cyrilzakka/clinical-trials huggingface dataset:
Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects

This study is designed to characterize the biological response of the epidermis, dermis and subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 70 years old
* Subject is willing and able to give written informed consent.
* Subject is committed to undergo an abdominoplasty procedure independent of this study.
* Subject is willing and able to comply with study instructions and commit to all visits for the duration of the study.
* Subject is in good general health and free of any disease state or physical condition that might impair evaluation or which in the investigator's opinion, expose the subject to an unacceptable risk by study participation.

Exclusion Criteria:

* Subject is currently enrolled in an investigational drug or a device study that specifically targets the abdominal area.
* Subject currently smokes.
* Subject has a clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
* Subject has used oral or inhaled steroids in the last 14 days and/or has been a chronic user of inhaled or oral steroids in the past such that the investigator feels subject may have compromised wound healing.
* Subject has used topical steroids in the abdominal area within the last 30 days.
* Subject is on any systemic immunosuppressive therapy.
* Subject has had prior surgery and/or treatment that alters the subcutaneous anatomy of the target treatment sites: liposuction, cryolipolysis, or high-intensity focused ultrasound.
* History of abdominal hernia.
* Subject has any of the following conditions:
* Allergy or intolerance to lidocaine,
* Other local skin condition (e.g., skin infection) at target treatment site,
* Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
* Chronic medical condition or use of medication that in the investigator's opinion would affect study participation or wound healing (such as diabetes, hepatitis, HIV, etc.).
* Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
* Post-salbutamol Forced Expiratory Volume in one second(FEV1) \< 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) \< 70%.
* Current or ex-smokers of ≥ 10 pack-years
* Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

* History or current diagnosis of asthma
* Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
* Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
* Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
* Patients with an oxygen saturation \< 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
* Contra-indications of cardiopulmonary exercise testing.
* Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.
The FAST OCT Study

This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.

Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment.

Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation.

The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Presenting with NST-ACS
* At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA)
* Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation
* The patient is willing to participate in the study
* Target vessel suitable for OCT imaging

Exclusion Criteria:

* Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow \<3
* Target lesion located within 5.0 mm of vessel origin
* Severe tortuosity
* Chronic total occlusion of the target vessel
* Target lesion is located in or supplied by an arterial or venous bypass graft.
* Impaired renal function (eGFR \<30ml/min) \*
* Pregnant or breastfeeding patients \*
* Patient has a known allergy to contrast medium \*
* Contraindication for the use of nitrates \*
* Life expectancy \<12 months
Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System

Trauma to the extremities such wrist, ankle, limb is very common and affects all population groups. It constitutes a significant public health issue. Standard radiography remains the basic imaging tool. However, as a 2-dimensional (2D) imaging modality it lacks sensitivity and specificity. Misdiagnosis rates are known to be high, especially for non-displaced fractures of the scaphoid and talus as well as erosions due to rheumatoid arthritis. Misdiagnosis leads to over treatment and unnecessary loss of productivity and quality of life including 6-12 weeks in a cast. Missed fractures can result in a chronic, non-healing fracture that may require surgical fixation and early arthritis of the joint. From a physician perspective, a missed diagnosis can result in a lawsuit and an expensive settlement/penalty.

Computed tomography (CT) offers high resolution and excellent visualization of bone and joint morphology, and Magnetic Resonance Imaging (MRI) delivers soft tissue and cartilage visibility. However, cost, space and workflow related issues make them prohibitive for small orthopedic clinics. Although the radiation dose of a CT scan has been reduced considerably in recent years, it is still significantly higher than a regular radiograph. The whole-body scanners also have difficulties in imaging patients in portable and weight-bearing conditions. Dedicated extremity CT scanners have been commercialized recently in an attempt to address the current deficiency. They still suffer from higher cost and at such have a limited installation base.

The aim of this one-year study is to demonstrate Tomo-E's clinical utility for diagnosis of wrist fractures. Tomo-E is a compact and stationary device that utilizes a distributed carbon nanotube (CNT) x-ray source array that will be specially designed for extremity imaging to collect all the projection views without any mechanical motion.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Undergone radiographic imaging of wrist for presumed or known scaphoid, wrist or distal radius fractures within 2 weeks or are scheduled to undergo such imaging.
* Able to provide informed consent

Exclusion Criteria:

* Patients will an intervening surgical procedure performed prior to study imaging.
* Institutionalized subject (prisoner or nursing home patient)
ESP Block vs. Traditional Pain Management for ERAS

Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.

Traditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.

We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.

