cyrilzakka/clinical-trials huggingface dataset:
Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA

The objective of this study is to determine if IV acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the PACU specifically in obese patients at risk for obstructive sleep apnea.

Obese adult patients at risk for having OSA will be randomized into two groups: those receiving intraoperative IV acetaminophen and those not receiving the drug. The patients will be blinded to the administration of acetaminophen. For the group randomized to receive the study drug, anesthesia providers will be instructed to administer 1000mg of IV acetaminophen intraoperatively immediately after induction. They may utilize narcotics and other pain medication perioperatively at their discretion according to their perceived patients' needs. Post-operatively in the recovery unit, all patients will be monitored according to current standards with appropriate oxygen supplementation as needed, and they may receive narcotics or other adjuncts as ordered by the anesthesia provider. Recovery nurses will record vital signs, Aldrete score, pain score, and drugs administered per standard protocol. The recovery nurses will be blinded to the study group, and no patients regardless of control vs. study group will be allowed to receive acetaminophen in the PACU or for six hours from surgery end time due to FDA approved dosing of IV acetaminophen no more frequently than every six hours. The patients' recovery data will then be de-identified and reviewed, and each of the groups' recovery time, narcotic use, pain score, and any complications will be examined and compared.

Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI greater than or equal to 30)
* Symptoms of obstructive sleep apnea as determined by an OSA questionnaire patients will complete preoperatively
* Prior diagnosis of obstructive sleep apnea
* Undergoing laparoscopic cholecystectomy
* 18 years old or greater

Exclusion Criteria:

* Negative OSA questionnaire or recent negative workup
* Open cholecystectomy or conversion to open procedure intraoperatively
* Allergy to acetaminophen
* Severe hepatic dysfunction
* Pediatric patients
* Patients unable to consent for themselves
Intra-articular Allocetra in Osteoarthritis of the 1st Carpo-metacarpal Joint

This study is a single center trial to assess the safety and efficacy of intra-articular administration of Allocetra to patients with 1st CMC thumb joint osteoarthritis (OA).

Osteoarthritis (OA) of the first carpometacarpal (CMC) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. For patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment.

Allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state.

This study is a single center safety and efficacy assessment trial to assess intra-articular administration of Allocetra in patients suffering from thumb osteoarthritis in the 1st CMC joint (basal thumb joint) who have not responded sufficiently to conventional therapies.

The study is comprised of a safety run-in stage to characterize safety of Allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of Allocetra injection to the basal thumb joint.

Patients will be followed for up to a year following treatment.

Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for this clinical study must fulfill all of the following:

1. Age 40 years or older.
2. Patients with OA of the first CMC joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications.
3. Score of 6 or higher on the Functional Index for Hand Osteoarthritis (FIHOA).
4. X-ray confirming OA of the first CMC joint of the target thumb with a Grade of 2 or 3 according to Eaton classification.
5. Blood tests from up to three months before treatment within protocol-defined limits.

Exclusion Criteria:

Subjects not eligible for this study include those that have any of the following:

1. Any significant injury, fracture, surgery, active local infection, deformity, severe Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand.
2. History of chondrocalcinosis in the target joint, concomitant rheumatic disease.
3. Previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit.
4. Other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia.
5. Pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.).
6. Secondary OA such as gout, hemochromatosis, rheumatoid/psoriatic arthritis.
7. Bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results.
8. For women of childbearing potential, a positive pregnancy test.
Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study

More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion).

Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.

Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.

As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.

The DCCT (Diabetes Control and Complications Trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control.

This study aims to test this hypothesis of significant improvement after one year following CSII initiation on glycaemic control.

Two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit.

Thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures.

Glycaemic control will be assessed both by the evolution of HbA1c during the study period and its last level at the end of the study. Its evaluation will be completed by counting of all symptomatic hypoglycemia occurence during the study.

Eligibility Criteria:
Inclusion Criteria:

* Children (\<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII.
* Children for whom it is the first initiation of CSII.
* Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form.

