cyrilzakka/clinical-trials huggingface dataset:
Assessing the Accuracy of the RevK Sensor

Evaluation of a new generation of sensors for monitoring blood hemoglobin. The newest version is RevK.

Evaluation of a new generation of sensors for monitoring blood hemoglobin with the Masimo non-invasive hemoglobin monitor. The newest sensor version is RevK.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female
* American Society of Anesthesiology Classification 1, 2 or 3
* Scheduled to undergo spine or hip surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the study investigators clinical judgement would not be suitable for research
Hospital to Home Outcomes

Home Nurse Visit post discharge.

To identify barriers to successful transitions that are most meaningful to patients and families, and use these identified barriers to iteratively adapt an existing nurse home visit program to address these barriers. This study will also test the efficacy of a nurse home visit intervention in improving post-discharge outcomes through a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient is under 18 years of age Patient is admitted to Cincinnati Children's Hospital Medical Center to hospital medicine, community pediatrics, adolescent medicine, neurology or neurosurgery.

Exclusion Criteria:

* Patient to be discharged someplace other than home (e.g., residential facility, psychiatric facility)
* Patient's home residence is outside the home nursing service area
* Patient is eligible for "traditional" home nursing services
* Caregiver is non-English speaking
Clinical Evaluation of Anaesthetic Efficacy of 4% Articaine Buccal Infiltration Versus Inferior Alveolar Nerve Block

Clinical evaluation of anaesthetic efficacy of 4% articaine buccal infiltration versus inferior alveolar nerve block during restorative dental treatment in mandibular first permanent molars


Eligibility Criteria:
Inclusion Criteria:

* Clinical Criteria:

  * Children aged between 6 years and 9 years having:
  * Mandibular first permanent molar with simple caries not involving pulp showing the following criteria: A. No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. B. Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.

Radiographic criteria:

* No sign of radiolucency in periapical or furcation area.
* No widening of PDL space or loss of lamina dura continuity.
* No evidence of internal/external pathologic root resorption

Exclusion Criteria:

* • Uncooperative children.

  * Children with systemic disease.
  * Lack of informed consent by the child patient's parent.
  * Refusal of participation.
  * Allergy from anesthetic agent.
  * Acute infection
Online Insomnia Intervention to Reduce Alcohol Use

Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.

The study will investigate the efficacy of Sleep Healthy Using the Internet (SHUTi), an online insomnia intervention, in reducing alcohol consumption and improving sleep in heavy drinkers with insomnia. The participants are ages 18-50 (N=100) who have insomnia and are heavy drinkers (at least weekly binge drinking episodes \[4/5+ drinks in one sitting for men/women\]). This intervention has a mixed methods randomized controlled trial design. Participants will be randomly assigned to either the online SHUTi intervention (N=50), or a patient education (PE) website (N=50). Quantitative data will be collected via online REDCap surveys and daily online diaries. Qualitative data will be collected via semi-structured telephone interviews. Data collection points will be pre-intervention, post-intervention, and 3- and 6-months postintervention.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* Fluency in English
* At least weekly binge drinking episodes (4/5+ drinks for women/men)\]
* Insomnia Severity Index (ISI) scores #15

Exclusion Criteria:

* No internet access
* Past or current substance use disorder (other than mild or moderate AUD)
* Obstructive sleep apnea
* Bipolar disorder, schizophrenia, or other psychotic spectrum disorder
* Pregnancy or nursing for women
* Any serious medical or neurological problems
Pain Screening in Refugee Survivors of Torture

The investigators are evaluating refugee torture survivors who are receiving services at the Weill Cornell Center for Human Rights. There are two research questions in this study: if the current standard of care results in the under or missed diagnosis of pain and pain syndromes, and if a validated pain screening tool can supplement the current standard protocol used in the assessments of survivors of torture.

The research plan consists of three components:

1. The Weill Cornell Center for Human Rights will coordinate with the research team regarding eligible subjects.
2. Researchers will contact potential subjects utilizing interpreter services.
3. Interested participants will be scheduled for an appointment for an examination by a pain physician and to complete the Brief Pain Inventory.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from any country over the age of 18
* refugees receiving services from the Weill Cornell Center for Human Rights

Exclusion Criteria:

* Have not experienced torture
* Subjects whose representative does not believe that they are a good candidate for the study
Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.

This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology Clinic.

The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤ 12 mm.

The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as:

* 350 kil0Hertz (kHz) acoustic frequency
* 7 MegaPascals (MPa) peak negative pressure
* 20 cycle pulse duration
* 17 Hz pulse repetition frequency

A maximum of 3 stones can be treated per subject.

Safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. Fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting with at least one kidney stone apparent on CT
* Individuals scheduled for clinical stone removal via ureteroscopy (URS)

Exclusion Criteria:

* Individuals under 18 years of age
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.)
* Individuals with uncorrected bleeding disorders or coagulopathies
* Individuals taking a clinically significant anticoagulant dose at the time of the procedure
* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm
* Individuals with a solitary kidney
* Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure
Diabetes Outcomes and Nurse Case Manager Study

This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.

The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources:

1. referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
2. referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care \& about to be discharged (Appendix 1).

Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* A1c \> 8.0 or
* BP \> 140/90 or
* LDL cholesterol \> 2.0 (72 mg/dl)

Exclusion Criteria:

* inability to speak English or to be assisted by somebody fluent in English
Study on Left Atrial Function of Atrial Fibrillation After Radiofrequency Ablation With Statin Therapy

A total of 120 patients with persistent atrial fibrillation (including continuous and long-standing persistent atrial fibrillation) and 60 patients with paroxysmal atrial fibrillation will receive radiofrequency ablation. Patients in each group will be randomly allocated into the statin treatment group and non-statin treatment group (allocation ratio, 1:1). Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation. This study will clarify whether the application of statin drugs can improve postoperative left atrial function. This study will identify the time course and influence factors of left atrial recovery of atrial fibrillation after the operation to guide the time and the degree of anticoagulation and effectively prevent thromboembolic events. At the same time, biochemical indicators are detected to analyze which indicators are related to the postoperative recurrence of atrial fibrillation, the incidence of postoperative thrombosis and the recovery of postoperative left atrial function. Furthermore, this study will investigate whether the application of statin drugs can improve postoperative left atrial function by affecting these indicators.


Eligibility Criteria:
Inclusion Criteria:

* All persistent or permanent AF patients with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
* paroxysmal atrial fibrillation with refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication.
* age is \<80 years

Exclusion Criteria:

* left ventricular dysfunction
* LA \>50 mm
* atrial thrombosis
* valvular heart disease
* hyperthyroidism
* patients who underwent prosthetic heart valve replacement
* patients with previous history of atrial fibrillation ablation
* Hyperlipidemia
* pregnant women
* patients with existing liver and kidney disease
* malignant tumors
* hematological system diseases
Evaluation of the Impact of Direct Conversation With Patients in the Compliance With the "Split-dose" Regimen Preparation for Colonoscopy Scheduled in the First Part of the Morning

Split-dose cleansing regimens for colonoscopies, independently from the type of laxative used, are now recommended over full (one day)-dose regimens from all the major guidelines. It is wellknown that splitting the dose (half of the dose the night before and half the day of the colonoscopy) is safe and guarantees a better cleansing of the colon and thus a higher chance of identifying mucosal lesions. This is crucial both in terms of achieving a high-quality colonoscopy and in terms of time and money saved.

Still, there are some issues about compliance and tolerability with split-dose regimens. Two recent prospective works have shown that only a small number of patients (33%) chooses the split-dose regimen when the colonoscopy is scheduled before 10 a.m. and when patients are forced to used the split-dose, 1/7 did not comply with it, especially if the procedure is before 10 a.m. The most common concerns are about early wake-up, travel interruption and fear of incontinence. Both these papers state that strategies to reduce this noncompliance are needed.

The investigators aim to prove whether an "active action" (an oral explanation before the colonoscopy about why split-dose regimens are better) may improve patients' compliance in endoscopies scheduled in the early morning (from 8 to 10 a.m).


Eligibility Criteria:
Inclusion Criteria:

* every patient who needs a colonoscopy

Exclusion Criteria:

* incapacity in reading and/or in oral comprehension
* contraindications in drinking the preparation
Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 5 years
* Uncomplicated falciparum malaria
* Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours
* Ability to tolerate oral therapy
* Informed consent by the patient or by parent/guardian for children
* Residence in study area

Exclusion Criteria:

* Known or suspected hearing deficits
* Adequate anti-malarial treatment within the previous 7 days
* Mixed infection
* Danger signs and signs of severe malaria as defined by the WHO
* Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
* Concomitant disease masking assessment of response
* History of allergy or intolerance against study medications
* Pregnancy
Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.


Eligibility Criteria:
Inclusion Criteria:

* On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
* Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
* Be able to wear the study lenses in the available powers.
* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* History of corneal refractive surgery.
* Other protocol-defined inclusion/exclusion criteria may apply.
Arterial Imaging of Inflammation and Resolution After Endovascular Surgery

This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.

Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo.

Acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages.

When 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site.

This study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 40,
* With resting or exercise ABI \<0.9, TBI \<0.6
* Have claudication or limb threatening ischemia \& planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA.

Exclusion Criteria:

* Evidence of active infection
* Hypersensitivity or allergy to contrast agents
* Chronic liver disease, renal disease (GFR\< 30) or chronic inflammatory disorders
* Insulin dependent diabetes
* Presence of metal within subject's body, pacemakers, or defibrillators
* BMI \< 20 or \>35
* Recent other major surgery or illness within 30 days
* Use of immunosuppressive medications or steroids
* History of organ transplantation
* Pregnancy, or plans to become pregnant, or lactating
Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery

This study intends to explore the effect of dynamic compliance guided individualized positive end-expiratory pressure titration strategy on reducing the level of postoperative atelectasis in obese patient who have laparoscopic bariatric surgery.The results of the study are to assess the effects of this intervention on the incidence，duration of postoperative atelectasis and other complications including hypoxemia etc. after laparoscopic bariatric surgery.And reducing the burden of postoperative atelectasis on patients and their families, hospitals and public resources.


Eligibility Criteria:
Inclusion Criteria:

1. Bmi ≥ 35 kg/ m2
2. over 18 years old
3. elective laparoscopic bariatric surgery (gastric bypass or sleeve)

Exclusion Criteria:

1. ASA \>IV
2. Lung bullae
3. thoracic surgery history
4. quit smoking less than 1 week
5. chronic obstructive pulmonary disease requiring oxygen
6. congestive heart failure (New York Heart Association classification ≥ III)
7. planned to be transferred to intensive care unit after surgery
8. Patients participating in another interventional study
9. Refuse to sign the informed consent
Is Orthostatic Hypotension Associated With Nondipping Hypertension

The aim of the study is to evaluate whether orthostatic hypotension is associated with nondipping hypertension.

Methods and patients: 400 subjects who are referred for 24hABPM will be filled questioner regarding their medical background and medications. All patients will be subjected to orthostatic test before connection to the 24 ABPM. The orthostatic changes in blood pressure and heart rate will be correlated to the changes in blood pressure and heart rate from day to night as recorded by the 24H ABPM.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are referred for ABPM

Exclusion Criteria:

* Known secondary hypertension
Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold

- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial

* Subjects:Adults with nasolabial fold
* Investigational Devices:

Study Device: SkinPlus-Hyal® Comparator Device: Restylane®

- Procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed, and the WSRS of his/her nasolabial fold wil be evaluated by the Investigator Treatment: The Injector will administer to the eligible subject the Study Device and Comparator Device respectively to the left and right nasolabial fold in a randomized manner. Post-Treatment: All subjects will visit the hospital at 2, 8, 16, 24 weeks since the day of administration, and will take pictures of the Nasolabial fold area and undergo efficacy and safety evaluation during each visit. The Photographic evaluator will evaluate the efficacy

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged over 20
2. Subjects who want to correct his/her nasolabial fold and have point 3 or 4 in WSRS of nasolabial fold and visually symmetric
3. Subjects who voluntarily decided the participation of the study and signed the informed consent
4. Subjects who agree contraception

Exclusion Criteria:

1. Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid
2. Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face
3. Subjects who have a skin disorder on the NLF area
4. Subjects who had permanent implants for dermal augmentation at the NLF area
5. Subjects who had a history of keloid formation or hypertrophic scar
6. Subjects who participated in other clinical trial within 3 months from screening date
7. Female subjects of childbearing potential who disagreed with medically acceptable contraception (e.g., condom, oral contraceptives continuing at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial
8. Subjects who is Drug abuser or alcoholism
9. Subjects who had previous treatment with Botox within 6 months from screening date
10. Subjects who had previous treatment for wrinkle with Retin-A within 1 months from screening date
11. Subjects who had previous treatment with tissue restorative biomaterials within 18 months from screening date
12. Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
13. Subjects who had antigen of HIV or type-B Hepatitis
14. Subjects who had anti-coagulant therapy within 2 weeks from the screening date
15. Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator