cyrilzakka/clinical-trials huggingface dataset:
Study of Exablate Model 4000 Type 1.0/1.1 Following the Treatment of Neuropathic Pain

The Exablate 4000 obtained CE Mark for the treatment of Neuropathic Pain in December 2012. The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.

The objective of this study is to capture the change in pain intensity, physical/emotional function, and pain impact for patients diagnosed with neuropathic pain who undergo an Exablate treatment.

The purpose of this post market study is to obtain real world data on the safety and performance of the Exablate treatment for neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 30 years or older
* Subject undergoing an Exablate procedure for their planned neuropathic treatment per local institution standard of care
* Subject has diagnosis of "definite" neuropathic pain (grading system IASP-NeupSIG)
* Patient has a score of 6 or higher on the Numeric Rating Scale (NRS)
* Subject has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different medication classes
* Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits

Exclusion Criteria:

* Subject diagnosed with a nociceptive chronic pain syndrome
* Subject does not agree to participate or is unlikely to participate for the entirety of the study
* Subject is currently participating in another clinical investigation with an active treatment arm
Effect of Chitosan Phonophoresis On Cubital Tunnel Syndrome

- This study will be conducted to answer the following question: Is there a statistically significant effect of chitosan phonophoresis on ulnar nerve conduction velocity, pain level \& function in patients with mild to moderate cubital tunnel syndrome?

- Fifty-four subjects suffering from mild to moderate cubital tunnel syndrome according to modified McGowan grading system (Palmer \& Hughes, 2010) from both sexes diagnosed clinically by electromyography will be recruited for this study. The Age of the participants will range from 20 - 40 years old. Participants with Body mass index between 18.5 and 24.9kg/m2.

EMS physio Ltd ultrasound device will be used in combination with chitosan nanoparticles gel.

Electrodiagnostic test will be performed for ulnar nerve conduction velocity using Neuropack S1 MEB-9004 NIHON KODEN, JAPAN. Visual analogue scale (VAS) will be used to determine pain level. Quick DASH will be used to determine hand function.Patients will have 3 sessions per week for 5 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Fifty-four patients suffering from mild to moderate Cubital tunnel syndrome from both sexes according to modified McGowan grading system (Palmer \& Hughes, 2010) \& have motor conduction velocity across the elbow less than 50 m/s or the difference between the motor conduction velocity across the elbow and that below the elbow exceeds 10 m/s (Padua et al., 2001).
2. Age ranging from 20-35.
3. All participants will have Body mass index between 18.5 and 24.9 kg/m2.

Exclusion Criteria:

* 1- Diabetic patients. 2- Cardiovascular patients 3- Patients with cervical spondylosis 4- Patients with cervical disc prolapsed 5- Patients with Thoracic outlet syndrome 6- Patients with carpal tunnel syndrome. 7- Pregnant women 8- Patients with fibromyalgia 9- Patients with epicondylitis 10- Patient with previous elbow injuries 11- Patient with Breast Cancer. 12- Patient with Guyon Canal syndrome 13- Smokers
The Extreme Significance of Bilateral Embolic Retinal Phenomena That Can be Life Saving

This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated.

Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood tests and dose adjustments of her medication.

The second case did not have general symptoms other than mild evening chills and her eye examination again was the start point of intensive investigation to find the reason of her bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was urgently treated.

Eligibility Criteria:
Inclusion Criteria:

* any patient who is found to have sure signs of bilateral retinal emboli.

Exclusion Criteria:

* all other bilateral retinal diseases.
Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis

This is a Multicenter prospective diagnostic study.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age Patient
* Woman presenting a peritoneal carcinosis presumed ovarian origin
* Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
* WHO 0 - 2
* Membership in a social security system
* Patient having given her written consent

Exclusion Criteria:

* Male
* Contraindication in the coelioscopy
* Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
* Patient deprived of freedom, under guardianship or guardianship
Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes

This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or hilar lymph nodes.

The investigators analyse the specificity and sensibility of this technique to diagnose tuberculosis in mediastinal and/or hilar lymph nodes.

Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a tuberculosis is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and without other lymph nodes that are more easily accessible or palpable will be included in this study.


Eligibility Criteria:
Inclusion Criteria:

* patients with enlarged mediastinal and/or hilar lymph nodes on chest CT highly suspicious of tuberculosis (suggestive clinical history, suggestive echographic findings ...) without pulmonary lesions suspicious for tuberculosis or in whom the first evaluation with sputum examination, classical bronchoscopy, induced sputum didn't result in any diagnosis.
* patients aged 18 years or older
* patients need to sign the consent form after reading the information form

Exclusion Criteria:

* synchronic pulmonary lesions suspicious for tuberculosis or already proven tuberculosis by microscopic exam, PCR-technique and/or culture
* other affected ganglionary sites more easily accessible (cervical, supraclavicular, axillary ... region)
The Impact of Gaming on Functioning Among People With Schizophrenia

The goal of this clinical trial is to test whether gaming intervention works well for persons with psychotic disorder. The main question to be answered is whether gaming works well in improving functioning, some other clinical outcomes or causing any adverse effects. Researchers will compare gaming group to usual care.

The overall goal of this study is to evaluate the effectiveness of gaming to improve functioning and clinical outcomes in people with psychotic disorders. Feasibility of the intervention will also be assessed. Our hypothesis are as follows:

Primary hypothesis:

1. Gaming is more effective on improving functioning 3- and/or 6-months follow-ups comparing to usual practices (TAU).

   Secondary hypotheses:
2. Gaming is more effective on improving clinical outcomes and treatment acceptance (symptoms, self-efficacy, the quality of life, drop-out from intervention) at 3-and/or 6-months comparing to usual practices (TAU).
3. Gaming do not cause more adverse effects up to 6 months, especially aggression at 3-and/or 6-months follow-ups comparing to usual practices (TAU).

The effectiveness of the gaming will be assessed using a controlled clinical trial with a pragmatic, multi-center, two-arms parallel-group design. Feasibility will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Finnish speaking
* A formal diagnosis of psychotic disorders (F20-F29, ICD-10; to be identified in medical records or other reliable sources by staff)
* Age between 18 and 60 years old
* Ability to participate in the study based on their own free will
* Ability to provide written informed consent

Exclusion Criteria:

* Clinical diagnostic criteria for a current major depressive, manic or hypomanic episode or mental retardation (ICD-10)
* Severe visual impairment
* Signs or diagnosis of gaming addiction
* Lack of ability to decide one's own participation (under guardianship)
* Substance abuse (other than nicotine dependence)
* Head injury, hemiplegia, or other neurological disorder
* Electroconvulsive therapy (ECT) in the past six months
First Human Dose Trial of NNC0215-0384 in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to describe the safety and tolerability of single intravenous (i.v.) and subcutaneous (s.c.) doses of NNC0215-0384 in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) treatment.


Eligibility Criteria:
Inclusion Criteria:

* Active RA, characterised by a DAS28 (CRP)(Disease Activity Score based on 28 joints and CRP) above 3.2 and a minimum of two swollen joints based on a 68/66 joint count at screening
* Concomitant treatment with MTX (7.5 - 25 mg/week both inclusive) for at least 16 weeks, with a stable dose for at least 6 weeks prior to dosing

Exclusion Criteria:

* Subjects with chronic inflammatory autoimmune disease other than RA
* History of or current inflammatory joint disease other than RA such as gout (crystal proven), psoriatic arthritis, juvenile idiopathic arthritis, current reactive arthritis or Lyme disease
* Any active or ongoing chronic infectious disease (e.g. chronic osteomyelitis, chronic pyelonephritis) requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
* Clinically significant cardiac or cardiovascular disease
* Past or current malignancy
* Latent or active tuberculosis (TB) as documented by: A positive QuantiFeron® test (test can be performed up to 2 months prior to dosing). One retest is allowed in case of inconclusive results.- A history of active TB within the last 3 years even, if treated effectively. - A history of active TB more than 3 years ago, if there is no documentation that the prior anti-TB treatment was appropriate in duration and type
Hypoglycemia and Autonomic Nervous System Function-B

This study tests the hypothesis that, compared to prior normal blood sugar, prior low blood sugar impairs cardiovascular autonomic function. The proposed studies will also test the hypothesis that the effects of prior low blood sugar on cardiovascular autonomic function are blocked by administration of a mineralocorticoid receptor antagonist.

