cyrilzakka/clinical-trials huggingface dataset:
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.


Eligibility Criteria:
Inclusion Criteria include:

* Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
* The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
* Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

* Subjects with rheumatoid arthritis or other inflammatory arthritis;
* Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
* Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
* Subjects with chronic constipation not related to opioid use;
* Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
* Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.
Comparative Effectiveness of HVT and Bowen Technique in Patients of SI Joint Dysfunction With Upslipped Innominates

Sacroiliac joint dysfunction (SIJD) is a common musculoskeletal condition characterized by pain and impaired function in the lower back and pelvis region.

The reported prevalence of sacroiliac joint pain in cases of chronic low back and lower extremity pain is estimated to be between 10 - 27%. Manual therapy techniques, such as High-Velocity Thrust (HVT) and the Bowen Technique, have emerged as potential treatment options for SIJD. HVT involves quick, controlled movements applied to specific joints to restore normal range of motion and alleviate pain. Conversely, the Bowen Technique is a gentle, non-invasive form of bodywork that utilizes subtle rolling movements over muscles and connective tissues to promote relaxation and restore balance within the body.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sacroiliac joint dysfunction confirmed by clinical assessment and imaging findings.
* The presence of an upslipped innominate observed on imaging studies.

Exclusion Criteria:

* History of significant trauma or surgery involving the sacroiliac joint region.
* The presence of inflammatory or infectious conditions affecting the sacroiliac joint.
* Contraindications to manual therapy interventions such as HVT or the Bowen Technique.
* Inability to comprehend study procedures or provide informed consent
Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children with Hypersomnia

Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia).

To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness.

Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness.

The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children.

The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.


Eligibility Criteria:
Inclusion Criteria:

* Children with excessive diurnal sleepiness hospitalized for an evaluation of hypersomnia symptoms
* Age\> 6 years old and \<18 years old
* Non opposition by both parents

Exclusion Criteria:

* Opposition of the child or parents to participate
* Patients under measure of deprivation of rights and liberty
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.

There are two group:

1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.

There are two group:

1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.

phase Intervention/treatment Condition or disease Not applicable Other: clear aligners Technique with class ii elastics. Other: fixed multibracket appliances with class ii elastics Malocclusion

Class ii Division 1 malocclusion

Eligibility Criteria:
Inclusion Criteria:

* - Patients with permanent occlusion at age 15-20 years.
* Patients with class II division I (half cusp or Less) with moderate overjet (2-4mm).
* Patients with normal or horizontal growth pattern.
* Mild crowding (_\<2 mm) in maxillary and mandibular arch.
* Patient with satisfactory periodontal health and good oral hygiene
* No previous orthodontic treatment
* Comprehensive medical and dental history ruling out any systemic disease.

Exclusion Criteria:

* Patients with periodontal disease.
* Patients with vertical growth pattern.
* Patients with missing or extracted teeth except third molar.
* Patients with temporomandibular joint disorder.
* Patients with Skeletal open bite.
* Patients with poor oral and gingival health
* Patients with neuromuscular disorder.
* Patients with severe skeletal class II.
Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy

The investigators hypothesis is that using the micropulse laser in patient with Central Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in significantly minimizing visual recovery time from this disease as well as potentially preventing recurrences.

The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity. This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with new diagnosis of CSC and no other comorbidities or prior retinal treatment
* Patients ranging from 30 to 60 years of age

Exclusion Criteria:

* Patients with no case of CSC
* Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration
* Patients with prior retinal treatment
Evaluation of a Novel Sutureless Drain Securement Device

To evaluate the feasibility, safety and efficacy of a novel suture-less drain securement device (K-Lock) via direct comparison to suture-based techniques. In this study the suture-less drain securement device will be compared to the use of sutures to secure drains. One will be secured with the K-Lock and the other will be secured with sutures.

Patients will be randomized to either A) left side K-Lock with right side suture-based technique or B) right side K-Lock with left side suture-based technique. Randomization will occur before study initiation with group A or group B being assigned to a study enrollment number.

Preoperatively:

The novel suture-less prototype device will be described and/or demonstrated to the patients, and the rationale for its development will be explained. They will have opportunity to ask questions and then they will be invited to participate in the study.

Written informed consent will be obtained.

Intraoperatively:

Surgical drains will be placed per the usual routine of the surgeon. Definitive drain fixation will occur when all of the pertinent incisions are closed and dressed. At that time, each drain will be secured according to the randomization scheme.

The amount of time it takes to secure and dress each drain will be recorded using a time-stamped video (e.g. iphone).

