cyrilzakka/clinical-trials huggingface dataset:
Assessment of Anti-inflammatory Markers Concentration, Effectiveness and Safety After Spinal Mesotherapy in Chronic Cervical Pain Syndrome

The aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine. The mesotherapy procedure will be performed five times, at weekly intervals. Blood will be collected before the start of mesotherapy, a week after its completion and after 3 months of follow-up. In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed.

Study aim:

The aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome.

Material and methods:

The study was conducted on patients aged 18 to 65 years, of both sexes, with local, chronic cervical spine pain syndrome, without radiation of symptoms to the upper limb. The study subjects were recruited at the National Institute of Geriatric, Rheumatology and Rehabilitation in Warsaw. Patients will be recruited according to the inclusion and exclusion criteria. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine.

Each patient will have blood collected before starting mesotherapy (on the same day) to determine anti-inflammatory markers (TNF-alpha, interleukin-6, interleukin-12). Again, a week after the end of mesotherapy (five treatments) and after 3 months of follow-up, blood will be collected to determine the same markers.

In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed. A Visual Analogue Scale (VAS) and the Laitinen scale will be used.

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic (\>12 weeks) cervical spine pain syndrome of muscular, myofascial nature without radiation to the upper limb
* recent MRI or CT scan of the cervical spine (up to 6 months)
* no serious diseases: cancer, rheumatology, metabolic
* no allergy to lignocaine 1% or injectable type I collagen

Exclusion Criteria:

* another cause of cervical spine pain
* lack of patient consent
Pre-emptive Trans-cutaneous Versus Trans-oral Ultrasound Guided Peritonsillar Infiltration With Bupivacaine During Tonsillectomy

Ultrasound as a technique is safe, readily available, quick and portable allowing more accuracy of different regional blocks and local infiltration. It allows imaging of the mouth, oropharynx, infrahyoid structures, larynx, vocal cords, and trachea. Recently, ultrasound has been shown to improve accuracy in ultrasound guided block with local anesthetic infiltration. The objective of our study is to compare the effect of pre-emptive trans-oral ultrasound guided peritonsillar infiltration versus trans-cutaneous ultrasound (US) guided peritonsillar infiltration with bupivacaine for post-tonsillectomy analgesia, on surgical field, and surgeon satisfaction(intra-operative reactionary bleeding).

Materials and Methods: the patients will be admitted for tonsillectomy at ENT department of the Al- Azhar university hospitals. The patients' ages between 3 to 15 years. Patients will be divided into Cutaneous group: patients will be submitted to Trans-cutaneous ultrasound guided peritonsillar infiltration with bupivacaine, and Oral group: patients will be submitted to Trans-oral ultrasound guided peritonsillar infiltration with bupivacaine.


Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status I-II with no airway complications or systemic diseases or known psychological diseases. Reason for their surgery was recurrent or chronic tonsillitis.

Exclusion Criteria:

* Infection at the site of injection, peritonsillar abscess or cellulites.
Clonidine-induced Spinal Acetylcholine Release: Normal Volunteers vs. Neuropathic Pain

The purpose of this study is to compare the amount of acetylcholine release after a single injection of clonidine in normal volunteers and individuals with neuropathic pain.

This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).

The way that nerve fibers carry pain information to the brain is thought to change after surgery and in cases of chronic pain. For this reason, some medicines work better to relieve pain in healthy people who have a sudden painful injury when compared to people after surgery or to people with chronic pain. Currently available pain medications may not relieve all types of pain or may relieve pain only at doses that produce side effects and potential complications.

The aim of this study is to understand the mechanisms by which intrathecal clonidine (or clonidine injected into cerebrospinal fluid) increases in potency and efficacy by examining the cerebrospinal fluid of healthy individuals, before and after clonidine administration, as well as looking at the spinal fluid of people with chronic neuropathic nerve pain. More specifically, in this study, researchers will compare acetylcholine release (a protein-like substance found in cerebrospinal fluid) in normal volunteers and patients with neuropathic pain after a single injection of clonidine.

After baseline measurements, including blood pressure and heart rate, participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.

Duration of the study for participants is 1 day, and includes 1 visit to the research center, lasting approximately 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers
* Patients with neuropathic pain

Exclusion Criteria:

* Pregnancy
* Allergy to clonidine
* Currently taking clonidine or other direct a2-adrenergic agonists
* Taking cholinesterase inhibitors
Different Types Of Laryngoscopes During Routine Intubation in Adult Patients

C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and Macintosh laryngoscope during routine intubation in adult patients.


