cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Cancer Imaging Approaches in People with Lobular Breast Cancer

The purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging approach for detecting and monitoring ILC, PET/CT scans using the radiotracer 18F-fluorodeoxyglucose (FDG). These scans will be referred to as FES PET/CT scans and FDG PET/CT scans.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient \> 18 years old
* Biopsy-proven metastatic ILC
* Confirmed ER+ breast cancer from either primary tumor or metastatic biopsy (ER receptor percent staining ≥ 10% of tumor cells by IHC)
* HER2-negative per ASCO/CAP
* ECOG Performance Status Score of 0, 1 or 2.
* Patient can have received up to 2 lines of therapy in the metastatic setting
* Life expectancy of at least 12 months

Exclusion Criteria:

* Low ER expression defined as ER \<10% of tumor cells by IHC
* Patients who have been on adjuvant ER-blocking endocrine therapy with SERM or SERD without an 8- and 24-weeks washout, respectively. (The use of aromatase inhibitors or ovarian suppression is permitted given that they do not block estrogen receptors).
* Pregnancy or lactation or parturient or nursing mother
* Patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of \<12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason.
Opioid Consumption After Orthopaedic Surgery

This is a randomized controlled study that will involve fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery) within our practice group. Consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). The control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative opioid counseling.

Over the past two decades in the United States, the opioid epidemic has escalated at a startling rate and prescription opioids are a large contributor to this problem. Studies show that there is an excessive amount of opioids being prescribed for orthopedic procedures. An accurate understanding of opioid consumption following common outpatient orthopedic surgery is imperative in order to treat pain appropriately relative to the surgery being performed without leading to excess narcotic prescribing.

The purpose of the study is threefold: to better understand typical opioid consumption following common outpatient orthopedic surgeries, to generate prescribing guidelines to optimize opioid prescribing, and to understand the effect of pre-operative opioid counseling on opioid consumption following these procedures.

This is a prospective randomized controlled study that will involve eight fellowship-trained board certified orthopaedic surgeons in four different subspecialties (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery). Consenting patients will be randomized to the treatment group (receiving preoperative counseling) or to the control group (no preoperative counseling). The control limb will provide us with information regarding average opioid consumption following common outpatient orthopedic procedures, and the study limb will allow us to evaluate the effect of the pre-operative counseling.

Basic demographic and surgical data will be collected. Primary outcomes will be assessed at the post-operative visit. These include the total number of opioid pills consumed, average daily pain scores, and adverse effects. Secondary outcomes include the number of days the medication was used, medication refill requests, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated to undergo outpatient orthopedic surgery in one of the four areas included in the study (hand surgery, sports surgery, shoulder and elbow surgery, and foot and ankle surgery).
* Age eligibility is \> 18 years of age.

Exclusion Criteria:

* Inpatient procedures.
* Pediatric patients (age \< 18 years).
* Known allergy to narcotic medication.
* Pregnant female patients.
* Non-English speaking patients
* History of chronic pain and/or narcotic use preoperatively.
Fascia Iliaca Compartment Block and IPACK Block in Total Knee Arthroplasty

The investigators sought to compare the effectiveness of postoperative pain control between the standard intravenous multimodal analgesia procedure used in managing patients undergoing total knee surgery, who experience severe postoperative analgesia needs, and multimodal analgesia procedures that incorporate ultrasound-guided peripheral nerve blocks (Fascia Iliaca Compartment Block or iPACK Block) during postoperative follow-up. The aim is to determine which procedure is more effective.

All patients who received a total knee replacement surgery conducted by orthopaedic surgeons at the operating theatre of Health Sciences University Ankara Atatürk Sanatorium Training and Research Hospital and underwent postoperative pain assessment by anaesthetists will be retrospectively reviewed as part of the study.

Postoperative pain management follow-up for patients who have undergone surgical procedures at Anaesthesiology and Reanimation Clinic is standard practice during patients hospitalization. Patients who have undergone painful and significant surgical procedures are typically given postoperative patient-controlled analgesia devices and are administered intravenous painkillers that are under the patient's control. As part of multimodal analgesia procedure, the investigators apply peripheral nerve blocks routinely to eligible patients, provided that the necessary criteria are met. Once the postoperative Anesthesiology and Reanimation clinic's follow-up form, the regional anaesthesia follow-up form, is completed, patients receive coordinated follow-up care from anaesthesiologists and surgical physicians in postoperative ward to monitor analgesic requirements and increase patient satisfaction. Hourly monitoring ensures that patients receive optimal care.

The aims of study to examine the effectiveness of these procedures. The investigators will include all patients who received elective total knee arthroplasty surgery in the operating room of Ankara Atatürk Sanatorium Training and Research Hospital within the past year (between 01 March 2022 and 31 March 2023) in retrospective file review and postoperative pain follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone elective total knee surgery
* ASA I-III patients

Exclusion Criteria:

* Those \<30 kg
* People under 18 years of age
* Patients with missing follow-up forms
* Patients with a history of chronic opioid or corticosteroid use
* Patients with a history of inflammatory gonathrosis
* Patients with synovectomy operation history
Feasibility Study of SPEEDI

The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.\[6\] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.


Eligibility Criteria:
Inclusion Criteria:

* infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
* medically stable,
* off ventilator support,
* demonstrate thermoregulation in an open crib by 35 weeks of PMA,
* live within 60 minutes of the hospital, and
* have one parent who is English speaking and willing to participate in the study intervention and assessments

Exclusion Criteria:

* genetic syndrome or
* musculoskeletal deformity
Split-dose Versus Same-day Reduced-volume PEG-ELS Plus Bisacodyl for Morning Colonoscopy

This study aims to compare split-dose vs. same-morning whole-dose of 2-litre PEG-ELS plus bisacodyl for bowel preparation for morning outpatient colonoscopy.

A good bowel preparation regime is one that is not only effective in cleansing the colon but should be relatively small in volume and well-tolerated by patients with minimal adverse gastrointestinal symptoms. At our centre, reduced-volume 2-litre PEG-ELS plus bisacodyl and low fiber diet is used for bowel preparation for patients undergoing colonoscopy. Patients undergoing morning outpatient colonoscopy would normally ingest the PEG-ELS and bisacodyl the day before. This regime has been shown to be better tolerated by patients without compromising the quality of bowel preparation when compared with conventional 4-liter PEG-ELS. However, previous study on patient satisfaction found that nearly half of the patients attending the outpatient colonoscopy service at our centre were dissatisfied with the bowel preparation regime used. Of the seven items considered in the evaluation of patient satisfaction, comfort level during bowel preparation was the main cause of unfavorable responses. Moreover, a separate study using the same bowel preparation regime at our centre found a high percentage of poor quality bowel preparation, which was associated with increased technical difficulty and patient discomfort during colonoscopy. There was clearly a need for a better bowel preparation regime. Current literature suggests that either taking reduced-volume PEG-ELS on the same morning instead of the previous evening, or splitting the bowel preparation, would be better. However, whether the former or the latter is better, is unknown. The aim of our study was to compare the use of same-morning whole-dose reduced-volume PEG-ELS and split-dose reduced-volume PEG-ELS for bowel preparation for patients undergoing morning outpatient colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients undergoing morning outpatient colonoscopy at the Endoscopy Unit, University of Malaya Medical Centre

Exclusion Criteria:

* In-patients, patients scheduled for afternoon colonoscopy, patients who used other bowel preparation regime than that assigned, patients who had incomplete examination not related o quality of bowel preparation e.g. obstructing tumour
BPO vs Hibiclens Soap for Surgical Preparation

This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center
* Subjects between ages 18-89

Exclusion Criteria:

* Subjects who self-report very sensitive skin
* Subjects who are sensitive to benzoyl peroxide
* Subjects who are allergic to chlorhexidine
* Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery)
* Subjects who had recent use of acne treatment
* Subjects who are not fluent in English.
First Step With Singulair® Therapy (0476-323)

In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.


Eligibility Criteria:
Inclusion Criteria:

* First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
* Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
* Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
* Patient's forced expiratory volume in one second (fev1) is \< 80% of predicted value

Exclusion Criteria:

* Patient on combination therapy
* Patient on long acting beta2 agonists
* Patient on using moderate to high doses of ICS. (ICS \>250 \&micro g/day flovent\&reg; or equivalent per day)
Applied Forces During Neonatal Intubation

This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)

This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.

Eligibility Criteria:
Inclusion Criteria:

* Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.

Exclusion Criteria:

* Refusal to participate.
Economic Evaluation German Drug-Eluting Stent Registry

Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis.

The study "Economic Evaluation of the German Drug-Eluting Stent Registry" examines the cost-effectiveness of drug-eluting stents compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, and re-intervention rates.


Eligibility Criteria:
Inclusion Criteria:

* Indication for coronary stent implantation
* Additional inclusion criteria BMS cohort:

  * Acute Coronary Syndrome
  * Diabetes Mellitus
  * Previous Percutaneous Coronary Intervention/Coronary Artery Bypass Graft
  * 3-Vessel Disease
MOTIVACTION - Study

Impact of a 4-week exercise intervention vs. a stress-management-training on physical activity (measured objectively and by questionnaire) of cancer patients of different entities and out-patient regimes.


Eligibility Criteria:
Inclusion Criteria:

* Physical activity \< 150 minutes /week
* Patients are currently receiving outpatient treatment (acute or maintenance therapy) or finished this therapy not longer than six months ago

Exclusion Criteria:

* Serious Orthopedic limitations
* Serious neurological disorders
* Serious cardiovascular diseases
* Bone metastases
* wound healing / scarring not completed
* Rehabilitation during the next eight weeks
Imaging of Islet Transplantation With PET and MRT

Islets of Langerhans intended for clinical transplantation are labelled with a radioactive tracer. The tracer is retained in viable cells of the transplant. At infusion (transplantation) of the islets into the portal vein the tracer can be followed for two hours with positron emission tomography (PET). Imaging and calculations can give estimates of the proportion of surveying islets and the rate of early destruction. Also the distribution of the islets into the liver can be viewed.

Background:

It is suspected that the current need for repeated islets transplantation to treat diabetes type I is dependent on an early destruction of the islets when infused into the portal vein.

Aim:

To trace the fate of the islet at and after infusion into the portal vein.

Method:

Islets are labelled in vitro with a radioactive tracer that can be measured with positron emission tomography. 10-20 percent of the graft is labelled. Just prior to start of infusion labelled islets are mixed with unlabelled islets (80-90 percent of the graft). The tracer used is FDG and stands for 2-\[18F\]-2-deoxy-D-glucose. At infusion the patient is placed in the combined computer tomography and PET camera to follow the infusion. The imaging is almost continuous for 2 h at and after infusion.

Expected results:

Calculations of proportion of surviving islets and rate of destruction. Localisation and distribution of islets in the liver of the recipient.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for clinical islet transplantation.
* Patient on waiting list for islet transplantation within the Nordic Network for Clinical Islet Transplantation
* Written Informed Concent
Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.

A loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites after abdominal surgeries. Major complications from creation and subsequent closure of a temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation, intra-abdominal abscess, anastomotic leak, wound dehiscence. Small-bowel obstruction (SBO) was the most common complication. SBO is caused by adhesions in the surgical site, with narrowing or angulation of the intestine causing obstruction. Prevention of these adhesions may reduce the frequency with which SBO is seen after this surgery. Furthermore, surgery to close the ileostomy is complicated by the presence of adhesions which make dissection of the ileostomy difficult, and increase the risk of injury of the small intestine during dissection, prolonging the operation time in an effort to minimize risk to the patient.

AlloMEM™ is human peritoneal membrane designated by the Food and Drug Administration (FDA) for use as a homologous tissue where native peritoneum is absent or traumatized. The AlloMem™ is not regulated as a device and no 510k submission has been made by the FDA. AlloMem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering solely regulated under 361 HCT/P because by FDA definition it is: minimally manipulated; intended for homologous use only; does not involve the combination of cell or other tissues, and does not rely on the metabolic function of cells for its primary function. Two animal studies have shown that AlloMEM™ can help prevent intra-abdominal adhesions and provides the biological framework for peritoneal remodeling. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 - 85 years old at the time of ileostomy formation
* Scheduled to undergo planned diverting loop ileostomy

Exclusion Criteria:

* Patients undergoing emergency surgery
* Patients with abdominal or pelvic abscess present at time of initial surgery
* Patients with a history of pulmonary embolism or deep vein thrombosis (DVT) within 1 year of surgery
Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair

Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 Patients Undergoing Cleft Lip And Palate Repair

Exclusion Criteria:

* CNS Disorders
* Respiratory Infection
* GERD
Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HPP documented in the medical records
* Presence of open growth plates by X-ray during Screening Period
* Tanner stage 2 or less during the Screening Period
* Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before Day 1. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study.

Exclusion Criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator.
* Diagnosis of primary or secondary hyperparathyroidism
* Hypoparathyroidism, unless secondary to HPP
* Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
* Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
* History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850
* Body weight \< 10 kg during the Screening Period