cyrilzakka/clinical-trials huggingface dataset:
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.


Eligibility Criteria:
Inclusion Criteria:

* Premature infant 28 to 33 weeks gestational age, inclusive, at birth
* Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
* Birth weight is greater than or equal to 700g to 1750g
* Appropriate birth weight for gestational age
* Singleton or twin birth
* Signed Informed consent

Exclusion Criteria:

* Infant's mother plans to exclusively breast feed
* 5 minute APGAR score is less than or equal to 4
* Major surgery that required general anesthesia prior to randomization
* Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
* Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
* Infant is currently participating in another clinical study
Foot Orthoses & Hallux Limitus in School-age Children

The most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations.

In the propulsion phase, once the hallux touches the ground, it does not move again until the moment of take-off, so when there is a limitation of the plantar flexion of the hallux, the compensation of this is appreciated in other anatomical locations during gait analysis.

For the propulsion phase to be effective, the first metatarsophalangeal joint must be maximally dorsiflexed.

If any structure or movement is altered, the axis varies. In the hallux, the joint surface on which the movement is performed is reduced and therefore affected at the dorsal level, causing a limitation of the main movement of this joint; dorsiflexion in closed kinetic chain, known as functional hallux limitus.

It is for this reason that it is proposed to study the application of plantar supports to favor the movement of dorsiflexion of the first metatarsophalangeal joint and avoid an early establishment of the hallux limitus.

Eligibility Criteria:
Inclusion Criteria:

* Interest in participating and completing the phases of the study and signing of the informed consent by the parents. Patients who do not meet any exclusion criteria will be included.

Exclusion Criteria:

* The exclusion criteria will be refusal to sign the informed consent, hypermobility, neurological diseases, previous traumatic history affecting one or both lower extremities, rheumatic pathologies, as well as patients with an angular value of the first metatarsophalangeal joint less than 10º and ankle flexion less than 10º with the knee in extension.
CapFlex-PIP© Motion

The purpose of this study is to describe and to compare the motion analysis parameters, i.e. motion and stability of proximal interphalangeal joints, which were treated with a CapFlex-PIP© implant or silicone implant and to generate basic knowledge about motion analysis of untreated healthy hands.


Eligibility Criteria:
Inclusion Criteria:

* Patients with proximal interphalangeal joint osteoarthritis in the index or middle finger, treated with a CapFlex-PIP© implant or with a silicone implant and with a follow-up time between 12 and 60 months after primary implantation or
* Patient with one untreated healthy hand without joint osteoarthritis
* Patient aged 50 years and over
* Patient willing and able to give written informed consent to participate in the study

Exclusion Criteria:

* Inflammatory disease (e.g. rheumatoid arthritis)
* Pregnant women
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Legal incompetence
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Phase I Pilot Study to Evaluate the Anti-glioblastoma Effect of S-Gboxin in Standard Treatment of Glioblastoma/Diffuse Midline Glioma and Response to Treatment (Regardless of Mutation Status)

The objective of this pilot study is to evaluate the efficacy of adding S-Gboxin to standard RT/TMZ treatment protocols in patients with glioblastoma multiforme (GBM) or midline glioma (DMG), regardless of their mutation status

This is a pilot study to evaluate the efficacy of adding the mitochondrial oxidative phosphorylation inhibitor S-Gboxin (OXPHOS) to standard treatment for glioblastoma multiforme or glioma.

Subjects will start oral S-gboxin orally twice daily and will evaluate the patients and vital status if they tolerate this dose at 3, 7and 15 days after initiation.

Patients will undergo MRI scans before treatment and then at multiple time points during their participation in this Clinical Trial to monitor early tumor response to treatment ( MRI dates will be scheduled by the clinical trial coordinator)

Peripheral blood samples will be collected at baseline, days 1-7-15-28-36-72 to compare biological indicators of treatment response. In some cases, circulating tumor cells (CTCs) will be monitored by real-time qRT-PCR to correlate with clinical data.

Patients will also be assessed for the side effects they experience. Disease-free and overall survival outcomes will be recorded.

Patients will also have their depressive symptoms, quality of life, and neurocognitive function assessed at multiple time points during and after treatment.

