cyrilzakka/clinical-trials huggingface dataset:
Follow-Up Study Validating a Blended Technique

A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site

In 2012, the investigators from Vidacare evaluated 4 techniques commonly used to identify the proximal humerus IO insertion site to determine if one technique resulted in more consistent successful placement of the IO needle set with a higher level of confidence among device operators performing the techniques. Results suggest that a combination of the best features of the 4 techniques may lead to optimal IO needle set placement more consistently. This study is needed to validate the "Blended" proximal humerus IO insertion technique to confirm that use of the technique results in proper site identification among device operators and results in increased confidence.To most closely evaluate the Blended proximal humerus insertion technique and how it is received by clinicians who perform these procedures in actual patients, device operators will include licensed/certified clinicians including, emergency medicine technicians/paramedics and nurses.

Eligibility Criteria:
Inclusion Criteria:

* Currently licensed/certified Emergency Medicine Technicians, paramedic, or nurse Have had no formal training on use of the proximal humerus IO insertion site Demonstrate proper use of the device and technique during training portion and obtain approval from the device trainer to participate

Exclusion Criteria:

* Previous training on establishing proximal humerus intraosseous vascular access
fMRI Study of Brain Neural Network and Plasticity After Stroke

The purposes of this study are to investigate the functional connectivity of motor network in patients of stroke and investigate the mechanism of brain plasticity for recovery after stroke.


Eligibility Criteria:
Inclusion Criteria:

* 1st-ever-stroke
* whose corticospinal tract was injured
* less than 1 month after stroke onset

Exclusion Criteria:

* Claustrophobia
* who use cardiac pacemaker
* intracranial metal
* uncontrolled hypertension or hypotension
Comparative Clinical Performance of 59% Hioxifilcon A Contact Lenses vs. Marketed Hydrogel Contact Lenses

The study will compare the short-term clinical performance and wearer and practitioner acceptability of a new-to-market spherical daily disposable (DD) hydrogel soft contact lens to a currently marketed spherical DD hydrogel soft contact lens.

This randomized clinical trial will compare the short-term clinical performance, and wearer acceptability of a new-to-market hioxifilcon A spherical daily DD contact lenses against marketed DD lenses in a short cross-over clinical trial.

The primary outcome variable for this study is overall subjective comfort.

Eligibility Criteria:
Inclusion Criteria:

* Currently wearing spherical DD contact lenses at least 5 days/week
* Vision correctable to 20/30 acuity in each eye with spherical DD contact lenses
* No ocular or systemic disease that contra-indicates soft contact lens wear

Exclusion Criteria:

* Participating in another clinical trial
* Vision not correctable to 20/30
Relypsa For ED Acute Hyperkalemia Control and Reduction (REDUCE)

The Investigator hypothesize that a single dose of patiromer will lower serum potassium levels in less than 6hrs. Since a dosage of 30g/day for a period of 4 weeks has been studied in at least two multicenter randomized controlled trials, the Investigator further hypothesize that a single dose of 25.2g of patiromer will be well tolerated in hyperkalemic patients in the Emergency Department setting. The FDA approved dosage of 25.2g is appropriate for this study because the research staff will enroll patients with moderate (K greater than 6 mEq/L) to severe hyperkalemia, and the higher dosage has typically been used in this population for more effective control.

This is an open label pilot study. Thirty patients with ESRD who qualify for emergent dialysis on the basis of serum potassium greater than 6mEq/L will be randomly assigned, using a random number generator in blocks of sixes, to standard-of-care (standard care) or patiromer group. Patients in the patiromer group will be given a single dose of 25.2g of patiromer in addition to standard-of-care treatment after randomization. Standard-of-care is defined as intervention or care provided by clinical provider according to individual practice pattern or hospital protocol. Each group of 15 patients will be observed with telemetry monitoring for 10 hours or till hemodialysis units become available for treatment (whichever comes first). Blood draws and electrocardiograms (ECGs) will be performed at enrollment and at 1, 2, 4, 6, 8 and 10hrs thereafter. Serum will be analyzed for basic metabolic panel and magnesium. Medications, including potassium lowering agents, administered during this period will be documented.

1. Informed consent will be obtained. 2. Subject will be randomized. 3. A. Randomized to Standard of Care (SOC): data will be collected on SOC treatment. 3. B. Randomized to patiromer group: subjects will receive a single dose of 25.2g of patiromer. SOC data will be collected. 4. all subjects will have blood drawn and ECGs (1 12 lead ECG and 1 Lead I Rhythm strip) done at baseline, 1, 2, 4, 6, 8 and 10 hours. Blood will be analyzed for basic metabolic panel and magnesium. 5. CRF completion-SOC data will be recorded in addition to current medications. 6. After subjects have received hemodialysis or reach the 10 hour study period, whichever comes first, the subject will be completed on the study.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients with serum potassium greater than or equal to 6.0 mEq/L
* Emergent dialysis not expected to be available for 6 hours

Exclusion Criteria:

* new clinically significant arrhythmia on initial ECG
* patiromer is contraindicated
* have received SPS
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Eligibility Criteria:
Inclusion Criteria:

* breast adenocarcinoma
* prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

* Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
* Any prior regimen with capecitabine
Self-Myofascial Release in the Posterior Myofascial Chain

The study investigates the relation between different segments of the posterior myofascial chain of the human body.

The intervention consists on apply self-myofascial release with a foam roller in one of the segments of the posterior myofascial chain of the participants, and then see if the treatment has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.

The study investigates the relation between different segments of the posterior myofascial chain of the human body.

The intervention consists on apply self-myofascial release with a foam roller in one of the segments of the posterior myofascial chain, and then see if the treatment has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.

Eligibility Criteria:
Exclusion Criteria:

* Pregnant women
* Musculoskeletal problems in the last month
* Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
* Psychological or nervous alterations
* Uncomprehension of the study protocol
Pediatric Epilepsy Trial in Subjects 1-24 Months

This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.


Eligibility Criteria:
INCLUSION CRITERIA:

* Have a confident diagnosis of epilepsy
* Must be experiencing 4 or more reliably detectable partial seizures per month while receiving at least 1 anti-epileptic drug (AED)
* Must weigh at least 7 lbs if currently receiving enzyme inducing antiepileptic drugs (EIADs) OR weigh at least 15 lbs if currently receiving non-enzyme inducing antiepileptic drugs (non-EIADs)
* Have no underlying chronic metabolism problems
* Have normal lab results
* Have a normal electrocardiogram (ECG)

EXCLUSION CRITERIA:

* Have a diagnosis of severe, progressive myoclonus.
* Have seizures not related to epilepsy.
* Have previously demonstrated sensitivity or allergic reaction to the study drug or its related compounds.
* Have progressive or unstable condition of the nervous system.
* Used experimental medication within 30 of enrollment into the study.
* Have any significant, chronic heart, kidney, liver or stomach/intestinal (GI) condition.
* Current use of the medication felbamate.
* Current use of adrenocorticotrophic hormone (ACTH).
* Following a ketogenic diet.
* Receiving vagal nerve stimulation (VNS).
An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy

The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.


Eligibility Criteria:
Inclusion Criteria:

* Gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented
* Disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). Patients may have also received prior adjuvant therapy if recurrence occurred \> 6 months after adjuvant therapy completion
* Evidence of measurable disease by radiographic technique
* Adequate organ function.

Exclusion Criteria:

* Clinically relevant ascites (i.e. requiring paracentesis)
* Severe weight loss
* NCI CTCAE Grade 3 hemorrhage \<4 weeks of starting study treatment
* Diagnosis of second malignancy within last 3 years
* History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
* Known HIV
* Serious acute or chronic illness
* Current treatment on another clinical trial
* Pregnant or breastfeeding
Endoscopic Ethanol Ablation of Communicating Pancreatic Cystic Neoplasms

Pancreatic cysts are common, and some pancreas cysts have malignant potential. Usual treatment of these cysts is either observation or surgical removal of part or all of the pancreas. Minimally invasive treatment via endoscopy has been described, using endoscopic ultrasound (EUS) guided ethanol injections. Such studies exclude cysts that communicate with the main pancreatic duct, to avoid burning the main pancreatic duct with ethanol. In this study, pancreas cysts communicating with the main pancreas duct are treated with ethanol via endoscopic retrograde cholangiopancreatography (ERCP) and/or EUS.

