cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Psychological Intervention in Patients Undergoing Total Knee Arthroplasty

The purpose of this study is to evaluate the effectiveness of a combined Pain Neuroscience Education (PNE) and Hypnosis (HyP) psychological intervention aiming at the control and prevention of pain and promotion of post-surgical recovery in patients undergoing Total Knee Arthroplasty

This is a prospective Randomized Controlled Trial (RCT), comparing an experimental group (EG), submitted to a PNE/HyP based psychological intervention, and a control group (CG), submitted to usual treatment and care.

After recruitment and evaluation of inclusion/exclusion criteria, patients entering the study will sign the Informed Consent. Baseline evaluation is performed at 1 month pre-surgery and, afterwards, patients are randomly assigned to EG (PNE+Hyp plus usual care) or CG (usual care only). The EG will be submitted to 3 pre-surgical and 1 (or 2) post-surgical reinforcement sessions. At 1 month post-surgery, the intervention group will be subdivided and participants will be randomly assigned to receive a reinforcement session or no intervention at this point. The psychological intervention sessions are based on the educative principles of Pain Neuroscience Education and on Hypnosis strategies for the promotion of pain control, positive coping strategies and psychological variables.

Patients will be evaluated on 6 moments: T0 - baseline, 1 month pre surgery; T1 - post intervention/24h before surgery; T2 - 72h post-surgery; T3 - 1 month post surgery; T4 - 6 months post surgery; T5 - 12 months post intervention. Patients will fill in self report measures and perform physiological evaluation to analyse relevant bio-markers (salivary cortisol and α-amylase) that are related to stress levels and SNS functioning and translate the impact of psychological interventions on physiological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Planned unilateral total knee arthroplasty due to gonarthrosis
* Giving consent to participate

Exclusion Criteria:

* Inability to write and read
* Cognitive deficit (assessed by MMSE)
* Revision TKA
* Bilateral TKA
* TKA for reasons other than gonarthrosis (fracture, malignancy or infection)
* Psychiatric or neurological deficit (e.g. Schizophrenia or Alzheimers')
* Diagnosis of rheumatoid arthritis, Psoriatic arthritis, Systemic lupus erythematosus, Anquilosant spondylitis or other severe disease
* Contralateral hip or knee arthroplasty in the previous 6 months
* Planned contralateral hip or knee arthroplasty in the next 6 months
Investigation of Brain Oxygenation and Blood Flow in Smokers

Cerebral oxygenation and blood flow in tobacco use disorder and their relation to smoking abstinence will be measured with MRI" ändern in "Cerebral oxygenation and blood flow in tobacco use disorder

In this study, cerebral oxygenation and tobacco-related attentional bias in smokers and non-smokers will be measured with magnetic resonance imaging (MRI).

In this study, the oxygen extraction fraction (OEF), the cerebral blood flow (CBF) and the cerebral metabolic rate of oxygen (CMRO2) are to be measured in smokers and non-smokers using MRI. On the one hand, the influence of chronic smoking (i.e. smokers versus non-smokers) and on the other hand the effect of acute nicotine administration (in smokers) on these parameters will be examined. Furthermore, the influence of these parameters on fMRI results is to be investigated using the example of a stimulus-reaction task. It can be assumed that the OEF does not change through nicotine administration, but differs in smokers and non-smokers and is associated with the strength of tobacco addiction in smokers. CBF and CMRO2 are expected to be reduced in abstinent smokers, but can be normalized by nicotine administration. In this study, 20 smokers and 10 never-smokers will be investigated. Never-smokers will be examined once with MRI and questionnaires, whereas smokers will be examined twice: before and after a smoking break.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65
* right-handed
* normal or correctable eyesight
* Sufficient ability to communicate with the investigators, to answer questions in oral and written form
* "Fully Informed Consent"
* "Written Informed Consent"
* Group 1 - Smokers: Occasional smoker or tobacco consumption disorder according to DSM 5
* Group 2 - Never-Smokers: Consumption of less than 20 cigarettes in life

Exclusion Criteria:

* women: pregnancy
* Withdrawal of the declaration of consent
* Exclusion criteria for an MRI scan
* severe internal, neurological and psychiatric comorbidities
* Pharmacotherapy with psychoactive substances within the last 14 days
* Current substance abuse
* Axis 1 disorder according to ICD-10 and DSM 5 (except tobacco use disorder and specific phobia within the last 12 months)
Dynamic Splinting for Patients With Adhesive Capsulitis

The purpose of this study is to compare two treatments for adhesive capsulitis.

