cyrilzakka/clinical-trials huggingface dataset:
Intraligamentary Injections and Post-endodontic Pain

This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.

The patients will receive a primary Inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance is felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over 60 seconds. After 10 minutes, the patients will be asked about the lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered as 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine, and 2% lidocaine. The patients will be randomly allocated to treatment groups with the help of an online random generator. The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours, and 72 hours after treatment. The pain score proforma shall be collected at the subsequent visit.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic carious exposed mandibular first or second molars.
* Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
* Vital coronal pulp on access cavity preparation.
* American Society of Anesthesiologists class I or II medical history.
* Ability to understand the use of pain scales.

Exclusion Criteria:

* Active pain in more than 1 tooth
* Teeth with fused roots.
* Radiographic evidence of an extra root.
* Large restorations with overhanging margins.
* Full crowns or deep periodontal pockets.
* Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs
* History of known or suspected drug abuse.
* Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
* Pregnant or breastfeeding patients.
* Patients with asthma, gastric ulcers, and bleeding disorders.
Rare Tumor Case Review

The purpose of this study is to do a literature review and combine all of the cases of the intrapericardial teratoma tumor and see if some conclusions can be made about this rare tumor in children.

We excised an intrapericardial teratoma tumor out of a child approximately one month ago.

This is a very uncommon tumor overall, and even more uncommon in children. The majority of reports in the literature are single case reports

I would like to report ours, as well as do a literature review to combine all of the cases and see if some conclusions can be made about this rare tumor in children.

Eligibility Criteria:
Inclusion Criteria:

* Children with intrapericardial teratoma tumors
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin

This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous Administration in Healthy Male Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Adult male subjects between 20 to 55 years of age
* 60kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27
* 12 g/dL ≤ Hemoglobin ≤ 16 g/dL within the 28 days prior to investigational product (IP)injection
* WBC ≥ 3.0Ⅹ10\^9/L, platelet ≥ 140Ⅹ10\^9/L within the 28 days prior to IP injection

Exclusion Criteria:

* Allergic to IP ingredients
* History of uncontrolled liver, kidney, respiratory, endocrine, neurology, immunology, hematology, mental symptom, circulatory and malignancy disease
* Prior exposure to EPO, darbepoetin, other EPO, immunoglobulin, IV iron supplementation
* History of hypersensitivity reaction to EPO, darbepoetin, excipient of IP or hyperergia to iron supplementation
* Epilepsy within the 6 months prior to IP injection
* Positivity for HIV antibody, HBsAg, HCV antibody test
* Spleen length \> 16㎝
A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax.

The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax.

The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment with intensive chemotherapy.

There will be an analyis of the CR rate, after all subjects have completed at least 12 cycles of treatment ( cycle =28Days) or discontinued earlier.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.
2. Age ≥ 18 years at the date of signing the informed consent form (ICF)
3. Newly diagnosed with AML based on 2016 WHO classification (Arber et al 2016) and not suitable for intensive chemotherapy defined as: age ≥75, ECOG performance Status 2 or 3, or any of the following comomorbitities: severe cardiac comorbities (including congestive heart failure, LVEF ≤ 50%, chronic stable Angina) , pulmonary comorbidity (DLCO ≤ 65% or FEVI ≤ 65%). moderate hepatic impairment (with total Bilirubin \>1.5 to 3x ULN) , renal impairment (eGFR≥ 30 ml/min/1.73m\^2 to 45 30 ml/min/1.73m\^2), or other comorbidity incompatible with intensive chemotherapy per Investigator assessement and approved by the Novartis Medical monitor)
4. .Not planned for hematopoietic stem-cell transplantation (HSCT)
5. .Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3

Exclusion Criteria:

1. Prior exposure to TIM-3 directed therapy
2. History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their excipients
3. Current use or use within 14 days prior to randomization of systemic, steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment.
4. Previous treatment at any time, with any of the following antineoplastic agents, approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating agents (HMAs) such as decitabine or azacitidine.
5. Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).
6. Live vaccine administered within 30 Days prior to randomization

Other protocol-defined Inclusion/Exclusion may apply.
Interleukin (IL)-13 as a Marker in Pediatrics Asthma

Asthma is a very common childhood chronic illness and is generally more severe in African Americans. The investigators attempted to determine whether a specific immune marker is associated with lung function and asthma severity.