After completion of the study, patients will be followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Glioblastoma according to RANO criteria by contrast-enhanced MRI or PET-CT (including diffuse midline glioma, gliosarcoma or giant cell glioblastoma), relapse or disease progression
* patient is able to understand and give consent to participate in the study
* Karnofsky performance score ≥ 60
* women of childbearing potential must have a negative pregnancy test result no later than 7 days before registration

Exclusion Criteria:

* pregnant
* known allergies
* active treatment on annotner clinical trial
* inability to complete with protocol or studio procedures.
A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses

The purpose of this study is to compare the comfort of three commercially available contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Have provided written informed consent
* Have discomfort when wearing contact lenses

Exclusion Criteria:

* Have an active ocular infection or significant slit lamp findings
* Participated in any other studies in the past 30 days
ALTROPANE® SPECT Imaging in Patients With Parkinson Disease

After a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation, subjects will be asked to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging. Subjects will undergo a second injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging within 2-6 weeks of the injection 1.

The underlying goal of this open label imaging study is to optimize the imaging outcome for ALTROPANE® in mild to moderate PD subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Subjects with PD (n=15) will be recruited to undergo ALTROPANE® SPECT. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a physical and neurological evaluation. Subjects will be asked to undergo an injection of ALTROPANE® followed by up to 60 minutes of serial dynamic imaging. Subjects will be asked to undergo a second imaging visit two-six weeks following the initial imaging visit to assess the reproducibility of the imaging outcome. The imaging analyses will be performed by an image-processing specialist who will remain masked to clinical severity. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a target region to occipital ratio. Striatal regions of interests for caudate and putamen will be defined and placement standardized based on previously optimized region placement protocols. Imaging data will also be analyzed using an automated objective striatal analysis software package.

Eligibility Criteria:
Inclusion Criteria:

* The participant is 30 years or older at time of PD diagnosis.
* Written informed consent is obtained.
* Participants have a clinical diagnosis of idiopathic Parkinson's disease of \< 7 years.
* Hoehn and Yahr stages I-III.
* Negative drug screen

Exclusion Criteria:

* The participant has atypical or drug-induced Parkinson's disease.
* The participant has dementia.
* The participant has a clinically significant clinical laboratory value and/or clinically significant unstable medical or psychiatric illness.
* Treatment within the six months prior to screening with bupropion, methylphenidate, reserpine, alpha methyldopa, or amphetamine.
* The participant has a history of alcohol, narcotic, or any other drug abuse within the past 2 years.
* The participant has received an investigational drug within 60 days of screening visit.
* Pregnancy
Application of ihMT MRI in Multiple Sclerosis

The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.

The development of in vivo biomarkers sensitive to myelin disruption (demyelination and remyelination) represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.

Eligibility Criteria:
Inclusion Criteria:

* For Patients and Controls :

  * Adult patient, male and female, age 18 to 45
  * Patient affiliated with health insurance coverage,
  * Patient who signed a free and informed consent after receiving detailed, understandable and honest information,
* For patients only :

  * Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria
  * Disease duration of less than 5 years
  * Patients treated or not treated with first-line disease modifying therapy
  * Detection of at least one post-Gadolinium injection active lesion identified on the initial brain MRI (T0)

Exclusion Criteria:

* For patients only :

  • Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive)
* For Patients and Controls :

  * Patients with the usual contraindications for MRI (pacemaker, agitation, metal shards, claustrophobia)
  * Patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position
  * Patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion
  * Woman who is pregnant and breastfeeding
  * Patients with a history of neurological or psychiatric condition
  * Patients under guardianship or trusteeship
Feasibility and Acceptability of a Physical Activity Behavior Change Intervention for Parkinson's Disease

The purpose of this study is to assess the feasibility, in regards to acceptability and implementation, of the Pre-Active PD intervention for increased high intensity goal-directed aerobic exercise engagement in people with early-stage Parkinson's disease (Hoehn and Yahr stage I \& II). In addition, the study aims to explore the effect estimates of the Pre-Active PD intervention on self-efficacy, motivation, stage of behavior change, and physical activity levels in people with early stage Parkinson's disease.

