cyrilzakka/clinical-trials huggingface dataset:
The Use of Intranasal Ketoralac for Pain Management (Sprix)

Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.

The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.

URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.

Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.

The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.

Eligibility Criteria:
Inclusion Criteria:

* Ureteroscopic stone removal surgeries with stenting
* Age ≥ 18 years and \< 65 years
* Stable patient with stable vital signs
* Mentally competent and is able to understand consent form

Exclusion Criteria:

* Unstable patients
* Patients with multiple trauma sites
* Patients with allergies to ketorolac or any of the components in the nasal spray preparation
* Patients with active peptic ulcer disease
* History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
* Renal disease or at risk for renal failure due to volume depletion
* Pregnant or nursing mothers
* Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor)
* Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert
A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC \<70 % predicted, FEV1 of \< 50% predicted, TLC \> 100% of predicted, and RV \> 135% predicted.
* Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
* Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
Pediatric Radio Frequency Coils Generic

The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC).

Pediatric Magnetic resonance (MR) imaging techniques have been limited by the unavailability of specialized radio-frequency (RF) coils for pediatric imaging. Typically, MR coils are designed for general purpose adult imaging and lack the mechanical design, flexibility and high channel count needed for pediatric imaging. Furthermore, pediatric patients are often positioned decubitus or prone rather than supine. This makes coil positioning even more challenging and often results in images with low SNR and poor image quality. Many coils used in clinical practice have fixed dimensions that do not fit within the realm of "one-size fits all," especially for the huge variation found in the pediatric patient population.

MRI coil development and optimization is performed by MR manufacturers and in research laboratories across the world including the Imaging Research Center (IRC) of Cincinnati Children's Hospital and Medical Center (CCHMC). Coil development and refinement involves evaluating the new coils on inert phantoms and then imaging examinations performed on healthy participants and patients. The focus of this study protocol is to evaluate the design and performance of investigational coils on patients and healthy participants.

Eligibility Criteria:
Inclusion Criteria:

Healthy participants:

* Male or Female
* Thermally stable
* Any age

Clinical patients:

* Male or Female
* Thermally stable
* any age

Exclusion Criteria:

Healthy participants \& Clinical patients

* Female participants who are pregnant or lactating
* Subjects iwth standard contraindications to MRI
Effects of Mild Hypobaric Hypoxia on Sleep and Post-sleep Performance

Hypobaric hypoxia (decreased oxygen supply to body tissues due to low atmospheric pressure) caused by exposure to high altitude disrupts sleep. Sleep deprivation is associated with degraded post-sleep performance of neurobehavioral tasks. The lowest altitude at which sleep and/or post-sleep performance are affected is not known. The study hypothesis is that sleep and/or post-sleep performance of neurobehavioral tasks will occur due to hypobaric hypoxia at altitudes of 8,000 or less.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* age 30 to 60 years

Exclusion Criteria:

* sleep disorders or abnormal sleep patterns
* mood or psychiatric disorders including claustrophobia
* altitude exposure above 5,000 ft in the previous 2 months
* born or raised at terrestrial altitude 5,000 ft or greater
* conditions that would disqualify for FAA Medical Certificate
* acute medical conditions
Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients

The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* COPD on necessity of long term oxygen therapy
* Able to give their written consent

Exclusion Criteria:

* Unstable patients with COPD
* Patients with restrictive respiratory disease
* Patients with cardiac or neurologic disease contre-indicating the different evaluations
Effect of Strawberries on Cardiovascular Disease Risk

It is important to identify and evaluate foods, such as strawberries, that can improve established and emerging cardiovascular risk factors, such as postprandial lipid and glycemic responses, and vascular health. Postprandial derangements may affect multiple metabolic pathways that lead to increased arterial stiffness. Research has demonstrated the potential of strawberries to ameliorate postprandial responses to a high fat/high glucose meal. Further research is needed to demonstrate this effect in better controlled clinical studies and explore whether metabolic effects lead to improved arterial health.

The investigators propose to examine the effects of adding 40 g of freeze-dried strawberry powder to a high fat/high glucose meal on postprandial cardiovascular risk factor including lipids, insulin, glucose, and arterial stiffness and central blood pressure. The investigators hypothesize that the bioactive components of strawberry powder will attenuate postprandial lipemic and glycemic responses, as well as improve measures of arterial health.


