cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Versus Magnesium Infusion in Reducing Agitations in Pediatric Patients Undergoing Adenotonsillectomy

The aim of this study is evaluating the efficacy and safety of dexmedetomidine versus Magnesium for reducing emergence agitation after adenotonsillectomy in children.

Secondary outcome is to reduce child needs for analgesics and to reduce their dose.

Preoperatively, Intravenous access using EMLA cream will be established in the ward. Child will be introduced to information about GA, OR and surgery. This information will include pictures of the staff and the OR, facemask, blood pressure cuff, etc. The child will move from ward to Pre-Anesthesia Care Unit accompanying his/her parents and anesthesia doctor to establish bonding. Cooperation on induction will be evaluated by using four-point scale with score of 1 to 2 being satisfactory and 3 to 4 being unsatisfactory. If the child develop agitation (Score 3 or 4) emergency Midazolam 0.1 mg/kg IV will be given and the child will be ruled out of study.

Monitors for non-invasive blood pressure, heart rate, electrocardiogram (ECG), pulse oximetry (SpO2) will be attached. Induction of anesthesia will be done using 8% Sevoflurane in oxygen gas with Atracurium 0.5 mg/kg and fentanyl 0.5 mcg/kg to facilitate tracheal intubation. The patients will be divided into three groups:

oGroup A (Dexmedetomidine Group): patients will receive Dexmedetomidine infusion (0.2 mcg/kg/hr) from the start of the surgery till the end of it.

oGroup B (Magnesium Group): patients will receive Magnesium infusion (10 mg/kg/hr) from the start of the surgery till the end of it.

oGroup C (Control Group): Patients will receive Normal Saline 0.9% infusion

Maintenance of anesthesia will be done by using of Sevoflurane 2% in oxygen gas. Controlled mechanical ventilation will be done to maintain normocapnia. Rescue doses of Fentanyl (0.5 mcg/kg) will be given if the patient develop pain. Intraoperative pain is defined as development of Tachycardia (\> 20% of baseline heart rate reading) and Hypertension (\>20% of Baseline Mean Arterial Blood Pressure reading) .

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II.
* Age group: 4-12 years old.
* The procedure expected to be completed within 1 hour.

Exclusion Criteria:

* Patients with expected difficult airway management.
* lack of consent.
* known adverse effects to dexmedetomidine.
* Mental retardation developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure..etc.)
* Hemodynamically unstable patients.
* Persistent cough or high airway secretions.
* Clinical signs of active infectious disease.
* Coagulopathy (INR \>1.5).
* Obesity (BMI \>30 Kg/m2 ).
* Surgical complication
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)

The main purpose of this study is to compare maintenance treatment with avelumab plus best supportive care (BSC) with BSC alone, to determine if avelumab has an effect on survival in patients with locally advanced or metastatic urothelial cancer that did not worsen during or following completion of first-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium
* Stage IV disease at the start of first-line chemotherapy
* Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy
* Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin
* No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )

Exclusion Criteria:

* Prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
* Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Persisting toxicity related to prior therapy (Grade \>1 NCI CTCAE v4.0); however, alopecia, sensory neuropathy (Grade 2 or less), or other (Grade 2 or less) adverse events not constituting a safety risk based on the investigator's judgement are acceptable.
* Patients with known symptomatic central nervous system (CNS) metastases requiring steroids
* Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms.
Evaluation of Physical Fitness and Physical Activity Levels of Pediatric Arrhythmia Patients With Pacemaker

The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with pacemaker compared with their healthy peers.

Studies in children with heart diseases suggest that physical activity levels are reduced relative to their peers, which in turn increases cardiovascular risk factors and cardiac rhythm problems. To the best of our knowledge, physical fitness and objectively measured physical activity levels of children with a pacemaker have not been studied. The aim of this study was to evaluate physical fitness and physical activity levels of pediatric arrhythmia patients with a pacemaker compared with their healthy peers.

