cyrilzakka/clinical-trials huggingface dataset:
Study of Refeeding to Optimize iNpatient Gains

The purpose of this study is to compare the efficacy, safety, and cost-effectiveness of lower calorie refeeding versus higher calorie refeeding in hospitalized adolescents with anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of AN
* atypical AN
* no hospital admissions for the previous six months
* meet hospitalization criteria: daytime heart rate (HR) \< 50 bpm or night time HR \< 45 bpm, blood pressure (BP) \<90/45 mmHg, temperature \< 35.6° C, or symptomatic orthostasis defined by increase in HR \> 35 bpm or decrease in systolic BP \> 20 mmHg or decrease in diastolic BP \> 10 mmHg from lying to standing

Exclusion Criteria:

* diagnosis of bulimia nervosa \[DSM-5\]
* currently in remission (as defined by weight and EDE-Q score)
* admission for food refusal without malnutrition
* current pregnancy
* chronic disease (e.g. immune/endocrine disorders, pulmonary, cardiac, or renal disease)
* current suicidality or psychosis
* \< 60% mBMI
Integrative Molecular Characterization Of MiT Family Translocation Renal Cell Carcinomas (IMCOR)

Microphthalmia transcription factor (MiT) family translocation renal cell carcinomas (TRCC) are rare subtypes of kidney cancers, which often arise in children and young adults. TRCC are characterized by translocations affecting transcription factors: Transcription Factor Binding To Immunoglobulin Heavy Constant Mu Enhancer 3 (TFE3) and Transcription Factor EB (TFEB). Little is known about TRCC molecular heterogeneity, in particular their transcriptomic and epigenetic subtype classification. Clinical behavior of TRCC is varying with age and Tumor, Node, Metastasis (TNM) stage. However, the biological basis of this aggressiveness is poorly understood.

PURPOSE: The primary goal of this study is to decipher specific alterations in aggressive TRCC, defined as cases with metastatic dissemination at diagnosis. To tackle this problem, a retrospective cohort of TRCC cases in children and young adults will be created. We will then perform integrative comprehensive multi-omics analysis of these tumors to identify genetic, epigenetic and immune biomarkers associated with metastatic behavior in a training and validation datasets. Comparison of the multi-omics data will be compared to other type of rare Kidney tumors as well as clear-cell renal cell carcinomas

This retrospective cohort study aims to allow tumor collection of TRCC from three different networks: the French research network in renal cancer (UroCCR), the International Society of Paediatric Oncology (SIOP) database and the network for rare renal carcinomas (CARARE). Those samples will be divided in training and validation datasets. We will also collect samples from patients with other rare kidney cancers and clear-cell renal cell carcinomas allowing comparisons of similarity and differences between these tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated for kidney cancer in a clinical center located in France

For molecular biology study :

* Patients with tumor sample available for genetic and epigenetic analysis. Tumor sample stored in Biological resource facilities and consent given from patient or from parents for the use of biological sample for biomedical research purposes.

Exclusion Criteria:

* Objection from patient or parents
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).

Parkinson's disease is not only a pathology of movements. There are many non-motor symptoms that complicate and impair patients' quality of life. Among those disorders are sleep disorders.

Insomnia is the most frequent symptom. Most patients report 2-5 awakenings per night and long periods of awakening which occupy 30 to 40% of their night.

Apomorphine is a dopamine agonist that may be administered with a pump . The objective of the study is to assess changes in the quality of sleep in Parkinson's disease patients treated with an apomorphine pump.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease patients for whom a treatment with an apomorphine pump is indicated

Exclusion Criteria:

* atypical parkinsonian syndrome
* cognitive impairment
* pregnancy
* breast feeding
* patient under a legal protection procedure
* patient denying to participate to the study
* lack of affiliation to a social security system
The Safety and Tolerability of an Aerobic and Resistance Exercise Program With Cognitive Training Post-stroke

It is estimated that 2 out of 3 patients with a stroke have some problems with their memory, difficulties performing certain tasks, making decisions and learning new things. In addition, many stroke patients do not get regular exercise and are often sedentary. Both physical and cognitive exercise have the potential to improve quality of life, cognition, and overall health, but the safety and tolerability of such interventions is not clear in stroke patients. The investigators will examine these outcomes by allocating stroke survivor participants to one of two groups: a combined exercise and cognitive training program and a sham control group.

Stroke is well recognized as the leading cause of disability in the United States. Cognitive deficits after stroke are common, even in those without dementia prior to the event, and stroke patients with worse cognition on hospital admission have worse outcomes. Cognitive deficits contribute to stroke-related disability and mortality. Evidence suggests an interaction between cognitive deficits and physical limitations, and cognitive rehabilitation may improve functional outcomes post stroke. Recent data also suggest that both cognitive training and exercise interventions improve cognition in stroke patients, but few randomized trials of these interventions, alone or in combination, have been conducted.

We will study the effects of a Combined Aerobic and Resistance Exercise Training (CARET) program and CTI interventions on the primary outcome of safety, feasibility, and adherence among ischemic or hemorrhagic stroke survivors with mild to moderate disability. We hypothesize that these interventions are safe and tolerable, and that they will lead to improvements in our secondary outcomes of cognitive performance and quality of life. We will also explore the role of Brain Derived Neurotrophic Factor in cognitive changes related to the physical exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke
* Modified Rankin Score (mRS) of \<4 at screening
* Recently discharged from the hospital or rehabilitation program
* Male or female ≥18 years of age
* Less than ideal physical activity ≥ 3 months prior to enrollment (less than ideal physical (as defined by the American Heart Association)
* Able to walk ≥10 meters with or without assistance

Exclusion Criteria:

* Unable to follow instructions for exercise and cognitive interventions
* Any uncontrolled medical condition expected to limit life expectancy or interfere with participation in the trial (i.e. unstable cancer, severe depression or anxiety by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria)
* Abnormal stress test, as determined by the treating physician (unless cardiology clearance provided)
* Active substance abuse or alcohol dependence
* Less than 6th grade reading level
* Uncorrected vision or hearing deficits that would preclude administration of the cognitive measures
* Unwilling or unable to provide written informed consent
Metformin for Abdominal Aortic Aneurysm Growth Inhibition

A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.

Subjects with no history of diabetes will be recruited from a cohort of patients with diagnosed AAA and a maximum aortic diameter of 30-49mm for men and 30-44mm for women.

A total of 500 subjects with AAA will be included in the study, 250 in each study arm. Patients will be randomised to metformin or standard care in a 1:1 ratio.

CT imaging and AAA US will be performed at baseline, 24 months and end of study, as well as if necessary according to clinical routine. Study drug will start at baseline and continue through completion.

When all enrolled subjects have completed the 24-month follow-up (including imaging) an interim analysis will be performed to assess for efficacy and safety; if there is no trend towards a positive effect or signs of a harmful effect of metformin, the study will be stopped at this phase.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent.
2. Male and female patients.
3. Age 50-80 years.
4. Documented AAA Ø 30-49 mm for men and 30-44 mm for women.
5. Fasting p-glucose \<7.0 mmol/L. Fasting is defined as no caloric intake for ≥8 h.

Exclusion Criteria:

1. Short expected survival.
2. History of current or previous diabetes mellitus.
3. Current or previous use of metformin.
4. Not expected to tolerate metformin.
5. Contraindications to metformin treatment according to SmPC
6. Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm development after aortic dissection or previous surgery of the infrarenal aorta.
7. Enrollment in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrollment of the current study.
8. If, in the opinion of the investigator, it is not in the patient's medical interest to participate in the study or the patient is unlikely to be able to comply with the study protocol.
9. Pregnancy.
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes

Although haemostasis aimed to maintain bloodless surgical field for better exposure for the surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair

Exclusion Criteria:

* coagulopathy
* sickle cell disease or sickle cell trait
* circumcised patient
* history of previous failed surgery
* severe chordee (\>30 degree after degloving).
To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.


Eligibility Criteria:
Inclusion Criteria:

* Single-level lumbar instrumented postero-lateral fusion from L2-L5
* Life expectancy greater than 2 years

Exclusion Criteria:

* Previous lumbar surgery
* Spine tumour/cancer
* Documented osteoporosis
* High grade (3 or 4) spondylolisthesis
Triheptanoin Treatment Trial for Patients With Long-chain Fatty Acid Beta-oxidation Defects

The purpose of this study is to determine if administration Triheptanoin is an effective treatment for defects of the long-chain fatty acid beta-oxidation in young adults or adults. Period of treatment and follow-up will be 16 months.