The purpose of this study is to examine the effects of two treatment regimens for adhesive capsulitis: dynamic splinting and/or manual physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic adhesive capsulitis
* greater than 50% limitation in active flexion, internal rotation, or external rotation
* Tight GHJ capsule in at least 2 directions
* Capsular end-feel primarily limits ROM
* Age 40- 64
* Normal X-Rays

Exclusion Criteria:

* Acute adhesive capsulitis
* History of Diabetes Mellitus
* Evidence of a cuff tear
* Recent history of trauma
* Evidence of glenohumeral DJD
* History of shoulder surgery
* Calcification of tendonitis demonstrated on a current X-Ray
* Abnormal X-Ray
* Cervical Radiculopathy/brachial plexus lesions
* Less than 2+/5 muscle strength during mid-line manual muscle testing
* Muscle Atrophy
* Presence of associated systematic conditions
* History of prior therapy for current condition
* Manipulation under anesthesia
* Non compliance
* Shoulder-Hand syndrome, Complex Regional Pain Syndrome
* History of prior injections for the current problem
* Patient receiving worker's compensation
* Shoulder symptoms with cervical provocative testing
* Positive X-ray findings in the acromioclavicular or sternoclavicular joints
* Abnormal physical signs or symptoms in the A-C or S-C joint
Clinical Benefits of B-Flow Ultrasound

The goals of this study are to evaluate the efficacy of the B-flow capability on the LOGIQ E9 system in three clinical focus areas.

1. Liver transplant patients: Improved real-time visualization of liver vessels is needed to improve diagnosis and assessment following stenting or angioplasty.
2. Renal artery disease: Improved real-time visualization of the renal arteries would enable a more rapid and accurate assessment of renal artery disease (stenosis, dissection, occlusion, aneurysm) and facilitate follow-up evaluations after renal artery interventions.
3. Pregnancy: We are proposing to use B-flow ultrasound as a way to evaluate placenta perfusion and assay for potential ischemia.


Eligibility Criteria:
Inclusion Criteria:

Subjects must be referred for a standard clinical ultrasound exam.

* Patients who have had a Liver Transplant and are referred for a liver ultrasound or angioplasty \& stent placement;
* Patients with hypertension, impaired renal function, or renal artery disease who are referred for a renal ultrasound or angioplasty \& stent placement;
* Pregnant women referred for an obstetrical ultrasound to evaluate a normal pregnancy for example to determine gestation or gestational age;
* Pregnant women referred for an obstetrical ultrasound to evaluate a high risk pregnancy due to a medical condition present before or during pregnancy for either the mother or the baby.

Exclusion Criteria:

* Minors;
* Prisoners;
* Unable to understand the nature of the study or to consent;
* Very sick or experiencing significant pain;
* Undergoing an emergency ultrasound;
* Pregnant and undergoing an ultrasound to evaluate suspected congenital malformation, abruptio placenta or fetal death.
Cytoflavin in Combination With Reperfusion in Stroke Patients

Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other neuroprotective drug which may be used in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent;
2. Men and women 18-85 y.o.;
3. A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;
4. NIHSS score of at least 5 and less than 24;
5. reperfusion therapy performed on admission;
6. The size of the ischemic focus according to ASPECTS score \>=6;
7. Time from stroke onset to admission not exceeeding 6 hours;
8. Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);
9. Patients who are able to follow the procedures of the Observational Study Program and strictly follow the doctor's instructions regarding drug therapy.

Exclusion Criteria:

1. Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
2. Hemorrhagic stroke;
3. Contraindications for CT scanning;
4. Initial severe disability requiring assistance in everyday life before stroke;
5. previous stroke with a residual neurological deficit;
6. Severe comorbidity with a life expectancy of less than 6 months;
7. Clinical or laboratory signs of an infectious disease on admission (with the exception of strokes that occurred in COVID-19 convalescents after the first 10 days of illness, and patients with asymptomatic SARS-CoV-2 infection detected during routine examination);
8. Pregnancy or lactation
Performance and Safety of the Innofix® Screw (IF25)

The purpose of this clinical investigation is to collect data about the safety and the performances of the InnoFix® screw : Clinical performances (Pain reduction due to the fracture treatment, maintenance of the stabilizaton of the treated fracture and mobility improvement) / Technical performances (Percutaneous implantation by mini-invasive approach, Efficiency of percutaneous implementation and efficiency of percuatneous cementing) / Safety performances (Preservation of the screw stability after implantation and preservation of the screw integrity after implantation). The safety and performance data about the InnoFix® screw will be used to obtain their CE marking according to the regulation (EU) 2017/745.

The principal objective of this clinical investigation is to assess the postoperative reduction in pain level of the patient at 6 weeks follow-up.


Eligibility Criteria:
Inclusion Criteria:

* The patient is 18 years old or more
* The patient is a cancer patient
* The patient needs a stabilization of a non-displaced pathologic fracture (complete or impending) of the pelvic bone
* The patient is symptomatic with musculoskeletal pain exacerbated during movement or weight bearing
* The patient has been informed and he has signed the informed consent
* The patient must be willing and able to comply with all study requirements including follow-up visits and radiographic assessments
* The patient is affiliated with the French social security system

Exclusion Criteria:

* The patient has got a displaced fracture or an unstable fracture justifying conventional surgical fixation
* The patient is a pregnant woman or considered getting pregnant during its investigation participation
* The patient presents medical conditions that could have an impact on the clinical investigation (under responsibility of the investigator)
* The patient has got one or more contraindications to general anaesthesia
* The patient has got an insufficient bone strength (severe osteoporosis, local infection, or tumor osteolysis) precluding a correct and long-term fixation
* The use of the InnoFix® screw can interfere with anatomical structures or physiological performances
* The patient has got an insufficient tissue coverage at the surgical site
* The patient has got a sepsis, fever, subcutaneous or cutaneous infection on the implantation way, deep abscess in contact with the fracture site
* The patient has got a mental or neuromuscular disorder that may cause fixation failure or postoperative complications
* The patient is allergic and/or hypersensitive to a component of the InnoFix® modules, of the InnoTool™ instruments and to the used cement
* The patient has got a haemostasis disorder ((INR \>1.5, platelets \<50x109/L)
* The patient participates to another clinical investigation
* The patient's life expectancy is lower than 6 months
* The patient is under guardianship, curatorship or legal protection
* The patient is deprived of liberty by a judicial or administrative decision
Trajectory of Neuroinflammatory Markers in Cerebrospinal Fluid Prior to and After Thoracic Aortic Surgery

Observational prospective pilot study to analyze the trajectory of neuroinflammatory protein expression in cerebrospinal fluid (CSF) in relation to systemic compartment in patients undergoing thoracic aortic surgery.

The aim of this study is to identify and unravel the biochemical (neuroinflammatory) pathways involved in postoperative delirium.

Patient undergoing thoracic aortic surgery will have an external lumbar drain (ELD) in situ on the day before surgery. This ELD remains in place during and three days after surgery to reduce the risk on periprocedural spinal cord ischemia. Paired measurements of CSF and blood will be analyzed.

Major (cardiovascular) surgery is frequently associated with cerebral dysfunction postoperatively. Major surgical procedures account for substantial systemic inflammatory activation. Interestingly, animal models have shown that surgery rather than anaesthetics trigger a neurocognitive decline. An increase of pro-inflammatory cytokines and activation of immune cells mediate this post operative cognitive decline. There is growing support that systemic inflammation can activate the innate immune system of the brain leading to inflammation in the brain ('neuroinflammation'). This neuroinflammation is suggested to play a pivotal role in postoperative delirium and postoperative cognitive decline due to surgery-related systemic inflammation. However little evidence is available on the extend of the neuroinflammation and which biochemical pathways are dysregulated in the brain after surgery.

Thoracic aortic surgery offers the unique opportunity to study the trajectory of protein expression in CSF prior to and after surgery in a non-invasive matter. It is standard of care that an external lumbar drain (ELD) is placed the day prior to surgery and this ELD will remain in place during three postoperative days.

To advance the understanding of the impact of major surgery to the brain, the investigators wish to study the trajectory of protein expression prior to and after thoracic aortic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Competent patients ≥ 18 years
* Patients who will undergo thoracic aortic surgery and will therefore receive an external lumbar drain as a standard of care procedure.

Exclusion Criteria:

* Patients with meningitis/encephalitis/brain abscess within the last 6 months
* Patients with other neurological conditions: brain injury (acute stroke, brain trauma or cerebral haemorrhage) within the last 3 months, known brain tumours, neurodegenerative disease or known pre-existing cognitive impairment (to a degree that would be compatible with mild cognitive impairment or more).
* Brain or spinal surgery within the last 3 months
* Active infection \<2 weeks before surgery
* Patients who object against storage of their body material for scientific reasons
Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris

Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris. The study aims to determine whether treatment with daylight as an illumination source is as effective as conventional, red light illumination.