This study examined the relationship between Interleukin (IL)-13 from phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function (measured as FEV1%), and total serum IgE levels in African American children with clinically diagnosed asthma

Eligibility Criteria:
Inclusion Criteria:

* African-American race, born in the U.S.
* Age 8-15 years
* Clinical diagnosis of asthma
* Subject is able to understand and follow verbal instructions in English

Exclusion Criteria:

* Asthma exacerbation in the 4 weeks preceding the research visit
* Oral/IV steroid use in the 4 weeks preceding the research visit
* Upper or lower respiratory tract infection in the 4 weeks preceding the research visit
* Antibiotic use in the 4 weeks preceding the research visit
* Use of a short-acting bronchodilator during the 6 hours prior to spirometry (lung function testing)
* Use of a long-acting bronchodilator during the 12 hours prior to spirometry (lung function testing)
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.

OBJECTIVES:

Primary

* Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.

Secondary

* Assess the quality of life of patients treated with this regimen.
* Determine the duration of response and time to disease progression in patients treated with this regimen.
* Determine the median survival of patients treated with this regimen.

OUTLINE: This is an open-label, nonrandomized, multicenter study.

Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC)

  * Stage IIIB (malignant pleural or pericardial effusion) disease
  * Stage IV disease
  * Recurrent and/or medically inoperable disease
* Measurable or evaluable indicator lesions
* No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids)

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
* Life expectancy ≥ 8 weeks
* WBC ≥ 3,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.0 mg/dL
* AST ≤ 2 times upper limit of normal
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant medical history or unstable medical condition, including any of the following:

  * Unstable systemic disease
  * Congestive heart failure
  * Recent myocardial infarction
  * Unstable angina
  * Active infection
  * Uncontrolled hypertension
* No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior radiation therapy to a major bone marrow-containing area
* At least 3 weeks since prior chemotherapy
* No more than 1 prior chemotherapy regimen for NSCLC
* No prior systemic cytotoxic chemotherapy for other malignant diseases
* No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab \[Herceptin®\], or gefitinib)
* No concurrent radiotherapy or chemotherapy
Efficacy of Offering a Self-sampling Device by the GP to Reach Underscreened Women

The ESSAG trial invests the impact of offering a free self-sampling device (SSD) on the cervical cancer screening rate of underscreened women. This study is aimed at women between the age of 31 and 65 who did not have a smear taken during the last 6 years. In order to assess the effect of a) providing the SSD, and b) the intervention of the general practitioner (GP) (either face-to-face, either by sending the SSD by letter), a randomized control trial is set up with three arms. The ESSAG trial evolves from a collaboration between Universiteit Gent and Vrije Universiteit Brussel, Katholieke Universiteit Leuven, Universiteit Antwerpen, Sciensano, het Centrum voor Kankeropsporing en het Belgisch Kankerregister, and is funded by "Kom Op Tegen Kanker".


Eligibility Criteria:
Inclusion Criteria:

* women between 31-64 years old
* living in Flanders
* eligible for the Flemish actions with regard to population screening
* without a smear registered in the Belgian Cancer Registry in the last 6 years
* registered as GMD patient in one of the participating GP practices

Exclusion Criteria:

* hysterectomy
* pregnancy
* (past) diagnosis of cervical cancer
Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)

The study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (DCM). These wearables track the heart rate, heart rhythm, tracks activity and step count. The VO2 peak will be measured via the exercise test.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18-75 years of age
2. Diagnosis of dilated cardiomyopathy

   * (Unexplained left ventricular enlargement (left ventricular end diastolic dimension (LVEDD) \>95th percentile for gender and height by echo or MRI)
   * (Left ventricular ejection fraction (LVEF) less than 50%)
3. CPET within 14 days prior to baseline visit with no intervening change in therapy
4. Echocardiogram or cardiac MRI within 1 year prior to baseline
5. Able to walk \>100ft without limitation
6. More than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study).
7. Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)

Exclusion Criteria:

1. Heart failure hospitalization within four weeks prior to enrollment
2. Non-cardiac limitation of activity

4. Prior exercise-induced syncope or exercise-induced sudden death 5. Primary exercise mode is swimming or stationary biking 6. Participation in competitive or high intensity exercise against medical advice 7. Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment 8. Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study
Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness

This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF
* Age: 6-18 years old
* Signature of informed consent of legal guardian and patient.

Exclusion Criteria:

* Being a smoker
* Having had an exacerbation in the last 3 months
* Having undergone gastric surgery
* Having enteral nutrition at present
* The patients will come from the HIUNJ of Madrid.
* Currently taking CFTR modulators
Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery

Purpose: This study aimed to investigate the impact of CYP3A4\*1G genetic polymorphism on metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176 patients receiving elective lower abdominal surgery under general anesthesia were recruited into this study. Genotyping of CYP3A4\*1G was carried out by direct sequencing. The plasma fentanyl concentration was detected 30 min after anesthesia induction by high performance liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24 h after operation. PCA fentanyl consumption and adverse effects were recorded during the first 24 h after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20-65 years
* Anesthesiologists (ASA) physical status I or II;
* With ±20% of ideal body weight;
* Received PCA administration;
* Agreed to participate the research

Exclusion Criteria:

* History of chronic pain;
* Psychiatric diseases;
* Diabetes mellitus;
* Severe cardiovascular diseases;
* Kidney or liver diseases;
* Alcohol or drug abuse (according to the criteria of DSM-IV);
* Pregnancy or at lactation period;
* Consumed drugs (1week) or foods (3 days) known to inhibit or induce the expression of CYP3A4 enzymes prior to surgery;
* Refused PCA administration;
* Disagree to participate to the research
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease

Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and effective long-term treatment regimen. Unfortunately, there are still no disease-specific treatment for ADPKD approved in the US. A rational step towards identifying such agents is to test therapies that have a proven safety profile with mechanisms of action that can counter the disease progression.

The purpose of this study is to investigate whether drinking increased amounts of water (water loading) might slow down polycystic kidney growth or kidney function decline. Water loading can cause the suppression of a pathway that causes fluid buildup and cyst growth. High water intake has been safely used in the clinical setting, such as in the case of kidney stone therapy. New York State tap water is widely available and safe, making it highly cost-effective as well.

The study will involve 11 visits to the study site over 19 months. Participants will need to follow specific dietary and fluid recommendations. There will be physical examinations and medical history assessments at each visit. Testing will include undergoing magnetic resonance imaging (MRI), blood and urine tests. Study participants will be compensated for their time. Detailed study procedures will be reviewed upon contact with the study team.

Eligibility Criteria:
Inclusion Criteria:

* pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
* estimated glomerular filtration rate of 40 ml/min or greater
* urine osmolality \> 400 mOsm/L

Exclusion Criteria:

* estimated glomerular filtration rate less than 40 ml/min
* low blood sodium levels
* syndrome of inappropriate diuretic hormone
* use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)
* use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or dDAVP
* contraindications to magnetic resonance imaging (MRI) (pacemakers, defibrillators, implanted electronic devices, metallic foreign body)
Contamination of Hospital Scrubs

This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will:

- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering

This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.

The outcome of interest is the contamination of scrubs with Staphylococcus aureus, Enterococcus species or Gram-negative bacteria as determined by surface swabs of healthcare worker scrubs after a full 8-hour shift. The outcomes will be analyzed both individually and collectively.

Contamination will be defined as:

- A swab that is determined to be positive for any Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.

Eligibility Criteria:
Inclusion Criteria:

* Nursing staff engaging in direct patient care
* Working in select/participating intensive care and intermediate care units
* Working at least 8 day shifts in one month (study period)

Exclusion Criteria:

* Pregnant
* Unable to provide consent
* Unable to follow study schedule
Functional Antigen Matching in Corneal Transplantation

Penetrating keratoplasty is one of the most commonly performed transplantation surgeries. Graft rejection is a major complication. HLA compatibility has already been demonstrated an effective prophylaxis in several retrospective investigations. The purpose of the investigators randomized clinical trial is to demonstrate superiority of HLA matching in comparison to random graft assignment with respect to the endpoint 'time to first endothelial graft rejection' in penetrating keratoplasty. The investigators will perform DNA-based allele resolution typing.


Eligibility Criteria:
Inclusion Criteria:

* Predicted waiting time for a 4/6 match lower than 6 months.

Exclusion Criteria:

* Minority
* Legal incapacity
Family Experience of Home Opioid Use After Pediatric Surgery

A systematic review examining outpatient opioid use identified only three pediatric studies published between 2015 and 2016. Of these three, two studies had a short-term follow up with patients at three days after discharge; moreover, these three studies were limited by focusing on one surgical population, restriction of data to 0-12 yr old participants, and the other being a brief report. As a result, there are no pediatric studies that have examined opioid use amongst 0-18 yr olds, across multiple surgery types, and beyond 3 days after discharge.

This study is being done to learn how long children (0-18 yrs) needed to use the prescribed opioid medication for and how families can be better prepared to provide adequate and safe pain management at home. Follow up will take place 28 days after discharge from the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Families are filling a prescription for opioid medications at Shoppers Drug Mart at The Hospital for Sick Children
* Parent has strong command of the English language (i.e., no interpreter required)

Exclusion Criteria:

* Child has used opioid medication at home within 6 months before the date of their surgical procedure
* Child has history of chronic pain
* Child is being discharged to a rehabilitation facility anticipated
A Study of EDP-235 in Healthy Subjects

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.

The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses of EDP-235 or placebo for 7-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* An informed consent document signed and dated by the subject.
* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit
* Pregnant or nursing females.
* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
* A positive urine drug screen at screening or Day -1.
* Current tobacco smokers or use of tobacco within 3 months prior to screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
* History of regular alcohol consumption.
* Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.