cyrilzakka/clinical-trials huggingface dataset:
XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States

A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months

This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders.

For this study, any persons from the Marketscan database with an asthma diagnosis and \>= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab.

Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date

The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases.

Eligibility Criteria:
Inclusion criteria:

We used all eligible Marketscan beneficiaries with an asthma diagnosis and omalizumab use between 07/07/2016 - 12/31/2018 (index period). Continuous enrollment in the Marketscan database was required to ensure the availability of claims data to capture study outcomes and covariates.

* Omalizumab cohort was defined as ≥1 prescription claims within the index period, with the date of first dispensing deemed the index date.
* Asthma was defined by ≥1 diagnosis code in any available diagnosis field on or prior to index date.

ICD-9-CM: 493.xx OR ICD-10-CM: J45.x

* 6-11 years of age at the time of index
* ≥12-months pre-index and ≥12-months post-index continuous eligibility in medical and pharmacy benefits
* Enrollment gap of ≤30 days will be considered continuous enrollment

Exclusion criteria:

Patients were excluded from the study if they had one or more of the following:

* Bronchial Thermoplasty at any time during data capture. Current Procedural Terminology (CPT): 31660, 31661
* Prior asthma-indicated biologic use during the 12 months pre or post-index

Omalizumab:

NDC: 50242004062; 50242004201 or HCPCS: J2357; S0107; C9217

Mepolizumab:

NDC: 00173088101, 00173088185 or HCPCS: J2182

Reslizumab:

NDC: 5931061031 or HCPCS: J2786

Benralizumab:

NDC: 0310173030 or HCPCS: C9466

Dupilumab:

NDC: 0024591400 or 0024591800
A Rehabilitation Tool to Determine Patient's Stay in Hospital After Joint Replacement

This is the research study of a rehabilitation tool that informs, guides and empowers clinicians to care for their patients. We hope to learn ways to improve patient outcomes, reduce costs and increase value to the healthcare system

The investigator hope to learn co-relation between the rehab tool and clinical findings and analyse association if any. Rehab tool will optimize care according to the patient's specific needs and provided insights to patients length of stay in the hospital. these data driven insights will be used to observe correlation between machine and clinic data

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for Primary unilateral total joint replacement
* Patient age should be more than or equal to 18 years.
* Patient must speak English

Exclusion Criteria:

* Patients undergoing bilateral primary knee replacement surgery
* Patients undergoing revision knee replacement surgery
* No uncorrectable deformity
* No deformity greater than 15 degree
* No hip arthritis
* No wheelchair dependency
* Patients not willing and capable to sign the written informed consent
XL999 Administered Intravenously to a Subject With Advanced Malignancies

Cancer is a worldwide clinical and economic problem. Conventional approaches to treating cancer include surgery, radiotherapy, and cytotoxic chemotherapy as single modalities or as combined therapies. Recently, targeted therapies including antibodies and small molecule inhibitors have also demonstrated clinical benefit. It is now possible to study different genetic lesions involved in cancer types due to advances in genomic methodologies. The investigational drug in this study, XL999 inhibits multiple receptor tyrosine kinases, including VEGF receptor (VEGFR2/KDR), platelet derived growth factor receptors (PDGFRβ), fms-like tyrosine kinase receptor 3 (FLT3), fibroblast growth factor receptors (FGFR1, FGFR3), RET, and KIT, and thus, interferes with multiple cellular processes simultaneously and will likely have effects on the integrity of tumor neovasculature and angiogenesis. Together with the ability to induce a novel cell cycle arrest, the spectrum of activities that XL999 exhibits may reduce both tumor cell proliferation and angiogenesis in the clinic.

The rationale and purpose of this maintenance study is to allow a subject receiving clinical benefit from XL999 to continue treatment.


Eligibility Criteria:
Inclusion Criteria:

* The subject is eligible to continue to receive XL999 in the absence of progressive disease and unacceptable XL999-related toxicity.

Exclusion Criteria:

* Progressive disease.
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis

This single-institution, phase II study is designed to test the ability to achieve donor hematopoietic engraftment while maintaining low rates of transplant-related mortality (TRM) using busulfan- and fludarabine-based conditioning regimens with busulfan therapeutic drug monitoring (TDM) for patients with various inherited metabolic disorders (IMD) and severe osteopetrosis (OP).


Eligibility Criteria:
Inclusion Criteria:

* 0 through 55 years of age
* Adequate graft available
* Adequate organ function
* Eligible Diseases:

  * Mucopolysaccharidosis Disorders:

    * MPS IH (Hurler syndrome)
    * MPS II (Hunter syndrome) if the patient has no or minimal evidence of symptomatic neurologic disease but is expected to have a neurologic phenotype
    * MPS VI (Maroteaux-Lamy syndrome)
    * MPS VII (Sly syndrome)
  * Glycoprotein Metabolic Disorders:

    * Alpha mannosidosis
    * Fucosidosis
    * Aspartylglucosaminuria
  * Sphingolipidoses and Recessive Leukodystrophies:

    * Globoid cell leukodystrophy
    * Metachromatic leukodystrophy
    * Niemann-Pick B patients (sphingomyelin deficiency)
    * Niemann-Pick C subtype 2
  * Peroxisomal Disorders:

    * Adrenoleukodystrophy with cerebral involvement
    * Zellweger syndrome
    * Neonatal Adrenoleukodystrophy
    * Infantile Refsum disease
    * Acyl-CoA-Oxidase Deficiency
    * D-Bifunctional enzyme deficiency
    * Multifunctional enzyme deficiency
    * Alpha-methylacyl-CoA Racmase Deficiency (AMACRD)
    * Mitochondrial Neurogastrointestingal Encephalopathy (MNGIE)
  * Severe Osteopetrosis (OP)
  * Hereditary Leukoencephalopathy with axonal spheroids (HDLS; CSF1R mutation)
  * Other Inherited Metabolic Disorders (IMD): Patients will also be considered who have other life-threatening, rare lysosomal, peroxisomal or other similar inherited disorders characterized by white matter disease or other neurologic manifestations for which there is rationale that transplantation would be of benefit, such as certain patients with Wolman's disease, GM1 gangliosidosis, I-cell disease, Tay-Sachs disease, Sandhoff disease or others.
  * Voluntary written consent

Exclusion Criteria:

* Pregnancy - menstruating females must have a negative serum or urine pregnancy test within 14 days of study treatment start
* Prior myeloablative chemotherapy exposure within 4 months of the start of conditioning on this protocol (patients excluded for this reason may be eligible for other institutional protocols)
* Uncontrolled bacterial, fungal or viral infections including HIV (including active infection with Aspergillus or other mold within 30 days)
Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

Considerable research has documented the optimization utility of stimulants in sleep deprived Soldiers and aviators, however, the research for enhancement purposes has demonstrated mixed results. One significant factor that may influence enhancement properties is general intelligence such that low performers exhibit stronger enhancement effects than high performers. The objective of this study is to determine whether stimulants (specifically, modafinil and Adderall) can enhance Soldier cognitive abilities and performance on military tasks. To do so, a within-subjects design will be employed using healthy, rested Soldiers and measuring performance on a set of basic cognitive assessments and operationally relevant tasks.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old.
* Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report
* Must have obtained at minimum 6 hours of sleep prior to all testing sessions, as assessed by actigraphy data and self-report. Should the actiwatch malfunction, reliance on self-report will suffice. If the subject does not meet this requirement, he will be asked to reschedule
* Must have refrained from consumption of stimulants (including caffeine) and over the counter medications which may induce drowsiness for a minimum of 16 hours prior to each test session, and nicotine, 8 hours, prior to all testing sessions, assessed by self-report.

Exclusion Criteria:

* Currently taking medications which induce drowsiness, such as over-the-counter antihistamines. Any self-medication will be assessed through self-report.
* No current medical conditions or medications affecting cognitive function or attention as determined by screening by study physician or medical practitioner
* Current or recent use (as determined by study physician or medical practitioner) of medications that may interact with the test articles. Determined by self-report and exclusion at the discretion of the study physician or medical practitioner.
* Any history of any attention deficit condition requiring medication. A history of any attention deficit condition with medication is disqualifying as the potential interactions with testing are unknown and would therefore produce a potential source of confounding or bias into the results of the study.
* Any history of psychological/psychiatric disorder.
* Any history of addiction or substance abuse as assessed through self-report.
* Any history of metabolic disorder such as dysthyriodism.
* Any history of significant cardiovascular disease or hypertension.
* Any history of hepatic or renal disorder.
* Females will be excluded given that the drugs administered could potentially negatively impact the very early stages of pregnancy.
* Any ingestion of substances that may interact with the test articles or potentially skew the results within the last 16 hours prior to testing including over-the-counter medications, supplements, etc. (see attached list to be reviewed with subject).
Clinical & Biochemical Effect of Atorvastatin in Nano Particles Gel in Periodontitis Treatment

Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients
* Patients with moderate periodontitis

Exclusion Criteria:

* Pregnant women
* Lactating women
* Patients with chronic diseases
The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home

The inclined position at 30 ° in case of transient respiratory discomfort is recommended since the consensus conference of September 2000. This recommendation is based on a low level of evidence (grade C). This advice is found in the health book, and in many tips for parents. However, it does not comply with the recommendations of the American Academy of Pediatrics for sleeping on the back, on a firm mattress and without other objects in the bed.

70% of pediatricians advise this position in a specific medical context according to a study of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.

Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of obstruction.

A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that the flexion of the neck causes the chin to be positioned against the chest and contributes to the suffocation of the infant. This is especially important in infants under 3 months whose neck muscles do not yet support the weight of the head.

The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a contributing factor, including the use of a pillow in the bed in 24.3% of cases.

It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car seat for an extended duration was at the origin of a significant desaturations rate, which was also found in the car bed group. The control group "hospital bed" was not subject to these desaturations. These results support the fact that only an adapted bedding that complies with the recommendations protects against asphyxiation.

Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on the back.

Hypothesis :

The inclined position in infants under one year of age is at risk of unexpected death of the infant by obstruction of the upper airways, because of the changes of position that it entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the covers.


Eligibility Criteria:
Inclusion Criteria:

* Infant from 0 to 12 months
* Lie in a proclive position while sleeping
* Whose parents / parent authority holders informed about the terms of the study and agree to answer the questionnaire

Exclusion Criteria:

* Refusal to participate
Efficacy and Safety of Intravenous + Oral Vs. Oral Amiodarone in Preventing Recurrence After Catheter Ablation in Patients with Persistent Atrial Fibrillation

This study aims to investigate the efficacy and safety of intravenous combined with oral amiodarone in preventing atrial fibrillation (AF) recurrence after catheter ablation in patients with persistent atrial fibrillation. Using a randomized controlled trial design, patients will be divided into two groups: intravenous + oral amiodarone and oral amiodarone alone. Through multiple follow-ups at 1, 3, 6, and 12 months post-procedure, the study will compare the two treatment regimens in terms of blood concentrations of amiodarone and its metabolites, efficacy (short-term recurrence \[SR\], long-term recurrence \[LR\], and patient quality of life), and safety (adverse drug reactions). Subgroup analyses will also be conducted to explore potential differences in drug treatment effects among populations with varying risk factors. This study aims to provide valuable clinical data for post-ablation management of atrial fibrillation, contributing to the development of optimized treatment strategies to enhance therapeutic outcomes and improve patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥18 years;
* First-time catheter ablation for persistent atrial fibrillation (defined as any - previous episode lasting ≥7 days);
* Symptomatic atrial fibrillation patients who have failed or are intolerant to at least one class I or III antiarrhythmic drug;
* Participants who are able to understand the purpose of the study, voluntarily agree to participate, and provide written informed consent.

Exclusion Criteria:

* Those unwilling or unsuitable to restart or continue antiarrhythmic drug therapy;
* Life expectancy \< 12 months;
* Severe liver or kidney dysfunction;
* Allergy to amiodarone components;
* Pregnant or breastfeeding women;
* Contraindications to amiodarone (e.g., blood pressure \< 90/60 mmHg; bradycardia \< 55 bpm, second- or third-degree AV block, or sick sinus syndrome);
* Thyroid disorders, such as hyperthyroidism or hypothyroidism.
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.


Eligibility Criteria:
Inclusion Criteria

Subjects are admitted into the study only if all of the following eligibility is true:

* Female
* Age limitation specific to the indication:

  * Primary Augmentation: Must be 18 years or older
  * Primary Reconstruction: No age limit
  * Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older.
* Adequate tissue available to cover implant(s)
* Willingness to follow study requirements (informed consent form, follow-up visits)
* Candidate for primary augmentation, primary reconstruction, or revision

Exclusion Criteria

Subjects are not eligible if any of the following criteria exist:

* Advanced fibrocystic disease, considered to be pre-malignant without mastectomy
* Inadequate or unsuitable tissue
* Active infection in the body at the time of surgery
* Pregnant or lactating
* Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator
* Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications
* Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
* Determination by physical examination that the subject does have any connective tissue/autoimmune disorder
* Existing carcinoma of the breast without accompanying mastectomy
* MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.
Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada.


Eligibility Criteria:
Inclusion Criteria:

* Surgical admission, with a noncardiac surgical interventions
* Aged between \>28 days and \<18years on the day of the surgical intervention

Exclusion Criteria:

* Non-surgical admission
* Surgical interventions with \<10 per group
* Cardio-thoracic and interventional cardiology procedures
Cold Press Test and Post Operative Pain Relationship

The goal of this clinical trial is to investigate whether it is possible to get a preliminary idea about the postoperative pain in the patient with the results of a practical cold press test applied to American Society of Anesthesiologists(ASA) 1 and 2, healthy, male patients aged 16-35 before extraction of the lower third molar. The main question it aims to answer are:

• Can post-operative pain be predicted with an cold test that can be applied more practically than conventional quantitative sensory tests applied preoperatively? Participants will need to keep their hands on ice for 240 seconds prior to third molar surgery. When they take their hands off the ice, they will be asked to describe their pain on the visual analog scale. After the operation, the participants are required to mark whether they use painkillers every 8 hours in their pain follow-up forms and the pain they feel according to the visual analog scale.

Depending on the endurance time of the participants to keep their hands on the ice; Two different groups were determined as less than 240 sec and equal to 240 sec. The pain scores and the amount of painkiller use between these two groups were compared with each other.


Eligibility Criteria:
Inclusion Criteria:

* The impacted third molar should be class 1 or 2 and position B according to Pell \& Gregory classification.
* The impacted third molar should be asymptomatic.
* The impacted third molar should be located in the mandible and be in the mesioangular or vertical position.
* To be male gender
* To be in American Society of Anesthesiologists 1 or 2 classification
* To be between the ages of 16-35

Exclusion Criteria:

* Intolerance to non-steroidal anti-inflammatory drugs
* Smoking more than 10 cigarettes a day
* Operation time exceeding 20 minutes
* Individuals who have performed third molar tooth extraction
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-MONO)

The main purpose of this study is to investigate the efficacy and safety of Tirzepatide monotherapy in Chinese participants with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes
* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment
* Are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment
* Have Body Mass Index (BMI) ≥23.0 kilogram per square meter (kg/m²)

Exclusion Criteria:

* Have Type 1 Diabetes
* Have a history of chronic or acute pancreatitis any time prior to study entry
* Are currently receiving treatment for diabetic retinopathy and/or macular edema
* Have a history of ketoacidosis or hyperosmolar state/coma
* Have a history of New York Heart Association Functional Classification IV congestive heart failure (CHF)
* Have acute or chronic hepatitis including a history of autoimmune hepatitis
* Use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
FIRAZYR General Drug Use-Results Survey (Japan)

The objectives of this survey are to collect data to report the safety and efficacy of Firazyr (Icatibant acetate) in the post-marketing phase in participants diagnosed with Hereditary Angioedema (HAE).


Eligibility Criteria:
Inclusion Criteria:

* Hereditary angioedema (HAE) participants in Japan who receive FIRAZYR for first time in the real world clinical setting.

Exclusion Criteria