15 patients with acne vulgaris received 4 treatment sessions at three-week intervals. First, 5-aminolevulinic acid (ALA) was applied to the entire face. Then the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to sunlight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

Photodynamic therapy (PDT) is considered an effective treatment for acne vulgaris .One of the most important drawbacks of PDT is the pain during illumination.

It has been shown that daylight PDT is an effective treatment for actinic keratosis. In order to examine the efficacy of daylight PDT for acne vulgaris, we used a split-face design: the face was divided into two symmetrical contralateral treatment areas: the left was covered with a light-impermeable dressing, while the right face was exposed to daylight. After 2 hours outdoors, the right side of the face was covered, and the left half was illuminated with red light.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of acne vulgaris on the face
* Acne lesions include inflammatory papules/ pustules/ nodules and cysts , and non-inflammatory open and closed comedones.
* Acne refractory to conventional therapies
* Patients who are unable or do not want to take oral isotretinoin
* Patients who cannot tolerate isotretinoin

Exclusion Criteria:

* History of oral retinoid use within 12 months of study entry
* Systemic antibiotics within 6 month of study entry
* Topical acne treatment within 1 month of study entry
* Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea
* Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or by any medication prescribed for the treatment of the systemic diseases (retinoids, antibiotics).
* Pregnancy or intention to get pregnant
* lactating woman
* Porphyria
* Photosensitive dermatoses
* Allergy to any component of the photosensitizer compound
* Personal history of melanoma or dysplastic nevi
* A beard or other facial hair that might interfere with study assessments;
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea

The investigators will examine the possible synergistic effects of obstructive sleep apnea (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part investigation:

* A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy controls.
* A three-month randomized placebo-controlled trial of continuous positive airway pressure (CPAP) in subjects with OSA+DM.


Eligibility Criteria:
Inclusion Criteria:

* OSA subjects: apnea-hypopnea index \>=10 and \<100
* DM subjects: clinical diagnosis of DM and glycated hemoglobin \< 8.0%

Exclusion Criteria:

* Hematocrit \< 32
* Pregnancy
* Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (18-75 years)
* Must have been following a restrictive diet
* Diagnosis of primary hypercholesterolemia or combined dyslipidemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia or familial hypoalphalipoproteinemia;
* Conditions which may cause secondary dyslipidemia.
* Uncontrolled diabetes mellitus (by hemoglobin A1c \[HbA1c\] \> 8%)
* Abnormal serum creatine kinase (CK) above the pre-specified level
* Abnormal pancreatic, liver or renal function
* Significant heart disease
Effects of Psyllium on Niacin Tolerability

The purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are starting ER niacin for clinical indication by a healthcare provider
* No prior use of psyllium for the past 2 months
* No prior use of niacin for the past 3 months
* Ability to give informed consent
* Must be reachable by telephone

Exclusion Criteria:

* Known contraindications to ER niacin, aspirin or psyllium (including: presence of nausea, vomiting, abdominal pain, intestinal obstruction, or fecal impaction; known hypersensitivity to ER niacin, aspirin or psyllium; severe hepatic dysfunction, transaminitis; history of gastrointestinal bleed attributable to aspirin induced gastritis)
* Patient who are unable to perform assessment of flushing using the standardized scales or questionnaires
* Patients who are pregnant
Additive Effect of Intravenous Acetaminophen on Postoperative Pain Control

This study aimed to evaluate the additive effect of acetaminophen on postoperative pain control in patients receiving nefopam and fentanyl-based patient-controlled analgesia.

Participants undergoing laparoscopic hysterectomy will be randomly assigned to treatment group or control group. After end of surgery, acetaminophen or normal saline (placebo) will be administered intravenously depending on the group assigned.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total laparoscopic hysterectomy due to uterine myoma, cervical cancer, endometriosis, uterine prolapse

Exclusion Criteria:

* Liver disease (aspartate transaminase OR alanine transaminase \> 80 IU/L)
* Chronic kidney disease (GFR \< 30 ml/min/1.73m2)
* History of drug allergy
* Chronic pain lasting more than 3 months
* Conversion to laparotomy
* Complex surgery (co-operation with colon surgeon or urologist)
* Limitation in expressing pain
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Expanded access to DCA as continued treatment for congenital lactic acidosis.

Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access. Study participants must travel to the study site for bi-annual evaluation by the study investigator. Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital lactic acidosis
* Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis Exclusion Criteria:
* Intolerance to DCA