Postoperatively:

The time until drain removal will be recorded for both groups.

On postoperative visit(s) on which a drain is removed, patients will complete a survey about their experience with the pertinent securement method/drain site.

Feasibility and ease of use of the novel drain device will be evaluated by evaluation of video recordings, qualitative feedback obtained from surgeons and/or O.R staff and nurses that handle and observe use of the device.

Safety of the novel drain device will be evaluated by inspecting device sites for signs of skin injury at each office visit and at the time of drain removal, including photographs of drain sites immediately before and after removal. It will also be assessed by feedback obtained in the patient surveys.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Patient of the Department of Plastic and Reconstructive Surgery
* Able to sign English language Consent form
* Undergoing any of the following procedures requiring placement of 2 or more drains (preferably bilateral) including: Breast reconstruction, Bilateral Breast Reduction, Abdominoplasty, Body Contour surgery (e.g. panniculectomy, brachiplasty, thighplasty)

Exclusion Criteria:

* Patients with unilateral drain placement
* Unable to sign English language consent form
* Allergy to Tegaderm Dressing
Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis

The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

This study has 2 components: a 4-week run-in period during which participants are treated with prolonged-release fampridine and undergo subjective and objective assessments of walking ability, the results of which are used to determine who responded to study treatment, and an observational period, during which treatment responders will continue prolonged-release fampridine treatment. The participants who do not meet the criteria to continue study treatment will be offered the opportunity to continue study participation but will not continue prolonged-release fampridine treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
* Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting multiple sclerosis (MS) per revised McDonald Committee criteria (\[Polman et al, 2011\]) as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months duration.
* Have a walking impairment as determined by the Investigator.
* Able to perform the Timed 25-foot Walk Test with or without a walking aid.
* Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
* Able to understand and comply with the requirements of the protocol.

Key Exclusion Criteria:

* Known allergy to pyridine-containing substances or to any of the inactive ingredients in the prolonged-release fampridine tablet.
* Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.
* An estimated creatinine clearance of \<80 mL/minute.
* Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 \[e.g., cimetidine\]).
* Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study.
* Female subjects who are currently breastfeeding.
* Previous exposure to fampridine.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Image Location and Performance of Left Bundle Branch Pacing

This is a prospective, multi-site, non-randomized, data collection study. The purpose of this study is to investigate the correlation between pacing sites and ECG morphology or pacing parameters during left bundle branch pacing (LBBP) and perform the use condition analysis to assess the long-term performance of pacing lead during LBBP.

His bundle pacing (HBP) is a physiological pacing, but also has some limitations, including high and unstable pacing threshold in 5-10% patients, low R-wave amplitude causing inappropriate pacing management, damage to the His bundle during implantation. On the other hand, left bundle branch pacing (LBBP), achieved via trans-ventricular septal approach with the pacing lead tip at the left side of the ventricular septum, has recently initiated and been widely practiced in China because of easy implantation, relatively narrow paced QRS duration, low and stable pacing threshold, high R wave amplitude, and the LBBB correction by a low pacing output.

As LBBP is in the early phase of clinical practice in China, in order to better conduct LBBP implantation and understand mechanisms of LBBP therapy, physicians often do imaging assessment of the pacing lead in patients implanted with LBBP based on clinical necessity.

Additionally, there is no report of mid/long-term correlation between lead location and ventricular electrical activity, nor mid/long-term pacing lead performance assessment during LBBP.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 80 years old;
* Patients providing signed Informed Consent;
* Patients indicated for permanent pacing and implanted with LBBP for at least 3 months, with documentation of implantation records;
* Patients who plan to receive cardiac CT examination.

Exclusion Criteria:

* Patients who have a history of allergy to contrast agent or refuse to use contrast agent in CT examination;
* Patients who are pregnant or have a plan for pregnancy during the study;
* Patients who are not willing to provide Informed Consent;
* Patients who have medical conditions that would limit study participation;
* Patients who were already enrolled in other clinical trial which would impact his/her participation.
Bioequivalence Study of UHAC 62 XX Tablets Compared With Capsules in Healthy Volunteers

Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) in fasted state.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 20 and \<= 35 years
* Weight: BMI \>= 18.5 and \< 25 (Weight (kg) / Height (m²)
* Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
* Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
* History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
* History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
* History of bleeding tendency
* History of alcohol or drug abuse
* Participation to another trial with an investigational drug within 4 months prior to the trial
* Whole blood donation more than 400 ml within 3 months prior to the trial
* Whole blood donation more than 100 ml within 1 month prior to the administration
* Donation of constituent of blood of more than 400 ml within 1 month prior to the trial
* Any medication which might influence the results of the trial within 10 days prior to the trial
* Excessive physical activities within 7 days prior to the trial
* Alcohol drinking within 3 days prior to the trial
* History of orthostatic hypotension, fainting spells or blackouts
* Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
Multicenter, Nonrandomized, Prospective Study of Pulmonary Embolism Removal With the AngioJet 6F Ultra System

The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.

Despite advances in prophylaxis, diagnostic modalities, and therapeutic options, pulmonary embolism remains a commonly under diagnosed and lethal entity. In the United States approximately 150,000 patients per year are diagnosed with acute pulmonary embolisms. Many additional deaths occur each year in the United States as a result of undiagnosed massive pulmonary embolisms. Taking these patients into account, it is thought that up to 600,000 patients develop a pulmonary embolism annually in this country. In patients with acute pulmonary embolism, the most common cause of early death is right ventricular failure.

In addition to anticoagulation therapy, several reperfusion therapies are being used to reverse right ventricular failure: systemic thrombolysis, surgical embolectomy, and catheter based therapy. Given the drawbacks of systemic thrombolytic therapy or surgical embolectomy, percutaneous catheter treatment is a reasonable alternative for patients with contraindications to systemic thrombolytic therapy or surgery. Current international consensus guidelines support the use of catheter interventions for selected pulmonary embolism patients at increased risk of adverse clinical outcomes.

The AngioJet Ultra PE Thrombectomy catheter introduces a pressurized high velocity saline stream through a catheter tip so that the clot within a blood vessel is trapped, broken into small pieces and aspirated from the body.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic pulmonary embolism patients \>18 years
2. Availability of a baseline contrast-enhanced chest computed tomogram or conventional pulmonary angiogram with evidence of pulmonary embolus in at least one main or lobar pulmonary artery ≥ 6mm in diameter
3. Availability of a baseline transthoracic echocardiogram with sufficient image quality permitting the measurement of right ventricular (RV) and left ventricular (LV) dimensions in the apical or subcostal four-chamber view
4. Echocardiographic evidence of right ventricular dilatation with a subannular RV/LV ratio ≥ 0.9 from the apical or subcostal four-chamber view
5. Appropriate informed consent was obtained from the patient or legal representative

Exclusion Criteria:

1. Patient has underwent Cardiopulmonary Resuscitation (CPR) in the last 48 hours
2. Patient is participating in any other clinical study
3. Pregnancy, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control)
4. Inability to comply with study Follow-up assessments (e.g. due to geographic)
5. Previous enrollment in this study
Feasibility Study of Unfractionated Heparin in Acute Chest Syndrome

The purpose of this study is to determine the feasibility of performing a larger multicenter phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome (ACS). Prespecified feasibility criteria consists of the ability to enroll potential study participants, which includes the timely notification of hospitalized patients with ACS, the capacity to consent eligible individuals, and the ability to appropriately randomize eligible patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring appropriate eligibility criteria, proper administration of the study drug, and the ability to completely and accurately collect clinical data of interest. The final aim of our pilot study is to provide preliminary data, with respect to treatment effect and variance, to allow sample size calculation in a larger trial given the lack of data available to help guide this process. The investigators hypothesize that the use of UFH in ACS will result in a decrease in the duration of hospitalization and improve other clinical outcomes, such as the duration of hypoxemia and duration of moderate to severe pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ACS defined as a new pulmonary infiltrate involving at least one segment of the lung on a chest x-ray or chest CT scan with 2 or more of the following: chest pain, tachypnea, dyspnea, cough, hypoxemia, or body temperature greater than or equal to 38.0 degrees Celsius
* Hemoglobin electrophoresis confirming HbSS, SC, or B0 (historical records sufficient)
* Age greater than or equal to 18

Exclusion Criteria:

* Any absolute contraindication to heparin
* Platelet count less than 50 per microliter (current admission)
* Historical diagnosis of moyamoya disease as documented in medical records
* Historical diagnosis of proliferative retinopathy as documented in medical records
* Current participation in a chronic exchange transfusion program
* Underlying hypercoagulable disorder other than sickle cell disease
* Currently receiving therappeutic anticoagulation
* Currently receiving antiplatelet agents
* Currently receiving estrogen containing oral contraceptives
* Chest CT scan documented PE performed as standard of care prior to study enrollment (current admission)