Exclusion Criteria:

* Children with a history of diabetes less than 12 months.
* Children with HbA1c values below 7.5 or above 10 before CSII initiation.
* Children treated by CSII for more than 3 months.
Study of the Decrease of Length of Stereotactic Body Radiation Therapy in Lung Cancer

Purpose :

Non small cell lung cancer (NSCLC) is among the most common cancers in the werstern world. Patients with stage I have the most satisfactory outcomes. The gold standard for treatment is still surgery, but this approach has recently been challenged by hypofractionnated stereotactic body radiation therapy (SBRT). Therefore, for patients who are not eligible for surgery due to their significant co-morbidity, or for those who refuse surgical resection, stereotactic radiotherapy is an efficient practical alternative. SBRT is well tolerated and efficient, in fact local control rate at 3 years reaches more than 90%. Most of guidelines recommand a dose between 48 and 60 Gy delivered in 3 at 8 fractions and 3 weeks. Biological effect depends on the dose distribution in time and decreases when the number of fractions or length of radiation treatment increase. Decreasing the length of treatment and the interval between fractions may improve efficiency of treatment and local control rate. Moreover, it may improve quality of life of patients. Nevertheless, an evaluation of safety of such shorter treatment course, with a phase I-II clinical study is needed.

Intervention :

Stereotactic Body Radiation Therapy in the treatment of stage IA - IB non small cell lung cancer (T1N0M0 or T2aN0M0)

Study type : Interventional

Study design : Endpoint classification : safety/efficacy study Intervention model : single group assignment Masking : open label Primary purpose : treatment

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0)
* None histologic or cytologic diagnosis of non small cell lung cancer stage IA-IB (T1N0M0 or T2aN0M0) with evolutionary criteria (increase on two successive CT scan and pathological hyperfixation in the TEP scan)
* Resectable tumor but patient unfit for surgical resection
* Resectable tumor but patient refusing surgical resection
* KPS \> 60%
* Pulmonary functions: FEV \> 40% theoric value, PO2 ≥ 70mmHg, PCO2 \< 50mmHg
* Patient who can hold appropriate immobilization in dorsal decubitus during approximately 30 minutes
* Age 18 years or older
* Not affected by a mental disease
* Understanding and be informed of the investigational nature of this study and must give written consent prior to the receiving of treatment per this protocol
* Inscription at the French Social Security

Exclusion Criteria:

* Patient pregnant
* Patient deprived of freedom or under guardianship
* Pulmonary functions : FEV \< 40% theoric value, PO2 ≤ 70mmHg, PCO2 \> 50mmHg
* Prior thoracic radiation treatment
* Prior radiation pneumonitis
Incidence of Poorly Controlled Diabetes in Surgical Population

Our study aims to determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore using preoperative HbA1c as a screening tool.

The study aims to determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore using preoperative HbA1c as a screening tool.

The investigators aim to follow up on the incidence of perioperative complications in this cohort. In the longer term, the investigators hope to evaluate the role of a preoperative diabetic screening and intervention program as an opportunistic "teachable moment" for surgical patients. This may help to achieve greater control of the disease burden in Singapore.

Specific aims:

Specific Aim 1: To establish the incidence of undiagnosed diabetes/prediabetes among surgical patients in Singapore, based on HbA1c level ≥ 6.1% prior to surgery Specific Aim 2: To establish the incidence of poorly-controlled diabetes among surgical patients in Singapore, based on HbA1c level ≥ 8% prior to surgery Specific Aim 3: To identify and characterize any association between preoperative HbA1c level and postoperative outcomes

Eligibility Criteria:
Inclusion Criteria:

1. Age \>21 years old
2. able to give informed consent
3. Scheduled to have preoperative blood taken during clinic visit

Exclusion Criteria:

1. Age \< 21 years old
2. unable to given informed consent
3. Not required to have routine preoperative blood tests taken
Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention

we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce myocardial injury and improve clinical outcomes in patients undergoing PCI.

Ever since the inception of percutaneous coronary intervention (PCI), it has been apparent that some myocardial injury was often associated with the procedure, and even asymptomatic minor post-procedural myocardial necrosis does have an important prognostic signification. The possible mechanisms of periprocedural myocardial injury were often attributed to distal embolisation of atheromatous material during the procedure, occlusion of minute side branches, occlusive dissection or no-reflow.

Prostaglandin E1 incorporated in lipid microspheres (lipo-PGE1) is a new galenic form of PGE1, with PGE1 incorporated into soybean oil microspheres 0.2 micron in diameter, using lecithin as surfactant. This drug preparation can protect PGE1 against inactivation in the lung and has targeting effect to tissues injured by arterial occlusion. It was shown in the experiments that, by the pharmacological effects such as improving endothelial function, dilating coronary and systemic microvessels, inhibiting platelet aggregation and reducing ischemia-reperfusion injury, lipo-PGE1 had a more marked protective effect in arterial occlusive tissue injury and a more potent platelet aggregation inhibitory effect than free PGE1. Clinical studies have demonstrated that lipo-PGE1 is a very valuable agent for the treatment of peripheral vascular disorders and diabetic neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* the presence of a non-ST-segment elevation acute coronary syndrome (unstable angina or non-ST-segment elevation acute myocardial infarction) sent to early PCI (within 72h of the onset of symptoms)

Exclusion Criteria:

* a ST-segment elevation acute myocardial infarction, non-ST-segment elevation acute coronary syndrome with high-risk features warranting emergency invasive approach, left ventricular ejection fraction \<35%, previous revascularization, or renal failure with creatinine \>3 mg/dl
Circulating Tumor Cells in mCRC for Liver Resection

Resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after liver resection. To optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

This is a single-center prospective study to evaluate the predictive value of circulating tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have curative resection of liver metastasis. Blood will be taken from patients within 7 days before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform for which CTC can be subsequently enumerated with or without sequencing performed. Patients are then followed up regularly with contrast CT scan for recurrence. The primary study endpoint is to define the cutoff value of CTC count in patients with early relapse \< 6months after liver resection. Seventy-seven patients will be recruited in 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age\>=18 years
2. Signed informed consent
3. Histologically or cytologically confirmed colorectal adenocarcinoma
4. Both primary tumor and liver metastases are amenable to curative resection.

Exclusion Criteria:

1. Presence of extrahepatic metastasis
2. History of other malignancies in the last 5 years
3. Patients unable to comply with the protocol
Clinical Significance of Appendicoliths in Elderly Patients Over 80 Years Old Undergoing Emergency Appendectomy

Acute appendicitis with an appendicolith is one of the most common abdominal emergencies in elderly patients and is more likely to progress to gangrene and perforation. This study aimed to analyze the clinical data of patients over 80 years old who underwent emergency appendectomy for acute appendicitis, to explore the clinical significance of appendicoliths, and to improve treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* Patients who aged 80 years or older, who received conservative treatment for less than 24 hours before surgery, who had no peri-appendiceal abscess larger than 2 cm in diameter on CT scan, who underwent emergency appendectomy, and who had postoperative pathological confirmation of acute appendicitis.

Exclusion Criteria:

* Patients younger than 80 years, those with malignancies, and those with incomplete clinical or pathological records were excluded from the study.
MyPaTH Story Booth

The MyPaTH Story Booth will use an (audio) "document" approach to elicit in depth experiential knowledge or perspectives from patients and caregivers by recording their personal stories.