The investigators will recruit 14 individuals with early stage Parkinson's disease (Hoehn and Yahr stage I \& II). The investigators will conduct a single arm cohort. (pre and post intervention) pilot feasibility study over 4 months with embedded process analyses of Preactive-HD, a physical activity coaching intervention program. Previous studies conducted by the investigators will be utilized to adapt the Engage-HD physical activity coaching program to people with early stage PD. The intervention will include a participant/coach interaction and disease-specific workbook grounded within the framework of self-determination theory. The coaching sessions will be conducted by an occupational therapist and will entail six coaching sessions (either face-to-face or remote video sessions via secure Webex connection via computer or smart phone, or phone call if internet/smart phone is not available to participant). The first session (approximately 45 min) will lay the groundwork for the program, and the remaining sessions will serve to provide directed support in relation to regular physical activity and exercise. Participants will develop physical activity goals and will be supported with individual physical activity progression. Participants will be given Fitbit devices as a motivational tool and to track activity progression.

Eligibility Criteria:
Inclusion Criteria:

1. Neurologist confirmed clinical dx for Parkinson's disease Hoehn \& Yahr stage I or II
2. Ambulatory for indoor and outdoor mobility without assistance or assistive device
3. Successful completion of Physical Activity Readiness Questionnaire (PAR-Q) (Thomas et al., 1992), or medical clearance from GP

Exclusion Criteria:

1. Musculoskeletal injury that would prevent participation in an exercise program
2. Other neurological disease or disorder such as stroke
3. Already engaging in aerobic exercise for at least 30 minutes for 5 or more days per week.
Effect of Meal Timing in T2D on Hepatocytes SRIT1 and Clock Genes

This study is undertaken to explore in T2D, the effect of meal timing on serum induced SIRT1 and Clock Genes mRNA expression in cultured hepatocytes. Fasting serum samples were collected from T2D participants, following two different meal timing schedules, either a diet with large breakfast and lunch with small dinner Breakfast Diet (3Mdiet) or an isocaloric diet with 6 small meals evenly distributed along the day Allday Diet (6Mdiet). The researchers will use an ex-vivo/in-vitro approach in which cultured medium will be conditioned with the fasted human serum collected from the two groups of T2D participants at baseline, after 2 weeks and after 12 week of the diet intervention.

The timing of many physiological processes, including glucose metabolism, is coordinated by the circadian clock gene system. The circadian clock regulation, optimize glucose metabolism for the consumption of high energy and carbohydrate (CH) meals in the early hours of the day and for fasting at evening and night. Circadian disruption which occurs when the meal timing is not aligned with the circadian clock rhythms like skipping breakfast, overeating CH at night or eating CH all day, lead to desynchronized clock genes and can result in adverse health outcomes like insulin resistance, obesity hyperglycemia and T2D. Although the clock genes are disseminated in almost all peripheral tissues, those localized in the liver, are particularly important for the regulation of glucose metabolism, influencing the enzymatic determinants of the hepatic glucose output, by enhancing glycogen storage and suppressing nocturnal hepatic glucose production (glycogenolysis and gluconeogenesis sequentially).Therefore, the disruption of the hepatic clock genes lead to fasting, nocturnal, and to postprandial hyperglycemia in T2D. The researchers had previously shown in T2D, that compared to 6Mdiet, the 3Meal diet timing schedule, was most effective in reducing body weight, HbA1c, overall hyperglycemia, and led to up-regulation of SIRT1 and Clock Genes mRNA expression in leukocytes. However, this effect of meal timing had never been explored in liver cells. The investigators hypothesized that compared to Allday Diet (6Mdiet), the serum collected from T2D participants following Breakfast Diet (3Mdiet) will up-regulate SIRT1 and Clock Genes oscillatory mRNA expression in cultured hepatocytes.

Eligibility Criteria:
Inclusion Criteria:

* T2D patients with stable treatment for at least 3 month preceding the study.
* HgA1c \>7.5 %.
* Age \> 30 years.
* BMI: 27-34 kg/m2.
* Treatment with antidiabetic drugs (i.e. metformin, DPP4 inhibitors, glinides) and GLP-1 analogs, will be allowed
* Anti-hypertensive treatment will be allowed.
* Lipid-lowering medication also allowed

Exclusion Criteria:

* Type 1 diabetes.
* Major illnesses (liver, heart, kidney, infectious, neurological, psychiatric, immunological, active malignancy).
* Change in weight of \> 4.5 kg within 3 month prior the diet onset.
* Night or rotating shift workers.
* Those who crossed more than 2 time zones during 2-week period prior to study onset.
Evolution of Ocular Growth in Myopic Children: a Prospective Cohort Study

Myopia and high myopia are the leading causes of visual impairment and blindness worldwide. The total number of myopic people globally was estimated to be 2.6 billion in 2020, and it could reach 4.8 billion by 2050 unless preventive interventions are implemented.

