cyrilzakka/clinical-trials huggingface dataset:
Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.

Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain "high risk" hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis.

One of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma \>30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.

Eligibility Criteria:
Inclusion Criteria:

* Infants less than 6 months of age
* clinical diagnosis of 1-4 cutaneous hemangiomas
* clinical diagnosis of 5 or more cutaneous hemangiomas
* clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2

Exclusion Criteria:

* Infants greater than 6 months of age
Shuotongo Ureteroscopy for Upper Urinary Tract Stones

The purpose of this study is to use the Shuotong ureteroscopy for surgical treatment of patients with upper urinary tract stones, taking advantage of the fact that the Shuotong mirror can be used for simultaneous lithotripsy and stone removal, thus maximizing the discharge of stones from the body and improving the stone removal rate.

Ureteroscopy via the natural lumen has the advantages of being non-invasive, safe and repeatable. This is where Shuotongo ureteroscopy, a new type of ureteroscopy, has not yet become fully popular. Usually, most patients with upper urinary tract stones are treated by ureteroscopy or with flexible ureteroscopy, because these endoscopes usually break the stones and ask the patient to drink more water to expel the stones by themselves, after the operation, it is usually easy to leave stones in the body, and some patients even form stone streets to block the ureter again after the operation. In some patients, stones may form again and obstruct the ureter again. The Shuotong Ureteroscopy has the advantages of stone crushing and stone removal, which can synchronize the process of stone crushing and stone removal and maintain a good surgical view. It has the advantages of simple operation, less trauma and high safety for the operation via natural channel, especially for the large stones in the upper urinary tract and Gantun stones.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Ureteral calculus Must be able to cooperate with the treatment

Exclusion Criteria:

* Patients had severe urinary tract infections; patients had other conditions which investigators thought not suitable for the study.
Metoclopramide Versus Ketorolac for Tension-type Headache

Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.


Eligibility Criteria:
Inclusion Criteria:

* Acute tension type headache

Exclusion Criteria:

* Contraindications to investigational medications
* Secondary cause of headache
BIIB023 Proof-of-Concept Study in Participants With Lupus Nephritis

The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).

Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
* Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Participants are permitted to have co existing Class V lupus nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
* Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary protein:creatinine ratio (uPCR) \>1.0 mg/mg.

Key Exclusion Criteria:

* Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
* Estimated glomerular filtration rate (eGFR) \<30 mL/min per 1.73 m\^2 (calculated using the abbreviated Modification of Diet in Renal Disease equation) or the presence of oliguria or end-stage renal disease requiring dialysis or transplantation
* Subjects requiring dialysis within 12 months prior to Screening
* History of renal transplant
* Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 \[rituximab\], anti-CD22 \[epratuzumab\], anti-BLyS/B-cell activating factor \[e.g., briobacept, belimumab\] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
The Efficacy of Topical Mesalazine Sustained-Release Tablets in Crohn's Disease Patients With Oral Ulcer

This study aims at evaluating efficacy and safety of topical using Mesalazine Sustained-Release Tablets in in the treatment of oral ulcers in patients with Crohn's disease.

The study will include three phases: screening, treatment and follow-up.

Screening: This phase will last a maximum of 7 days and subjects eligibility will be evaluated after informed consent signature.

Treatment: Subjects are randomly assigned to treatment and will be treated for 7 days. Daily oral ulcer area and symptoms were recorded during the treatment period. A randomization visit will take place on day 0 and an end-of-treatment visit will take place between day 6 and 8.

Follow-up: 28 days after the end of treatment. Efficacy of treatment was evaluated by the oral ulcer remission or decreasing.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18\~65, both gender.
* Patients with oral ulcer and confirmed Crohn's disease.

Exclusion Criteria:

* Contraindications to study drugs.
* Underwent or will accept oral Surgery.
* Patients are not able to sign the informed consent or not comply with the study protocol.
* Planning for pregnancy, pregnancy and lactating women.
* Enrolled in other clinical trials in the past 30 days.
* Patients with concurrent / new other serious diseases will affect the effectiveness and safety evaluation.
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2303 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from CLAF237A2303
* Other protocol-defined exclusion criteria may apply
Bone Mineral Density in Adults With Hyperphenylalaninemia

Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems.

The foundation of this diet is a phe-free medical product/formula made from free amino acids. Based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. Despite the obvious benefits of the diet, it has been suggested that the dietary restrictions may be associated with poor bone health in these patients. However, data supporting this has been reported in studies with small sample sizes and/or inadequate sample populations that include children. There is a paucity of data on bone health in adults with HPA.

The investigators propose an observational study to describe the bone health status among adults with a diagnosis of HPA and to compare them to established normative age and gender-specific values among healthy individuals. The investigators hypothesize that adults with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan compared to the established normative values.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HPA at birth
* Aged 18 or older

Exclusion Criteria:

* Peri-menopausal women
* Menopausal women
* Patients taking bisphosphonates
* Pregnant women
* Women who have been pregnant within one year of study enrollment
* Women who have breastfed within one year of study enrollment
Role of Lung Ultrasound Imaging in the Comparison of Two Mechanical Ventilation Strategies During Laparotomy

The use of positive end-expiratory pressure (PEEP) and recruitment maneuvers during laparotomy will limit the development of atelectasis and therefore improve the aeration score.

Postoperative pulmonary complications contribute to the morbidity of surgical patients. During general anesthesia, up to 90% of patients will develop atelectasis, which is thought to be a major contributing factor to their development. The adjustment of ventilator settings to prevent the occurrence of atelectasis and reduce pulmonary complications remains controversial. Despite the use of similar mechanical ventilation strategies, two recent studies (IMPROVE, PROVHILO) involving 1300 patients diverged in their conclusions regarding the impact of these strategies in the prevention of pulmonary complications. In these studies, the absence of imagery to assess the pulmonary end-result of the different ventilation strategies complicates the interpretation of their results.

On arrival in the operating theatre, each patient will undergo a baseline lung ultrasound examination. The anesthetic technique and monitoring will be standardized. The radial artery will be cannulated after induction of anesthesia for blood gas monitoring. Ventilator settings will be adjusted according to randomization.

A second lung ultrasound examination will be performed 5 minutes following induction of general anesthesia. In the PEEP group, a lung ultrasound examination will be performed immediately following the first recruitment maneuver. A lung ultrasound examination will also be performed at the end of surgery before emergence of general anesthesia.

Fifteen minutes after arrival in the recovery room, a last lung ultrasound examination will be performed. Fraction of inspired oxygen (FiO2) and vital signs will be recorded during each ultrasound examination. Arterial blood samples will be collected simultaneously. The aeration score will be calculated for each lung ultrasound examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Scheduled for surgery by laparotomy (expected to last at least 2 hours)
* American Society of Anesthesiologists classification: physical status 1-3

Exclusion Criteria:

* Previous thoracic procedure (thoracic drain, thoracotomy, thoracoscopy)
* Contraindication to the placement of an arterial line
* Very severe chronic obstructive pulmonary disease
Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants

The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.


Eligibility Criteria:
Inclusion Criteria:

① Infants under 1 year old scheduled for elective surgery under general anesthesia

② American Society of Anesthesiology physical status I, II

Exclusion Criteria:

* Any pulmonary disease
Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial

This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate OSA

Exclusion Criteria:

* hypopharynx obstruction
* ASA classification of physical status)\>3
* allergy toDexmedetomidine
* COPD stage IV
* Asthma with exacerbation
* severe CHF
* age \< 18 year-old
* claustraphobia
* any reason : can not tolerate CPAP
* second or third degree AVB
Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery

Background:

There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position.

Hypothesis:

In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position.

Aims:

To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery.

To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure.

Methods:

Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.

Recruitment: Patients scheduled for spine surgery were Main outcome: Optimal PEEP determined after a pulmonary recruitment manoeuvre in supine and in prone position and every hour during the surgery in prone position.

Secondary outcomes: Pulmonary compliance, blood gas analysis and hemodynamic parameters

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Spine prone surgery lasting ≥2 hours.
* Absence of known pulmonary pathology.

Exclusion Criteria:

* Pregnancy or lactation.
* Contraindication to alveolar recruitment maneuvers (risk of barotrauma, hemodynamic instability).
* Body mass index (BMI) \>35.
* Heart failure defined as IC \<2.5 L/min/m2 and/or inotropic support requirements prior to surgery.
* Diagnosis or suspicion of intracranial hypertension (intracranial pressure \>15 mmHg).
Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung cancer (NSCLC). Participants will be sequentially enrolled to receive progressively increasing doses of momelotinib (MMB) in combination with erlotinib. Escalation of momelotinib (MMB) doses will proceed to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT) during the first 28 days of combined erlotinib and momelotinib (MMB) treatment. There will be four dose levels and each treatment cycle will consist of 28 days.


Eligibility Criteria:
Key Inclusion Criteria:

* Metastatic NSCLC with documented EGFR exon 19 deletion or exon 21 (L858R) substitution mutation
* Treatment naive OR one prior standard chemotherapy that is platinum-based
* Adequate organ function defined as follows:

  * Hepatic: Total bilirubin \< upper limit of the normal range (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
  * Hematological: absolute neutrophil count (ANC) ≥1500 cells/mm\^3, platelet ≥ 100,000 cells/mm\^3, hemoglobin ≥ 9.0 g/dL
  * Renal: Serum creatinine \< ULN OR calculated creatinine clearance (CLcr) of ≥ 60 ml/min
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Key Exclusion Criteria:

* Known positive status for human immunodeficiency virus (HIV)
* Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C)
* Presence of \> Grade 1 peripheral neuropathy
* Symptomatic leptomeningeal, brain metastases, or spinal cord compression.
* History of interstitial pneumonitis

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Aortic Cross Clamping Time, and Postoperative Respiratory Function

Does the duration of cardiopulmonary bypass, and aortic cross clamping affects the post operative pulmonary function.

Cardiac surgery usually is done under cardiopulmonary bypass. As the blood contacts with the artificial tubing of the circuit, there is release of mediators which affects pulmonary function. Of no doubt that the duration of cardiopulmonary bypass, and cross clamping time, will affect the spell over of such mediators. Follow up of the pulmonary function, and arterial blood gas is mandatory in such group of patients.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* elective open heart surgery

Exclusion Criteria:

* Patients with myocardial ischemia or previous infarction
* low ejection fraction \<30%
* history of AF
* implanted pacemaker
* uncontrolled hypertension
* renal impairment (creatinine \>1.8 mg/dl)
* hepatic dysfunction
* insulin dependent diabetes
* chronic pulmonary disease
Pompe Pregnancy Sub-Registry

This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Pompe Registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician.

The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Pompe disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with alglucosidase alfa or avalglucosidase alfa.

Study Design Time Perspective: Retrospective and Prospective

Eligibility Criteria:
Inclusion Criteria:

Eligible women must:

* be enrolled in the Pompe registry (NCT00231400)
* be pregnant, or have been pregnant with appropriate medical documentation available.
* provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed.

Note: It is recommended that pregnancy data be collected on eligible women regardless of infant enrollment. In the event of patients having multiple pregnancies, participation in this Sub-Registry is encouraged for each individual pregnancy.

Exclusion Criteria:

There are no exclusion criteria for this Sub-Registry