cyrilzakka/clinical-trials huggingface dataset:
Promote Awareness of the Driving Abilities of Post-stroke Patients.

Patients with cerebrovascular accident (CVA) may present with a deficit of awareness of the disorders which results in a lack of correct self-estimation of their own abilities and difficulties in terms of both cognition and driving. It is therefore important to develop tools to help professionals take this deficit into account in their driving assessments and also to help patients better identify their real abilities.

This research project thus proposes a protocol making it possible to promote decision-making whether or not to resume driving by multidisciplinary teams.

The main objective is to determine to what extent video feedback promotes awareness of the ability to manage post-stroke patients, compared to a group of control patients receiving the usual recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Stroke (ischemic and / or hemorrhagic) between 1 month and 6 months
* Holder of a driving license for more than 3 years
* No resumption of driving
* MoCA score ≥ 10
* Affiliation to a social security scheme or beneficiary of such a scheme
* Having signed a free, informed and written consent
* Medically stable

Exclusion Criteria:

* Aphasia with severe comprehension disturbances, severe hemineglect, unstable epilepsy, severe visual disturbances (binocular vision \<6/10, visual field \<120 ° in binocular, \<50 ° to the right and to the left beyond the central point, \<30 ° vertically.
* History of neurological disease responsible for cognitive impairment
* Need for vehicle modifications except automatic gearbox
* Subject being in a period of exclusion from another protocol
* Insufficient command of the French language
* Protected adults (curators)
* Pregnancy declared
* Being unable to issue their consent
The Functional Consequences of the CTNS-deletion for the TRPV1-receptor in Cystinosis Patients

Cystinosis is a rare autosomal recessive disorder, characterized by the abnormal accumulation of cystine in the lysosomes. Cystinosis is mostly caused by mutations in the cystinosin gene (CTNS). The major mutation, which is present in almost 50% of the cystinosis patients, is a 57-kb deletion. This deletion removes the first 9 exons and a part of exon 10 of the CTNS gene. Exon 10 of the CTNS gene is a upstream 5' region that encodes for the CARKL gene and also for the first two noncoding exons of the transient receptor potential channel, vanilloid subfamily member 1 (TRPV1) gene.

TRPV1 belongs to the transient receptor potential (TRP) superfamily of cation channels. TRPV1 is primarily expressed in sensory nerves and is activated by heating (\>43°C) and a wide range of chemical stimuli. One of these chemical stimuli is capsaicin, the pungent ingredient in hot chilli peppers. The effect of binding of the exogenous ligand capsaicin with the TRPV1 receptor is well known to provoke the release of a number of bioactive substances including calcitonin gene-related peptide (CGRP). These substances, in turn, act on target cells in the surrounding tissue such as mast cells, immune cells and vascular smooth muscle cells. The resulting response is characterized by redness and warmth (secondary to vasodilatation), swelling (secondary to plasma extravasation) and allodynia (i.e. hypersensitivity to heat and touch secondary to alterations in the excitability of primary sensory neurons).

The present study wants to test the following hypotheses:

(i) The DBF response to topical applied capsaicin is decreased in cystinosis patients, compared to matched control subjects.

(ii) The skin sensitivity response after topical applied capsaicin is decreased in cystinosis patients, compared to matched control subjects.

(iii) The temperature sensitivity is decreased in cystinosis patients, compared to matched control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Only healthy controls: Subject is in good health, based on medical history and physical examination
* White (Caucasian) male or female subjects, aged \> or = 8 year.
* Subject is capable and willing to give informed consent.

Exclusion Criteria:

* Any abnormality of the skin which may interfere with the study assessments.
* Excessive hair growth on the volar surface of the forearm.
* Excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study and incapable to cover the forearms for 24 hours prior to the study period.
* Subject using topical treatments on the forearm.
* History of sensitivity to the fruits of capsicum plants (e.g. chilli peppers).
* Any situation that can compromise the study, including a predictable lack of cooperation from the volunteer.
* Female subject is pregnant or breastfeeding.
Iron Fish for Dominican Republic (DR) Infants

This study evaluates the feasibility of cooking with an iron ingot, Lucky Iron Fish™ (LIF), and evaluate the natural history of hemoglobins and iron status among infants of families using this iron ingot in a population with a high prevalence of iron-deficiency anemia. Participants are mother-infant dyads, and are randomized to one of two arms: Lucky Iron Fish™or enhanced standard of care.

Iron deficiency and iron-deficiency anemia contribute significantly to global pediatric morbidity, predominantly affecting women and preschool aged children in resource-limited settings. Iron-deficiency in infancy has been linked to neurodevelopmental delay.

Current methods of iron repletion and supplementation have proved inadequate. The Lucky Iron Fish™ is a iron ingot, the size of a small bar of soap, that is made of pure iron. When boiled, it releases bioavailable iron into water, which is then used for food preparation and/or drinking. Participants in the LIF arm are instructed to acidify the water with citrus juice (provided).

All participants are followed at the same intervals to complete questionnaires and study-related labs.

Eligibility Criteria:
Inclusion Criteria:

* Mother ≥ 18 years of age
* A newborn delivered at ≥ 35 weeks
* Infant Child followed by (or will be followed by) affiliated clinic (Niños Primeros en Salud \[NPS\]) OR Infant delivered at Angel Ponce, the local maternity hospital of Consuelo, Dominican Republic.
* Mother is Spanish speaking
* Mother permission is provided (informed consent)

Exclusion Criteria:

* Maternal history of Sickle Cell Disease (homozygous)
* Concurrent enrollment in related study of LIF on anemia of young children (CHOP study #16-012631).
* Inability to understand and speak Spanish
* Severe cognitive impairment or severe psychiatric disease which would prohibit the answering of study questions
Brazilian Reality of Hepatocellular Carcinoma

National, multicenter, retrospective, non-randomized observational study (Real World Evidence-RWE) with the purpose of analyzing the epidemiological profile of Hepatocellular Carcinomas (BCLC A, B or C), clinical management, progression profile and overall survival of castrated patients treated in national oncology care reference centers, within the last 6 years (between 2017 to 2022).

Hepatocellular carcinoma is the third leading cause of cancer-related deaths worldwide. Prognosis strongly depends of the underlying liver disease, tumor-specific characteristics such as tumor load, extrahepatic spread and portal vein branch thrombosis, as well as access to treatments. The Brazilian reality of hepatocellular tumor clinical presentation varies widely and the management profile, treatments adopted and response rates are little described. Taking into consideration the heterogeneity of health services in reference centers in Brazil, knowing the epidemiology profile and treatment of these tumors is of paramount importance to improve care for patients, deepen the knowledge in these diseases and foster for the generation of new regional researches. The primary objective of this study is to determine and describe the epidemiological profile of hepatocellular carcinoma BCLC (Barcelona Algorithm of Liver Cancer) stages 0, A, B and C of patients followed in Brazilian reference oncology centers, within the last 6 years (between 2017 to 2022). The secondary objective is to describe the treatment and endpoints patterns of 2 disease cohorts: early disease (BCLC 0, A and B) and advanced disease (BCLC C).

Eligibility Criteria:
Inclusion Criteria:

* Male and female;
* Above 18 years old;
* Hepatocellular carcinoma diagnosis (confirmed by biopsy or imaging);

Exclusion Criteria:

* Fibrollamelar carcinoma, hepatoblastoma, intrahepatic cholangiocarcinoma, neuroendocrine tumors or other less common types of liver tumors;
* Patients with incomplete staging data;
* Patients with only 1 visit to the participating site healthcare service, with loss to follow-up prior to the second visit to the participating site healthcare service;
* Previous treatment for hepatocellular carcinoma in another institution;
* Treatment with investigational drugs in a clinical trial.
A Safety and Efficacy Study to Evaluate AIV001 in Wound Healing Following Surgical Incision

To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds

This is primarily a safety study to evaluate the safety of AIV001 when administered near incisional wounds. A unique model was used to assess incisional scarring, safety and biomarker assessments. Women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. Up to 10 incisions were made on abdominal skn and treated as assigned. And data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. Exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for an abdominoplasty
* Nonsmoker
* Fitzpatrick I-IV
* Weight \>45Kg
* BMI \<= 35

Exclusion Criteria:

* Existing scars in study area, active infection
* Any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study
COVID-19 Seroconversion Among Front Line Medical and Paramedical Staff in Emergency, Intensive Care Units and Infectious Disease Departments During the 2020 Epidemic

The epidemic due to the Sars-CoV2 virus is spreading in France, without knowning precisely since when the virus has actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the Diamond Princess boat also report almost 50% of asymptomatic forms of Covid-19. The medical and paramedical staff of the front-line services for the care of patients infected with Covid-19 are in fact potentially exposed to the risk of occupational contamination due to the large number of patients treated, including in the pre-epidemic phase. Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form.

The epidemic due to Sars-CoV2 is spreading in France, without it being knowning precisely since when the virus actually circulated on the territory. Data from China but also systematic samples taken from the passengers of the boat Diamond Princess also report almost 50% of asymptomatic forms of Covid-19. Medical and paramedical staff are in fact potentially exposed to the risk of professional contamination, with probably a different risk between the first-line referent hospitals and the others, due to the large number of patients treated in the first, including in the pre-epidemic phase (average of 190 consultants per day at the emergency department Pitié-Salpêtrière for example). Therefore, and despite the application of standard protective measures, it is possible that a certain number of these personnel already have or will contract Covid-19 disease, including in its asymptomatic form. Knowledge of this seroconversion rate, if it is found to be higher than that of the general population, could lead to a review of the measures to protect personnel from other emerging infectious risks.

