

Key Exclusion Criteria:

* Individuals with only chilblains lupus, lupus panniculitis, lupus tumidus and/or localized acute CLE involving only 1 distinct body area at screening and Day 1.
* Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis).
* Presence of active skin conditions other than cutaneous lupus that may interfere with assessing lupus-specific skin lesion(s) (eg, psoriasis, and/or drug-induced lupus).
* Meet protocol-specified infection or lab criteria.

  * Any active infection that is clinically significant (per investigator judgment).
* Any history of clinically significant liver disease.
* Significant cardiovascular disease.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test

This is a study to determine if HC2 HPV testing in the anal canal can detect high-risk HPV and whether this aids in identifying individuals are risk for anal cancer or precancerous lesions.


Eligibility Criteria:
Inclusion Criteria:

1. male or female 18 years of age or older
2. screened for anal dysplasia, including MSM and women -

Exclusion Criteria:

1. subject has had a previous treatment for anal cancer.
2. subjects that have used enemas or other foreign substances, in the anal canal or anal sex within 24 hours of collection.
3. subjects that have bleeding disorders or use anticoagulation treatments. -
Platelet Function During ECMO (Extra Corporeal Membrane Oxygenation)

Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment. The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane. Platelet transfusions carry risks such as infections with bacteria or yeast, and development or worsening of pulmonary hypertension. It is likely that if fewer platelet transfusions can be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and patient outcomes improve. In order to better understand platelet function during ECMO, the investigators plan to serially determine the circulating platelet mass, plasma platelet factor 4 concentration, megakaryocyte mass (estimated by plasma thrombopoietin concentration), and platelet function as quantified by PFA100. Any patient on ECMO will be eligible for this pilot study of 5 patients. By understanding changes in platelet function, we hope to design a future study that may modify the frequency or need for platelet transfusions during ECMO.

Platelet transfusions are routinely administered during neonatal ECMO, with an average of 1.3 platelet transfusions per day being administered while a patient is undergoing ECMO treatment.1 In general, a platelet transfusion is ordered for a patient on ECMO if the platelet count falls below 100,000/uL in order to prevent generalized hemorrhaging.1,2 The cause of thrombocytopenia during ECMO largely involves platelet adherence to the oxygenator membrane,3 but other mechanisms are also likely to be involved.4 Platelet transfusions carry risks as well as benefits.5 Infections with bacteria or yeast are the most commonly reported complications of platelet transfusions,6,7 but with multiple platelet transfusions the development or worsening of pulmonary hypertension may be another common adverse effect.8,9 Pulmonary hypertension can be the result of administering biologically active pro-inflammatory proteins (known to be present in platelet transfusions) into the venous circulation. Of note, the first capillary bed encountered will be within the pulmonary circulation.

It is likely that if fewer platelet transfusions could safely be administered during the ECMO run, the cumulative adverse effects of platelet transfusions would diminish and thereby patient outcomes might improve.

Eligibility Criteria:
Inclusion Criteria:

* Any patient on ECMO will be eligible for study.