Investigators enrolled clinically stable pediatric patients and used the echocardiogram to evaluate cardiac functions of all patients. Physical fitness was assessed using the Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic Holter device was used to record the physical activity level for consecutive 7 days.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria of the Pacemaker Group:

* Permanent pacemaker
* Being 7-18 years of age
* Able and willing to complete the informed consent process
* Able to walk and co-operate

Exclusion Criteria:

Exclusion criteria of Pacemaker Group:

* Unstable medical condition
* To have severe neurological, severe orthopedic problems
* To have severe heart failure and another systemic disease or acute infection
* Down Syndrome
* The control group will consist of healthy subjects.
A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir

A Retrospective Study to Evaluate the Safety and Efficacy of a Nucleoside-Sparing Regimen of Darunavir, Ritonavir, and Dolutegravir


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Received a regimen of darunavir 800 mg/ritonavir 100 mg in combination with dolutegravir 50 mg QD for ≥24 weeks as documented in EMR
* Laboratory reports (CD4, viral load, SrCr) available at time points +/- 4 6 weeks from 12, 24, 36, 48 weeks from start of regimen
* Resistance data (if applicable)

Exclusion Criteria:

* Received a regimen of darunavir/ritonavir in combination with dolutegravir for \<24 weeks duration
* Patients receiving darunavir/ritonavir + DTG+NRTI's
* Missing laboratory data in ≥2 study time points
* Patients missing more than five doses over two weeks prior study visit
Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis Subjects

The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

This study assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved body surface area (BSA) ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 at screening and at baseline

Exclusion Criteria:

* Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, or other skin conditions at (eg, eczema) that would interfere with study evaluations
* Subject has known history of Crohn's disease
* Subject has any other significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol
* Subject has not stopped using certain psoriasis therapies as defined in the study protocol
* Subject has previously used ustekinumab or any anti-IL-17 biologic therapy
* Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in the study
* Female subject is unwilling to use highly effective methods of birth control unless 2 years post-menopausal or surgically sterile
The Study of Apatinib Plus CIK as the Third Line Therapy for Patients With Advanced Gastric Cancer

The purpose of this study is to evaluate the safety and efficacy of Apatinib combined with cytokine-induced killer cell (CIK) vs Apatinib as the third line therapy for patients with advanced gastric cancer.

400 patients with stage Ⅳ Gastric Cancer,who had received surgery and chemotherapy,will be randomly divided into group A（receive Apatinib and CIK treatment ) or group B（just receive Apatinib),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK treatment (every 1 year) and Apatinib (continuous).Patients in group B will receive only Apatinib (continuous) .

Eligibility Criteria:
Inclusion Criteria:

* Patients who can accept curative operations 18-70 years old
* Histologically confirmed with gastric cancer at stage Ⅳ
* Patients who can accept oral drugs;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1.

Exclusion Criteria:

* Hemoglobin\<8.0 g/dL,White blood cell \<3 X 10\^9/L;Platelet count \<75 X 10\^9/L; alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Pregnant or lactating patients
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection
* Patients who are suffering from serious autoimmune disease
* Patients who had used long time or are using immunosuppressant
* Patients who had active infection
* Patients who are suffering from serious organ dysfunction
* Patients who are suffering from other cancer
* Other situations that the researchers considered unsuitable for this study.
Text Messaging to Improve Adherence To Repeat Colonoscopy In a Veterans Affairs (VA) Hospital

Colorectal cancer is a common but preventable condition, and increasing colorectal cancer screening is one of the most impactful public health contributions in the field of gastroenterology. Text messaging is a simple, cheap, and rapid method to reach patients that may improve adherence to colonoscopy appointments as well as simplify the process of bowel preparation. The purpose of the study is to evaluate the feasibility of a pilot bidirectional text messaging intervention on attendance for screening/surveillance colonoscopy and bowel preparation quality at an urban VA hospital. The goal is to improve adherence to colonoscopy among patients who are due for a repeat colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

• Has previously undergone a colonoscopy and is currently due for a repeat screening or surveillance colonoscopy at the VA.

Exclusion Criteria:

* Patients not due for screening or surveillance colonoscopy. This will be based on 2020 guidelines from the U.S. Multi-Society Task Force on Colorectal Cancer.
* Patients with personal history of colorectal cancer (CRC)/inflammatory bowel disease/ hereditary colon cancer syndrome or family history of hereditary colon cancer syndrome. These criteria will be determined based on ICD9/10 codes or the medical record.
Calcitriol in the Treatment of Immunoglobulin A Nephropathy

Immunoglobulin A (IgA) nephropathy is the common primary glomerulonephritis in the world. Much literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy of Calcitriol in the treatment of IgA nephropathy. Forty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to Calcitriol for six months or no treatment. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of Calcitriol in the treatment of IgA nephropathy, which has no specific treatment at present.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Biopsy-confirmed IgA nephropathy
* Proteinuria \> 0.8 g/day in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment for at least 3 months or estimated glomerular filtration rate \< 60 ml/min/1.73m2
* Corrected serum calcium level \< or = 2.45 mmol/l
* Willingness to give written consent and comply with the study protocol

Exclusion Criteria:

* Pregnancy, lactating or childbearing potential without effective method of birth control
* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
* History of malignancy, including leukemia and lymphoma within the past 2 years
* Systemic infection requiring therapy at study entry
* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* History of drug or alcohol abuse within past 2 years
* Participation in any previous trial on paricalcitol
* Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
* Patients receiving treatment of corticosteroid
* On other investigational drugs within last 30 days
* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
* History of non-compliance
* Known history of sensitivity or allergy to paricalcitol or other vitamin D analogs
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered

To provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Age from \> 12 months to ≤ 18 years of age at the time of enrollment.
2. Diagnosis of diffuse midline glioma, H3 K27-altered according to the WHO 2021 Classification of Tumors of the Central Nervous System diagnostic criteria including diffuse intrinsic pontine glioma (DIPG). In the absence of a pathologically confirmed diagnosis, a grade IV glioma involving the thalamus, hypothalamus, brainstem, cerebellum, midbrain, or spinal cord, or with a pontine epicenter and diffuse involvement of the pons.
3. Patient has completed definitive radiation therapy as part of standard-of-care treatment or was unable to undergo radiation.
4. Karnofsky performance status ≥ 50 for patients ≥ 16 years of age and Lansky performance status ≥ 50 for patients \< 16 years of age; patients who are unable to walk because of paralysis, but who are upright in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
5. Patients must have adequate bone marrow, liver, and renal function:
6. For females of childbearing potential, negative urinary or serum pregnancy test.
7. Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.
8. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant
9. Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.

Exclusion Criteria:

1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of OKN-007 and other ongoing clinical trials.
2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting OKN-007 treatment, whichever is shorter.
3. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
4. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with OKN-007 due to safety concerns.
5. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with OKN-007.
6. Known hypersensitivity to OKN-007 or any component in its formulation.
7. Patients taking prohibited medications as described in the current Investigator's Brochure.
8. Patient is pregnant or actively breastfeeding.
Viability and Cardiac Resynchronization Therapy

30% of heart failure patients that receive a device for cardiac resynchronization therapy fail to show clinical improvement. The reason for lack of response is still unclear but factors such as scar tissue in the heart musculature, inadequate lead placement, device-settings and the degree of dyssynchrony before implant seems to be important. In this study, these factors are further investigated.

Cardiac resynchronization therapy (CRT) is an established therapy for patients with severe heart failure, depressed left ventricular function and a wide QRS-complex. Large clinical trials have demonstrated unequivocal improvements in functional status, morbidity and mortality. However, 30 % of heart failure patients treated with a CRT-device do not benefit clinically. Several factors have been suggested to be important for the response to CRT such as mechanical dyssynchrony, presence of scar tissue in the myocardium, and device-optimization (among others). It is the purpose of this study to investigate the importance of these factors.

