cyrilzakka/clinical-trials huggingface dataset:
Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.

The primary aim of this study is to show the non-inferiority of 15 mg intraoperative dose of ketorolac as compared to the standard 30 mg ketorolac by looking at the VAS scores 4 hours after an adult spine surgery.

Opioids have traditionally been the cornerstone of acute postoperative pain management. Problematic side effects such as nausea, vomiting, ileus, urinary retention, excess sedation, and respiratory depression are significant disadvantages with the use of opioids. Alternative treatments have been sought. The concept of adding a nonsedating non opioid analgesic agent is appealing and has been validated by previous studies. Nonsteroidal anti-inflammatory drugs (NSAID) are nonsedating and combine analgesic and anti-inflammatory properties ideal for pain after surgery.

Ketorolac is a potent intravenous nonsteroidal anti-inflammatory drug (NSAID), and a non selective cyclooxygenase inhibitor which mediates pain, inflammation and fever. It has been evaluated and used for treatment of moderate to severe pain including postoperative pain. Although intravenous route is not approved by Health Canada, its use is supported in medical literature and clinical practice.

Previous studies have demonstrated the effectiveness of standard 30 mg intravenous ketorolac as an adjunct to opioids for postoperative pain relief. Standard parenteral dose recommended by manufacturer for healthy non elderly population is 30 mg based on a number clinical trials.

Alberta Health Services (AHS) Pharmacy formulary has approved the intravenous use of ketorolac in the dosage range of 10-30 mg depending the patient's weight and medical comorbidities.

NSAIDs, including ketorolac, have an analgesic ceiling effect in which higher doses do not provide any additional pain relief but may increase the likelihood of side effects. Single dose IM ketorolac have been studied in the past showing no difference in analgesia with the 30 and 90 mg dose. Because of risk of drug toxicity and unwanted side effects, patients should be given the lowest effective ketorolac dose. Low dose ketorolac was studied in the adolescents undergoing spine surgery and showed that dose of 0.2mg/kg (11mg) provides supplemental analgesia postoperatively. However, there were no previous studies found on review of the literature using medline search that look at parallel comparison between intraoperative doses of ketorolac in terms of efficacy and safety profile.

Eligibility Criteria:
Inclusion Criteria:

* Patients booked for 1-2 level spine laminectomies and/or decompression
* Adult 18 - 65 years
* Weight of 50 - 110 kg

Exclusion Criteria:

* Previous lumbar laminectomy
* Current anticoagulant use with INR \> 1.2
* Narcotic use \> 4 weeks
* Known allergy or sensitivity to NSAID or morphine
* Renal insufficiency with creatinine \>100 umol/L
* Known liver disease
* History of gastrointestinal bleeding
* Pregnancy, history of bronchial asthma
* NSAID use 2 days before surgery.
A Phase 1/1b Study of IAM1363 in HER2 Cancers

This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.

This is a Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations.

This study consists of the following 3 parts, which are described in further detail below:

* Part 1 (Monotherapy Dose Escalation)
* Part 2 (Dose Optimization)
* Part 3 (Simon 2-Stage Evaluation)

Part 1 will enroll participants with a confirmed, relapsed/refractory malignancy with documented diagnosis of HER2 alterations including participants with brain metastases. Once a provisional maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) has been determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363. Following completion of Dose Optimization, Part 3 will be opened to enroll tumor-specific cohorts utilizing a Simon 2-Stage Minimax Design to evaluate IAM1363 at the selected dose(s).

