cyrilzakka/clinical-trials huggingface dataset:
Treatment of Chronic Thoracic and Neck and Upper Extremity Pain

To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.

This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.

Patients are studied in 2 groups in each region.

* Group I-local anesthetic only.
* Group II-local anesthetic with 6 mg of non-particulate Celestone.

All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of at least 18 years of age
* Subjects with a history of chronic, function-limiting thoracic or cervical pain with or without upper extremity pain of at least 6 months in duration
* Subjects who are able to give voluntary, written informed consent to participate in this investigation
* Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
* Subjects have not had recent surgical procedures within the last 3 months.

Exclusion Criteria:

* Compressive radiculopathy
* Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
* Uncontrolled major depression or uncontrolled psychiatric disorders
* Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease
* Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
* Women who are pregnant or lactating
* Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
* Patients with multiple complaints involving concomitant shoulder osteoarthritis, due to the overlap of pain complaints
* Inability to achieve appropriate positioning and inability to understand informed consent and protocol
* History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers.
Cognitive Behavioral Therapy for Hyperacusis

The main purpose of this study is to investigate whether cognitive behaviour therapy (CBT) can be useful for people suffering from Hyperacusis.

Also, the investigators are interested in investigating this group of patients on psychiatric and somatic comorbidity, personality traits, and startle response to sounds.

The investigators will also study the audiological measures commonly used in Sweden to measure hyperacusis, and investigate their validity.

The investigators hypothesize that CBT might be helpful for patients suffering from Hyperacusis.

Hyperacusis, defined as unusual intolerance to ordinary environmental sounds, is a common problem for which there are no controlled trials on psychological treatment. Given the avoidance strategies present in hyperacusis, and similarities with problems such as tinnitus and chronic pain, cognitive behaviour therapy (CBT) is hypothesized to be helpful for patients with hyperacusis. In this randomized controlled study of 60 patients with hyperacusis, CBT was compared with a waiting list control group using the Loudness Discomfort Level test (LDL), the Hyperacusis Questionnaire, the Hospital Anxiety and Depression Scales, the Quality of Life Inventory and an adapted version of the Tampa Scale of Kinesiophobia. There were significant between-group effects in favour of the CBT group on all measures except for the HADS anxiety scale. Between-group effect sizes were moderate to high, with Cohen's d = 0.67 and 0.69 per ear, respectively, for the primary measure LDL, and ranging from d = 0.32 to 1.36 for the secondary measures. The differences between groups ceased to exist when the waiting list group was treated later with CBT, and the treatment results were largely maintained after 12 months. In conclusion, CBT is a promising treatment for hyperacusis, although more research is necessary.

Eligibility Criteria:
Inclusion Criteria:

* Patient understands and can speak Swedish well
* Hyperacusis is the primary audiological problem
* Loudness discomfort thresholds below 90 dB
* Hearing levels better than 40dB on the best ear
* Resident of Uppsala, Stockholm or Vastmanland
* Possibility to travel to Uppsala or Vasteras for examination and treatment

Exclusion Criteria:

* Scoring "moderate" or "high" on suicidality, according to M.I.N.I
* Moderate to severe depression
* Psychotic disorders
Exercise and Inflammation

The purpose of this study is to test the hypothesis that aerobic exercise leads to attenuation of the inflammatory response to lipopolysaccharide (LPS) stimulation.

Aerobic exercise - the most widely recommended health behavior - is recognized to reduce the risk of coronary heart disease, so much so that consensus panels routinely include it as part of a cardioprotective regimen for healthy people, but the physiological or mechanistic basis of this protection is uncertain. Understanding the mechanisms has considerable public health significance because it will allow development and testing of targeted interventions to produce comparable cardioprotective effects more directly or in cases where aerobic exercise is not possible. This application proposes to test the hypothesis that aerobic training leads to attenuation of the inflammatory response to LPS stimulation and to examine the role played by exercise-induced increases in vagal activity, improvements in mood, and decreased expression of Toll Receptor 4 (TLR4), the cognate receptor for endotoxin expressed by monocytes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-45 years old
2. English-speaking
3. Ambulatory
4. BMI \< 32
5. Pre-menopausal (women only) with regular cycle lengths between 26-32 days
6. "Average" fitness as determined by American Heart Association standards (VO2max \< 43 ml/kg/min for men, \< 37 ml/kg/min for women) VO2max test

Exclusion Criteria:

1. Use of anti-psychotic medications
2. Current of past major depressive disorder, or total symptom score \> 10
3. BMI\<18
4. Heart disease
5. Hypertension
6. Diabetes mellitus
7. Neurologic disease
8. Smoking
9. Individuals with ischemic heart disease, cardiac arrhythmias, peripheral vascular disease, orthopedic problems such as foot, leg, hip and spine problems,movement disorders, other neurological disorders affecting gait or balance, conditions or treatments associated with impaired thermoregulation, or other medical problems, for which aerobic training would be contraindicated.
10. Use of any medication with autonomic effects
11. Use of birth control medication
12. Ischemic changes, abnormal blood pressure responses, significant ectopy
13. Appears to be at high risk to be unable to adhere to study protocol
The Effect of Bariatric Surgery to Central Sensitization

Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

Weight loss in patients with knee OA reduces pain and provides functional improvement. It has been shown that bariatric surgery combined with diet and exercise changes have positive effects on weight loss, knee pain and function.

Neuropathic pain is a disease that affects the somatosensory system or pain that results in a lesion. It has been reported that neuropathic pain is more frequently seen in patients with high body mass index.

The hyperreactivity of the central nervous system (CNS) plays an important role in the chronic pain of OA patients. It has been shown that CNS becomes hypersensitive in people with chronic OA pain and central sensitization phenomenon plays an important role in pain complaints reported by these patients.

The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

Eligibility Criteria:
Inclusion Criteria:

* Patients decided to undergo bariatric surgery
* Patients with knee pain more than 3 months.

Exclusion Criteria:

* Patients with mental impairment,
* Patients with inflammatory rheumatic disease,
* Patients who had previously undergone knee surgery
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage)

7 to 14 days actimetry recording in order to exclude sleep deprivation just before hospitalisation for differential diagnosis of hypersomnia

This is an observational study

Urine drug screening will also be performe

The suty includes four centers in France

The study duration is of one year

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged \> 18 years
* Patient with a sleepiness evoking a primary hypersomnia
* Epworth sleepiness scale \> 10
* Information note signed

Exclusion Criteria:

* Patient with type 1 or 2 narcolepsy and/or known hypersomnia
* Frank cataplexy
* Not stable metabolic, neurological or psychiatric disease
* Patient treated by a medicine acting on the central nervous system
* Patient having a shift work or having made a transmeridian flight of more than 3 hours lag in the previous month the research
* Non affiliation to social security
* Pregnancy
* Patient under guardianship or curatorship
Efficacy of Internet Use Disorder Prevention

Background. The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention approaches. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies.

Methods. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, will be randomly assigned to a) PROTECT intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms and the promotion of problem solving, cognitive restructuring and emotion regulation skills.

Discussion. The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention. It is theory- and evidence-based (guideline 1) and addresses both risk-reduction and strength-promotion (guideline 3), it considers current research and epidemiology (guideline 4) and ethical standards (guideline 5) such as professional secrecy and is designed as a systemic intervention (guideline 8) at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate).


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 12 to 18 years
* Written informed consent
* High-risk for IUD (Screening: CIUS \>= 20)

Exclusion Criteria:

* Current IUD diagnosis or treatment
* Comorbid depression
* Comorbid anxiety disorder (social phobia or performance anxiety)
Pharmacokinetic (PK) Study of OxyNorm Injections in Chinese Patient

This is a single center, open label, randomized, parallel group single dose intravenous (i.v.) administration study. The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.

After up to 7 days screening period, Eligible Patients will be randomized to 1 of 3 groups, and begin treatment with single dose of OxyNorm® 2.5,5, and 10mg.