Eligibility Criteria:
Inclusion Criteria:

* 200 American Society of Anesthesiology I-III patients between 18-80 years old undergoing elective abdominal surgery and planned to be intubated orotracheally will be included in the study.

Exclusion Criteria:

* Patients with upper respiratory problems and predicted difficult airways will be excluded from the study.
Utility of CD64 and TLR2 Assays to Diagnose Acute Pulmonary Exacerbations in Cystic Fibrosis

Cystic fibrosis (CF) is the most common inherited disease in the western world. On a yearly basis, 56% of CF patients, or nearly 17,000 individuals in the US, suffer from acute pulmonary exacerbations (APE). The purpose of this study is to test a candidate assay for its ability to diagnose APE, the most important disease event in CF. While previous studies have been able to identify biomarkers of CF prognosis and risk stratification, three markers have demonstrated characteristics ideal for APE diagnosis: CD64, TLR2, and GILT. CD64 is a cellular receptor, expressed on numerous cells of the immune system, whose role is to bind antibodies which are attached to infected cells or pathogens. TLR2 plays a major role in early host-microbial interactions. GILT has been shown to be more precise in targeting immune responses against antigens and influences T lymphocyte response. This study looks to identify the differences in the expression of neutrophil CD64 and CD4+ T cell TLR2 and GILT between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition. The study also looks to compare sensitivity and specificity of the assays above to standard measures, such as health related quality of life scores (CFQ-R), loss of lung function, white blood cell counts and CRP, for diagnosing acute exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CF.
* Age 18 years old or greater.
* Presentation at baseline health OR at the start of treatment for a pulmonary exacerbation of CF.
* Ability to perform reproducible Pulmonary Function Tests
* Ability to produce sputum.
* Willingness to complete a health-related quality of life questionnaire
* Willingness to comply with study procedure and provide written consent.

Exclusion Criteria:

• Presence of a condition or abnormality that, in the opinion of the Principal Investigator (PI), would compromise the safety of the patient or the quality of the data.
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis

Objectives: To establish if there are differences between an ultrasound-guided transrectal prostate biopsy (BPTE) and a transperineal prostatic biopsy (BPTP) with and without a multiparametric Magnetic Resonance (RMmp) in patients with clinical suspicion of prostate cancer (PC) to first prostatic biopsy in terms of:

1. Rate of detection and diagnosis of prostate cancer.
2. Aggressiveness of the detected tumors.
3. Association of the marker \[-2\] proPSA and the prostate cancer health index (PHI) and microRNAs for the diagnosis of tumors.
4. Adverse effects of the intervention and subjective perception of the patient: pain and degree of satisfaction, and impairment of quality of life.
5. Cost-effectiveness analysis of the different intervention options.

Study Design: Randomized, single-blind prospective clinical study to compare four schemes: RMmp + BPTE vs. BPTE 12 cylinders vs RMmp + BPTP vs BPTP 12 cylinders.

Study population: Patients with clinical suspicion of prostate cancer with PSA between 3-20 ng / mL and normal or abnormal rectal examination, candidates for a first prostate biopsy.

Research techniques: BPTE standard of 12 cylinders compared to RMmp previous to BPTE vs BPTP of 12 cylinders compared to BPTP with previous RMmp.


Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent prior to performing any of the specific procedures of the study
* Age between 50 \* - 75 years (\* 45 years, if family history)
* Patients with clinical suspicion of prostate cancer
* Indication of a first biopsy during the study period.
* Life expectancy greater than 10 years.

Exclusion Criteria:

* Patients previously randomized in the present study.
* Patients submitted prior to a prostate biopsy.
* Patients with a previous diagnosis of prostate cancer and / or previous prostate surgery.
* Patients with a previous episode of acute prostatitis of infectious origin in the 3 months prior to inclusion in the study.
* Patients with an active urinary tract infection and / or any previous pathology of severity in the 3 months prior to inclusion.
* Impossibility of performing transrectal or transperineal biopsy and / or magnetic resonance.
* Patients who have received hormonal treatment prior to androgen blockade in the 6 months prior to inclusion in the study.
* History of other tumors.
Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage

The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.

Although outcome of variceal hemorrhage has been improved in the last two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. Occurrence of gastric varices (GV) rupture is less often than esophageal varices (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even tougher problem than EV hemorrhage. Facing these challenges, there is no consensus on the best treatment of GV hemorrhage and therefore it is mainly empirical. Endoscopic treatment is an alternative in the management of GVH. Injection sclerotherapy has been applied to arrest GV hemorrhage but it is associated with a high rebleeding rate (50\~90%) and thus is regarded as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation for EV hemorrhage has been documented, however, endoscopic variceal ligation for GVH is not as promising because of its high rebleeding rate around 50%. Endoscopic injection of N-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for GV hemorrhage than other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around 30\~50%. The theoretical advantages of tissue glue derives from its unique ability to plug the varix lumen immediately. Each injection of tissue glue in conventional use was usually prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml Lipiodol. Therefore, we hypothesized that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml Lipiodal) may obliterate the varices in further distance and broader area and that may achieve more effective hemostatic results than conventional dose. Therefore we designed a randomized trial to test the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver cirrhosis and/or hepatoma
* Aged 18 to 80, who had endoscopy-proven acute GVB
* Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
* Endoscopic signs of active bleeding from the GV
* Adherent blood clots, white nipple signs, or erosions on the GV
* The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources
* Who or their legally authorized representatives gave informed consent

Exclusion Criteria:

* Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
* Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.
Snow Disease Surveillance System Study

The study investigates whether shared online access to epidemiological data for general practitioners, disease prevention officers, emergency care services and microbiology laboratories changes clinical practice with regard to testing, diagnosing and treatment of communicable diseases. The main hypothesis is that "online access for general practitioner to epidemiological data about communicable diseases changes clinical practice for testing, diagnosing and treatment of communicable diseases".

We will collect data from general practitioners (GP) offices by installing local data extraction solutions. Each installation will build a local anonymous database of GP consultations extracted from the local electronic patient record (EPR) system. These anonymous data records will be used to produce local disease statistics before they are exported to a centralized server available in the Norwegian Health network. The centralized server will produce daily reports about the epidemiological situation in the patient population. We will combine the syndromic data from the GP offices with data from the microbiology laboratories on the hospitals that covers the study areas. The epidemiological data will be made available to the intervention areas in the study through web based and customized client applications.

By using data extracted from the GP offices EPR databases and the microbiology laboratories we will investigate the study hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering General Practitioner (GP) working in a GP office

Exclusion Criteria:

* The GP does not use a Electronic Patient Record (EPR) system
Comparative Assessment of Esophagitis in Cases With and Without Esophageal Motility Disorders: A Prospective Study

Achalasia is a neuro-degenerative disorder marked by changes in the peristalsis of the esophagus and the lack of relaxation in the lower esophageal sphincter (LES), thought to be due to damage to the myenteric plexus with an unknown cause.1 Per-oral endoscopic myotomy (POEM) is an established endoscopic treatment modality for achalasia. Leading gastrointestinal (GI) societies endorse POEM as one of the primary treatment option for achalasia.This study aims to characterize and compare the morphological characteristics of reflux related erosions after the POEM procedures versus those in cases without esophageal motility disorders.

Data collection

1. Demographic characteristics: Age, gender, type of achalasia
2. Manometry findings (pre and post POEM): integrated relaxation pressure, lower esophageal sphincter pressure
3. Comorbidities
4. Medications
5. Eckardt score: before procedure and 3-months after Procedure
6. POEM procedure details: length of esophageal and gastric myotomy, adverse events, length of hospital stay
7. Evaluation at 3-months Symptom: standardized questionnaire (GERDQ) Endoscopy: grade of esophagitis Erosions vs ulcers Dimension of erosions Anatomical location (according to clock)

POEM will be performed using a standardized technique.8 The patients will be prescribed a single dose anti-secretory medicine (equivalent to 40 mg esomeprazole) for two months after POEM. Consecutive patients who meet the inclusion and exclusion criteria will be followed up after 3 months. PPIs will be discontinued for at least 4 weeks prior to objective evaluation of GERD. Each patient returning after 3 months for follow up will undergo several follow up examinations, including GERD questionnaire scoring, Esophagogastroduodenoscopy, 24 hour pH impedance test. Presence of endoscopically visible esophagitis . Endoscopic findings such as anatomical location, dimensions of the mucosal breaks will be compared to general population with diagnosis of GERD who have endoscopically visible esophagitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18y,
2. confirmed diagnosis of Achalasia,
3. No contraindication to POEM,
4. erosive esophagitis on endoscopy

Exclusion Criteria:

1. Non-esophageal esophageal motility disorders,
2. Treatment other than POEM,
3. current PPI use before assessment for GERD
Multicenter Single-port Colectomy RCT

This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.

The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* colon adenocarcinoma
* curative resection
* age : 20 \~ 85

Exclusion Criteria:

* distal transverse colon cancer
* splenic flexure colon cancer
* descending colon cancer
* emergency operation
* obstruction
* perforation
* ASA 3 or 4
* pregnant woman
* tumor associated with FAP, HNPCC, or IBD
* distant metastasis
* adjacent organ invasion
* synchronous colorectal cancer
* other malignancy within last five years
GRIP: Maximum Isometric Grip Strength Assessed with Three Different Hand-held Dynamometers

Maximum isometric grip strength (MIGS) is a cost-effective, easily accessible, valid and reliable outcome measure for assessing upper body strength in both, adults and children. The the JAMAR Hydraulic Hand Dynamometer is the current gold standard for measuring MIGS. For certain age- and activity-groups, alternative devices may be more appropriate. To date, the quality criteria (test-retest-reliability and validity) of the JAMAR Smart Hand Dynamometer and the Martin Vigorimeter compared to the current gold standard are not yet investigated. Furthermore, no reference values for different age-, sex-, or activity level groups exist with regard to underlying disease entities for these three devices.

This quality analysis of test-retest reliability and validity (PART 1) serves as a basis for a further sensitivity analysis, whereby in a second step, a database with valid personalised age-, sex- and activity-related reference values for the respective measurement instrument, considering chronic concomitant diseases, is to be generated. The objectives of this study are therefore to 1) assess the test-retest reliability (intrasubject and intersession) and validity of JAMAR© Hydraulic and JAMAR© Smart dynamometers and Martin Vigorimeter (PART 1) and 2) undertake a sensitivity analysis providing valid personalised reference values for precision medicine (PART 2).

Thus, no study has yet comprehensively investigated all relevant influencing factors in a single and thus homogeneous study setting, so bias can be expected from this alone. The findings of this two-step study should enable physicians and therapists to compare the grip strength measurements of their patients with normative values in relation to their age, sex and activity group, as well as to any underlying chronic diseases that may be present. This allows realistic treatment and training goals to be set and patient performance to be interpreted.

Eligibility Criteria:
Inclusion Criteria Part 1:

* Male and female volunteers with age 18-64 years
* Body mass index \< 30 kg/m2
* Informed consent signed

Inclusion Criteria Part 2:

* Male and female volunteers with age ≥ 10 years
* Informed consent signed (if age \< 14 years, signed by parents or legal guardians)

Exclusion Criteria Part 1 and 2:

* Disease or injury (e.g., musculoskeletal or neurological) that could affect upper extremity strength
* Physical impairment of the upper extremity (visible swelling or the presence of a splint or cast)
* Acute pain or infection
* Cognitive impairment (inability to understand and/or follow directions)
* Insufficient language of the German language
Mechanisms of Low Levels of Apolipoprotein B

To determine mechanisms of low levels of apolipoprotein B.

BACKGROUND:

Elevated apoB levels are associated with an increased risk of coronary heart disease. Hypobetalipoproteinemia (HBLP) is characterized by apoB levels less than the 5 percentile. Dr. Welty, the principal investigator, sequenced mutations for truncated forms of apoB-67, apoB-55 and apoB-44.4 which causes HBLP, described a kindred from the Framingham Heart Study with HBLP due to an unidentified apoB gene mutation and purified apoB-67 containing lipoprotein particles. Heterozygous apoB-67 subjects have one normal allele making apoB-100; therefore, apoB levels would be predicted to be at least 50 percent of normal; however, they are 24 percent of normal. Dr. Welty has shown that these lower than expected levels result from decreased production of VLDL apoB-100, LDL apoB-100 and apoB-67, increased catabolism of VLDL apoB-100, and increased direct removal of apoB-67 from VLDL.

DESIGN NARRATIVE:

The first aim is to locate the apoB gene mutation in the Framingham kindred. The second aim is to perform stable isotope studies in the apoB-55 and apoB-44.4 kindreds to determine if apoB metabolism for these shorter truncations is similar to that for apoB-67. In aim three, apoB-100 synthesis is studied in heterozygous apoB-70 transgenic mice. If it is 25-25 percent of normal litter mates, the mechanism for this reduction in apoB-100 levels will be studied in hepatocytes isolated from the transgenic mice. In specific aim 4, size and composition of VLDL are compared in apoB-67 subjects and controls to determine if larger size or compositional changes account for the faster catabolism of VLDL apoB-100. The study has been extended through June 2007.

Eligibility Criteria:
No eligibility criteria