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years
* Have relapsed/refractory HER2-altered malignancy
* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
* Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM
* Eastern Cooperative Oncology Group (ECOG) performance score 0-1
* Have adequate baseline hematologic, liver and renal function
* Have left ventricular ejection fraction (LVEF) ≥ 50%

Key Exclusion Criteria:

* Clinically significant cardiac disease
* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well-controlled HIV (e.g., CD4 \>350/mm3 and undetectable viral load) are eligible
* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C
* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
* Uncontrolled diabetes
* History of solid organ transplantation
* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1
* Patients requiring immediate local therapy for brain metastases
Promiseb Topical Cream for Cradle Cap

The purpose of this study is to evaluate the efficacy and safety of Promiseb Topical Cream in cradle cap.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cradle cap
* Must be at least 30 days old
* Must be in good health as determined by investigator
* Naive to prior cradle cap therapy (may have used mineral, olive oils)

Exclusion Criteria:

* Known food, topical product or medicinal allergies.
* Prior use of corticosteroids, antifungals or keratolytics for Cradle Cap
* Weighing less than 7 lbs
A Comparative Study of Endoscopic Submucosal Dissection and Photodynamic Therapy for Early Esophageal Cancer

The purpose of this study was to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.

Background: Photodynamic therapy (PDT) is recommended by the NCCN guidelines as an effective method for the treatment of early esophageal cancer. However, there is no clinical trial data so far on whether its efficacy can be compared with that of standard Endoscopic submucosal (ESD). Our team will conduct a detailed study on it.

Aim: to compare the efficacy and safety of Photodynamic therapy (PDT) and Endoscopic submucosal (ESD) dissection in the treatment of early esophageal cancer.

Methods: This study intends to recruit 46 patients with early esophageal cancer and randomly divide them into two groups: one group to receive ESD and the other group to receive PDT.The efficacy and safety were observed after 2 years of follow-up.

Primary endpoints: The recurrence rates at 3 months, 6 months, and 2 years were compared.

Eligibility Criteria:
Inclusion Criteria:

* High-grade intraepithelial neoplasia of the esophagus
* 18-80 years old
* The tumor was confined to the lamina propria of the mucosa
* The tumor invaded the submucosa and was limited to 200 microns

Exclusion Criteria:

* The tumor invaded the entire circumference of the esophagus
* The tumor invaded the muscularis or submucosa more than 200 microns
* The patient has difficulty tolerating anesthesia due to other diseases
* Pregnant or breastfeeding women
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex

This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.

Objective:

To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy.

Hypothesis:

Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Undergoing laparoscopic cholecystectomy
* Anticipated surgical duration \<2 hours
* ASA physical status classification 1-3
* Willing and able to consent in English or Spanish
* No personal history of neuromuscular disease

Exclusion Criteria:

* Preoperative urinary catheter
* History of problems with urination
* Current use of anticholinergic medications (e.g., antihistamines, phenothiazines, antidepressants, antipsychotics)
* Current UTI or urogenital problem (incontinence, known bladder retention, prostate hypertrophy)
* Planned intraoperative insertion of a urinary catheter
* ESRD (GRF \<30 mL/min)
* ESLD (AST or ALT \> 3x reference range)
* Planned postoperative intubation/ventilation or admission to ICU
* Allergy to sugammadex, neostigmine, glycopyrrolate, or rocuronium
* Pregnant or nursing women
* "Stat" (emergent) cases
* Known or suspected neurological condition (e.g., Alzheimer's, h/o of stroke, multiple sclerosis, Parkinson's)
* Patients on toremifene (a selective estrogen receptor modulator)
* Women on oral contraceptives who do not wish to use a non-hormonal method of contraception for 7 days following surgery
Omics Sequencing of Specimen Derived From Patients With Endometriosis

Endometriosis is a type of chronic inflammatory gynecological disease, mainly took place in peritoneal cavity. In order to investigate the possible correlation between microbes and endometriosis, the investigators planed to perform 16S rDNA amplicon sequencing, metagenomic sequencing and metabolomic sequencing of paired samples derived from feces, cervical mucus, blood and peritoneal fluid.


Eligibility Criteria:
Inclusion Criteria:

1. The subject who is female.
2. The subject who is infertility or sub-fertile.
3. The subject whose age was between 18-52 years old.
4. The subject who is suspected to have endometrioma.
5. The subject whose menstrual cycle length is between 28-35 days.
6. The subject without the history of abdominal or pelvic surgery.
7. The subject who has dysmenorrhea.
8. The subject who has dispareunia.
9. The subject who was informed the risks and benefits of the experiment and provided written informed consent, and gave their approval.
10. The subject who has chronic pelvic pain and the pain get worse during periods.
11. The subject who has no sexual activity within a week.
12. The subject who has no history of acute or chronic pelvic inflammatory disease.
13. The subject who has confirmed EM with biopsy.
14. The subject without hormonotherapy within 6 months.
15. The subject without medical history of antibiotics within 6 months.

Exclusion Criteria:

1. The subject who has hernia.
2. The subject who is pregnant.
3. The subject who has malignant tumor.
4. The subject who has Gene Therapy history.
5. The subject who has abdominal or pelvic surgery history.
6. The subject who has peritonitis.
7. The subject who is below 18 years old or over 52 years old.
8. The subject who can not endure laparoscopy.
9. The subject who has cardiovascular disease.
10. The subject who has systemic or regional acute inflammation.
11. The subject who has chronic liver or kidney disease.
12. The subject whoes body mass index ≤ 18.5 or ≥ 28 (kg m-2).
13. The subject who has coagulation defects or hematologic diseases.
14. The subject who has tuberculosis or chronic obstructive pulmonary disease.
15. The subject whoes alcohol consumption ≥ 60 g d-1, or smokers (≥20 cigarettes d-1).
16. The subject who has hypertension, diabetes, hyperthyroidism and ect.
17. The subject whoes medical history of transfusion, stem cell or bone marrow transplantation.
18. The subject who has contraindication of tracheal intubation anesthesia.
19. The subject who received hormonotherapy within 6 months.
20. The subject who has immunodeficient, allergic or autoimmune diseases.
21. The subject who used antibiotics within 6 months.
22. The subject who is drug abuse.
Investigating Handwriting Characteristics and Underlying Factor in Children With Autism Spectrum Disorder

The mechanism of the motor problem in children with autism spectrum disorder (ASD) in handwriting has been investigated in the following three aspects, including collecting dynamic handwriting performance, exploring the related underlying factors, and investigating corresponding brain activities. This study aimed to investigate the underlying factor of handwriting issue in children with ASD. There are four study aims. The first is to examine the differences of handwriting performance between children with ASD and TD using kinetic and kinematic measurements and handwriting difficulties questionnaires. The second is to investigate the group difference of the underlying motor factors, including fine motor ability and sensorimotor ability. The third is to explore the relationship between underlying motor factors and handwriting performance. The fourth is to explore the corresponding cortical activity during writing in children.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5-12 years old

Exclusion Criteria:

* who have a diagnosis of a seizure disorder, genetic condition, neurological condition, uncorrected significant hearing or visual impairment, and/or intellectual disability
* having non-verbal intelligent ability score lower than 70, determining by TONI-3
* unable to follow instructions during the process
Effect of Parental Presence on Anxiety of Children During Induction of Anesthesia

Anxiety is when children feel scared, worried, or nervous before or during anesthesia induction. This can happen because they don't know what's happening, are scared of the hospital or medical equipment, or are worried about being separated from their parents.

When parents are present, they can:

* Provide emotional support and reassurance
* Distract the child from scary things
* Help the child feel more calm and safe This can help reduce the child's anxiety levels.

When parents are not present, children may feel:

* More scared and anxious
* Alone and unsupported
* More worried about what's happening This can increase the child's anxiety levels. we can prepare children and parents beforehand about what will happen
* Allow parents to be present during anesthesia induction
* Use distraction techniques like toys or videos
* Use gentle and calm anesthesia induction techniques By doing these things, we can help reduce anxiety in children and make the experience less scary for them.

Induction of pediatric anesthesia represents a highly stressful event for children, often resulting in preoperative anxiety that can impair the child's perioperative experience and result in adverse postoperative outcomes. It has been proposed that parental presence during induction of anesthesia Preoperative anxiety is linked to postoperative maladaptive behaviors, such as pain following surgery, insomnia, conflicts between the child and his parent, separation anxiety, increased urinary frequency during the night, reduced appetite, lack of interest, agitation, and alienation.may be a non-pharmacologic intervention to reduce children's anxiety. In patients with extreme anxiety, unfavorable postoperative behaviors after anesthesia induction are likely to result in long-term issues, which adversely affect the process of recovery, and also develop a feeling of inadequate care. Parental presence at anesthesia induction is the interaction that takes place in the induction room during the course of anesthesia induction between the child, parent, anesthesiologist, and perioperative nurses.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients
* aged 5-10 years
* minor surgery
* duration \<1 hour
* ASA 1 and ASA 2 patients

Exclusion Criteria:

* Patients and attendant refusal
* Emergency surgeris
* Renal insuffciency
* Age less than 5 and more than 10 years
BIomarkers to Predict the Outcomes of Sepsis

Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.

Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. There are reports that the mortality rate of sepsis patients is 25-30%, and the hospital mortality rate of septic shock is as high as 40-60%. According to Lancet data, in 2017, there were 48.9 million cases of sepsis worldwide, resulting in approximately 11 million deaths, accounting for 19.7% of the total global deaths. Surviving sepsis patients often experience secondary infections and chronic organ dysfunction, which affects their long-term quality of life and poses a huge socio-economic burden. The World Health Organization (WHO) has identified sepsis as a global health priority and called for improving the level of sepsis prevention and treatment. With the advancement of medical technology, the diagnostic and treatment guidelines for sepsis are constantly updated, and clinical treatment capabilities have been improved. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.

Eligibility Criteria:
Inclusion Criteria:

-

The clinical diagnostic criteria for sepsis or septic shock that comply with the 3rd edition of the International Consensus on Sepsis and Sepsis Shock (Sepsis-3.0) are:

1. Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) ≥ 2 points;
2. Sepsis-3.0 diagnostic criteria for septic shock: Sepsis with persistent hypotension, after sufficient fluid resuscitation, still requires vasopressor drugs to maintain average arterial pressure ≥ 65mmHg, and serum lactate level\>2mmol/L (18mg/dL).
3. Age 18 to 85 years old

Exclusion Criteria:

1. patients with autoimmune disease, acquired immunodeficiency syndrome, agranulocytosis (\<0.5 × 109/L), malignant tumors or other serious chronic diseases (heart failure, Liver failure, end-stage renal disease, etc.);
2. Receiving glucocorticoid treatment;
3. Pregnancy;
4. Refuse enrollment or give up active treatment. -
Sentinel Node Biopsy Vs Observation After Axillary PET

Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation.

Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.


Eligibility Criteria:
Inclusion Criteria:

stage 1:

1. female
2. ≥18 years old
3. invasive ductal carcinoma or DCIS proved by core needle biopsy
4. tumor size ≤ 5cm
5. negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
6. patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection)

stage 2:

1. female
2. ≥18 years old
3. invasive carcinoma proved by core needle biopsy
4. has plan for breast conserving surgery and adjuvant radiation after surgery
5. negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV\<0.27)
6. patients is accessible for the follow up

Exclusion Criteria:

stage 1:

1. distant metastases
2. in the procedure of neoadjuvant therapy
3. positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
4. pregnancy or breastfeeding
5. axillary biopsy or axillary surgery before LymphPET
6. suffer from diabetes mellitus and without well control of bloodglucose
7. previous malignancy
8. allergic to tracer of LymphPET

stage 2:

1. distant metastases
2. in the procedure of neoadjuvant therapy
3. positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
4. pregnancy or breastfeeding
5. axillary biopsy or axillary surgery before LymphPET
6. suffer from diabetes mellitus and without well control of bloodglucose
7. previous malignancy
8. allergic to tracer of LymphPET
A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects

The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection


Eligibility Criteria:
Inclusion Criteria:

* Chronically infected with Hepatitis C Virus (HCV) genotype 1
* Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or Hepatitis B Virus
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with Hepatitis C Virus infection
* HIV and/or HBV positive
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

WOCBP will be enrolled as in-patient for 16 days