Strategies to slow the progression of myopia, such as contact lenses, orthokeratology, atropine, and increased time spent outdoors, have shown promising results, although evidence varies depending on the method. However, most research has been conducted in Asia, and there are few studies on ocular growth in myopic children in Europe. Meanwhile, the prevalence of myopia is also increasing significantly in Europe, particularly in France.

Understanding the growth of the myopic eye in European children is crucial. Cohort studies of myopic children are scarce and do not always include high-quality imaging. A cohort of myopic children with prospective collection of the best retinal and corneal images, along with ophthalmological exams to detail and model the growth of the myopic eye, will provide valuable insights to enhance our understanding of ocular growth and its inter-individual variability.


Eligibility Criteria:
Inclusion Criteria:

* Myopia in at least one eye, defined as a refractive error in spherical equivalent ≤ -0.50 diopters (autorefraction under cycloplegia)
* Affiliated or beneficiary of a social security system
* Explicit consent from a holder of parental authority

Exclusion Criteria:

* Presence of trauma in both eyes
* Presence of inflammatory conditions in both eyes
* History of intraocular surgery (cataract, filtering surgery, intra-vitreal surgery) in both eyes
* Patient benefiting from legal protection measures
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Patients with severe haemophilia A receiving emicizumab will often need concomitant FVIII to provide haemostatic cover during major surgery. This prospective, open-label, uncontrolled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq, a recombinant factor VIII, in combination with emicizumab prophylaxis in male patients over 12 with severe haemophilia A undergoing major surgery.

Eligibility Criteria:
Inclusion Criteria:

* Severe haemophilia A (FVIII activity \[FVIII:C\] \<1%) according to medical history
* Male patients at least 12 years of age
* Previous treatment with any FVIII product(s) for at least 150 exposure days
* On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
* Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations

Exclusion Criteria:

* Coagulation disorder other than haemophilia A
* Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) according to medical history
* Severe liver or kidney disease (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels \>5 times the upper limit of normal; or creatinine \>120 μmol/L)
* Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
* Already had surgery in this study
* Current participation in another interventional clinical trial
* Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit
Prospective Post Market Clinical Follow-Up of the Primary Knee Endoprosthesis BPK-S Integration

Prospective, monocenter post market clinical follow-up of a primary knee replacement bearing the CE-mark.

200 subjects will be recruited and followed up for up to ten years or until revision of the primary knee endoprosthesis, whichever occurs first. Documentation of clinical and radiological parameters within the clinical routine pre-operative and post-operative at 3 and 12 months and 2, 5 and 10 years to evaluate time to revision, pain situation, knee functionality, mobility and stability.


Eligibility Criteria:
Inclusion Criteria:

* Congenital or acquired knee joint defects/deformation or
* Defects or malfunction of the knee joint or
* Arthrosis (degenerative, rheumatic) or
* Post-traumatic arthritis or
* Symptomatic knee instability or
* Reconstruction of flexibility or
* Patients with metal hypersensitivity (ceramic tibia/femur)

Exclusion Criteria:

* Illnesses which can be treated without using a knee joint implant.
* Acute or chronic infections near the implantation
* Systemic diseases and metabolic disorders
* Serious osteoporosis
* Serious damage to the bone structures that impedes stable implantation of the implant components
* Diseases that impair bone growth, e.g. cancer, renal dialysis, osteopenia, etc.
* Bone tumors in the area of the implant anchoring
* Obesity or overweight of the patient
* Overload of the knee implant to be expected
* Abuse of medication, drug abuse, alcoholism or mental disease
* Lack of patient cooperation
* Sensitivity to foreign matter in the implant materials
* Patients under the age of 18
* Patients participating in another trial