cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute cervical spinal cord injuries (SCI).


Eligibility Criteria:
Major Inclusion Criteria:

* Sensorimotor complete, traumatic SCI (ASIA Impairment Scale A) for cohorts 1,2,3
* Sensorimotor incomplete, traumatic SCI (ASIA Impairment Scale B) for cohorts 4,5
* Last fully preserved single neurological level (SNL) from C-4 to C-7
* From 18 through 69 years of age at time of injury
* Single spinal cord lesion on a post-stabilization magnetic resonance imaging (MRI) scan, with sufficient visualization of the spinal cord injury epicenter and lesion margins to enable post-injection safety monitoring
* Informed consent for this protocol and the companion long term follow-up protocol must be provided and documented (i.e., signed informed consent forms) no later than 37 days following injury
* Able to participate in an elective surgical procedure to inject AST-OPC1 21-42 days following SCI

Major Exclusion Criteria:

* SCI due to penetrating trauma
* Traumatic anatomical transection or laceration of the spinal cord based on prior surgery or MRI
* Any concomitant injury that interferes with the performance, interpretation or validity of neurological examinations
* Inability to communicate effectively with neurological examiner such that the validity of patient data could be compromised
* Significant organ damage or systemic disease that would create an unacceptable risk for surgery or immunosuppression
* History of any malignancy (except non-melanoma skin cancers)
* Pregnant or nursing women
* Body mass index (BMI) \> 35 or weight \> 300 lbs.
* Active participation in another experimental procedure/intervention
Severe Alcohol-use Disorder: a tDCS and Response Inhibition Training Intervention

Most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators propose that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.

Treating Alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. Alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. The investigators proposes that two non-pharmacological interventions, Transcranial Direct Current Stimulation (tDCS) and Inhibitory Control Techniques (ICT) may act on both systems when combined. tDCS has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ICT is able to modify the automatic approach tendencies towards appetitive cues.

The investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial Direct Current Stimulation (tDCS) with active or control Inhibitory Control Technique (ICT ); or sham (placebo) tDCS with active or control ICT.

Patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe alcohol-use disorder (DSM-5 criteria), hospitalized for detoxification.
* Severity of alcohol use disorder must be at least moderate (at least 4 DSM-5 criteria)
* Aged between 18 and 65 years
* Comorbidity with anxiety disorders and depressive disorders is allowed
* Patients must be illegal drug free for 3 weeks at beginning of trial
* Pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. They are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time.
* Patients must be reachable for follow-up

Exclusion Criteria:

* Previous neurological conditions (epilepsy, traumatic brain injury, stroke)
* Present delirium, confusion or severe cognitive disorder
* Schizophrenia, chronic psychotic disorders, bipolar type 1 disorder.
* Any severe, life-threatening disorders
* High suicidal risk
* Specific contraindications for tDCS: metallic plates in the head
* Alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.
Efficacy of Dexpanthenol in Thermic Erythema

The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Phototype: I to IV according to Fitzpatrick scale

Exclusion Criteria:

* Pregnant or nursing women
* Subjects registered as being in exclusion period in the French Health Minister file of subjects
* Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested
Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use

The purpose of this study is to learn if women gain weight using progestin-only methods of contraception and if so, how much. The investigators will look at users of two progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of users of a non-hormonal method, the copper intrauterine device.

The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition will increase more than the copper-IUD users. The investigators will collect body composition data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and activity using validated questionnaires.


Eligibility Criteria:
The study has finished enrolling new participants.

Inclusion Criteria:

* Participants between the ages of 18 and 45 years
* Participants starting the copper IUD or implant through their provider
* First study visit must occur within 14 days of method insertion

Exclusion Criteria:

* DMPA in the past 16 weeks
* POPs, LNG-IUC, or the implant in the past 4 weeks
* Thyroid disease
* Autoimmune disease
* Diabetes (excluding gestational)
* History of eating disorder
* Currently taking antidepressants for \< 6 months
* Currently taking antipsychotics
* Currently taking oral glucocorticoids (steroids, i.e. prednisone) for more than 6 months
* Currently breastfeeding
* Less than 6 months post-partum
Emotion Regulation and Binge Eating in Youth With Obesity

This study will investigate neural activation patterns in emotion- and cognition-related brain regions during an emotion regulation task involving cognitive reappraisal, and their associations with age and pubertal status, among overweight children and adolescents with loss of control eating as compared to overweight and normal-weight controls.

Loss of control (LOC) while eating (i.e., the sense that one cannot control what or how much one is eating) is prevalent among children and adolescents. LOC eating is associated with a range of physical and psychosocial health impairments, including obesity and the development of partial- and full-syndrome eating disorders. Early identification is thus critical for preventing or minimizing these adverse health outcomes. However, little is known about the development of LOC eating in children and, consequently, there is a paucity of effective interventions. Impairments in emotion regulation appear to be involved in the onset and maintenance of eating pathology in obese samples. To date, emotion regulation in youth with LOC eating problems is poorly understood, and research on underlying neurodevelopmental substrates is virtually nonexistent. The proposed research aims to characterize neurocircuitry involved in emotion regulation among 30 overweight children with LOC eating as compared to 30 overweight and 15 normal-weight controls without LOC. Participants will complete a cognitive reappraisal task whilst situated in an MRI scanner, the purpose of which is to characterize neural activity involved in reappraisal versus an emotion maintenance control condition. The proposed research aims to advance the field's understanding of the nature and correlates of LOC eating in overweight children so as to inform intervention development.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed, aged 10-17 years.

Exclusion Criteria:

Participants will be excluded if they

* are currently taking any medications known to affect mood or weight (e.g., antidepressants, steroids);
* have a current diagnosis of a mood disorder or an eating disorder involving purging or suppressed body weight (e.g., bulimia nervosa or anorexia nervosa);
* are unable to read and understand English fluently;
* are currently pregnant;
* are a current smoker; or
* have metallic foreign bodies, face or neck tattoos, or other conditions that would prohibit fMRI scanning. Participants will complete a mock scan (see below) to ensure that their head and trunk size can be comfortably accommodated in the scanner.
Evaluation of Shade Matching Capacity of a Contemporary Composite Dental Material

One of the main difficulties encountered in esthetic dentistry is the complexity associated with shade matching and layering technique to achieve optimal esthetic outcomes. To ensure an esthetic outcome, an imperceptible match of the color of the restorative material to that of the tooth is of utmost importance. Recently, a new shade matching composite that utilizes "smart chromatic technology", developed by Tokuyama was claimed to be able to capture the structural color of its surroundings teeth. Our main objective is to assess the blending capacity of OMNICHROMA composite material in anterior restorations of patients attending the Jordan University Hospital. Both visual and instrumental measurements will be performed and the differences between the shade of the composite resin and the tooth structure will be measured. In addition, multi chroma composite restorations will be placed for the purpose of comparison (control).

In the present study, the restorations will be placed under rubber dam isolation for moisture control. The cavities will be prepared according to the concepts of minimal invasive dentistry. Prior to placing the composite resin, the margins of the cavities will be finished using ultra fine grit diamond burs·and beveled in a 1-mm area. Deep cavities suspected to be near the pulp be lined with RMGI. Inclusion criteria: class Ill and Class IV carious lesions.

The enamel margins of the cavities will be acid etched for 60s with 37% phosphoric acid and then rinsed thoroughly with water spray. Afterwards, the dentin bonding system will be applied, left undisturbed for 20 s and then excess removed using an air syringe and light cured for 20s. The restorative composite material will be placed in incremental layers, adapted, each layer cured for 40s. After polymerization, the restorations will be finished under profuse water spray using diamonds, Sof-Lex finishing discs and polishers.

All restorations will be placed by one dentist (Pl). Written informed consent will be provided to all participants prior to starting the treatment

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients
* Patients requiring anterior restorations
* Vital teeth
* Absence of periodontal or pulpal disease
* Patients willing to sign informed consent and returning for follow up

Exclusion Criteria:

* Patients with extensive caries and tooth loss
* Patient with periodontal disease
* Patients with poor oral hygiene and lack of motivation
* Patient with severe extrinsic or intrinsic discolorations
Perioperative Lidocaine Administration in Thoracoscopic Surgery for Improved Postoperative Pain Control

Placebo-controlled study to analyze the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .

Thoracoscopy (thoracic surgery) is a video-assisted minimally invasive operation in thoracic surgery, which is associated with pain after surgery. Trial drug Lidocaine is approved as pain medication. This placebo-controlled study analyzes the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .

Half of the patients will receive NaCl 0.9% (a saline solution without active ingredient) instead of Lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing video-assisted thoracoscopic procedures under general anaesthesia.
* American Society of Anesthesiologists (ASA) physical Status classes I to III
* age ≥ 18 years
* Patient informed consent

Exclusion Criteria:

* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
* Contraindications to self-administration of opioids
* Women who are pregnant or breast feeding
* Steroid therapy
* Chronic pain therapy
* Atrioventricular block grade II to III
* Congestive heart failure
* Liver insufficiency
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution

The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
* Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
* Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
* Monocular vision (only one eye with functional vision) or fit with only one contact lens.
* Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
* Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
* Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
* Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
* Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.
* Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
* Participation in any investigational clinical study within 30 days of baseline visit.
* Other protocol-defined exclusion criteria may apply.
Effect of a Protein-enriched Drink on Muscle Function

There is no conclusive evidence about the effect of intake of protein-enriched drink after and acute high intensity exercise bout on muscle function and damage. The investigators aimed to study the effect of a protein-enriched drink on muscle function recovery following an acute high intensity exercise bout. The present counterbalanced, crossover, and double blind study will involve a total of 12 active men.

Participants will run downhill (-10%) during 30 min at a intensity equivalent to 75-80% of their maximum heart rate (previously determined). After the exercise bout, participants will have either the placebo or the experimental drink. The investigators will measure muscle function and damage-related parameters right after the exercise as well as the three following days. This protocol will be repeated after a wash out period of 3 weeks, where the participants will have the other drink. The investigators will control exercise and diet three weeks before study entry, during the experimental week as the investigators as during the wash out period.

Eligibility Criteria:
Inclusion Criteria:

* Recreational triathletes with 2 years of experience
* Maximum oxygen uptake : ≥55 ml/kg/min
* Fat mass: 8-20% measured by dual energy x-ray absorptiometry
* Not participating in another study
* Not having ergogenic aids
* Not participating in a weight loss program
* Normal electrocardiogram
* Participants must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment

Exclusion Criteria:

* History of cardiovascular disease
* Diabetes or hypertension
* Medication for hypertension, hyperlipidemia, hyperuricemia or other illness.
* Smoking
* Other significant medical conditions that are life-threatening or that can interfere with or be aggravated by exercise.
* Unwillingness to either complete the study requirements or to be randomized into control or training group.
Dexcom G4 in a Population With Normal Oral Glucose Tolerance Test

The purpose of this study was to obtain reference values of CGM in healthy individuals using the Dexcom G4 sensor and evaluate whether reported low glucose values by the Dexcom G4 sensor are really low when confirmed by capillary testing.

Evaluation of the profile of blood glucose using Dexcom G4 in a population with normal oral glucose tolerance test. The investigators have used information from a previous study of 60 participants using Dexcom G4, CGM system. A non-randomized, days 1-7 blinded and days 8-14 non-blinded CGM trial, the study was performed to evaluate the profile of blood glucose using CGM in the population with normal oral glucose tolerance test (OGTT). All enrolled subjects with at least three time-points with evaluable values from CGM system and the reference capillary value obtained from HemoCue during the whole study period were included in the Intent-to-Treat (ITT) population

Eligibility Criteria:
Inclusion Criteria:

1. Normal oral glucose tolerance test
2. Normal HbA1c value
3. Age of 18 years or older

Exclusion Criteria:

1. Known diabetes
2. Known prediabetes
3. Corticosteroid use during the last month
4. Planned corticosteroid use during the study
5. Pregnancy or planned pregnancy during the study period
6. Paracetamol use during the last 2 days
7. Planned paracetamol use during the study
8. Allergy to any adhesives used for CGM or clorhexidine
KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution

Risperidone is widely used in the treatment of schizophrenia, bipolar disorder, and aggression associated with moderate or severe Alzheimer's dementia. In vitro studies have shown that constituents of tea and cola beverages can result in insoluble complex formation with risperidone, potentially reducing risperidone oral absorption. The purpose of this study is to investigate the effect of tea and cola beverage on the pharmacokinetics of risperidone oral solution.

In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a 1 mg dose of risperidone oral solution with either water, tea or cola beverage. Blood samples will be collected and risperidone's pharmacokinetics will be monitored up to 48 hours postdose. Primary endpoint is area under the plasma concentration-time curve of risperidone.

Recruitment starting date is December 4, 2023.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-45
* Healthy
* Systolic blood pressure ≥110 mmHg
* Heart rate ≥ 50/min
* Normal ECG
* Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.

Exclusion Criteria:

* Significant disease
* Mood disorder or suicidality
* Smoking
* Using oral contraception pills or other regular medication
* Pregnancy (current or planned) or nursing
* Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
* Donation of blood within three months prior to the entry into this study
* Significant overweight / small or hard-to-find veins
* BMI \< 18.5 kg/m2
* Insufficient Finnish language skills
Treatment for Migraines With an Implantable Device

The purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed.


Eligibility Criteria:
Key Inclusion Criteria:

* Be diagnosed with multiple migraines per month of moderate to severe intensity;
* Be refractory to medication;
* Be an appropriate candidate for the surgical procedures required for this study;
* Be willing and able to comply with all study related procedures;
* Be capable of reading and understanding patient information materials and giving written informed consent.

Key Exclusion Criteria:

* Have onset of migraine after age 50;
* Have a significant psychiatric disorder;
* Have previously been treated with occipital nerve stimulation;
* Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
* Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect;
* Have a condition currently requiring or likely to require the use of MRI or diathermy;
* Have an active implantable device;
* Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.