100 patients with ischemic cardiomyopathy, eligible to CRT according to current guidelines, will be included. Patients are randomised to two arms. One group will have atrioventricular (AV)-optimization after implantation, the other AV -and interventricular (VV)-optimization. After 4 months patients are crossed-over to the other arm. Preimplantation patients are MR-scanned and low-dose dobutamine stress-echocardiography is performed. Furthermore patients will be examined by echocardiography and evaluation of clinical status

1. Mechanical dyssynchrony can predict response to CRT. b. Measures of mechanical dyssynchrony is related to myocardial viability and conduction.
2. Individual optimization based on conduction times will increase benefit to CRT. b. The effect of adding VV-optimization is related to myocardial viability.
3. \> 30 % of non-viable tissue globally in the myocardium is predictive of lack of CRT- response. b. Non-viable tissue located in the area of the left ventricular lead is predictive of non-response.

Eligibility Criteria:
Inclusion Criteria:

* LVEF\</= 35%, QRS-duration\>/= 120 ms, NYHA-class II- IV.
* Ischemic heart disease (\> 50% stenosis in 1 or more major epicardial coronary artery or prior PCI or CABG.)
* Optimal treatment ( beta-blocker, ACE-1 or ARB and spironolactone)

Exclusion Criteria:

* Pregnancy
* Unstable angina pectoris
* Chronical atrial fibrillation
* Severe valvular disease
* Dementia or mental retardation
* Severe claustrophobia
* Acute myocardial infarction \< 3 months
* Severe health condition threatening short-term survival
* Severe kidney insufficiency, GFR \< 35 ml/min/1.73 m2
* Metal implants contraindicative of magnetic resonance scan
Feasibility Trial Testing the Bionic Pancreas With ZP4207

The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon\*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus.

\*dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

This was a single-center, open-label, 2-part, randomized cross-over trial. The trial was to enrol up to 20 adult patients with type 1 diabetes mellitus and assess the safety and efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.

In Part 1, patients participated in two 1-day treatment arms in random order (iPhone-based BP using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon) according to a pre-generated randomization scheme. In Part 2, it was planned to enrol additional patients to participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and iLet using Lilly glucagon) according to a pre-generated randomization scheme. However, due to unavailability of the iLet, the sponsor decided to stop the trial upon completion of Part 1. Part 2 of the trial using the iLet was consequently not conducted.

One day the BP will use glucagon analogue ZP4207 (dasiglucagon) and the other day the BP will use Lilly glucagon. Subjects will also receive insulin lispro through the BP on both days. The trial will be conducted at single center, the Massachusetts General Hospital Diabetes Center in Boston, MA.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with T1DM for at least 1 year, as defined by the American Diabetes Association
2. Age ≥ 18 years
3. Prescription medication regimen stable for \>1 month (except for medications not expected to affect trial safety or outcome, in the judgment of the investigator)
4. Diabetes managed using an insulin pump for \>=6 months
5. Patients in good health according to age (medical history, physical examination, vital signs, 12-lead electrocardiograms \[ECGs\], laboratory assessments), as judged by the Investigator

Exclusion Criteria:

1. Previous exposure to ZP4207 or adverse reaction to glucagon
2. History of liver disease or current abnormal liver function tests (LFTs)
3. Renal failure
4. Anemia
5. History of coronary artery disease or congestive heart failure (class III or IV)
6. History of transient ischemic attack or stroke
7. Seizure disorder
8. Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM
9. Other endocrine disorders
10. Use of oral anti-diabetic medications
11. Electronically powered implants
12. Hypertension (≥160/100 mm Hg despite treatment)
13. Inadequate venous (vein) access as determined by trial nurse or physician at time of screening