Eligibility Criteria:
Inclusion Criteria:

* Patients with tumor pain / postoperative pain, or subjects with pain caused by other diseases;
* Patients aged \>30 to ≤ 60 years;
* Body weight ≥ 45kg, and BMI range ≥19, \<24;
* Karnofsky score ≥ 70;
* Expected survival is above 3 months;
* The results of liver function and kidney tests must meet the following criteria:ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
* The electrocardiogram examination results are normal;
* Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

* Have hypersensitivity history to any opioids;
* Have known hypersensitivity to any of compositions of the study drugs;
* Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
* Patients with respiratory depression, cor pulmonary, or chronic bronchial asthma;
* Patient unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
* Patients with hypercarbia;
* Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
* Patients with alcoholism or drug abuse history;
* Positive ant-HIV or syphilis antibody test result;
* Urine screening before study is positive for the opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
* Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study.
* Subjects who participated in a clinical research study within two months of study entry.
* Patients who are currently taking opioids.
Effectiveness of Tobacco Cessation Interventions in Sweden

Smoking is still one of the most important risk factors causing morbidity and mortality in Sweden. Every year, 12,000 Swedish citizens die prematurely from smoking, and smoking is responsible for up to 60% of the inequity in health.

Though the smoking prevalence is relatively low in Sweden in an international context (8% and 10% for men and women respectively in 2016), specific vulnarable groups have a very high prevalence; e.g. about 80% in alcohol and drug abusers. Furthermore, Sweden has a unique high prevalence of snus users and in 2016 the daily use of tobacco was 25% for men and 14% for women. In addition, products such as cigarettes, snus, and e-cigettes are often mixed.

Despite the fact that about a thousand counsellors have been trained in manual-based person-centred tobacco cessation interventions in Sweden, the effectiveness of the interventions remains unknown, as a follow-up on effect of in-person interventions is not systematically collected in Sweden. Therefore, as of today it is not possible, on a national level, to compare the effectiveness of differences in these interventions, providers, or different groups of tobacco users including disadvantaged and vulnerable groups.

In this study the investigators will evaluate the effectiveness of already implemented in-person cessation interventions targeting smoking, use of snus and/or e-cigarettes, focusing on disadvantaged and vulnerable groups of tobacco users. Furthermore, important factors associated with a successful outcome after controlling for confounders will be identified (in relation to programme, patients and setting).


Eligibility Criteria:
Inclusion Criteria:

* All adult tobacco users (of at least 18 years of age), including disadvantaged and vulnerable patients, receiving an in-person intervention (incl. online meetings) for tobacco cessation (smoking, snus and/or e-cigarettes) are eligible for inclusion in the project after giving informed consent.
* Both individual and group-based interventions can be included.

Exclusion Criteria:

* Withdrawing consent.
* Reduced ability to give informed consent, due to inadequate language skills, dementia, and other conditions.
The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft

patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.

to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients.
* Patients suffering from alveolar cleft with anterior fistulas.
* Age Between 7 and 13 Years
* Both sexes.
* Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
* Highly motivated patients.

Exclusion Criteria:

* non motivated patients
Phosphate Metabolites in Brain of Humans Aged 50+

The objective of this research project is to determine in elderly subjects (\>50 year old) by 31P-MRS the brain concentration of phosphorous metabolites species and fluxes, before and after consumption of 2 commercially available oral nutrition products


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 50 and 75 years
* Healthy, based on the medical screening visit
* Normal BMI for age (18.5-29.9 kg/m2)
* Able to understand and to sign a written informed consent prior to trial entry
* Informed consent signed

Exclusion Criteria:

* Known type 1 or type 2 diabetes, on anamnesis
* Family history of type 2 diabetes (parents)
* Any other metabolic disease possibly impacting the postprandial glucose and insulin response (on anamnesis, to the opinion of the medical expert)
* Malabsorptive disorders including but not limited to pancreatitis, Crohn's disease, etc, to the opinion of the medical expert
* Any ongoing medication impacting dietary fat absorption and metabolism like statins, bile acid sequestrants, lipid lowering medications, or fibrates , to the opinion of the medical expert
* Any ongoing medication impacting the postprandial glucose and insulin response (like beta blockers), to the opinion of the medical expert
* Any ongoing medication impacting brain metabolism or function (neuroleptics, antidepressants, anti-epileptics), to the opinion of the medical expert
* Ongoing chemotherapy
* Any food supplement intake (e.g. MCT, ketone salts = Calcium, Sodium, Potassium, Magnesium) or special diet (e.g. ketogenic diet) possibly impacting basal ketone levels, to the opinion of the medical expert.
* Claustrophobia
* Hearing disorders (the participant placed into the MRS tunnel should be able to hear from the operators, for safety purpose)
* Having any metallic, electronic, magnetic, or mechanical implants, devices, or objects, for safety reason linked to magnetic field exposure (MRS):

  * Aneurysm clip(s)
  * Cardiac pacemaker
  * Implanted cardioverter defibrillator (ICD)
  * Electronic implant or device
  * Magnetically-activated implant or device
  * Neurostimulation system
  * Spinal cord stimulator
  * Cochlear implant or implanted hearing aid
  * Insulin or infusion pump
  * Implanted drug infusion device, like portacath® for instance
  * Any type of prosthesis or implant
  * Artificial or prosthetic limb
  * Any metallic fragment or foreign body
  * Hearing aid
  * Other implant
* Subject injured by a metallic object or foreign body
* Allergy to cow milk or soy proteins
* Currently participating or having participated in an investigational trial during the past month
* Subjects not willing and/or not able to comply with scheduled visits and the requirements of the research protocol.
* Subject having a hierarchical link with the investigator or co-investigators.
Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

The aim of this work is to study the value of GnRH antagonist subcutaneous administration as an alternative to coasting in prevention of severe OHSS and its impact on embryos quality \& the outcome of ICSI.

Infertility affects up to one in seven couples all over the world. In vitro fertilization-embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) are commonly used in the management of infertility attributable to tubal factor, significant endometriosis, male factor and also persistent unexplained infertility. Recruitment and development of multiple follicles in response to gonadotrophin stimulation are necessary for successful assisted reproduction. In young ovulating women undergoing IVF treatment, the standard stimulation protocol can result in either poor response or ovarian hyperstimulation syndrome (OHSS).

OHSS is a serious and potentially life-threatening iatrogenic complication of controlled ovarian hyperstimulation (COH) which may cause serious impact on patient's health. OHSS is the most feared complication of IVF-related ovarian stimulation, which in its severe form leads to hospitalization and in the worst case scenario fatal complications. As many as 33% of IVF cycles have been reported to be associated with mild forms of OHSS. The incidence of moderate OHSS is estimated to be between 3% and 6%, while the severe form may occur in 0.1-3% of all cycles. Among high risk women the incidence approaches 20%.

Development of multiple follicles forms the basis of OHSS. Exogenous human chorionic gonadotrophin (hCG) administration for the final maturation of oocytes or endogenous production of hCG after pregnancy is the second factor needed for the development of severe OHSS. Severe OHSS is characterized by massive ovarian enlargement, pleural effusion, ascites, oliguria, hemoconcentration, and thromboembolic phenomena. Coasting is described as a withholding therapy while continuing with releasing hormone agonist/antagonist administration, until safe levels of estradiol (E2) are attained. GnRH antagonists causes an immediate suppression of E2 levels and therefore could prevent OHSS in GnRH antagonist cycles. A comparison between coasting and GnRH antagonist administration in women at high risk of OHSS during ovarian stimulation for IVF with GnRH agonist long protocol, in the hope of preventing the drawbacks of prolonged coasting.

Eligibility Criteria:
Inclusion Criteria:

* infertile women
* age 20-40
* at high risk for OHSS

Exclusion Criteria:

* refuse to participate