Subjects will undergo EUS and/or ERCP as outpatients. For cysts shown to communicate with the main pancreas duct, a balloon catheter will be placed in the main pancreatic duct via ERCP. The balloon catheter will isolate the cyst from the main pancreatic duct, allowing ethanol injections of the cyst. A pancreatic duct stent will be placed in some patients, requiring repeat endoscopy for removal at another time.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a pancreatic cystic lesion, at least 2 cm in maximum diameter
* Cyst may communicate, or definitely communicates, with the pancreatic duct (based on prior CT, MR, ERCP, or EUS images)
* Treatment of the cystic lesion is desired due to symptoms or concern for subsequent malignancy
* Age at least 18 years
* Able to give informed consent
* Surgical treatment has been considered and a surgical consultation offered to the patient, OR the subject's cyst does not meet consensus criteria for surgical resection. (Current consensus criteria for resection are one or more of the following: cyst is symptomatic, ≥ 3 cm in diameter, contains a mural nodule, cytology of cyst fluid is positive for malignancy, or main pancreatic duct diameter is \> 6 mm.)

Exclusion Criteria:

* Known or suspected pregnancy, or nursing
* History of pancreatitis within 3 months prior to study endoscopy procedures
* Cyst has a primarily microcystic architecture on EUS
Study Evaluating GAP-486 on Heart Rhythm in Patients With Coronary Artery Disease

The purpose of this study is to learn the effects of a test drug on heart rhythms, which may become life-threatening if left untreated, and to provide data to see if the drug is well tolerated and safe.


Eligibility Criteria:
Inclusion Criteria:

* Patients with or without ICDs (implantable cardioverter defibrillators)
* Patients undergoing an electrophysiology study for evaluation of ventricular rhythm
* Patients with a history of heart disease

Exclusion Criteria:

* Patients with uncontrolled blood pressure
* Patients with certain cardiac risk factors
* Patients with significant kidney or liver problems
Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial

The objective of this study is to assess the impact of emollient therapy on gain in weight and length among preterm and low birth weight babies.

The study will be conducted at the Department of Pediatric Medicine unit 1, KEMU / Mayo Hospital Lahore. Total of 140 neonates fulfilling the eligibility criteria will be enrolled. They will be randomly divided into two groups - A and B. Mothers of the neonates in group A will be advised massage with sunflower oil while mothers of the neonates in group B will be advised massage without any emollient. Babies will closely be followed up and their weight and length will be measured at six months of age and will be analyzed using SPSS v 23.0.

Eligibility Criteria:
Inclusion Criteria:

* Neonates of both genders
* Both breast fed and non-breast fed infants
* Neonates with birth weight between 1.5 and 2.5 kg
* Preterm neonates born between 28 and 37 completed weeks of gestation

Exclusion Criteria:

* Neonates with genetic syndrome, infection or with a history of admission in NICU due to any reason will be excluded.
Interscalene Block Versus Combined Infraclavicular-Anterior Suprascapular Blocks for Shoulder Surgery

Postoperative analgesia after shoulder surgery remains a challenge in patients with preexisting pulmonary pathology, as interscalene brachial plexus block (ISB), the standard nerve block for shoulder surgery, carries a prohibitive risk of hemidiaphragmatic paralysis (HDP). Although several diaphragm-sparing nerve blocks have been proposed, none seems to offer equivalent analgesia to ISB while avoiding HDP altogether. For instance, even costoclavicular blocks, which initially fulfilled both requirements, were subsequently found to result in a non-negligible 5%-incidence of HDP.

In this randomized trial, the authors set out to compare ISB and combined infraclavicular block-anterior suprascapular nerve blocks (ICB-ASSNB) for patients undergoing arthroscopic shoulder surgery. The authors hypothesized that ICB-ASSNB would provide equivalent postoperative analgesia to ISB 30 minutes after shoulder surgery and therefore designed the current study as an equivalence trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroscopic shoulder surgery
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 kg/mt2

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy (assessed by history and physical examination)
* Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
* Obstructive or restrictive pulmonary disease (assessed by history and physical examination)
* Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* Allergy to local anesthetics (LAs)
* Pregnancy
* Prior surgery in the neck or infraclavicular region
* Chronic pain syndromes requiring opioid intake at home
The Renal Safety of Tenofovir Alafenamide in HBV-related Acute-on-chronic Liver Failure: Real-World Study

Tenofovir alafenamide (TAF) and entecavir (ETV) are the preferred agents in patients with predisposing factors for nephrotoxicity, but few studies to date have directly compared the renal safety of the two antiviral drugs in patients with acute-on-chronic liver failure (ACLF). Hence, the investigators compared the risk of kidney function decline among patients with HBV related acute-on-chronic liver failure (HBV-ACLF) treated with ETV or TAF.From April 2020 to June 2021, a total of 272 HBV-related ACLF hospitalized patients in the Xiangya Hospital of Central South University were enrolled in this prospective study. Chronic hepatitis B was diagnosed by hepatitis B surface antigen and/or hepatitis B virus deoxyribonucleic acid (HBV-DNA) positivity for ≥6 months. ACLF was diagnosed based on the criteria proposed by the APASL Working Party. All patients received antiviral therapy with TAF (25 mg QD, n=100) or ETV (0.5mg QD, n=172), and comprehensive medical treatments. Clinical and laboratory data were collected to evaluate the progression of chronic kidney disease (CKD) .


Eligibility Criteria:
Inclusion Criteria:

* the presence of hepatitis B surface antigen (HBsAg) in the serum for at least 6 months.
* evidence of active viral replication as documented by measurable HBV DNA in the serum (≥2000IU/mL).

Exclusion Criteria:

* Less than 18 years old.
* history of ESKD or kidney transplantation.
* unknown baseline estimated glomerular filtration rate (eGFR).
* coexistence with other liver diseases such as alcoholic liver disease, autoimmune hepatitis, drug-induced liver injury, or other viral infections(hepatitis A, C, and E virus or HIV infection).
* concomitant with malignant tumor or other serious diseases affecting survival time.
* patients with missing data. follow-up period of \<48 weeks.
Topical Palm Tocotrienols on Skin Biophysical Properties

A single-center, double-blind, randomised, placebo-controlled parallel-group study.

Selected subjects will be randomised into active and control groups in a ratio of 1:1. Investigational products assigned will be applied on the facial skin as part of daily skin care routine. The effects will be observed during the 24-weeks of use.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy female individuals, aged 25 - 45 years old, inclusive
2. Fitzpatrick skin type II to IV
3. In generally good health and skin condition as determined by the PI or designee, based on medical history reported by the subject.
4. Willing to provide informed consent and comply with study procedures

Exclusion Criteria:

1. Has a history of chronic drug or alcohol abuse
2. Is current smoker
3. History of severe allergic reactions to topical products or vitamin E
4. Participant with severe and uncontrolled comorbidities (including but not limited to e.g. diabetes, hypertension, kidney failure)
5. Pregnant, breastfeeding, or planning pregnancy
6. Participant with known skin conditions (including but not limited to e.g. sensitive skin, eczema and diseased skin e.g. contact dermatitis), uncontrolled medical conditions, or any other condition that could interfere with the study evaluations or increase risk to the participant
7. Participant with compromised/broken skin, tattoos, scarring, excessive hair growth, very uneven skin tone, or other conditions that would interfere with evaluations or increase risk
8. Participation in another study within 4 weeks of screening visit
Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis

1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
2. To see the change in morbidity and mortality after changing the interval of surgery after PCD

In present study we plan to determine the appropriate timing of surgical intervention after PCD in step up approach of Infected pancreatic necrosis (IPN).

The investigators also intend to evaluate the role of PCD in obviating the surgical intervention in the management of IPN and evaluate the risks \& benefits of extended treatment policy of PCD in step up approach of IPN in comparison to early surgery after PCD.

Eligibility Criteria:
Inclusion Criteria:

* All patients with diagnosis of IPN (UK GUIDELINES) managed with percutaneous catheter drainage (PCD) for 10 to 15 days and not showing significant improvement on PCD will be included

Exclusion Criteria:

1. Patient showing significant improvement on PCD within 10 days of its insertion.(Significant improvement on PCD is defined as resolution of fever, acceptance of enteral nutrition, decrease in total leukocyte count, reversal of organ system failure)
2. Sterile pancreatic necrosis
3. An acute intra abdominal event ( perforation of hollow viscus, bleeding, or the abdominal compartment syndrome) during or within 10 days after PCD insertion
4. Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
5. Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy