cyrilzakka/clinical-trials huggingface dataset:
Ethanol and Cannabinoid Effects on Simulated Driving and Related Cognition: Substudy III

The overarching goal of this study is to characterize the effects of ethanol and cannabinoids on simulated driving and related cognition.

To study the effects of ethanol clamped at BAC 0.04% (equivalent to consuming approximately 2 drinks over 1 hour) and oral Dronabinol (10 mg capsule) on driving.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 21 to 55 years of age (extremes included).
* Exposed to cannabis at least once.
* Exposed to alcohol at least once.
* Able to provide informed consent.

Exclusion Criteria:

* Cannabis naïve
* Alcohol naïve
* Positive pregnancy screen
* Hearing deficits
* Sesame oil allergy
Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA

The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.


Eligibility Criteria:
Inclusion Criteria:

* Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)
* Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

Exclusion Criteria:

* Septic failure
* Second or more failure in the revision group
* Associated surgical procedure as osteotomy, allograft...
* Not full weight bearing postoperatively
* Refusal to participate
Dynamic Stability Exercises in Patients With Hypermobile Ehlers-Danlos Syndrome and Hypermobility Spectrum Disorder

Background:

Symptomatic hypermobility may lead to a number of restrictions in daily life. So far, there is a lack of effective treatments. A whole-body dynamic stability exercise intervention targets to stimulate the dynamic stability and activation of the proprioceptive system and thereby intends to improve patients' health. The aim of the current study was to examine the feasibility, acceptability and impact of a whole-body dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder.

The aim of the current study was to examine the feasibility, acceptability and impact of a dynamic stability exercise intervention in patients with hypermobile Ehlers-Danlos syndrome and hypermobility spectrum disorder.

Methods:

This is a mixed-methods feasibility study. Fifteen patients (14 women and 1 man) with hypermobile Ehlers-Danlos syndrome or hypermobility spectrum disorder and chronic pain were recruited from two pain specialist clinics in the South-East of Sweden. A dynamic stability exercise program for daily home-exercise was applied during five physiotherapist led sessions distributed over seven weeks. Patient reported outcome measures (PROMs) included pain and function, psychological well-being and quality of life. The clinical tests included walking and balance. Through qualitative interviews patients and physiotherapists described their experiences of the assessments and intervention. Assessments were done at baseline, after the intervention, and at the 3-month follow-up.

The specific research questions are:

1. Do retention rates, adherence rates and adverse events allow continuation to a large scale RCT?
2. What are the tendencies of impact of the exercise program on pain, function, psychological well-being and quality of life?
3. Which of the outcome measures used are appropriate and acceptable?
4. What are the patients' and physiotherapists' experiences of the exercise program and protocol.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were adults aged 18 to 67 years old, with generalized hypermobility (castori. A framework), persistent pain (i.e. longer than three months) in at least two of four quadrants of the body and ability to perform the exercises.

Exclusion Criteria:

Exclusion criteria were cancer-related pain, underlying neurological disease, presence of severe psychiatric disorders, known substance abuse, patients in the process of finding optimal medication as well as patients with previous experience of similar exercises.
Control and Reward Circuits in Obsessive Compulsive Disorder

The purpose of this study is to examine the brain functioning of OCD patients and healthy controls before and after treatment with Exposure and Response Prevention (EXRP) therapy.

The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive control) and the capacity to anticipate, respond to, and learn from reward (reward processing) are key processes for human behavior. Dysfunction in these processes has been hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. We will use multimodal imaging to investigate neural circuits that support cognitive control and reward processing, using OCD as a model system. The short-term goal is to clarify how circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will inform future transdiagnostic studies. The long-term goal is to identify control and reward circuit-abnormalities as targets for new transdiagnostic treatments.

Eligibility Criteria:
Inclusion Criteria for Patients:

* Male and females with OCD aged 18-55
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD
* Not on psychotropic medication

Exclusion Criteria for Patients:

* Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
* Comorbid psychiatric conditions that significantly elevate the risk of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality)
* Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)
* Use of psychotropic medication
* Females who are pregnant or post-menopausal

Inclusion Criteria for Healthy Volunteers

- Male and females aged 18-55

Exclusion Criteria for Healthy Volunteers

* Presence of metallic devices or dental braces in the body that are contraindicators for MR imaging
* Any psychiatric diagnosis
* Use of psychotropic medication
* Diagnosis of OCD in a first degree relative
* Females who are pregnant or post-menopausal
* Unstable medical conditions that need attention and would make participation in the study unsafe (e.g. very high blood pressure)
The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers

To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.

The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.

Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing age must use adequate contraception

Exclusion Criteria:

* A history of serious somatic or psychiatric disease
* Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month)
* Daily intake of any medication except contraceptives
A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants

The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health \[NIH\] response defined complete response \[CR\] and partial response \[PR\]) at Week 24.


Eligibility Criteria:
Inclusion Criteria:

Part A and Part B

* Must have a confirmed diagnosis of steroid dependent or refractory classic cGVHD defined at any time post-hematopoietic cell transplantation (HCT) as: a) refractory disease - progressive cGVHD manifestations requiring prednisolone at greater than or equal to (\>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cGVHD manifestations requiring glucocorticoid \>= prednisolone 0.25 mg/kg/day or \>=0.5mg/kg every other day for at least 8 weeks Part A
* Treated at least 2 or more therapies for cGVHD (including glucocorticoids)
* Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy
* Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B
* Treated at least 3 lines therapies for cGVHD (including glucocorticoids)
* Participants who are treated with ibrutinib in their second-fourth line of therapy

Exclusion Criteria:

Part A and Part B

* Known or suspected active acute GVHD
* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A
* Treated with an investigational agent for their identified last-line of conventional salvage therapy
* Pregnant, breastfeeding during last-line of conventional salvage therapy Part B
* Pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US

The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 month history of GERD symptoms
* Treated with unchanged optimized PPI treatment for any GERD indication during a consecutive 4 week period
* Remaining GERD symptoms despite optimized PPI treatment
* Able to read and write in US English, and able to comply with study requirements

Exclusion Criteria:

* Patients that have not experienced any GERD symptom improvement at all during PPI treatment
* Involvement in the planning or conduct of the study
* Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
Evaluation of the Signal to Noise Ratio at Various Retinal Layers

Compare the signal to noise ratio of each device at various retinal layers.

Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal layers from the same group of subjects

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients \> 18 years old who have full legal capacity to volunteer on the date the informed consent is signed.
2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date.
3. Subjects who agree to participate in the study.

Exclusion Criteria:

1. History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
2. Fixation problems which may prevent obtaining good quality images in either eye.
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS

The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.

Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.

Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).

The study is designed as a randomised, single blind clinical controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
* Dysfunction or pain on abduction
* Had a normal passive glenohumeral range of movement
* Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
* Positive Hawkins-Kennedys test.

Exclusion Criteria:

* Shoulder pain bilateral (both shoulders required treatment)
* Earlier operated in affected shoulder
* Had multidirectional instability
* Had the cervical syndrome
* Rheumatoid arthritis
* Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
* Not able to understand spoken or written Norwegian
* Considerable emotional distress
* Needed anticoagulant medicine
* Being pregnant
* Had had Shock Wave Therapy or Supervised Exercises before.
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Study objectives:

* To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery
* To characterize the molecular landscape of arrhytmogenic MVP

Study design:

-Prospective explorative observational study

Study population:

-90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery

Prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and CMR imaging biomarkers will be examined in patients with arrhythmogenic MVP compared to those without arrhythmogenic MVP (controls). Molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic MVP will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep RNA single cell sequencing. Using CMR in 90 patients with MVP before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. To assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with E-patch at baseline and at 6 months after mitral valve surgery. During surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.

Eligibility Criteria:
Inclusion criteria

* Age 18 and over
* Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care

Exclusion criteria

* Secondary mitral regurgitation
* Primary mitral regurgitation not due to degenerative disease (including rheumatic disease)
* Co-existing moderate or severe aortic valve disease
* Congenital heart disease
* Inherited or acquired cardiomyopathy
* Non-incidental or symptomatic coronary artery disease
* Uncontrolled atrial fibrillation (resting heart rate \> 100/min)
* Pregnancy
* Unable to undergo CMR
A Comparison of Incisionless Ultrasound Guided Thread Carpal Tunnel Release and Mini Open Carpal in Patients With Bilateral Carpal Tunnel Syndrome

To compare the incisionless thread carpal tunnel release with the standard mini-open carpal tunnel release (standard of care) in patients with bilateral carpal tunnel syndrome. Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release. The investigators hypothesize that the incisionless thread carpal tunnel release (TCTR) will be no different than the standard mini-open release (MOR) with regard to symptom improvement and safety and will be less painful, result in quicker return to work and will be less costly.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of bilateral CTS with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months
* Willingness to undergo bilateral carpal tunnel surgical treatment with one side having the TCTR and the other a mini open carpal tunnel release
* Age 18-65 years of age
* Clinical examination findings (compression test, Tinels, Phalens, etc) consistent with carpal tunnel syndrome.
* Persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy.
* Electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist
* Able and willing to complete all follow-up appointments

Exclusion Criteria:

* Previous CTS surgical release on any of their hands
* Diabetes mellitus
* Hypothyroidism
* Significant Hand arthritis (rheumatologic or osteoarthritis)
* Pregnancy
* Electromyographic evidence of any condition other than CTS affecting the hand
* Workman's compensation
The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot

The goal of this study is to test the hypothesis that repeated consumption of artificial sweetener reduces sweet taste intensity.

Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Some studies have found correlations between AFS use and weight gain and/or diabetes \[1-4\] while others have indicated that AFSs may aid in weight loss \[5\] or have no effects on body mass index (BMI) \[6\]. In rats, exposure to AFS leads to reduced chow intake following a sweet preload \[7, 8\], higher body weight \[9, 10\] and increased glucose responses and decreased GLP1 release following an oral glucose tolerance test \[11\] compared to exposure to caloric sweeteners. Given that the five FDA approved AFSs are found in thousands of foods \[12\] this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the consequences of AFS use, since alterations in sweet taste perception that occur in response to AFS exposure may promote weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Fluent in English

Exclusion Criteria:

* History of oral nerve damage,
* presence of known taste or smell disorder,
* food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),
* history of CNS disease,
* diabetes,
* history of DSM-IV major psychiatric disorder, including alcohol and substance abuse, chronic use of medication that may affect taste,
* conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies, recent smoking history),
* aberrant stimulus ratings,
* contra-indication for fMRI,
* uncomfortable swallowing in supine position.
Improving Therapeutic Adherence With a Co-constructed Program Involving Both Patients and Health Care Professionals

Background Cystic fibrosis is a life-threatening genetic disorder responsible for pulmonary failure and multi-systemic complications involving specific and large medical care burden. To date, no program has shown its effectiveness in improving therapeutic adherence. A new approach to develop a co-constructed program involving patients and professionals may contribute to improve therapeutic adherence.

Objectives The aim of the MUCOBS-Trial project is to create a program to increase therapeutic adherence and to evaluate its efficacy in adult patients with cystic fibrosis in 3 CF centers in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Cystic Fibrosis
* Aged 18 or more
* Speaking / understanding French
* Followed in one of the participating centers (CRCM of the Auvergne-Rhône-Alpes region)
* Resident in Auvergne-Rhône-Alpes
* Affiliated to the general health insurance scheme

Exclusion Criteria:

* Transplanted Patients
* Patients who participated in the working group for the co-construction of the intervention
Foot Core Exercise Training with Telerehabilitation

The aim of this study was to investigate the effects of lower extremity exercises combined with foot core exercise training on lower extremity pain, foot functionality, static and dynamic parameters of gait, and postural stability in individuals with rheumatoid arthritis using synchronous and asynchronous telerehabilitation methods.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with rheumatoid arthritis
* Being between the ages of 18-65
* Being willing to participate in the study

Exclusion Criteria:

* Having a neurological disease
* Having a pulmonary or cardiovascular problem that may affect daily life activities
* Sensory system disorders
* Having a history of surgery on the lower extremities or trunk
* Experiencing dizziness
* Having a cognitive disorder
* Having an additional rheumatic disease
Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain

The primary objectives of this study are to:

* Evaluate recruitment procedures and adherence rates;
* Evaluate the ability to understand the concepts of pain neurophysiology;
* Evaluate the acceptability of an intervention program based on pain neuroscience education and exercise by institutionalized older adults and the institutions where they are.

Participants will be older adults with pain that are institutionalized and assess the feasibility of implementing an intervention consisting of pain neuroscience education in addition to exercise. It is antecipated that the intervention will consist of 1 to 2 sessions per week during 8 weeks and will be delivered in small groups. Participants will be assessed for pain intensity, duration, catastrophizing, fear of movement, knowledge of pain neuroscience, depression and performance.

Eligibility Criteria:
Inclusion Criteria:

* Be institutionalized in any type of response (nursing home, day care, ...), be able to read and write, have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body, and have a statement from the institution's physician authorizing participation in the exercise sessions.

Exclusion Criteria:

* Have any contra-indication to exercise and have cognitive limitations (evaluated through the Montreal Cognitive Assessment questionnaire).