Eligibility Criteria:
Inclusion Criteria:

* 20-50 years of age
* LDL-C below 160 mg/dL
* Triglycerides below 350 mg/dL
* No stage II hypertension (BP below 160/100 mmHg)
* Not taking medication for elevated lipids, blood pressure, or glucose

Exclusion Criteria:

* Allergies to strawberries
* Known intolerance to high fat meals
* History of cardiovascular disease, kidney disease, diabetes or inflammatory diseases such as GI disorders and arthritis
* Use of non-steroidal anti-inflammatory or immunosuppressant drugs
* Conditions requiring the use of steroids
* Use of medication or supplements for elevated lipids, blood pressure or glucose
Self-compression Mammography in Clinical Practice

Every year millions of mammograms are performed worldwide, representing the primary examination for the early diagnosis of breast cancer. Despite continuous advances in medicine and technology, an aspect of mammography has not changed in over fifty years: the breast is still compressed on the detector because this allows to reduce the thickness of the breast thus improving the quality of the diagnostic image and reducing the dose of radiation necessary to obtain a clear image. Many women perceive as painful this compression, including women who have been treated for breast cancer.

Pain can discourage asymptomatic women to present themselves periodically to screening mammography, while an increasing number of women in follow-up after conservative surgery have to withstand the pain caused by mammography.

Some studies mention various factors that are responsible for pain when performing mammography: breast sensitivity, anxiety level, expected pain and staff attitude. Some studies have also identified breast density, breast volume and menstrual phase as other influencing factors, although not all studies support these hypothesis. The technical characteristics of the equipment can greatly affect annoyance, sense of oppression, pain. The technological proposals to reduce the discomfort of the patients concern various items: flexible compressors, self-compression devices under the supervision of the technician who performs the positioning and the minimum initial compression, environmental factors such as equipment noise reduction, chromatic, sound and sensory effects (eg: aromatic diffusers).

The aim of our study is to evaluate the effectiveness of the self-compression compared to the standard one, in reducing annoyance, a sense of oppression and pain, and to evaluate the difference of the average glandular dose given to the woman for each projection.

Self-compression may help reaching better compression tolerating the discomfort and pain induced thus allowing to achieve a lower thickness, a lower glandular dose and a better image.


Eligibility Criteria:
Inclusion Criteria:

* Women in follow-up after surgery
* Symptomatic women undergoing mammography
* Early diagnosis in asymptomatic women outside the organized screening program (these women are predominantly aged 40-44 / 75-85)
* Women with familiar risk

Exclusion Criteria:

* Augmentation prostheses
* Women in screening with active invitation
* Physical impossibility to use the self-compression command
* Inability to provide consent
A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.


Eligibility Criteria:
* Patients must have parathyroid carcinoma or severe primary hyperparathyroidism; \* Abnormally elevated calcium levels above 12.5 mg/dL; \* Not be pregnant or nursing; \* Not have had any type of cancer other than parathyroid carcinoma within the last 5 years.
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection

To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count \<= 200 cells/mm3.

Allowed:

* PCP prophylaxis with aerosolized pentamidine in patients with CD4 count \> 200 cells/mm3, only at the discretion of the treating physician.

Patients must have:

* HIV positivity.
* Absolute CD4 count of 150 - 500 cells/mm3.
* At least 6 months of prior zidovudine therapy.
* No active opportunistic infection requiring ongoing therapy.
* Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Neoplasm other than basal cell carcinoma of the skin.
* Clinically significant cardiac disease.
* Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing.
* Unwilling to comply with protocol requirements.

Patients with the following prior conditions are excluded:

History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Antiretroviral agent or interferon.
* Systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic agents, or other drugs that can cause neutropenia or significant nephrotoxicity.
* Rifampin or rifampin derivatives.
* Systemic anti-infectives.

Required:

* At least 6 months of prior zidovudine. Active drug or alcohol abuse.
Effectiveness of Aligners Versus Rapid Maxillary Expansion

Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.

Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology. This two-arm parallel-group randomized prospective clinical trial will include patients with: indications for maxillary expansion treatment, age between 6 and 10 years old, mixed dentition, good standard of oral hygiene, good compliance during treatment as assessed by the practitioner. Patients will be assigned to one of two expansion methods (arm A: Invisalign® First clear aligners, arm B: tooth-borne Hyrax-type maxillary expander) according to a computer-generated randomization list shortly before the start of expansion Primary outcome measure will be the change in palatal morphology (palatal volume and surface area variations). Secondary outcomes will be: arch dimensions (upper inter-canine width, upper inter-molar width, anterior segment length, posterior segment length), complications, patients' satisfaction and periodontal health. Due to the nature of the intervention blinding will not be possible. Potential statistical differences between the two intervention groups will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients who have been diagnosed with transverse maxillary deficiency;
* mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
* fully erupted upper and lower first molars;
* transversal discrepancy ≤5mm
* demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
* subjects willing to consent to the trial and comply with the trial regime.

Exclusion Criteria:

* any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
* permanent teeth extraction-based treatment (third molars excluded);
* morphologic crown anomalies;
* auxiliary treatment during arch expansion stage (such as crossbite elastics);
* posterior interproximal reduction;
* orthognathic surgery treatment planned;
* cleft palate or severe facial deformities.
Usability of the CollaGUARD Adhesion Barrier Following Hysteroscopic Adhesiolysis

Assess the feasibility of CollaGUARD following Hysteroscopic Adhesiolysis.

Intrauterine adhesions following gynaecological surgery is a major complication which may cause a range of severe clinical symptoms in women. IUA's can result in menstrual abnormalities, dysmenorrhea and infertility. In pregnancy, adhesions are related to miscarriage, ectopic pregnancy, abnormal placentation, premature labor and delivery and possibly birth defects.

CollaGUARD adhesion barrier is a transparent bioresorbable film approved in Europe for the prevention of postoperative adhesions in patients undergoing abdomino-pelvic laparotomy or laparoscopy.

This study will assess the feasibility of using CollaGUARD adhesion device in hysteroscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with intrauterine adhesions and found eligible for hysteroscopic adhesiolysis
* Willing to use additional contraception throughout study

Exclusion Criteria:

* Be pregnant or having a suspected molar pregnancy, lactating, or planning to become pregnant at any time during the study
* Has suffered or currently suffers from a gynaecological malignancy
* Has undergone a previous hysteroscopic surgery (such as removal of fibroids)
Optional Sub-study to Intraoperative Imaging With ICG Registry

The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.

Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>= 18 years of age
* Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.
* Good operative candidate as determined by the treating physician and/or multidisciplinary team
* Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

* Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
* Vulnerable patient populations
New Acute Treatment for Stroke - The Effect of Remote PERconditioning

This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect.

The aims of this study are:

1. To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations.
2. To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.

Final inclusion and informed consent takes place after first MRI in patients eligible for rtPA.

Follow-up MRI after 24h and 1 month. Clinical outcome at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Significant ischemic stroke suspicion (NIHSS 1-24) and paresis of an extremity.
* Treatment with rtPa within 4.5 hours from debut of symptoms.
* Age above 18 (changed from 01.01.2010 to no upper age limit)
* Independent in daily living before the acute onset of symptoms. (mrs\</=2)
* MR scan showing DWI lesion, consistent with acute ischemic stroke.

Exclusion Criteria:

* Contraindications for iv rtPA
* Onset of symptoms older than 4.5 hours
* Previous diseases of the brain: Intracranial aneurisms or arteriovenous malformations. Brain surgery or hemorrhagic stroke. Former ischemic stroke within the last 3 months.
* Heart diseases: Infectious endocarditis or suspicion of septic emboli, pericarditis, ventricular thrombosis, aneurisms of the heart wall or major heart failure.
* Serious diseases: Cancer, AIDS, dementia, significant abuse, renal failure, liver diseases such as liver failure, cirrhosis, portal hypertension, active hepatitis.
* Pregnancy
* Major ischemic stroke where the patient is unconscious.(NIHSS \> 25).
* Symptoms suspect for migraine, Multiple sclerosis, TIA or another neurological disease than ischemic stroke.

MR scan:

* Contraindications for MRI scans
* Tumor cerebri, cerebral abscesses
* Known hypersensitivity to Gadovist or any of its ingredients, acute or chronic severe renal impairment (GFR \< 30 ml/min/1.73m2), acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
* Caution with using Gadovist to patients with severe cardiovascular disease, and only to be used after a risk-benefit assessment.
* Caution with using Gadovist in patients with low threshold for seizures.

Lab data:

* Blood glucose \< 2, 8 mmol/l or \> 22 mmol/l
Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care

Screening youth in the primary care setting is one way to identify adolescents who may be at-risk for future alcohol problems. The current study tests the new NIAAA screening guide questions, which ask about friend and adolescent drinking, to see how well these questions work to predict subsequent alcohol use, problems, and involvement in other risk behaviors, such as sexual risk-taking and delinquency. In addition, the investigators plan to provide a brief motivational intervention for some at-risk teens and see whether alcohol use differs for those teens who receive the intervention and those teens who receive enhanced usual care. The results of this study have the potential to significantly impact the standard of care for identifying and intervening with at- risk youth in primary care settings.


Eligibility Criteria:
Inclusion Criteria: 1

* 12-18
* speak English

Exclusion Criteria:

* cognitive impairment