Eligibility Criteria:
Inclusion Criteria:

* Any permanent medical or paramedic staff of participating services who have given written consent to participate
* Having a social security insurance.

Exclusion Criteria:

* Non-permanent staff (occasional staffing), administrative staff, technical staff of participating services.
* Staff who were not active during the inclusion period.
Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).


Eligibility Criteria:
Inclusion Criteria:

Age (25- 55) years. Height (150 -170) cm.

Exclusion Criteria:

Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.
Efficacy and Safety of Berberine in the Treatment of Diabetes With Dyslipidemia

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human. These findings have not been tested in a clinical trial. This randomized, double blind, placebo controlled and multi-center study has demonstrated that berberine is effective in lowering plasma glucose concentrations, reducing serum HbA1c and anti-dyslipidemia in type 2 diabetic patients with dyslipidemia.

Berberine, a natural plant alkaloid, has not been well investigated for clinical application in the treatment of diabetes. The present study evaluated the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. 116 patients with type 2 diabetes and dyslipidemia were assigned in a randomized, double-blind, and placebo-controlled 4-clinical center study to receive berberine (1.0g daily) or placebo for 3 months. The primary efficacy outcomes were changes in plasma glucose and serum lipid levels. The glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin resistance in a randomly selected subjects of 54 patients. The baseline characteristics were similar in berberine and placebo groups. After 3 months, fasting and post load plasma glucose levels, HbA1C, triglyceride, total cholesterol and LDL-C levels were all significantly reduced in the berberine group compared with the placebo group (p\<0.0001, p\<0.0001, p\<0.0001, p=0.002, p\<0.0001 and p\<0.0001 respectively). The GDR was significantly increased after 3 months of berberine (p=0.037), while no change was found in the placebo group (p=0.86). BMI, systolic blood pressure and serum IL-6 levels were all significantly reduced after treatment in berberine group as compared with the placebo group (p=0.016, p=0.041 and p=0.014, respectively). Our results show berberine to be effective and safe in the treatment of persons with diabetes and dislipidemia. This agent may be useful in the treatment of patients with type 2 diabetes, and could play a role in treatment of metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 25 -70 years;
2. Newly diagnosed type 2 diabetes according to the 1999 World Health Organization criteria;
3. Dyslipidemia with TG\> 150mg/dL (1.70mmol/L), and/or TC\>200mg/dL (5.16mmol/L), and/or LDL-C\>100mg/dL (2.58mmol/L) according to the National Cholesterol Education Program's Adult Treatment Panel III (NCEP: ATPIII) without previous treatment.
4. BMI:19 - 40 kg/m2.

Exclusion Criteria:

1. Moderate or severe liver or renal dysfunction, psychiatric disease or severe infection;
2. Severe dysfunction of the heart，New York Heart Association class ³ Ⅲ phase;
3. History of acute diabetic complications;
4. Pregnancy or planned pregnancy.
5. Present or previous use of drugs for treatment of diabetes or dyslipidemia;
6. Fasting plasma glucose \>8mmol/L and/or post load plasma glucose level \>17mmol/L after 2-week run-in.
Cafeteria-Based Study of Weight Gain Prevention

To investigate two cafeteria-based methods of weight gain prevention in overweight men and women.

BACKGROUND:

Obesity is a risk factor for a number of adverse medical and psychosocial outcomes. Solving the obesity problem will require a much greater emphasis on prevention. Treatment research indicates that interventions focusing directly on the food environment (structured meals and control of food stimuli) have considerable promise for weight control. Prevention research has found little support for trying to modify characteristics (e.g., knowledge, beliefs, skills) of individuals, perhaps because this approach does little to modify the food environment. The research will be implemented in a workplace cafeteria where employees eat year-round and where the nutritional composition of the food can be modified.

The study was initiated in response to a Request for Applications issued in October, 2001 on "Environmental Approaches to the Prevention of Obesity". The Request for Applications was jointly issued by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Environmental Health Sciences, the National Center for Minority Health and Health Disparities, the Office of Behavioral and Social Sciences Research, and the National Heart, Lung, and Blood Institute.

DESIGN NARRATIVE:

The influence of two promising interventions on food intake, weight change, and related outcomes will be investigated. The first intervention consists of a training program aimed at reducing the energy density of participants' diets inside and outside of the cafeteria. The second intervention consists of financial incentives to encourage the consumption of cafeteria foods lower in energy density. Participants will be 195 Caucasian and African-American men and women between the ages of 21 and 65. They will have a BMI of 23-35 and will have characteristics associated with an increased risk of weight gain. Selection and intake of lunch foods will be measured with digital photography and cashiers' computerized records of food purchases. Cafeteria patrons will be randomly assigned to 1) a measurement-only condition; 2) an intervention designed to teach participants how to reduce the energy density of their diets; or 3) the reduced energy density intervention plus financial incentives for choosing cafeteria foods low in energy density. The potential moderating influence of individual differences characteristics on outcome will also be evaluated. Outcome measures will be administered repeatedly during the intervention and at 9- and 18-month follow-ups. The assessments will include measures of anthropomorphic and blood lipid variables, nutritional intake (both in and out of the cafeteria), physical activity, overeating, eating self-efficacy, and weight-related quality of life.

Eligibility Criteria:
No eligibility criteria
BCAAs in Concussion 2.0

This study is a randomized, placebo-controlled, double-blinded, therapeutic exploratory clinical trial of branched chain amino acids (BCAAs) in the treatment of concussion. The aim of the study is to determine whether administration of high-dose BCAAs compared to placebo promotes concussion recovery.

Annually, approximately 2 million concussions occur in the pediatric and young adult population. Approximately 30% of those diagnosed with concussion will experience persisting symptoms lasting beyond 28 days. Concussion is a heterogeneous injury to the brain that precipitates a complex pathophysiological process that can result in a cascade of deleterious side effects. At present, there are no targeted therapeutics that can mitigate or prevent the deleterious effects of concussion. In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three branched chain amino acids (BCAAs) (valine, isoleucine, and leucine) were significantly reduced after injury. When these brain-injured animals received dietary supplementation with BCAAs, the concentrations of these amino acids were restored in the injured hippocampus and the injured animals demonstrated significant cognitive improvement to levels comparable to those obtained in non-injured control animals. The pilot study (NCT01860404) provides evidence of BCAAs in concussed adolescents and young adults providing a dose-response effect in reducing concussion symptoms and a return to baseline physical activity in those treated with higher total doses of BCAAs, warranting this larger trial to inform clinical practice around BCAA treatment in concussion.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females,11 - 23 years of age.
2. Weigh at least 40kg.
3. Meeting concussion criteria for the American Congress of Rehabilitative Medicine.
4. Present within 4 days of injury.
5. Post-menarchal females must have a negative urine pregnancy test and must use an acceptable method of contraception.
6. Informed consent by the participant, or for participants \<18 years old both informed consent by a parent/guardian and child assent.

Exclusion Criteria:

1. Evidence of moderate or severe Traumatic Brain Injury (TBI), including Glasgow Coma Scale (GCS) \<13, TBI requiring hospital admission, or TBI requiring neurosurgical intervention.
2. Prior concussion or TBI within 90 days.
3. Known history of maple syrup urine disease or known family history of maple syrup urine disease.
4. Any investigational drug use within 30 days prior to enrollment.
5. Hypersensitivity to any ingredient in the active or placebo products.
6. Participants who are pregnant, planning on becoming pregnant during the study duration, or breastfeeding.
7. Non-English speaking participants or parent/guardian.
Liquid Biopsy in High-grade Gliomas and Meningiomas

The general objective of this project is to evaluate the value of cell-free DNA circulating in plasma as a marker of tumor evolution in patients with high-grade gliomas and meningiomas.

To this end, we propose to longitudinally collect four samples of plasma at the following time points:

* T0: before surgery;
* T1: one month after surgery;
* T2: one month after the end of radiotherapy;
* T3 at the time of radiological progression.

The goal is to evaluate whether changes in plasma concentration of circulating cell-free DNA can help predict progression-free survival, overall survival, and response to therapies.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Finding, on an MRI scan of the brain with gadolinium, of a brain lesion compatible with a primary brain tumor, intra- or extra-axial, suspected for a high-grade glioma or a high-grade meningioma, manifested with new onset neurological symptoms
* Clinical indication to perform a biopsy or surgical resection of the lesion
* Karnofsky Performance Status (KPS) ≥ 60
* Signature of informed consent

Exclusion Criteria:

* Absolute contraindications to magnetic resonance imaging or to the administration of gadolinium (e.g. patients with pacemakers or other non-magneto-compatible devices)
* Known positivity for HIV, HCV or HBV
* There are clinical, biological or instrumental data suggesting that the brain lesion is non-neoplastic in nature (e.g., abscess, vascular malformation, inflammatory disease of the Central Nervous System)
* Women who are pregnant or breastfeeding