Triheptanoin treatment, in patients with long-chain fatty acid beta-oxidation defects, could cause not only a great improvement in their quality of life, also could prevent life-threatening signs, reducing symptoms and serious complications of their disease, like cardiomyopathy, Reye-like syndrome episodes and rhabdomyolysis. This result would occur by the effect of propionyl CoA primer on the Krebs cycle and, at the same time, would produce a gluconeogenic effect.

This treatment opens the door to be used in other diseases such as pyruvate carboxylase deficiency, glycogen storage disease and other diseases with energy problems.

All patients will be followed up until 16 months.

Eligibility Criteria:
Inclusion Criteria:

All patients with any of the following conditions:

* Long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency (LCHAD).
* Very long-chain acyl-coenzyme A dehydrogenase deficiency (VLCAD.)
* Mitochondrial trifunctional protein (MTP).
* Carnitine palmitoyltransferase I deficiency (CPT I).
* Carnitine Palmitoyltransferase II (CPT II).
* Carnitine-acylcarnitine translocase deficiency (CACT).

Positive skin biopsy: patients were deemed to commence the dietary treatment with Triheptanoin after evaluating the individual response in vitro in cultured fibroblasts. This response is based on the measurement of the production of propionyl-CoA, the incubation with fatty acids odd-chain, compared with control group fibroblasts.

The informed consent must be signed by the patient or family, in the case of minors.

Exclusion Criteria:

* No patient/family collaboration or the application of dietary treatment.
* No in vitro test response.
* Do not meet the inclusion criteria.
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18-80 years of age
* Subjects has provided informed consent
* Subjects must present with symptoms and/or pathology of the sinus or temporal bone region.
* Subject scheduled for additional radiological follow-up and/or endoscopy/surgery.
* CBCT exam performed within a maximum of 2 days of the conventional CT.

Exclusion Criteria:

* Subjects under the age of 18 years, or over the age of 80 years
* Unable to collect all required case information
* Subjects not willing to consent, or consent is withdrawn
* Women in pregnancy or suspected of being pregnant confirmed by pregnancy test
Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis

When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. However, these recommendations are rarely followed in France. These recommendations were not applied in the Children's Emergency Department of BREST University Hospital. The investigators changed the protocol and shared it with the caregivers of the emergency unit. The investigators studied the impact of this change of protocol

The main purpose was to assess the proportion of children rehydrated by nasogastric tube(NG) after protocol change. Secondary outcomes were to assess hospital length of stay and sides effects.

It is a retro and prospective study. The first phase took place from June to September 2018 and the second from June to September 2019. Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included.

Eligibility Criteria:
Inclusion Criteria:

Any child presenting to pediatric emergencies for acute gastroenteritis requiring nonoral rehydration was included

Exclusion Criteria:

* acute gastroenteritis on return from tropical countries
* child with endocrine system diseases requiring parenteral rehydration
* history of chronic pathology requiring enteral feeding
Pegzilarginase in Subjects <24 Months Old with Arginase 1 Deficiency

This is an open-label, multicentre study to evaluate the safety, PK, and activity (PD) of weekly subcutaneous (SC) administration of pegzilarginase in subjects with ARG1-D who are \< 24 months of age. The study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.

CAEB1102-301A is an open-label, single-arm, non-controlled, repeat dosing, multicentre study to evaluate the safety, PK, and activity (PD) of weekly SC administration of pegzilarginase over 12 weeks in subjects with ARG1-D who are \< 24 months of age.

This study will consist of:

* A screening period of up to 4 weeks to ensure the subjects meet the study eligibility criteria and establish baseline plasma arginine
* A treatment period of 12 weeks
* A safety follow-up period of 8 weeks with visits 1 week and 8 weeks after the last dose.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be \< 24 months of age on the date of informed consent
2. Confirmed diagnosis of ARG1-D documented in medical records by at least 1 of the following methods:

   1. elevated plasma arginine levels
   2. a mutation analysis revealing a pathogenic variant
   3. red blood cell (RBC) arginase activity
3. Subjects must weigh \> 8 kg due to clinical trial related blood collection volumes required
4. Written informed consent by parent/legal guardian, in accordance with national stipulations, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
5. At least one value of plasma arginine ≥ 180 μM during screening
6. Documented confirmation from the Investigator and/or dietitian that the subject can:

   1. attempt to maintain a stable, age-appropriate level of protein consumption, including natural protein, and EAA supplementation within approximately ± 15% of dietitian recommended diet
   2. attempt to maintain current use of ammonia scavengers, if prescribed

Exclusion Criteria:

1. Other medical condition(s) or comorbidity(ies) that, in the opinion of the Investigator, would interfere with study compliance or data interpretation
2. Hyperammonaemic episode (plasma ammonia levels \> 100 μM) with ≥ 1 symptom related to hyperammonaemia requiring hospitalisation or emergency room management within the 4 weeks before the first dose of study drug
3. Active infection requiring anti-infective therapy within \< 2 weeks before first dose of study drug
4. Known active infection with human immunodeficiency virus, hepatitis B, or hepatitis C
5. History of hypersensitivity to polyethylene glycol (PEG) or any of the excipients included in the study drug that, in the judgment of the Investigator, puts the subject at unacceptable risk for AEs
6. Currently participating in another therapeutic clinical study or has received any investigational agent within 30 days (or 5 half-lives, whichever is longer) prior to first dose of study drug
7. Previous liver or haematopoietic stem cell transplant
8. Use of botulinum toxin within 16 weeks prior to first dose
A Phase I Dose Escalation Study of Intratumoral VCN-01 Injections With Gemcitabine and Abraxane® in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine the safety and tolerability of three intratumoral injections of VCN-01 combined with Abraxane®/gemcitabine, and to determine the recommended phase II dose of VCN-01 combined with Abraxane®/gemcitabine.

Investigational treatment is a dose-escalation regimen consisting of three VCN-01 intratumoral injections (once every 28 days at the same dose) in combination with intravenous Abraxane® and gemcitabine.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female patients aged 18 years or over
* Patients must provide written informed consent
* Life expectancy above 3 months
* Patients willing to comply with treatment follow-up, and to accept a biopsy at day 29 after initiation of the treatment
* Patients with histologically confirmed diagnosis of unresectable pancreatic adenocarcinoma with symptoms related to the primary tumor. Abraxane® plus Gemcitabine should be the appropriate standard of care to be administered.
* ECOG Performance status 0 or 1
* Adequate baseline organ function (hematologic, liver, renal and nutritional)
* Use a reliable method of contraception in fertile men and women

Exclusion Criteria:

* Active infection or other serious illness or autoimmune disease
* Treatment with live attenuated vaccines in the last three weeks
* Known chronic liver disease (liver cirrhosis, chronic hepatitis)
* Treatment with another investigational agent within its five half-lives prior to VCN-01 infusion
* Viral syndrome diagnosed during the two weeks before inclusion
* Chronic immunosuppressive therapy
* Known concurrent malignant hematologic or solid disease
* Pregnancy or lactation. Patients must agree to use effective contraception or be surgically sterile.
* Patients receiving full-dose anticoagulant / antiplatelet therapy
* Patients with Li Fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency
Positive Psychology for Physical Activity Promotion

This study is for physically inactive adults. Participants will be enrolled in the Positive Psychology and Physical Activity intervention designed to help them overcome barriers to physical activity, based on the principals of positive psychology.

This will involve six weekly one-hour group-based sessions at a local YMCA with a trained group leader. In addition to the in-person sessions, there will be text messages sent to participants about physical activity that include positive psychology content.

The investigators propose to conduct a pilot study to test feasibility and proof-of-concept for a positive psychology intervention program to promote exercise among low-active overweight and obese adults. The program will be (a) a 6-week, group-based intervention, (b) delivered at local YMCAs, and (c) supplemented with text messaging. In an additive design, participants will be randomized in a 2:1 ratio to PPPA (n = 40) versus a control intervention (n = 20) including only the standard PA promotion components of the PPPA intervention (i.e., PA education, self-monitoring, and goal-setting), with equal frequency of staff contact and text message delivery. All participants will be followed for 3 months, and will receive a 3-month YMCA membership to equate access to PA facilities. As a secondary aim the investigators will examine effect sizes for PPPA versus the standard PA intervention on putative mediators that may underlie the efficacy of PPPA in improving PA outcomes, including positive and negative affect, optimism, happiness, life satisfaction, social support for PA, and PA enjoyment. The proposed research will set the stage for an RCT to test a novel PA promotion intervention that can be readily disseminated.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary or low-active, (defined as \< 60 min/week of structured physical activity)
* Able to receive and respond to a text message at the time of screening

Exclusion Criteria:

* History of coronary artery disease
* History of stroke
* History of uncontrolled hypertension
* History of asthma
* History of chronic obstructive pulmonary disease (COPD)
* History of diabetes
* History of osteoarthritis or orthopedic problems that limit physical activity
* BMI greater than 40