cyrilzakka/clinical-trials huggingface dataset:
Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

The primary objectives of this study are: (Phase 1b) to investigate the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) for magrolimab in combination with cetuximab; and (Phase 2) to evaluate overall response rate (ORR) of magrolimab in combination with cetuximab in participants with Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutant and KRAS wild-type colorectal cancer (CRC).


Eligibility Criteria:
Key Inclusion Criteria:

* Histological Diagnosis

  * Phase 1b only: Advanced solid malignancy with an emphasis on colorectal cancer (CRC), head and neck, breast, pancreatic and ovarian cancers who have been treated with at least one regimen of prior systemic therapy, or who refuse systemic therapy, and for which there is no curative therapy available.
  * Phase 2:
* KRAS Mutant CRC: Advanced KRAS mutant CRC who have progressed or are ineligible for both irinotecan and oxaliplatin based chemotherapy
* KRAS Wild-Type CRC: Advanced KRAS wild type CRC who have progressed or are ineligible for fluoropyrimidine, irinotecan, and oxaliplatin based chemotherapy and who are relapsed or refractory to at least 1 prior systemic therapy that included an anti-epidermal growth factor receptor (EGFR) antibody, such as cetuximab, panitumumab or others.
* Adequate performance status and hematological, liver, and kidney function
* Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Key Exclusion Criteria:

* Active brain metastases
* Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents.
* Phase 2 only: second malignancy within the last 3 years.
* Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV)
* Pregnancy or active breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ultrasound Guided Nerve Block for Hip Fracture Pain Management at Emergency Department

The main objective is to determine if ultrasound guided suprainguinal iliac fascia block leads in better clinical outcomes such as pain management or time to home discharge.

Determining effectiveness in ultrasound guided suprainguinal iliac fascia block as a tool of comfortability of patients with less use of opioids and their side effects and its possible influence in early discharge to home has no evidence in orthopedics literature till today.

Ultrasound becomes an accessible tool at Emergency Departments and Orthopedic Surgeons are increasingly interested its clinical use.

This clinical trial wants to investigate if its use for hip nerve block leads in better clinical outcomes such as pain management or time to home discharge.

Eligibility Criteria:
Inclusion Criteria:

* Low energy Hip Fracture

Exclusion Criteria:

* Don´t meet Inclusion Criteria
* Present any other synchronic fracture.
* Drug allergy for drugs used for nerve blocking
* Skin infection at injection site.
* Contraindication due to comorbidities.
* Pathologic fractures.
* Cognitive impairment
* Do not give his consent.
Stage I/II NSCLC Perioperative Chemotherapy

The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.

In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.

Eligibility Criteria:
Inclusion Criteria:

Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less

Exclusion Criteria:

NSCLC stage III or IV
Lower Silesia Culotte Bifurcation Registry (LSCBR).

The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis.

The study contains a retrospective analysis of subjects who have undergone PCI in two high-volume cooperative Cardiac Departments in the Lower Silesia Region (Poland) between April 2012 and January 2024. Data regarding all performed PCI from these periods were prescreened in terms of bifurcation lesion with subsequent implantation of two stents using the Culotte technique or the DK-Culotte technique. The indication for percutaneous coronary intervention (PCI) was based either on a judgment made by the Heart Team or on a particular clinical indication (ongoing ischemia, lack of will for the alternative treatment options, presence of significant angiographic CAD suitable for PCI due to ESC/ESH recommendation). The decision to perform the two-stent technique PCI was left to the operator's dissertation based on clinical and angiographical features. All patients were thoroughly informed about all therapeutic options and PCI-related risks before providing written informed consent for the procedure. There were no clinical or vessel-related exclusion criteria (lesion anatomy, length, tortuosity, severity). However, patients who had undergone PCI with coronary stents prior to the index procedure with respect to the bifurcation lesion studied were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Presence of significant changes in the coronary bifurcation requiring the implantation of two coronary stents using the Culotte or DK Culotte technique.

Exclusion Criteria:

* Patients who underwent PCI with coronary stents prior to the index procedure for the bifurcation lesion studied.
Dose-Escalated Spine SbRT for Localized Metastasis to the Spinal Column

This study is being done to determine the feasibility and tolerability of a novel regimen of spine stereotactic radiosurgery (SSRS). SSRS delivers high doses of radiation to tumors of the spine using precision techniques.

In standard medical care, conventional SSRS is delivered in only 1 or 2 treatments. When this treatment is delivered in only 1-2 treatments, a high dose is used which can increase the side effects of treatment. This study aims to test an alternative technique of delivering SSRS over 5 treatments. By delivering the radiation therapy over multiple treatments, the dose of radiation is less per treatment.

Given the limitations with conventional external-beam radiotherapy, spine stereotactic radiosurgery was developed as an alternative treatment for localized spine metastasis. Stereotactic radiosurgery is an alternative treatment option to conventional palliative radiotherapy, which has gained acceptance over the last decade. Clinical experience with spine stereotactic radiosurgery has showed high rates of pain control and improvement in neurological function in patients with epidural compression.