This study involves three interventions, which are performed in random order. Each intervention involves a 3-day inpatient visit. There is a space of 1-3 months between interventions. The three interventions are: 1) placebo with a hyperinsulinemic euglycemic clamp, 2) spironolactone with a hyperinsulinemic hypoglycemic clamp, or 3) placebo with a hyperinsulinemic hypoglycemic clamp. Each 3-day inpatient visit includes the following. On Day 1, autonomic testing is performed. Autonomic testing includes assessment of Baroreflex Sensitivity (BRS). BRS is assessed using the Modified Oxford procedure, which involves sequential administration of nitroprusside and phenylephrine while measuring heart rate and beat to beat blood pressure with a finapress and assessing Muscle Sympathetic Nerve Activity (MSNA). MSNA is measured using microelectrodes placed near the peroneal nerve. On Day 2, hyperinsulinemic clamps are performed with pre-treatment with either placebo or spironolactone. Modified Oxford Procedures are performed prior to and during each clamp on Day 2. On Day 3, the autonomic testing performed on Day 1 is repeated..

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Males and females age 18 to 55 years

Exclusion Criteria:

* Pregnancy
* Lactation
* Clinically evident coronary artery, cerebrovascular, or peripheral vascular disease, or presence of systemic illness that might affect autonomic function. Such illnesses include diabetes mellitus, congestive heart failure, hypertension, renal, pulmonary, hepatic disease, anemia, malignancies, untreated thyroid disease, and alcoholism.
* Current major depressive illness
* In all subjects, any individuals on oral, injected, inhaled or topical corticosteroids within the last year or oral contraceptives within the past 3 months will be excluded.
* Use of medications other than thyroxine
* Known hypersensitivity to nitroglycerin, nitroprusside and/or phenylephrine.
* Blood pressure \> 140/90 mmHg
* Creatinine \> 1.5 mg/dL
* Serum potassium \>5.2 mmol/L
* Estimated GFR \< 50 mL/min
* Use of Viagra, Cialis, and similar drugs within 72 hours of admission.
X-ray-free Protocol for Pectus Deformities Based on Magnetic Resonance 1 Imaging and a Low-cost Portable Three-dimensional Scanning Device

Pectus excavatum (PE) and pectus carinatum (PC) are the most frequent chest wall deformities in humans. They are usually clinically recognized in early childhood or adolescence, with aggravation during the pubertal growth spurt. PE is a depression of the anterior chest wall, most frequently involving the lower sternum.

In this study we use simultaneously compared chest CT, MRI, and 3D scanning fro both PE and PC assessment .

The aim of this study is to compare a standard protocol using chest CT to a non-irradiant protocol with 3D scanning and MRI.

The primary endpoint was to assess the inter observer concordance and the correlation between the HI (Haller Index) evaluated with MRI and the EHI (External Haller index) evaluated with 3D scanning. The secondary endpoints were to assess the concordance with chest CT the variation of the HI evaluated in inspiration and expiration with MRI and also the correction index (CI) between chest CT and MRI in the PE group, .


Eligibility Criteria:
Inclusion Criteria:

* children (\< 18 years of age)
* with a pectus deformity
* recent (within the past month) chest CT, cardiothoracic MRI, and 3D scanning data were available.

Exclusion Criteria:

-
Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma

The investigators hypothesis is that there will be improvement in FEV1 in patients with severe asthma. This is a retrospective data study that reviews preexisting medical records; no patients will be enrolled.

The investigators plan is to retrospectively evaluate spirometry on patients with severe asthma who have undergone bronchial thermoplasty. The procedure will have been done according to the recommended protocol of three separate sessions. For each patient all available spirometric data obtained before and after thermoplasty will be used. Data will be collected from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures done at St. Francis have been performed by a single physician and he is providing their spirometric data for the investigators study. The following data will be collected for all participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history, smoking history, baseline spirometry before and after bronchodilators, post thermoplasty spirometry before and after bronchodilators.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* severe asthma diagnosis
* decreased FEV1

Exclusion Criteria:

* \< 18 years of age
Effect Physical Exercise in Morbid Obesity

This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese

This study is a Randomized Clinical Trial, with individuals with morbid obesity, and will be consists of 3 groups:

1. Group 1 (G1 EXERCISE): This group will participate in an physical exercise program twice a week in hospital.
2. Group 2 (G2 - LIFESTYLE AND EXERCISE): This groups will receive the same G1 intervention associated with a weekly group followed up with techniques of cognitive behavioral therapy with a psychologist
3. Group 3 (G3 - CONTROL): This group will keep medical appointments information and routine procedure in the hospital.

Will be included in study the individuals with morbid obesity who do not have contraindications to practice low-intensity exercise.

Exclusion criteria are contraindications to physical exercise, individuals with cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association), orthopedic problems, severe retinopathy, severe neuropathy, drug addicts and severe mental illness, metabolic or blood pressure decompensated.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with morbid obesity
* Individuals do not have contraindications to practice low-intensity exercise.

Exclusion Criteria:

* Contraindications to physical exercise
* Cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association)
* Orthopedic problems
* Severe retinopathy
* Severe neuropathy
* Drug addicts and severe mental illness
* High blood pressure or metabolic decompensation
Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion

The Proper position of a laryngeal mask airway (LMA) requires confirmation to ensure the adequacy of laryngeal seal and pulmonary ventilation. This confirmation may help in prevention of the peri-operative airway complication and ventilation events associated with LMA placement

It is common practice to inflate the cuff of LMA with the maximum recommended volume (size 3, 20 ml; size 4, 30 ml; size 5, 40 ml), as illustrated in several studies , but it may become more rigid which may cause displacement of the LMA and decreases the airway sealing of LMA, more pressure on pharyngeal mucosa which might cause severe mucosal ischemia leading to post- operative sore throat, dysphagia or hoarseness.

Ultrasonography can reliably confirm correct placement of supraglottic devices like laryngeal mask airway (LMA) and rules out causes of inadequate ventilation , also it was found to be a sensitive in detecting rotational malposition of LMA in children.

the replacement of air with saline in LMA cuffs enable detection of cuffs in the airway allowing visualization of the surrounding structures and tissues as the ultrasound beam can be transmitted through the fluid-filled cuffs without being reflected from air mucosal interface.

the adequacy of LMA position will be confirmed by a fiberoptic laryngoscope (FOL)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18- 60 years of either sex, ASA physical status I - II, weighting 50-100 kg, who will scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

* - Patients whom LMA is contraindicated as patients who are at an increased risk of gastric aspiration as (obstetrics, hiatal hernia or esophageal reflux ), patients with high airway resistance e.g. (bronchospasm or pulmonary edema), patients with low pulmonary compliance e.g. (obesity), cases of an inability to open the mouth or an infection or pathologic abnormality within the oral cavity or pharynx and nonsupine position of operation .
* Patients with a known or predicted difficult airway as patients with class III and IV Modified Mallampati Score or with score \> 5 wilson's risk score.
* Patients with cardiovascular disease (congestive heart failure, coronary artery disease), history of renal or hepatic insufficiency, and endocrinal Diseases will be excluded from the study.
Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female

The purpose of this study was to investigate the effect of ultrasound cavitation on insulin resistance, HbA1c and skin fold in patients with abdominal central obesity.

Few researchers have detected the effects of ultrasonic cavitation on insulin resistance in subjects with central obesity. However, there were many conflicts and no clear evidence in the literature concerning the superiority of cavitation on body contour adjustment. Consequently, this study aimed to investigate the effects of ultrasound cavitation, aerobic exercise and a low-calorie dietary program on insulin resistance and total plasma HOMA ir and body contouring in female with abdominal obesity.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects with central obesity.
* Female participants aged between 25 to 40 years.
* Body Mass Index (BMI) ranged from 30 to 35 kg/m2 as high BMI indicates more obesity and central obesity.
* Waist circumference greater than 88 cm, indicative of abdominal obesity.
* Diagnosed with insulin resistance (HOMA-IR \> 2.9).
* Sedentary lifestyle, defined as engaging in less than 150 minutes of moderate-intensity physical activity per week.
* Willingness to provide informed consent and comply with study procedures.

Exclusion Criteria:

* • Subjects diagnosed with DM (HbA1c more than 6.5%).

  * History of metabolic disorders such as type 1 diabetes or thyroid disorders.
  * Subjects with BMI less than 30 kg/m2.
  * Subjects diagnosed with heart disease, liver as well as kidney diseases.
  * Subjects who take oral contraceptives.
  * Subjects with gestational Diabetes.
  * Pregnant or breastfeeding women were excluded from the study.
  * Use of weight-loss medications or supplements within the past six months.
  * Previous surgical procedures for weight loss or body contouring.
  * Contraindications to ultrasound therapy (e.g., metal implants in the abdomen, active skin infections).
  * Participation in another clinical trial within the last three months.
AZD7325 Japan Multiple Ascending Dose (MAD) Study

The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects

Exclusion Criteria:

* Significant illness, as judged by the investigator, within 2 weeks of Day 1
* Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor