cyrilzakka/clinical-trials huggingface dataset:
Acute Effect of Lemborexant on CSF Amyloid-Beta and Tau

This study will look at the effects of lemborexant on Alzheimer's disease biomarkers found in the cerebrospinal fluid (CSF) and blood in individuals who are poor sleepers

This study will determine the acute effect of lemborexant on CNS tau phosphorylation and other Alzheimer's disease biomarkers in individuals with poor sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 years
* Any sex
* Any race/ethnicity
* Mini-Mental Status Examination score (MMSE) ≥ 27
* Positive plasma amyloid-beta test (i.e., amyloid-positive)
* Pittsburgh Sleep Quality Index \>5

Exclusion Criteria:

* Cognitive impairment as determined by history of MMSE \< 27
* Inability to speak or understand English
* Any sleep disorders other than insomnia
* No history of moderate-to-severe sleep-disordered breathing and STOP-Bang score \> 5
* History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
* No more than mild sleep apnea (AHI \<16) on PSG
* Sleep schedule outside the range of bedtime 22:00-midnight
* Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
* Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
* Stroke
* Hepatic or renal impairment
* Pulmonary disease (PI discretion)
* Type 1 diabetes
* HIV or AIDS
* Neurologic or psychiatric disorder requiring medication (PI discretion)
* Suicidal ideations
* Alcohol, tobacco or marijuana use (PI discretion)
* Use of sedating medications (PI discretion)
* Inability to get out of bed independently
* In the opinion of the investigator, the participant should be excluded due to an abnormal physical examination.
* Current pregnancy
* Body Mass Index \>35
* History of migraines (PI discretion)
* History of drug abuse in the last 6 months
* History or presence of any clinically significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI participant is not a good candidate.
* Urinary or fecal incontinence
* Concurrently enrolled in another trial of an investigational drug or device
Validation of a French Quality of Life Questionnaire Adapted to Persons Who Have Suffered a Stroke

The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation.

The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice.

The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older.
* Patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at Dijon CHU and included in the Dijon Stroke Registry cohort.
* Patients who have provided oral informed consent.
* Patients with national health insurance cover

Exclusion Criteria:

* History of symptomatic stroke.
* Meningeal haemorrhage.
* Severe visual or hearing handicap making it difficult to complete the questionnaire.
* Global severe aphasia and mutism making communication with the patient impossible-.
* Unable to read or speak French.
* Dementia prior to the stroke.
* Psychiatric disorders and dependence on alcohol/drugs.
* Bedridden before the stroke.
* Other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.
Slowly Digestible Carbohydrates and the Ileal Brake

The ileal brake is a feedback mechanism controlling stomach-mediated transit of a meal, for which gastric emptying can be used as an indicator. Previously, slowly digestible carbohydrates (SDCs) were shown to activate the ileal brake in a rat model; the current research aimed to determine the effect of common SDCs in humans.

Diets containing slowly digestible carbohydrates (SDCs), in the form of starch-entrapped microspheres that digest into the ileum, were previously shown to reduce food intake in a diet-induced obese rat model by activating the gut-brain axis. These results suggested that SDCs trigger the ileal brake, which is a feedback mechanism controlling stomach-mediated transit of a meal. The ileal brake is characterized by delayed gastric emptying rate and increased satiety. The goal of this work was to determine if common SDCs trigger the ileal brake in humans, using gastric emptying rate as a proxy indicator. In a human study, SDCs were delivered through a semi-solid yogurt matrix, and gastric half-emptying time and postprandial glycemic response were assessed. The study was a five-arm, double-blind, crossover design with a one-week washout period between treatments (n=20, 9 females, 11 males). Four different carbohydrate ingredients (SDCs: isomalto-oligosaccharides (IMO), Xtend® sucromalt, and raw corn starch; and non-SDC: maltodextrin) were incorporated individually, or in combination, into yogurt products matched in energy density and viscosity. Participants consumed 300 g test meals of yogurt formulated with one or a combination of the carbohydrate ingredients after an overnight fast. Gastric emptying rates and glycemic response were measured using a 13C-labeled octanoic acid breath test and continuous glucose monitors, respectively. Glucose readings were continuously monitored 24 h prior to and 48 h after test meal consumption, and breath samples were collected for a 4 h period following test meal consumption.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5 - 25 kg/m2
* Stable weight for the past 3 months (i.e. +/- 2..5 kg)
* Regular eating patterns, including breakfast consumption

Exclusion Criteria:

* Gastrointestinal disease
* Smokers
* Peri- or post-menopausal women
* Celiac disease (yogurts may contain ingredients with wheat origin)
* Allergies, including dairy, lactose, and gluten
* Pregnant and lactating women
* Following a weight reduction program or having followed one during the last 3 months
* Acute or chronic disease
* Alcohol consumption \> 30 units/week
* Hypertension
* Diabetes
* Previous bariatric surgery
Radioimmunotherapy (RIT) in MULTIPLE MYELOMA Using the Antibody B-B4 Radiolabelled With IODE 131

The first step of this protocol called step pre-treatment study the biodistribution and pharmacokinetics of a tracer dose of radiolabeled antibody. The second step called step therapy study the toxicity and antitumor effects of antibody B-B4 coupled with increasing doses of iodine 131. At least 17 patients will be included for an estimated duration of 2 years to determine the maximum tolerated dose and dose limiting toxicity. The immediate side effects, medium and long terms will be analyzed. After determining the toxic dose limit, patients will be treated at the maximum tolerated dose, for a total of 15 patients at this level, which will measure the objective tumor response to treatment. These patients will be followed for 1 year after injection therapy.

ÉcouterLire phonétiquement


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of multiple myeloma (\> 10% plasma cells on a previous myelogram)
* Secretion of a monoclonal immunoglobulin
* No myelodysplasia evaluated by myelogram
* Disease refractory or relapsed after at least 3 lines of therapy
* Patients with a dated and signed the consent form
* Collection of autologous peripheral blood stem cells containing at least 2. 106 CD 34 + cells / kg
* Age\> 18 years
* Performance status \<2 (see Annex I), life expectancy of more than 3 months
* No chemotherapy or radiotherapy within 4 weeks before inclusion
* No major surgery within 4 weeks preceding the assessment of inclusion
* No bisphosphonates within 2 weeks prior radioimmunotherapy, except for treatment started more than three months ago.
* Normality of the biological assessment:
* Creatinine less than or equal to 1.5 times the normal laboratory
* Liver: less than or equal to 1.5 times the normal laboratory (free and conjugated bilirubin, SGOT, SGPT, gamma GT PAL)
* Hemoglobin ≥ 8 g/mm3
* ≥ 3 WBC 000/mm3
* Neutrophils ≥ 1 500/mm3
* Platelets ≥ 100 000/mm3

Exclusion Criteria:

Patients with other cancers except uterine carcinoma in situ or basal cell skin carcinoma

* Patients with other (s) condition (s) Severe (s) to prevent tolerance to study and conduct the study to completion
* Patient is pregnant or unwilling to take a contraceptive treatment for three months after treatment
* Collection of peripheral blood stem cells containing less than 2106 CD 34 + cells / kg
* Patients enrolled in another experimental treatment protocol
* Patients who already received treatment with radioimmunotherapy
* Myelodysplasia assessed by myelogram
* Patient with thyroid
* Patient unable to sign informed consent ÉcouterLire phonétiquement
Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis

In Hong Kong, joint diseases are common health problems as identified by the Elderly Health Service under the Department of Health. It accounts for most of the disability of the elderly in Hong Kong. In particular, osteoarthritis (OA) is on the rise and the prevalence of OA increases with age. Women are more likely to have OA in knee and hip joints after menopause. A study in 2000 reported that among Hong Kong people aged 50 and above, 7 percent of men and 13 percent of women suffered from OA. With an ageing population, it is expected that OA will become a major public health problem in Hong Kong and worldwide and the socio-economic cost of supportive care to these patients can become a major burden to Hong Kong society and many regions in the world. Early diagnosis and prevention of OA and effective technology for treatment monitoring are very important. At present, the management of OA is not optimal and standard quality indicators suggest that the majority of persons with the disease do not receive appropriate care. Over half of the population affected with OA are unaware of the diagnosis. The research team have developed a quantitative and fully automated non-contrast MRI application for early detection and monitoring of joint diseases. The whole project was funded by the Innovation and Technology Fund (ITF) (MRP/001/18X ) started in January 2019. This clinical trial is part of the quantitative assessment of this developed technology. The team anticipate this innovation will address both OA diagnosis, surveillance and management. This can potentially increase diagnostic capabilities with minimum efforts, improving patient awareness, and improved treatment monitoring of the disease state after the interventions. Thus, the proposed technology is expected to provide betterment in the quality of life for the elderly population.


Eligibility Criteria:
Inclusion Criteria:

* All Patients over the age of 18
* All patients must provide their written consent

In the OA group

* Patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification)
* All patients must have pain symptoms for more than or equal to 2 months
* Radiological evidence of osteoarthritis

Exclusion Criteria:

* Contraindication to MRI
* Patient with a mental disability
* Claustrophobia
* Inflammatory arthritis
* Ongoing Pregnancy and breast-feeding
* Presence of severe diseases like terminal cancers
* Presence of metalwork in the knee
* Significant hematological diseases;
* Non-consenting patients who have not provided the written Informed Consent
* Gross lower limb deformity
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. The main question\[s\] it aims to answer are:

Is the procedure effective in reducing BMI to the target level in 12 months? Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (i.e., age between 18 and 70 years).
* BMI ≥ 35 kg/m²;
* Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate \[GFR\] \<30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible;
* Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
* Signed informed consent.

Exclusion Criteria:

* Patients on peritoneal dialysis
* Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months;
* Ongoing or active malignancy during the last 5 years
* Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification;
* Previous stomach, oesophagus or duodenum surgery;
* Technical non-feasibility in the opinion of the endoscopist;
* Clinical signs of active infection;
* Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
* Active drugs or alcohol abuse;
* Pregnancy, lactation (desire to become pregnant during study duration);
* Enrolment in other clinical studies;
* Contraindication to general anaesthesia;
* Other conditions to exclude the subject in investigators opinion;
* Refusal to sign informed consent. -
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B

The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.

After signing the ICF and screening examination the subjects are to be included in the Non-interventional lead-in period in which the subject will receive standard FIX prevention. The lead-in period will last for at least 6 month for every subject.

After completiong the lead-in period subjects will enter the main (interventional) period.

At the first visit of the main period subjects will recieve investigational product ANB-002.

The main period ends 18 months after the administration of ANB-002, after which subjects will switch to the follow-up period and will be evaluated up to 5 years after the ANB-002 infusion.

Eligibility Criteria:
Inclusion Criteria:

* Men diagnosed with hemophilia B aged 18 or older
* FIX activity ≤2%
* Absense of FIX inhibitor
* ≥150 previous exposure days of treatment with FIX concentrates

Exclusion Criteria:

* Any diseases of blood and hematopoietic organs other than hemophilia B
* A history of any gene therapy, including ANB-002
* Diagnosed HIV-infection, not controlled with anti-viral therapy
* Active HBV or HCV infection
* Anti-AAV5 antibodies
* Any active systemic infections or recurrent infections requiring systemic therapy
* Any other disorders associated with severe immunodeficiency
* Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder
* Malignancies with less than 5 years of remission
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD

This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose, phase 3 study to evaluate the safety and efficacy of Biphentin® methylphenidate hydrochloride (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.

Subjects who met study entry criteria were enrolled in the Double-blind Phase and were randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period.

The safety and tolerability, and efficacy assessments will be conducted throughout the study.

Biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more similar to immediate release methylphenidate.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 6 up to 18
* ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile
* In need of treatment for ADHD and able to have 2-day washout from previous medication
* Females of child-bearing potential not pregnant and practice birth control
* Subject and parent/guardian willing to comply with protocol
* Signed consent and assent

Exclusion Criteria:

* Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of Intelligence (WASI)
* Current primary psychiatric diagnosis of other listed disorders
* Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family history of sudden death, glaucoma
* Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days from screening
* Planned use of prohibited drugs
* Is pregnant or breast-feeding
* Significant ECG or laboratory abnormalities
* Experimental drug or medical device within 30 days prior to screening
* Hypersensitivity to methylphenidate
* Inability or unwillingness to comply with protocol
* Well controlled on current ADHD treatment
* Inability to take oral capsules
Blood Transfusions in Preterm Infants

A cross sectional study to assess the effect of blood transfusions on the outcome of preterm infants

This is a cross sectional study carried on preterm infants who are staying in the hospital as "growers"; to gain weight. We will assess blood transfusion received by these preterm infants in details.

Eligibility Criteria:
Inclusion Criteria:

* Grower preterm infants

Exclusion Criteria:

* Severe illness, Hypovolemic shock, Hypoxia, Oxygen therapy, Surgical intervention
A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types

A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Men and women must follow methods of contraception as described in the protocol

Part 1 Arms A and B: Metastatic Melanoma

- Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0

Part 1 Arm A:Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma.

Part 1 Arm A: Advanced HCC

* Participants with histological confirmation of Hepatocellular Cancer (HCC)

Part 2 Arm A: Metastatic NSCLC

- Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC)

Part 2 Arm B: Advanced or Metastatic RCC

* Histological confirmation of Renal Cell Carcinoma (RCC)
* ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70%

Exclusion Criteria:

- History of allergy or hypersensitivity to study drug components

Part 1 Arm A: Advanced HCC

* History of hepatic encephalopathy or evidence of portal hypertension
* Active coinfection with hepatitis D virus infection in participants with HBV

Part 2 Arm A:Metastatic NSCLC

- Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy

Other inclusion/exclusion criteria apply.
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis

The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years old
* Must be willing to practice 2 adequate methods of contraception for the duration of the study
* Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
* Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
* Ability to provide written informed consent

Exclusion Criteria:

* Women who are pregnant or nursing
* History of other current inflammatory arthritis
* History of opportunistic infection
* History of recurrent infections or current infection 2 weeks prior to start of study
* Presence of significant, uncontrolled medical problems
* Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
* Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
* Receipt of live vaccine within 8 weeks prior to study start
* Rheumatoid arthritis, functional class IV as defined by ACR criteria