cyrilzakka/clinical-trials huggingface dataset:
Clinical Study to Determine Safety and Efficacy of FPlus for Wrinkle Treatment

Patient demand for non-surgical, non-invasive, and no-downtime wrinkle and rhytides treatment procedures has grown dramatically over the past decade as new treatments and technologies have been introduced.

This study was performed in order to evaluate the efficacy and safety of the Invasix FPlus System, an innovative noninvasive system intended for wrinkles and rhytides treatment.

Subjects were treated for face wrinkles and rhytides reduction and followed for 3 months after last treatment. In order to evaluate treatment efficacy, pre and post treatment photos were introduced to three uninvolved physicians for blinded evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with mild to moderate facial wrinkles and rhytides .
* Males and females 21 - 65 years of age.
* Willingness to follow the treatment schedule, and have photographs taken.

Exclusion Criteria:

* Pacemaker or internal defibrillator, or other implanted metallic or electronic device.
* Permanent implant in the treated area such as metal plates and screws or silicon, unless deep enough in the periosteal plane.
* Avoid treatment if intra-dermal or superficial sub-dermal areas have been injected with Botox/HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
* Current or history of skin cancer, or any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders.
* Pregnancy or nursing.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
* Poorly controlled endocrine disorders, such as diabetes.
* Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies, or use of anticoagulants in the last 10 days.
* Any facial surgery performed within 12 months prior to treatment.
* Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3 months.
* Having received treatment with light, laser, RF, or other devices in the treated area within 6 months.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* Treating over tattoo or permanent makeup.
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
Medico-economic Evaluation of Strategies for the Lead Extraction of Implantable Defibrillator and Pacemakers

The growing use and the expanding indications for cardiovascular implantable electronic devices (CIEDs) have been associated to an increase of device removal. The indications of CIEDs removal are infectious (55%) or noninfectious (45%) such as upgrading of devices, nonfunctional devices and thrombosis. Removal can be performed according to transvenous or surgical procedures. Transvenous lead removal (TLR) must be done by experimented cardiologists and respecting current consensus. TLR can be done with conventional techniques involving inserting locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue. These conventional procedures have a success rate of ≈65%. TLR thanks to laser sheath has been validated and improved the success rate until \>95%. However, the TLR from chronically implanted CIEDs still carries a significant risk of procedural failure, morbidity, and mortality, related to tearing of the great vessels and cardiac structures, even when performed by experienced operators. Even if the transvenous extraction using laser sheath seems to be more effective, this strategy would be more expensive.

Considering the availability of several strategies for TLR and the cost heterogeneity of procedures, a cost assessment in real life of these therapeutic strategies is essential for an optimal choice of therapeutic strategies.

The study will compare the strategies of percutaneous extraction to surgical extraction.

* Mechanical percutaneous extraction is the conventional technique using locking stylets and telescoping sheaths around the pacing leads to separate them from the surrounding scar tissue.
* Laser-assisted lead extraction is most often used in complex procedures and dissolves rather than tear the scar tissue.
* Sternotomy is the surgical procedure used when leads cannot be removed by percutaneous extraction. It is rarely employed.

Eligibility Criteria:
Inclusion Criteria:

* - Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2013-2017

Exclusion Criteria:

* - None
Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome

This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008


Eligibility Criteria:
Inclusion Criteria:

* The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol
* The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization):

If the subject is \< 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.

If the subject is = 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed.

* Colonic procedure results must be known prior to randomization into the study and dispensing study medication
* During the two-week screening phase, the subject must have conducted self assessments on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment using the telephone data entry system

Exclusion Criteria:

* As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician
* Subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study
* The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar

The purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.

Scar contractures develop and extend to the underlying connective tissue and then muscles, leading to reduction in joint range of motion and affecting the day-to-day activities.

Most patients (irrespective of age, gender and ethnicity) believe that even a small improvement in scarring is worthwhile , any research that may help improve scar outcome is meaningful.

The need of this study has developed from the rarity of information about the difference between the effectiveness of iontophoresis and phonophoresis in enhancing the overall appearance of surgical scar.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* same approach of medications
* scar size varies from 5-15 cm

Exclusion Criteria:

* have cardiac / pacemakers
* have significant health problems
* obese patients (BMI more than 30)
* uncooperative patients
Combination of Percutaneous Screw Fixation and Cementoplasty for Lytic Bone Metastases

In oncology, therapeutic progress has allowed a significant increase in life-expectancy: a growing number of cancer survivors live to more advanced metastatic stages. Consequently, the prevalence of secondary bone lesions is increasing, which are frequent and disabling. They are responsible for pain and a high risk of pathological fractures. The average prevalence of pain in cancer represents 53% for all stages combined and 64% for metastatic stages.

Analgesics, radiotherapy and surgery are widely used in this context, but are not without side effects.

Cementoplasty is an interventional radiology procedure that has improved the palliative management of bone lesions. It consists of a percutaneous injection of polymethylmethacrylate-based cement, whose physical and chemical properties provide resistance to compressive stress during weight-bearing activities. However, one of the main disadvantages of cement is its low resistance to torsional stress, as evidenced notably in vitro tests. Thus, cementoplasty alone is very effective at the spinal level (compressive forces) to reduce pain and risk of fracture, but much less effective at the level of other bones that are subjected to torsional stresses, notably the pelvis and femur (40% fracture rate at one year after cementoplasty alone of femoral metastasis).

Fixation using a combination of metal screws and cement provides resistance to torsional and compressive stress. In addition, it has been shown that there is a significant risk of secondary screw displacement if screws are not combined with cement in secondary bone lesions. Combination of percutaneous screw fixation and cementoplasty is a mini-invasive procedure which allows limiting complications and the duration of treatment: early standing up, almost no blood loss, reduced risk of venous thromboembolism (VTE), rapid healing.

The aim of this prospective study is to evaluate feasibility, safety, and efficacy of combination of percutaneous screw fixation and cementoplasty for lytic bone metastases.

Eligibility Criteria:
Inclusion Criteria:

* patients who received osteosynthesis/cementoplasty for Lytic Bone Metastases

Exclusion Criteria:

* patient's refusal to participate
Sup-ER Splint for Children With Birth Related Brachial Plexus Injury

This study evaluates the ability of a newly designed splint called "Sup-ER Splint" to improve the arm function and anatomy of children with birth related brachial plexus injuries.

The brachial plexus is a group of 5 nerves from the spinal cord that provide the movement and sensation of an upper extremity. In some difficult deliveries, traction on the shoulder may lead to damage to the brachial plexus and will result in an arm that is paralyzed. This is called 'birth related brachial plexus injury' (BRBPI). This may occur in up to 1/1000 births and the nerves may be injured minimally to severely. About 2/3 of children with this injury will recover to quite functional levels simply by maintaining looseness of joints while their nerves slowly heal. Some children have nerve injuries severe enough that they require surgical reconstruction with nerve grafts and nerve transfers to achieve even adequate function. One almost universally common outcome, even in children with otherwise "good" recovery, is that the motions of external rotation of the shoulder and supination of the forearm are weaker, later to recover, and often incomplete. Even beyond these direct functional weaknesses, because the arm is positioned poorly, joint contractures and imbalance of these motions can interfere with other upper extremity movements like elbow flexion, even when elbow flexion itself is well recovered. More importantly, lack of full motion leads to long term changes in the structure, growth, and posture of the shoulder requiring further musculoskeletal surgery, or a child with permanent deformity or disability. Surgery cannot completely correct this deformity. Any gains in active and passive range of motion during the first year of life may improve these long-term shoulder outcomes. The investigators have instituted a program of early passive repositioning mostly using a custom Sup-ER (Supination and External Rotation) splint during early growth and development to improve arm position and range of motion where ER and Sup are weak. In compliant patients in a pilot study, the speed and strength of recovery of ER and Supination are improved compared to historical controls. It is a novel splint and protocol designed by the investigators and has significantly changed the care received by patients in BC. This study will evaluate the use of Sup-ER splint in multiple centres over a five year period by assessing the arm function at common time points in recovery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of brachial plexus injury at birth.
* Significant deficit in external rotation and/or supination of the affected limb based on clinical assessment using the Toronto Active Movement Scale at 6 weeks of age: External Rotation ≤ 2 and/or Supination ≤ 2
* Tightness in Passive Range of Motion of external rotation: any angle of less than 180°.
* Age 6-8 weeks for complete protocol fulfillment.

Exclusion Criteria:

* Neuromuscular disorder.
* Unwillingness or inability to comply with the requirements of this protocol.
China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction

To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.


Eligibility Criteria:
Inclusion Criteria:

1. Age\>18 years;
2. Within 24 hours of infarctional chest pain onset;
3. ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB);
4. Voluntary participation in the study with consent forms signed.

Exclusion Criteria:

1. Critically illness due to STEMI;
2. Long-term (\>20 min) cardio-pulmonary resuscitation (CPR);
3. Suspected aortic dissection or acute pulmonary embolism;
4. Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls.
5. Serious cardiogenic shock and do not responding to hypertensive agents;
6. Uncontrolled acute left heart failure or pulmonary edema;
7. Malignant arrhythmias uncontrolled by anti-arrhythmia agents;
8. Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month;
9. Presence of active hemorrhage at any part of the body (including menstruation);
10. Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;
11. Current usage of anticoagulants (such as Warfarin or new anticoagulants);
12. . Serious hepatorenal dysfunction \[ATL≥5 ULN (upper limit of normal), Cr\>134μmol/L (2mg%) or eGFR\<45ml/min/1.73m2\];
13. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;
14. . Severe infection:
15. . Very weak or frailty;
16. . Neuropsychiatric system diseases;
17. . Malignancies;
18. . Other pathophysiological conditions with expected survival time \<1 year;
19. Allergy to the ingredients of this investigational drug;
20. Women who are in pregnancy or nursery;
21. Participation in clinical study of other traditional Chinese medicine (TCM);
22. Unsuitability to participate in this study due to other diseases.
COMPLICATIONS RELATED CARBOXYHEMOGLOBIN LEVELS IN SECOND HAND SMOKING PEDIATRIC TONSILLECTOMY PATIENTS

The purpose of this study was to determine whether high carboxyhemoglobin level is a risk factor for postoperative adverse events in children exposured to carbon monoxide, especially enviromental tobacco smoke.

Also we want to measure bleeding volume and compare it with the carboxyhemoglobin levels.

Eligibility Criteria:
Inclusion Criteria:

-Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.

Exclusion Criteria:

* Active smokers, history of prematurity, bleeding disorders, hemolysis, severe pulmonary disease, home oxygen use, and inpatient hospitalisation≥24 h.
Optical Coherence Tomography Angiography Criteria Of The Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia (Comparative Study).

This study aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia.

All patients will be examined by optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-angio) .

The size, the location, the criteria of the choriodal neovascular membrane will be examined and imaged.

Study include 50 cases of CNV in age related macular degeneration and 50 cases of CNV in pathological myopia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age related macular degeneration should be at least 50 years of age with CNV with no other causes.

Patients with pathological myopia where axial length more than 26 mm or refractive power more than -6 diopter with CNV in OCT with clear media and OCT-angio can be used.

Exclusion Criteria:

* Exclude other pathological causes of CNV .
A Mindfulness Approach to UA for Afro-descendants

The goal of this clinical trial is to test an app-based mindfulness training program in an Afro-descendant population. The main question\[s\] it aims to answer are:

* What changes, if any, does the app need?
* Is it effective in reducing anxiety among this population?

Participants will be asked to:

* Use an app-based mindfulness training program daily
* Complete online surveys at baseline and 2 months post-treatment initiation
* Complete focused interviews via Zoom at baseline and 2 months post-treatment initiation
* Complete daily voice diaries via Zoom


Eligibility Criteria:
Inclusion Criteria:

* GAD-7 ≥ 10
* Self-identify as Black American and/or Afro-descendant
* Located in United States or Canada
* Able to speak English
* Owns a smartphone

Exclusion Criteria:

* Any usage of psychotropic medication: not on a stable dosage 6+ weeks
* As needed (i.e., prn) benzodiazepine use
* Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
* Cohabiting with a study participant
Pain and Smoking Study

This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain

Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (\>50%) with chronic pain continue to smoke.

This study aims to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK Control), a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.

Eligibility Criteria:
Inclusion Criteria:

* Veterans enrolled at VA Connecticut or VA Central Western Massachusetts
* Current Cigarette Smokers
* Willing to make quit attempt in next 30 days
* Pain intensity 4 or greater on scale 0-10, self-reported

Exclusion Criteria:

* Non-English speaking
* No access to telephone/Lack of Telephone Access
* Severely impaired hearing
* Active diagnosis
* Terminal Illness
* Refusal to provide informed consent
* Enrolled in concurrent smoking cessation programs/research
Analysis of miRNA Expression in Endometrial Cancer

The TCGA project identified four distinct prognostic groups of endometrial carcinoma (EC) based on molecular alterations: (i) the ultramutated subtype that encompasses POLE mutated (POLE) cases; (ii) the hypermutated subtype, characterized by MisMatch Repair deficiency (MMRd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as No Specific Molecular Profile (NSMP). Although the prognostic value of TCGA molecular classification, NSMP carcinomas present a wide variability in molecular alterations and biological aggressiveness. Given that the study aims to evaluate the miRNA expression profile to identify novel potential biomarkers to better stratify the EC patients, taking into account the molecular status


Eligibility Criteria:
Inclusion Criteria:

* age\>18yo
* histological diagnosis of endometrial cancer
* tumor resection
* patient's informed consent

Exclusion Criteria:

* patients with other neoplasia within the last 5 years
Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye

This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism

Exclusion Criteria:

* Uncontrolled systemic disease
* Have undergone refractive surgery or any surgery involving a limbal or corneal incision
* Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
* Temporary or permanent occlusion of the lacrimal puncta
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed.

In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute pancreatitis
* age \> 18 years
* written informed consent

Exclusion Criteria:

* ongoing need for opiates
* \>96 hours after onset of symptoms
* chronic pancreatitis
* post-ERCP pancreatitis
* intraoperative diagnosis
* pregnancy
* malignancy
* received nutrition before randomisation