Eligibility Criteria:
Inclusion Criteria:

* Zubrod Performance Status 0-2
* Localized spine metastasis from a solid tumor from the C1 to L5 levels (a solitary spine metastasis, two separate spine levels, or up to 3 separate sites; each of the separate sites may have a maximal involvement of 2 contiguous vertebral bodies)
* Patients with epidural extension are eligible as long as there is a ≥ 2 mm gap between the spinal cord and the edge of the epidural lesion
* Paraspinal disease extension is allowed as long as it measures ≤ 5 cm in the greatest dimension and that it is contiguous with the spine metastasis
* For patients enrolled in cohort 2, the minimum time to re-irradiation should be 6 months
* Numerical Rating Pain Scale (NRPS) score of ≥ 5 at the index site(s) (as rated when the patient is not taking pain medication)

Exclusion Criteria:

* Radiosensitive histologies (myeloma, lymphoma, germ cell tumors, small cell lung cancer)
* Non-ambulatory patients
* \>50% loss of vertebral body height or spinal instability to due pathologic compression fracture
* Frank spinal cord compression, spinal cord displacement, or epidural extension within 2 mm of the spinal cord
* Rapid neurologic decline
* Patients for whom an MRI of the spine is medically contraindicated
* Pregnant women
Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth

In Hong Kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (\>90%) of the decayed teeth were left untreated. There is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in Hong Kong. The objective of this study is to compare the effectiveness of 38% silver diamine fluoride (SDF), 5% sodium fluoride (NaF) varnish and placebo control in preventing dentine cavitated caries in primary molars in preschool children when applied semi-annually over 30 months. Around 770 preschool children attending Grade 1 in selected kindergartens will be invited to participate in this clinical trial. Only generally healthy children with written parental consent will be included. At baseline, clinical examination will be conducted in the kindergarten to assess the tooth and oral hygiene status of the included children. After the baseline examination, the children will be randomly assigned to one of the following three study groups and the occlusal (biting) surfaces of their primary molars will receive the corresponding interventions: Group A - semi-annual topical application of 38% SDF; Group B - semi-annual application of 5% NaF varnish; and Group C - semi-annual application of placebo control with tonic water. Clinical examination of the study teeth in the children will be conducted every 6 months after the baseline to assess the outcome of the intervention. The primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. The null hypothesis tested is that there is no difference in the effectiveness of semi-annual application of 38% SDF and that of 5% NaF varnish versus placebo control in preventing dentin occlusal caries in primary molars of preschool children. The results of the proposed study will provide evidence to strengthen or refute the recommendation regarding the use of SDF for preventing occlusal caries in primary molars. The study findings will be valuable for guiding decision-making among dental practitioners and health policymakers on whether SDF should be complemented in a school-based caries prevention program.


Eligibility Criteria:
Inclusion Criteria:

1. be healthy
2. have at least one caries-free (no cavitation) primary molar

Exclusion Criteria:

1. are uncooperative or refuse examination
2. have major systemic disease
3. present with either acute pain or infections or have gingival ulceration or stomatitis
4. have known sensitivity to fluoride, silver or other heavy-metal ions
5. are currently involved in any other research that may impact on the present study
Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization

The success of in vitro fertilization is based mainly on uterine implantation embryo. An excessive uterine contractility may interfere with implantation by a movement of the embryo in the uterus. The inhibition of the uterine contractility may have a positive effect on success rate of in vitro fertilization. It is through parenteral injection of glucagon and its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the time of embryo transfer, the investigators intend to improve the pregnancy rates obtained after IVF.

Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer, the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes before the embryo transfer. The uterine contractility will be measured by ultrasound before and after injection to document the impact of Glucagon on it and we will proceed to embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM
* Less than 40 years old
* Women with stimulate in vitro fertilization cycle
* Women able to give her consent

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* Women with diabetes
* Women with hypertensive disorders
* Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit
* Cons-indication to taking Glucagon:

  * Hypersensitivity to product
  * Pheochromocytoma or history of pheochromocytoma
  * Insulinoma
  * Taking a beta-blocker (drug interactions)
Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI

Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI

Recently, studies have reported that strong LDL cholesterol lowering through PCSK9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. However, the LDL cholesterol reduction effect on statin is different from that of Westerners and Asians, and studies on the LDL cholesterol reduction effect of Koreans on the early use of PCSK9 inhibitors are insufficient. Therefore, we would like to study the effect of reducing LDL cholesterol by administering Evolocumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.

Eligibility Criteria:
Inclusion Criteria:

1. Over 19 years old
2. Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form.
3. Patients who underwent percutaneous coronary stenting for acute coronary syndrome

Exclusion Criteria:

1. Patients who have previously taken statins,
2. Patients with active liver disease or patients with three times or more increase in AST or ALT
3. If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib,
4. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
5. The remaining life expectancy is expected to be less than a year.
6. Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment
7. Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals
Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery

This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and quantitative blood loss (QBL).

Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early intervention is dependent on care providers ability to accurately estimate ongoing blood loss. Studies in the past have shown that obstetricians and midwives tend to overestimate blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50 percent when a large volume of blood is lost.

Multiple studies have shown that routine hemoglobin assessment in postpartum patients after uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to increased cost of care without any added benefit and causes inconvenience to the patients. However knowing how imprecise blood loss estimation can be it is reasonable to screen women for anemia prior to discharge.

Eligibility Criteria:
Inclusion Criteria:

All antepartum patients receiving prenatal care at the Broadway Practice and plan to deliver at Allen Hospital in NYC.

Exclusion Criteria:

Patients who gave consent to participate in the study but did not deliver at Allen hospital.
Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery

The purpose of this study is to evaluate the possible association between portal vein flow pulsatility and acute kidney injury after cardiac surgery. Participants will undergo assessment of portal vein flow and intra-renal blood flow using bedside Doppler ultrasound before surgery and daily for three days after cardiac surgery.

Acute kidney injury is a frequent complication after cardiac surgery. Venous congestion from right ventricular dysfunction and fluid overload can impair kidney perfusion resulting in the cardio-renal syndrome.

An increase in the variation of blood flow velocity in the portal vein during the cardiac cycle called portal pulsatility is a sign of congestive heart failure. Portal pulsatility occurs when increased central venous pressure results liver venous congestion. The presence of abnormal portal pulsatility could be used as a marker of venous congestions in other organs such as the kidneys. Discontinuous intra-renal vein flow is a risk factor for death or re-hospitalization in heart failure patients and could be seen in patients with portal pulsatility.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older.
* Undergoing cardiac surgery with the use of cardiopulmonary bypass
* Able to provide consent.

Exclusion Criteria:

* Chronic renal replacement therapy before the procedure.
* Chronic kidney disease stage 5 defined as a estimated glomerular filtration rate by the MDRD equation (eGFR-MDRD) of 15 mL/min/1,73m2 or less.
* Critical pre-operative state defined as aborted sudden death, preoperative cardiac massage, preoperative ventilation before anaesthetic room, preoperative inotropes or intra-aortic counterpulsation balloon.
* Patients previously diagnosed with a condition interfering with Doppler evaluation of the portal system: Portal vein thrombosis, Cirrhosis.
* Patients with documented AKI before surgery.
* Confirmed or suspected pregnancy.
* Kidney transplant recipients.
CIED Infection Quality Initiative Demonstration Project

The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.

Retrospective data will be collected pre-intervention. The interventions will then be implemented for a total of six months and will continue through the data collection period. Prospective data collection will start three months after the intervention is started and will continue for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Cardiovascular Implantable Electronic Device (CIED) in place
* Presumed CIED infection, as defined by:

  1. Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia
  2. Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection

Exclusion Criteria:

* Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis
* Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection
* Patients with left ventricular assist devices (LVADs)
Sleep, Exercise, Nutrition and Survivorship in Prostate Cancer

The primary objectives of this study are to examine sleep, exercise, and nutrition in prostate cancer.

The primary objective of this study is to determine whether exposure to a website with recommendations about sleep and lifestyle for patients with prostate cancer and caregivers leads to an improvement in sleep and healthy lifestyle.

Eligibility Criteria:
Inclusion Criteria:

1. Adult U.S. male age \>18 with prostate cancer OR
2. Adult U.S. male or female \>18 who is a family member/partner/caregiver of a prostate cancer patient AND
3. Telephone and internet access AND
4. Able to read, comprehend, and sign informed consent in English AND
5. Perceived deficits in sleep, nutrition, and/or physical activity

Exclusion Criteria:

1. Age \<18 years
2. Not English proficient
3. No or irregular access to the same telephone number and/or mailing address
4. No or less than weekly access to the internet
5. Patients who do not have a diagnosis of prostate cancer
6. Caregivers/family members for a condition other than prostate cancer
7. Mental or cognitive impairment that interferes with ability to provide informed consent
8. Surgery within the past 6 weeks or planned within the next 3 months (must wait until cleared to participate)
9. Other restrictions or upcoming events that affect sleep, physical activity or nutrition (e.g. doctor's orders)
How to Study Ventilatory Physiology With the Help of Surface Electromyography (EMG) Recordings

Respiratory muscles seem to be activating differently in critically ill patients than in healthy persons. Needle electrodes would provide artefact-free signal information about muscle activation. However, needle recordings are an invasive technique which limits its feasibility in clinical setting. Intention of this study is to investigate if surface electromyography could be used to measure recruitment patterns of ventilatory muscles.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age

Exclusion Criteria:

* brain death of injury
* high spinal cord injury
* severe ARDS (static compliance below 40, PFI below 150)