cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Percutaneous Lumbar Epidural Adhesiolysis and Neurolysis on Low Back Pain

Clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. Improvement will be assessed in relation to the clinical outcome measures of pain and function.

Improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group.

Compare adverse event profile in both groups

Patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections.

Single-center, prospective, controlled, double blind, randomized study. If non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. All patients will be unblinded at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* History of chronic, function limiting low back pain of at least 6 months in duration
* Able to give voluntary, written informed consent
* Able to understand investigational procedures and willing to return for follow-ups
* No recent surgical procedures within last 3 months

Exclusion Criteria:

* Large contained or sequestered herniation
* Cauda Equina symptoms and/or compressive radiculopathy
* Narcotic use of no greater than 100mg/day Hydrocodone, 60mg Methadone, or 100mg Morphine
* Uncontrolled major depression or psychiatric disorder
* Uncontrolled or acute medical illness
* Chronic sever conditions that could interfere with outcome assessments
* Women who are pregnant or lactating
* Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
Arizona Prehospital CPR Quality Improvement Project

The quality of cardiopulmonary resuscitation (CPR) provided to patients with out-of-hospital cardiac arrest (OHCA) is often suboptimal. There now exist monitors/defibrillators that allow for the measurement and real time feedback of the quality of chest compressions and ventilations. In addition to giving the prehospital provider the benefit of real time CPR quality feedback via voice and visual cues, the CPR quality data acquired using these devices can be utilized as part of an on-going quality assurance/quality improvement program.

The first objective of the proposed project is to quantify the quality of chest compressions and ventilations provided in the state of Arizona to patients with OHCA and to determine whether the quality of CPR is related to patient outcome from OHCA.

A second objective of this project is to determine whether use of audiovisual feedback improves both CPR quality and patient outcome in the pre-hospital setting.

Phase I: In the first phase of the project, the EMS systems will utilize the E-series units to treat all patients with OHCA. The audiovisual feedback prompts will be inactivated during this phase. The EMS providers will be instructed to follow the standard CCR protocol, as is currently the practice. Aside from the change in monitor/defibrillator equipment, the treatment of OHCA patients during this phase will be identical to the treatment that is currently performed. The quality of CPR will be measured using the accelerometer-based system. The data will be stored in the defibrillator and will be downloaded upon completion of the call. The first phase will be conducted for approximately 6 months from the time each site initiates the use of the E-series monitor/defibrillators.

Phase 2:In the second phase of the project, the EMS providers will undergo training on how to use the audiovisual feedback prompts. The providers will continue to treat patients according to the CCR protocol but will now receive audio and/or visual feedback on the quality of CPR that they are performing. The providers will select the preferred feedback method(s) - audio, visual or both. As in phase I, the CPR data will be stored in the defibrillator and will be downloaded upon completion of the call.

The total number of EMS personnel who will be trained is approximately 450. In Phase I, there were 219 OHCAs (80% from Mesa Fire Dept, and 20% from Guardian Medical Transport). So far in Phase II, there have been about 100 OHCAs.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Medical Services personnel at 8 fire departments in AZ who treat patients with out of hospital cardiac arrest (OHCA)

Exclusion Criteria:

-
The NURLIFE Program for the Management of Bariatric Surgery Patients

to analyze the influence of the new intervention in the perioperative period and impact on several clinical and humanistic endpoints. In the evaluation phase, an experimental, controlled, and randomized study (RCT) will be developed, with an intervention group (IG) and a control group (CG). The CG will receive the usual care and the IG, will receive the intervention for an expected period of one year. This project aims to be the first study to investigate the effect of a long-term specialized case-management intervention (face-to-face and e-health) in patients who are candidates for bariatric surgery during all the perioperative periods

