cyrilzakka/clinical-trials huggingface dataset:
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among children at high risk for serious RSV disease. A secondary objective was to compare the incidence of medically-attended lower respiratory infections (LRIs) between treatment groups.

A randomized, double-blind, palivizumab-controlled, multi-center, multi-national trial conducted during 2 Northern Hemisphere RSV seasons with an intervening season in the Southern Hemisphere. Each child only participated during a single RSV season. Approximately 6,600 children at risk for serious RSV disease were to be randomized in a 1:1 ratio to receive either 15 mg/kg of palivizumab or motavizumab by IM injection every 30 days for a total of 5 doses.

Eligibility Criteria:
Inclusion Criteria:

* 24 months of age or younger at randomization (child must be randomized on or before his/her 24-month birthday) with a diagnosis of chronic lung disease (CLD) of prematurity requiring medical intervention/management (i.e., supplemental oxygen, bronchodilators, or diuretics) within 6 months before randomization

OR:

* 35 weeks gestational age or less at birth and 6 months of age or younger at randomization (children were to be randomized on or before his/her 6-month birthday)

Exclusion Criteria:

* Hospitalization at the time of randomization (unless discharge was anticipated within 10 days)
* Mechanical ventilation or other mechanical support (including continuous positive airways pressure \[CPAP\])
* Life expectancy \< 6 months
* Active RSV infection (a child with signs/symptoms of respiratory infection must have had negative RSV testing)
* Known renal impairment
* Known hepatic dysfunction
* Chronic seizure or evolving or unstable neurologic disorder
* Congenital heart disease \[CHD\] (children with uncomplicated CHD \[e.g., patent ductus arterious (PDA), small septal defect\] and children with complicated CHD that were currently anatomically and hemodynamically normal could be enrolled)
* Known immunodeficiency
* Mother with HIV infection (unless the child has been proven to be not infected)
* Known allergy to Ig products
* Receipt of palivizumab, RSV-IGIV, or other RSV-specific monoclonal antibody, or any other polyclonal antibody (for example, hepatitis B IG, IVIG, VZIG) within 3 months prior to randomization
* Anticipated use of palivizumab or IVIG during the study (blood transfusions permitted)
* Previous receipt of RSV vaccines
* Participation in other investigational drug product studies
Cilostazol Following Peripheral Endovascular Procedures

To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease.

This is a multi-center, randomized, single-blinded, phase III, controlled trial investigating the safety and effectiveness of dual antiplatelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral, infrainguinal angioplasty or stenting or both for the management of peripheral arterial disease (intermittent claudication or critical limb ischemia). The study will include in total 200 patients randomized on a 1:1 basis to receive either dual antiplatelet therapy for 6 months cilostazol 100 mg once daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily for 12 months. The study's primary endpoint will be the composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, major amputation, target limb open surgical or endovascular revascularization). Additional therapy with clopidogrel 75mg daily will be added in either group for one month in case of stent placement. Secondary endpoints will include quality of life assessment using dedicated questionnaires, drug- and procedure-related complication rates, target-limb revascularization rates, clinical improvement (ABI and Rutherford-Becker classification changes). Clinical follow up will be performed at 1, 6 and 12 months and will include physical examination, ABI measurements, Rutherford-Becker classification. Maximum follow up period will be 2 years after the index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled infrainguinal (femoropopliteal or infrapopliteal or both) angioplasty and/or stenting.
* Surgical or endovascular treatment of Inflow iliac artery significant stenosis if deemed necessary.
* Symptomatic severe intermittent claudication (Rutherford-Becker 3) or critical limb ischemia (Rutherford-Becker 4-6).
* Informed consent signed

Exclusion Criteria:

* Any contraindication to aspirin or cilostazol intake
* No pedal arch outflow
* Sole iliac artery treatment
* Standard contraindications to angioplasty
* Acute or sub-acute limb ischemia
CHAMP App Feeding Difficulties Repository

This repository will consist of home monitoring data, videos, and images of patients with feeding difficulties for asynchronous remote patient monitoring of manually entered data sent by parents to the healthcare team using the CHAMP App for children with feeding difficulties. This information will be collected under a research protocol and this repository is for future research applications.

Around 25% of children are reported to have some degree of feeding issues of whom 3-10% have more severe feeding disorders1. Many of these feeding issues and difficulties can also lead to a need for supplemental nutrition in a child's diet due to the impact on growth. Those requiring supplemental nutrition may find themselves having to be fed using tube feedings (TF), which carries its own set of obstacles and factors to consider. While feeding problems have been estimated to occur in 25%-35% of children observed as exhibiting normal growth, that number may spike to 85% in those with GI-related growth disorders2. This highlights the need to ensure treatment plans and programs are in place to assist this patient population.

At Children's Mercy Hospital, GI specialists care for children who have a variety of conditions, caring for the whole child and addressing physical, mental, emotional, and social aspects. By using a combined approach, and promoting research that seeks to improve care, significant improvements in children's health have been reported. One specialty this has been evident in at Children's Mercy is the cardiac patient population. There have been improvements in growth, feedings, and timeliness of interventions seen with the use of CHAMP® App in the single ventricle population (a statistically significant difference in the frequency of growth failure, with no patients having growth failure during CHAMP use)3-4. By harnessing the experience and knowledge gained through the CHAMP® App research study, there is a great potential for children suffering from GI conditions to also benefit from this form of remote patient management and monitoring, especially when it comes to treating children with supplemental nutrition needs. There are no known Gastroenterology- Feeding mobile health software platforms with a dedicated research repository in pediatrics.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolling in this research repository must also be enrolled in an applicable study (STUDY00002775, STUDY00003221) wherein they have consented to use CHAMP App
* Parent-Legally authorized representative can read one of the eleven languages that the CHAMP App is available in.

Exclusion Criteria:

• All patients and parents/Legally authorized representative not meeting the above specified criteria
High Resolution Gastric Mapping and Gastroduodenal Manometry

Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia.

The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).


Eligibility Criteria:
Inclusion Criteria

* Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
* Ability to perform appropriate informed consent

Exclusion Criteria

* Known cardiac arrhythmia or major ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (\> 460 msec) or bradycardia (\< 45 beats/minute)
* Conditions precluding safe use of taVNS
* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
* Use of opioids
* Vulnerable study population
* Pregnant women
HBOT Application in Erectile Dysfunction

Recent studies have shown that hyperbaric oxygen therapy (HBOT) can induce angiogenesis and improve impaired organ function. HBOT was also recently suggested as a possible therapy for ED due to surgical injuries. However, the effect of HBOT on non-surgical related ED has not been investigated to date.

The objective in this study was to assess the effect of HBOT on patients with ED by means of sexual function questionnaires and novel imaging techniques.

A prospective analysis of men, age 18 years or older, with a clinical diagnosis of erectile dysfunction, reporting decreased and weakened nocturnal penile tumescence of six months duration or longer.

Patients were treated at The treatment comprised 40 daily hyperbaric sessions, 5 days a week, in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minutes air breaks every 30 minutes and 1 meter per minute compression and decompression.

Sexual function Efficacy of the treatment was assessed using the International Index of Erectile Function (IIEF) questionnaire which was filled by all patients at baseline and within 2 weeks of the last HBOT session. In addition, assessing efficacy was the global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.

Six patients underwent two MRI scans 1-2 weeks prior to and after HBOT. Imaging was conducted in using a 3Tesla system (MAGNETOM Skyra, Siemens Medical Solutions, , Germany). The MRI protocol included anatomic T1 and T2 sequences and DCE. The MRI DCE sequence parameters are detailed in supplementary section.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* clinical diagnosis of erectile dysfunction
* reporting decreased and weakened nocturnal penile tumescence of six months duration or longer

Exclusion Criteria:

* penile anatomical defects,
* any active or history of malignancy including prostate cancer
* spinal cord injury
* any major psychiatric disorder uncontrolled with treatment
* claustrophobia
* chronic lung disease
* chronic middle ear or sinus diseases.
Nutritional Adequacy of a FODMAP Diet in Children

This pilot study aims to establish whether a low FODMAP diet is safe in children with functional gastrointestinal disorders. The practicality of implementing this diet will be evaluated as well as symptom improvement and quality of life. A larger intervention trial, if deemed appropriate, will then follow to assess symptom efficacy in children.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 10-16 years
* Informed consent and assent obtained
* Patients with diagnosed FGID according to Rome III criteria: i.e. category H2b (irritable bowel syndrome) and H2d (childhood functional abdominal pain)

Exclusion Criteria:

* Patients with other gastrointestinal conditions (e.g. coeliac disease, inflammatory bowel disease)
* Patients with food allergies
* Patients with a weight for age below -2 Standard Deviations (SD) (below 0.4th centile) on the UK WHO growth charts.
* Patients with known micronutrient deficiencies determined by blood levels prior to study
* Patients without informed consent and assent obtained
Cooperative Group for Clinical Research in G-POEM (POP), Jiangsu, China

Diabetic gastroparesis, postsurgical gastroparesis, idiopathic gastroparesis and primary pyloric stenosis are debilitating gastrointestinal motility disorder. However, there is limited medical therapeutic options for these diseases. Gastric peroral endoscopic pyloromyotomy (G-POEM) is an emerging novel endoscopic technique which is reported as a minimally invasive therapy. But so far, the efficacy and safety of G-POEM on these diseases are rarely explored. So, there is a cooperative group composed of five clinical centers for clinical research in G-POEM.

Participants are randomly devided into 'G-POEM group' and 'Esomeprazole+Mosapride group'. In G-POEM group, each participant receives G-POEM treatment. In Esomeprazole+Mosapride group, each participant receives Nexium 40mg bid + Mosapride Citrate Tablets 5mg tid. The whole outcome measure time fram is up to two years. Outcome evaluations include: gastric emptying imaging, gastric antrum volume, gastric emptying time, gastroparesis cardinal symptoms index and gastroesophageal reflux disease questionnaire. All the outcomes are assessed at different time points (from baseline to 6 months, 12months and 24months).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 16 to 80 years old
2. Full sufficiency in literacy
3. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
4. Refractory gastroesophageal reflux disease induced by postsurgical gastroparesis

Exclusion Criteria:

1. Severe heart, lung, and cerebrovascular disease
2. Severe hematopoietic system disease
3. Abnormal blood coagulation function
4. Oropharyngeal abnormalities
5. Severe spine malformation
6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
7. Severe inflammation or huge ulcers in stomach
8. Mental and psychological disorder
Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap

Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Retinal oximetry in various chorioretinal diseases will be measured with Oxymap.

Eligibility Criteria:
Inclusion Criteria:

* Healthy eyes and eyes with various chorioretinal diseases, including diabetic retinopathy, retinal vein occlusion, epiretinal membrane, macular hole, inherited chorioretinal diseases, glaucoma, retinal detachment, etc.

Exclusion Criteria:

* Eye with medial opacity.
Efficacy of Melatonin in Decreasing the Incidence of Delirium in End of Life Patients

The purpose of this study is to determine if melatonin administration to end-of-life patients is effective in preventing the development of delirium compared with those who do not receive this treatment. Delirium is a difficult to control symptom commonly seen in patients at the end-of-life. A person who is delirious is unable to think clearly and cannot make sense of what is going on around him/her.

All patients over the age of 19 admitted to the tertiary palliative care unit and hospice residence who could meet the study requirements will be asked within 48 hours of admission for their interest in participating in the study. All those who interested in taking part will be referred to a research nurse for initial assessment for eligibility. For eligible patients who have consented to participate in the study, a research nurse who is not directly involved in the patient's care will approach the patient. A detailed subject information containing pertinent information on the study will be provided and ample time (up to 24 hours) will be given for consideration. The research nurse will explain the consent form to the patient and obtain consent signature if he/she agrees to participate. Once formal consent obtained, the eligible patient will be enrolled in the study.

Patients will be assigned randomly to one of the two arms of the study and receive nightly doses of melatonin 0.5 mg or placebo. Patients will be monitored for 14 days or until the development of delirium or the occurrence of death.

Patients will be assessed twice a day for delirium, around the end of each nursing shift, i.e. every 12 hours (at 0330 \& 1530h) for fourteen consecutive days or until the development of delirium. The diagnostic tool used to detect delirium is the Confusion Assessment Method (CAM).

The primary outcome measure is incidence of delirium, defined according to the Confusion Assessment Method (CAM).

Data on harm will be collected. For example, adverse effects from melatonin such as excessive daytime drowsiness, headaches, nausea , transient depression have been reported in the medical literature. Patients will also be monitored closely for the development any of these adverse effects during the treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the test site
* Adult patients over 19 years of age
* Patients who can provide informed consent
* Patients who are able to tolerate oral medications

Exclusion Criteria:

* Patients with existing delirium or dementia on admission
* Patients with poor clinical performance
* Patients taking melatonin prior to admission
* Patients taking medications that interact with melatonin
* Patients who are unable to provide informed consent
* Patients who are enrolled in any other research study involving drugs/devices
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma

To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older.
2. HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
3. Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
4. A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm.
5. No prior treatment for HCC.
6. At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
7. Performance status (PS) ECOG score ≤1.
8. Child-Pugh score ≤7.
9. Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
10. Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal.

Exclusion Criteria:

1. Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
2. Previous liver transplantation;
3. History of other malignancies;
4. Previous history of severe mental illness;
5. Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
6. Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
7. Other reasons were judged by the investigator to be unable to enroll.
A Study to Assess the Effectiveness of Certolizumab Pegol in Patients With Axial Spondyloarthritis in Daily Life

The primary purpose is to assess the effectiveness of certolizumab pegol in patients with axial spondyloarthritis under routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* The patient personally signed and dated a Patient Data Consent Form (PDCF) prior to Visit 2. No data can be entered into the electronic Documentation form (eDF) prior to signature of the PDCF.
* The patient must have a clinical diagnosis of active axial spondyloarthritis (axSpA), \[ankylosing spondylitis (AS) or nonradiographic axial spondyloarthritis (nr-axSpA)\] according to the diagnostic criteria used by the physician in routine clinical practice.
* The decision to prescribe Certolizumab Pegol (CZP) is made by the physician independent of the patient's participation in the NIS.
* The patient must be newly prescribed CZP according to local regulations or guidelines (eg, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4).
* Treatment is according to instructions in the Summary of Product Characteristics (SmPC) for patients considered by the treating physician to be reliable and capable of adhering to the observational plan (eg, able to understand and complete questionnaires).
* If a patient is participating in an ongoing investigational study, then he/she will not be able to take part in this study.

Exclusion Criteria:

N/A