Modeled after the Storycorps project and healthtalk.org, MyPaTH Story Booth will use an (audio) "document" approach to elicit in depth experiential knowledge or perspectives from patients and caregivers by recording their personal stories. Narratives provide a powerful framework for understanding patient problems and the larger process of illness, coping, and seeking health care. Narratives can provide meaning, context, and perspective for patients' situations and insight into failures in health care delivery, particularly for marginalized patients. MyPaTH Story Booth will provide simple instructions for how participants can work with an interview partner (e.g., a family member or friend) to record their story. MyPath Story Booth may be launched sequentially at each PaTH site to establish an initial archive of patient and caregiver narratives. Individuals who record narratives will be asked to provide limited "tags" to populate a searchable database (e.g., their age, sex, interview topic). The audio booth and procedures will also be made available to PaTH affiliated researchers who wish to augment the narrative database with narratives of patient partners from specific study populations.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18

Exclusion Criteria:

* Researchers will exclude individuals who are not 18 years of age or older and/or do not provide informed consent
Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

Background: Chronic kidney disease (CKD) is a major public health threat associated with significant morbidity, high mortality, and reduced quality of life. However, empirical evidence is limited on strategies to enhance the effectiveness of care for CKD. The objective of the trial is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies in preserving kidney function among patients with CKD at primary care clinics in Singapore.

Methods: A pragmatic, randomized controlled trial, in 4 socioeconomically diverse primary care clinics (polyclinics) in Singapore over 3 years. A total of 896 participants with CKD Stage 3 or worse aged ≥40 and \<80 years will be enrolled, with 224 from each polyclinic. Participants enrolled in each polyclinic will be randomly allocated to the intervention or usual care group in a 1:1 ratio.

Intervention includes four components 1) training nurses as health coaches for motivational conversation and CKD specific lifestyle counseling on diet and exercise, using hybrid follow-up approach of in-person, telephone, and secure WhatsApp video meetings; 2)Training physicians in algorithm-based standardized management of CKD and hybrid care delivery;3) subsidy on sodium-glucose transport protein-2 inhibitors (SGLT-2i) for CKD; and 4) regular CKD case review meetings.

Patients in the usual care arm will be treated by physicians and nurses who and are not trained in SKOPE treatment algorithms.

Study outcomes:

The primary outcome will be the eGFR total slope from randomization to final follow-up at 36 months. secondary effectiveness outcomes will be 1) Change in CVD risk score as measured by The Million Hearts Longitudinal ASCVD Risk Assessment score 2) Change in CKD quality of life measured by KDQOL-36TM


Eligibility Criteria:
4.3 Inclusion Criteria

* Patients with CKD Stage 3 or Stage 4 defined as persistent reduction in Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula eGFR ≥15 and \< 60 ml/min/1.73m2 for at least 3 months based on two eGFR readings at least 3 months apart and the last eGFR should be measured at least 3 months ago.
* Receiving care at the polyclinics in Singapore for at least one year at the time of recruitment
* Age \>=40 and \<80 years
* Singaporean or permanent resident

4.4 Exclusion Criteria

* On kidney replacement therapy
* Pregnancy or breastfeeding
* Known terminal illness
* Recent hospitalization during last 3 months
* History of leg or foot ulcers, severe mental illness, prior kidney transplant
* Inability to provide informed consent
The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis

This study aime to investigate the effects of balance and proprioception exercises using two different methods (classical balance training and Balance System™ SD) in addition to strengthening exercises on dynamic balance, pain, functional status and quality of life in patients with knee osteoarthritis (OA).

It is known that knee OA leads to a decrease in proprioception and balance disturbances. Falls due to balance disorders often occur during dynamic activities such as walking and stair climbing. Therefore, correction of balance disorders is of great importance to prevent falls and associated fractures in the elderly population, in which knee OA is common. In addition, loss of proprioception in the knee joint, muscle weakness, and balance disorders are also known to contribute to the development of knee OA itself. Therefore, treatment of balance disorders may also slow the progression of the disease. This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This is a single-center randomized trial with 3 parallel arms.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they had a knee OA diagnosis according to the American College of Rheumatology (ACR) diagnostic criteria, had suffered from knee pain for at least six months, had radiologically verified bilateral knee OA of grade II or III according to the Kellgren-Lawrence classification and had not previously participated in a regular exercise program.

Exclusion Criteria:

* Patients who had undergone knee surgery, who had received hyaluronic acid or corticosteroid injections into the knee within six months, and patients with conditions that might affect balance were excluded from the study.