The "nurse-led case-management" intervention program will allow to improve the management of the bariatric surgery process by patients in collaboration with the health team, with a view to improving health and adopting healthy lifestyles, which enhance better results. This intervention program is expected to be a mixed program with e-health technologies. Behavioural changes will be predictably one of the main objectives, with perception of the barriers and facilitators of them, from the perspective of training the patient for the physiological changes that result from the entire process of bariatric surgery. Thus, it is expected that the primary focus of the program will be health education and motivation for lifestyle changes, the promotion of healthy lifestyles and promotion of physical activity, with a view to improving anthropometric data and metabolic risk factors, as well as smoking cessation and alcoholic habits. As such, the contribution of a multidisciplinary team that is managed by a case-manager appears to be the most efficient intervention, and this activity aims to determine the set of procedures and their temporal sequence, the skills of the team, the flow of patients through the different elements of the team and the duration of the program.

Eligibility Criteria:
Inclusion Criteria:

* As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
* Agree to participate in the study

Exclusion Criteria:

* Surgical complications
* Psychiatric diseases and neurological disorders
A Study of Perampanel as Add-on Therapy in Adult and Adolescent Participants With Focal Seizures

The primary objective of the present study will be to assess the effectiveness of add-on perampanel in participants with focal seizures in a real-life clinical setting.


Eligibility Criteria:
Inclusion Criteria:

1. Prescribe perampanel according to the approved indication
2. Participants with focal seizures with or without secondary generalization
3. Participants with seizure frequency data available at the baseline visit
4. Based on the physician's clinical judgment, the participant seizure activity is not controlled sufficiently with the current treatment with 1-3 AEDs and it is in the participants best interest to be prescribed adjunctive perampanel
5. The decision to prescribe perampanel is made by the physician before and independently of his/her decision to include the participant in the study
6. Treatment with perampanel is not yet started before baseline

Exclusion Criteria:

1. Participants contraindicated for perampanel use (according to SmPC)
2. Participants with moderate to severe renal impairment
3. Participants with severe hepatic impairment
4. Pregnant or lactating women
5. Participants suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation
Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study).

The primary aim of this study is to quantify and compare the hemodynamic control of cardiac index in patients who receive either goal-directed therapy or standard hemodynamic management in lung resection surgery

The investigators hypothesize that the percentage of the intraoperative time in which the cardiac index is equal or superior to 2.2 l/min/m2 is higher in goal directed therapy

Eligibility Criteria:
Inclusion Criteria:

* Adults patients ( 18 years old)
* Written informed consent
* Elective lung resection surgery (open or thoracoscopic lung lobectomy)

Exclusion Criteria:

* Severe obesity
* Moderate to severe aortic insufficiency
* Renal failure requiring hemodialysis
* Left ventricle ejection fraction less than 35 %
* Urgent surgery
Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

The patients with primary erectile dysfunction (IIEF-EF \<26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.


Eligibility Criteria:
Inclusion Criteria:

* Men over 18 years of age
* Presence of ED for more than 3 months in over 50% of sexual intercourses.
* Baseline ED domain score under 26 on the IIEF-15 EF domain.
* Patient agrees to participate in the trial by providing signed informed consent.

Exclusion Criteria:

* EHS score of 4.
* Patients with an INR over 3.
* Patients with sickle-cell anemia.
* Patients with clinical suspicion of hypogonadism (AMS over 36).
* Endocrine diseases that present with ED, such as acromegaly, gigantism, Addison's disease, hyperprolactinemia, androgen deficiency.
* Active vesicular, prostrate or colon cancer.
* Radical prostatectomy or other radical pelvic surgery.
* History of pelvic radiation therapy.
* Patients with ED of psychological origin.
* Spinal cord injury or other neurological diseases associated with ED.
* Anatomical penile dysfunction, penile implant.
* Patients with active infections or lesions on the penis or pubic area.
* Patients with ED secondary to drug therapy (antiandrogen therapy, alpha blockers for BPH, use of corticosteroids, medication for Parkinson's disease, antipsychotics).
* Abuse of psychoactive substances.
Constant Current Versus Constant Voltage Subthalamic Nucleus Deep Brain Stimulation in Patients with Parkinson's Disease

To compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery.

This is a randomized, parallel controlled, multi-center study to compare the efficacy, programming burden, power consumption, and physicians' and patients' satisfaction between current mode and voltage mode of deep brain stimulation in each period one year after surgery. Participants will be followed for up to 12 months. Approximately 180 PD participants will be recruited from up to 14 sites. Participants will be randomized to current mode or voltage mode after DBS surgery and be comprehensively assessed at baseline and follow up according to the protocol developed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease
* Aged 18 to 75, no limited sex
* After bilateral STN-DBS, yet not powered on

Exclusion Criteria:

* Mental disorders or dementia
* Pregnant, lactating women or women who are unable to take effective measures to prevent pregnancy
* Serious health conditions, such as tumors, liver or kidney diseases, etc.
* Epilepsy or other seizure disorders
* Patients with severely deviated electrode placement
* Patients who were unable to voluntarily sign an informed consent form
* Patients who did not agree to cooperate with follow-up
Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies

Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies

Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
* Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity.
* Evidence of CD123 expression from a local laboratory.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

* Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Clinically significant cardiac disease including congestive heart failure \> New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
Ropinirole Controlled Release (CR) as an Adjunctive Agent in the Treatment of Major Depression

This is an 8 week study for patients who are currently taking antidepressant medication but not fully responding. Ropinirole CR would be taken in conjunction with current antidepressant medication. Patients come into the clinic once a week when starting on the medication and then once every other week for the remainder of the 8 weeks.

We hope to learn whether ropinirole CR (controlled release formulation) is safe and effective when taken with an antidepressant to reduce the symptoms of depression. Adults who have a diagnosis of major depression and are currently taking an adequate dose of antidepressant medication will be sought for participation. They will continue to take the antidepressant medication and will receive ropinirole CR, an investigational medication, for eight weeks during which information will be collected about mood and cognitive functioning.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old
* Currently experiencing major depression
* On at least an adequate dose of fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, bupropion, mirtazapine or duloxetine for at least 6 weeks (monotherapy). Exclusion Criteria:1. Pregnant females or females of child bearing years not using adequate birth control in the opinion of the investigators
* Known sensitivity to ropinirole
* Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators.
* Significant abnormalities observed in screening laboratory evaluation
ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease.

Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.


Eligibility Criteria:
Inclusion Criteria:

* Elective thoracoscopic wedge resection
* Speaks and understands Danish
* FEV1 \>= 60% of expected

Exclusion Criteria:

* Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.)
* Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
* Air leak on intraoperative sealing test
* Patients previously included in study
* Planned intraoperative frozen section with possible lobectomy
* Previously included in current study
* Planned frozen section diagnostics
* Previous ipsilateral anatomic lung resection
Ranibizumab for Myopic Neovascularization

The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Myopic and CNVM

Exclusion Criteria:

* Patients with poor compliance

  * Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
  * Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
  * Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
  * Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
  * Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
  * Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age;
* provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* complete a confidentiality disclosure agreement;
* be in good general health as determined by the Investigator/designee;
* agree not to participate in any other oral/dental product studies during the course of this study;
* agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
* agree to refrain from the use of any non-study oral hygiene products;
* agree to return for all scheduled visits and follow study procedures; and.
* have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge

Exclusion Criteria:

* self-reported pregnancy or nursing;
* severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* active treatment of periodontitis;
* fixed facial orthodontic appliances;
* a history of kidney stones;
* known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
* any diseases or conditions that might interfere with the safe completion of the study; or
* an inability to undergo any study procedures.
Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept

The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.


Eligibility Criteria:
Inclusion Criteria:

Physicians eligibility:

* Licensed and practicing ophthalmologist
* Prescribed and administered aflibercept to at least one patient in the past 6 months

Patients eligibility:

* Patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit.
* Patient is aged 18 years or older.
* Patient is able to understand and sign the consent form and patient questionnaire.
* Patient can understand the native language of the country in which the study is being conducted.
* Patient has not participated in a clinical trial for the treatment of an aflibercept indication (e.g., wAMD, CRVO, or DME) in the past 12 months.