Exclusion Criteria:

* Unconscious or mentally incompetent patients or those who refuse to participate in the study.
Laser Ablation of Papillary Thyroid Microcarcinoma

The purpose of this study is to explore whether percutaneous laser ablation (PLA) is a safe and effective alternative to removing papillary thyroid microcarcinoma (PTMC) with surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Papillary thyroid cancer documented by

  * (a) Bethesda VI cytology,
  * (b) Bethesda III, IV, V, or VI cytology AND BRAF V600E mutation, or
  * (c) Bethesda V cytology AND high risk ultrasonographic features documented by either the ATA high suspicion or TIRADS 5 nodule characteristics

To ensure the majority of cases will be eligible based on criteria (a) or (b), we will enroll ≤ 2 patients based on criteria (c).

* Maximum diameter ≤ 13 mm
* Declined active surveillance
* The thyroid lesion must be primarily solid with ≤ 25% cystic compent
* No US evidence of extrathyroidal extension through the thyroid capsule
* No imaging evidence of lymph node metastasis
* Preserved contralateral vocal cord function prior to PLA

Exclusion Criteria:

* Thyroid cancer that is non papillary thyroid cancer (PTC)
* Thyroid lesion with \> 25% cystic component
* Lesion with US evidence of extrathyroidal extension through the thyroid capsule
* Clinical or ultrasonographic evidence of lymph node metastasis
* Pregnancy
Filter Initial & Long Term Evaluation After Placement and Retrieval Registry

A prospective data registry for all patients who undergo IVC (Inferior Vena Cava) filter placement or retrieval at Stanford. Potential enrollees will already be undergoing the procedure. If patients are willing, they will be prospectively enrolled prior to the procedure. As part of the study, chart and clinical data reviews will be used to track patient progress and response to the treatment.

Patient clinical data will be used in a clinical registry. Before a patient is to undergo their initial procedure for filter placement/retrieval, we will approach them for consent to participate in the study. If patients consent, we will follow clinical data from the procedure, and perform prospective follow-up over time to track clinical response and effects of the placement or removal procedure.

Various real-world protocols involving advanced filter removal (including laser-assisted filter removal) will be investigated by conducting registry-based clinical trials.

Participants will only be enrolled if they will be undergoing an IVC (Inferior Vena Cava) filter placement/retrieval procedure.

Eligibility Criteria:
Inclusion Criteria:

* Participants are adults, 18 years old or older
* Participants will be undergoing a procedure to have an IVC filter placed or removed

Exclusion Criteria:

None
Effects of Sympathy and Touch on Anxiety of Patients Undergoing Fiberoptic Bronchoscopy

The purpose of this study is to evaluate the effect of verbal expression of sympathy and touch on anxiety of patients undergoing fiberoptic bronchoscopy


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing diagnostic fiberoptic bronchoscopy
* hospitalized patients

Exclusion Criteria:

* patients who have undergone fiberoptic bronchoscopy
* not hospitalized patients
* cognitive impairment
* refusal to enroll
Secure Self-monitoring Through a Combination of Connected Objects: Implementation in COVID-19 Patients Monitored at Home

Currently, COVID+ infected patients who are on ambulatory home monitoring self-assess their health status simply by completing questionnaires and measuring their temperature twice a day. The SECURADOM project proposes to facilitate the follow-up of COVID+ or suspected COVID+ infected patients, followed at home, by collecting clinical signs on a telephone application and to monitor physiological safety parameters (respiratory rate, heart rate, temperature, blood pressure, activity) using connected objects developed by the company WITHINGS. This daily monitoring, which can be transmitted by patients to the doctors in charge of their surveillance, will improve the quality and safety of home monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Adults, men and women, 18 y/o or more
* Patient diagnosed COVID positive with RT-PCR positive or very suggestive symptoms and a contagion (contact with sick subjects) that can be managed on an outpatient basis.
* Patient in possession of a smartphone (with Android or iOS) allowing the installation of the Withings Health Mate application
* Patient with access to an internet connection for the use of Withings connected products at the containment site
* Voluntary patient who has not objected to his or her participation
* Patient affiliated to or beneficiary of a social security scheme

Exclusion Criteria:

* Pregnant Women
* Patient with severe symptoms requiring hospitalization as recommended by the French Ministry of Health (23/03/2020)
* Patient without social protection or affiliated to the AME (State Medical Aid)
* Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship) Articles L1121-5 to L1121-8
* Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study.
Ondansetron Combined with Dyclonine Hydrochloride to Improve Patient Experience in Unsedated Esophagogastro-duodenoscopy

The goal of this clinical trial is to learn if administering ondansetron prior to esophagogastroduodenoscopy (EGD) can alleviate the gagging reflex, nausea and vomiting in Chinese patients undergoing unsedated diagnostic EGD. The main questions it aims to answer are:

Does taking ondansetron prior to EGD reduce the discomfort of patients during the endoscopic process? Does taking ondansetron prior to EGD reduce the intensity of patient gagging and nausea, and the incidence of vomiting ? Researchers will compare premedication of oral ondasetron and topical pharyngeal anesthesia (dyclonine hydrochloride mucilage) with topical pharyngeal anesthesia only to see if ondansetron can exert the above-mentioned effects.

Participants will be treated with one of the following regimens according to the randomization result:

* Oral ondansetron of 8 mg 2 hours prior to endoscopic process and dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process;
* dyclonine hydrochloride mucilage to be gurgled 15 minutes prior to endoscopic process.

After the endoscopic process is finished, patients will be asked to fill in a questionnaire that contains the following items, all measured by NRS 0-10:

* Overall discomfort;
* Intensity of gagging;
* Willingness to undergo unsedated EGD again if indicated.


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for diagnostic EGD: patients with symptoms in which EGD may influence di-agnosis and/or disease management, including dysphagia, odynophagia, esophageal refluc symptoms, persistent vomiting, gastrointestinal bleeding, and other upper gastrointestinal symptoms.
* Signing a written informed consent.

Exclusion Criteria:

* Contraindications for esophagogastroduodenoscopy.
* History of upper gastrointestinal tract surgery.
* Severe diseases of the heart, kidney, respiratory system, central nervous system, and hematopoietic system.
* Pregnancy.
* Neuropsychiatric disorders, severe depression and severe anxiety.
* Allergy to ondansetron or dyclonine hydrochloride.
Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

The purpose of this research is to determine if functional muscle stimulation, directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.

Ongoing research (NCT02098265) suggests that noninvasive EEG driven Brain Computer Interface (BCI) systems hold the potential for facilitating recovery in the chronic phase after stroke by synchronizing central or brain activity with peripheral movements and thereby harnessing brain plasticity.

The specific aims of this study are:

Aim 1: To investigate the efficacy of active FES vs. passive FES, as measured by changes in behavioral measures. The investigators hypothesize that improvements in motor function will be significantly greater using the active FES therapy than the passive FES therapy.

Aim 2: To investigate the relationship between brain functional activation patterns and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain fMRI and EEG measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.

Aim 3: To investigate the relationship between brain white matter integrity and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain DTI measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.

Eligibility Criteria:
Inclusion Criteria:

* New-onset ischemic stroke 12 months prior - chronic time frame;
* Right hand dominant - affected arm;
* Mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment;
* No upper extremity injury or conditions that limited use prior to the stroke;
* Must be able to provide informed consent on their own behalf.

Exclusion Criteria:

* Inability to competently participate in study procedures
* Concurrent upper extremity therapy, other neurological or psychiatric disorders
Special Survey on Parkinson's Disease (PD) Patients Without Concomitant Use of L-Dopa

The survey is conducted to collect safety and effectiveness information in Parkinson's Disease patients treated with Pramipexole without concomitant L-Dopa supplementation in the daily clinical settings in Japan.


Eligibility Criteria:
Inclusion Criteria:

Patients with Parkinson's disease who do not receive L-Dopa supplementation

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip
Clinical Evaluation of Removing Blood Stasis Therapy in Treating Acute Cerebral Hemorrhage Safety and Efficacy

The purpose of this research is to use the "Removing Blood Stasis Decotion" of traditional Chinese medicine treating the acute stage of cerebral hemorrhage with stroke associated pneumonia to explore the impact of "Removing Blood Stasis Therapy" on intestinal microbial flora either within the time window from 6 to 72 hours onset.

objective: to investigate the impact and immunologic mechanism of using the "Removing Blood Stasis Decotion" treatment in SAP after Acute Cerebral Hemorrhage with the concept of Intestinal Micro Ecological Regulation.

Methods: from 2017.01 to 2022.12, 240 cases of AICH, 306 cases of hypertension will be included in 7 research centers. The AICH patients are randomly into 3 groups within 6 to 72hrs from onset, thus there are 3 groups and the treatment will last for 10 days: group A，Removing Blood Stasis herbal medicine(8 herbals); Group B, herbal medicine without Poxuezhuyu activating herbal(6 herbals); Group C, placebo medicine of Chinese medicine.All the patients will be treated according AHA guideline of AICH and will be set to the brain CT and chest X-ray at the onset, 24h later and 10-14days after treatment. The venous blood，feces Specimen and the sputum will be collected in the time point of 6 to 72hrs within onset , 24h later, and 10-14days after treatment.So the rate of enlargement of brain hematoma and the development of SAP in the 72h later, mortality rate in the two weeks and the disability rate in the 90 days can be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years old while younger than 80 years old
* acute cerebral hemorrhage confirmed by brain CT scan within 6 to72 hours from onset
* GCS≥6
* Sign the informed consent form

Exclusion Criteria:

* Tests have confirmed that cerebral hemorrhage caused by brain tumor, blood diseases, cerebrovascular malformation (anomaly) or aneurysm, etc;
* patients with Severe heart, liver and renal insufficiency.
* Intolerance to traditional Chinese medicine (TCM), allergic constitution.
* patients with severe cerebral hernia in the early onset
* Compliance is poor.