cyrilzakka/clinical-trials huggingface dataset:
Pain Neuroscience Education in Patients With Total Knee Arthroplasty

The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and physiological processes involved in a pain experience and, more importantly, defocus the issues associated with the anatomical structures. PNE provides compelling evidence in reducing pain, disability, pain catastrophization, and limited physical movement in musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal problem, especially in people over 50 years old, and lead to decrease in knee range of motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor outcomes are common. The lack of satisfactory results suggests that some practices should be revised. Although PNE could be useful as an intervention, to our knowledge, there is no randomized controlled trial in the literature investigating the effects of PNE in patients with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in patients with KOA.


Eligibility Criteria:
Inclusion Criteria:

* Having a body mass index between 19-40 kg/m2,
* Having had a unilateral TKA,
* Knee pain score to be 4 and above daily according to the visual analog scale,
* Ability to read, speak and understand Turkish.

Exclusion Criteria:

* Prosthesis disorders requiring re-surgery,
* Having visual, auditory and cognitive impairment,
* Secondary TKA such as rheumatoid arthritis,
* Acute pain,
* Pregnancy, drug and alcohol use,
* Having bilateral TKA,
* Not volunteering to participate in the study
The Safety and Efficacy of Neramexane in Patients With Moderate to Severe Alzheimer's Disease

Memory loss and difficulties with thinking associated with Alzheimer's disease may be due to chronic release of a brain chemical called glutamate. Glutamate helps transmit messages between nerve cells through interaction with a certain type of receptor (N-methyl-D-aspartate, NMDA) on the cell. Neramexane is a new drug that blocks the effects of excessive glutamate at the receptor (NMDA receptor antagonist).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of moderate to severe Alzheimer's disease;
* ambulatory patients

Exclusion Criteria:

* folate deficiency;
* clinically significant central nervous system disease other than Alzheimer's disease;
* clinically significant pulmonary, gastrointestinal, renal, hepatic, endocrine or cardiovascular disease
Effect of Paired Testing to Poorly Controlled Chinese Diabetes on Glycemic Control and Self Care

This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled diabetes patients in China.

Self monitoring of blood glucose (SMBG) in insulin treated type 1 and type 2 diabetics has consistently been demonstrated to confer benefits, and is considered an essential part in the management of diabetes. In China, utilization of SMBG among diabetes patients is low. Even among those who perform SMBG regularly, the daily testing frequency falls short of those recommended in international and national clinical guidelines. There is thus a need to create the awareness of the benefits of SMBG and at the same time establish a SMBG regimen that is deemed practically feasible and cost effective for diabetes patients.

Paired testing entails the act of measuring glucose level before and after an event that may impact the glucose level in a patient, e.g. meals, exercise, medication adjustment, and thereafter responding to any abnormal glucose levels/patterns by modifying lifestyle and/or medication.

This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioral aspects of poorly controlled diabetes patients in China.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes mellitus
* HbA1c ≥ 8% measured within the a month prior to enrolment
* Have not been performing SMBG on a regular (daily) basis within the 3 months prior to enrolment
* Willing and able to use Accu-Chek® Active blood glucose meter to perform daily SMBG
* Willing and able to complete participant questionnaires
* Willing and able to visit the physician at month 3 and month 6
* Provide informed consent prior to enrolling in the study

Exclusion Criteria:

* Any retinopathy that required photocoagulation or retinal surgery in the 6 months prior to enrolment or that may require photocoagulation or retinal surgery during the study
* Any clinically significant condition that required hospitalization in the last 2 months prior to enrolment or that may require hospitalization (e.g. elective surgery) during the study
* Any clinically significant psychosis or cognitive impairment
* Unlikelihood to comply or complete the study
* Women who are pregnant, lactating or planning to become pregnant during the study period
University of Minnesota Transplant Registry

Under Transplant Information Services (TIS), the University of Minnesota Transplant Registry (UMTR) will serve as the repository for core research data.

UMTR is a system of ongoing registration of cases seen in the transplant program at the University of Minnesota. The registry will: (1) provide core outcomes data and background information necessary to conduct outcomes management research in solid organ transplantation and advanced lung disease, and (2) support cutting edge research through existing program specific databases in liver, intestine, pancreas, islet, kidney, heart and lung transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Received a transplanted organ at the University of Minnesota
* Living donor who donates an organ at the University of Minnesota

Exclusion Criteria:

* Did not receive a transplant at the University of Minnesota
* Did not donate an organ at the University of Minnesota
Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1

The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>/=30 kg/m2
* willingness and ability to follow the proposed dietary intervention
* informed consent

Exclusion Criteria:

* previous or planned bariatric surgery in the next 1 year
* current or planned participation in any structured weight-loss programs in the next 6 months
* current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
* bipolar disorder or attention deficit hyperactivity disorder
* current use of anti-depressant or anti-psychotic medications
* eating disorder or any other active disorder that may lead to significant weight changes
* working night shifts
* pregnancy or planned pregnancy in the next 1 year
* uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin
Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis

The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:

Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?

Patients will be closely followed and clinical information will be recorded.

Acute pancreatitis is one of the most common causes of acute hospital admission, which is unpredictable and contributes to high health-care costs even death. Recurrent acute pancreatitis is defined as two or more discrete episodes of acute pancreatitis, and has an estimated annual incidence of 8-10 per 100 000. Cholelithiasis, alcohol and Hyperglyceremia are the most commonly recognized causes of acute pancreatitis. About 80% of RAP patients can be identified through routine investigations identify (include proper history, physical examination, CT, MRI, endoscopic ultrasound); however, in up to 20% of cases whose cause remains unclear are known as idiopathic RAP. For RAP patients with clear cause, removal of the cause can effectively reduce or prevent recurrence. For patients with idiopathic RAP, the treatment options are not clear and have been subject to debate. At present, the natural course, outcome and therapeutic effect of RAP is still not clear. Therefore, the prospective cohort can clarify the clinical characteristics of RAP more comprehensively and deeply and to accumulate evidence for treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent acute pancreatitis.

Exclusion Criteria:

* Unwilling or unable to provide consent.
Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Type 2 Diabetes Mellitus

The study is aimed to evaluate the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating selective patients with type 2 Diabetes Mellitus. We hypothesized that autologous bone marrow stem cell transplantation would promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulate local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

To study the safety and efficacy of bone marrow mononuclear cell transplantation in type 2 diabetics. According to the intervention and baseline characteristics, patients are divided into 4 arms.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* age 30-70
* stable doses of medication for at least 3 months
* BMI \<35 and \>18.5

Exclusion Criteria:

* secondary cause for hyperglycemia
* pregnancy or nursing
* positive autoimmune antibody of diabetes
* severe complication or concurrent diseases
* active infection or febrile illness
* allergy to iodine
* history or signs of aortic aneurysm
* history or active pancreatic diseases
* known substance abuse or alcoholism or heavy smoking
* not suitable for other conditions upon investigators' expertise
Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy

To compare the postoperative analgesic effect of two ultrasound guided approaches of quadratus lumborum block (QLB) (anterior and intramuscular) for radical cystectomy.

The quadratus lumborum block (QLB) is one of the abdominal wall block techniques used to anesthetize thoracolumbar nerves . The QLB technique was described initially by Blanco et al. in 2007 (not published), then reported initially by Kadam in 2013. Since then, QLB has evolved with the development of the ultrasound-guided nerve block. To date, several randomized controlled trials have reported effective postoperative analgesia, with non-intramuscular QLB for cesarean sections, laparoscopic gynecologic surgery and hip hemiarthroplasty .

The intramuscular QLB (QLBi) technique was first reported by. This approach is different from others in tubouchi for QLB; although the injection target sites of the other approaches are planes around the quadratus lumborum muscle, the intramuscular approach penetrates the fascia of the quadratus lumborum muscle, where local anesthetics are injected. Therefore, QLBi is relatively easier to perform compared with other QLB approaches.

The incidence of urinary bladder cancer in the Middle East and Africa is greater in areas with high rather than low SH prevalence.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40-70years.

  * BMI: 20-30 kg.m2
  * Sex: both males and females.
  * American Society of Anesthesiologists (ASA )physical status: I-III.
  * Operation: radical cystectomy

Exclusion Criteria:

* • Patient's refusal to participate in the study.

  * known allergy to local anesthesia (LA),
  * coagulopathy or thrombocytopenia,
  * body mass index (BMI) above 30 kg .m 2, and infection at site of injection.
  * Chronic pain syndromes,
  * Prolonged opioid medication,
  * Patients on regular use of analgesic or who received analgesic 24 h before surgery
Outcomes of Acute Myeloid Leukemia Patients

1. To assess overall survival of AML patient.
2. To measure rate of disease free survival.
3. rate of non relapse mortality.
4. rate of complete remission .
5. percentage of refractory disease.
6. percentage of relapsed disease.

Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow which is characterized by malignant clonal expansion and differentiation arrest of myeloid progenitor cells.

The etiology of AML is heterogeneous. In some patients, prior exposure to therapeutic, occupational or environmental DNA-damaging agents is implicated, but most cases of AML remain without a clear etiology.

The incidence of AML had been higher than that of the other three subtypes of leukemia ( \[ALL\], \[CML\], and \[CLL\])\& accounts for the highest percentage (62%) of leukemic deaths.

AML is primarily a disease of older adults. The age-adjusted incidence for those aged 65 years or older is 20.1 per 100,000 persones in comparison to 2.0 per 100,000 person-years for those younger than 65 years old.

Males are 1.2-1.6 times more likely to develop AML during their lifetime as evidenced by population-based studies in the US, UK, Canada, Denmark, Australia and Algeria. AML is one of the most common form of Hematological Malignancy in adults and has the shortest survival (5-year survival = 24%). Curative therapies, including intensive chemotherapy and allogeneic stem cell transplantation, are generally applicable to a minority of patients who are younger and fit, while most older individuals exhibit poor prognosis and survival. Differences in patient outcomes are influenced by disease characteristics, access to care including active therapies and supportive care, and other factors. After many years without therapeutic advances, several new therapies have been approved and are expected to impact patient outcomes, especially for older patients and those with refractory disease.

Eligibility Criteria:
Inclusion Criteria:

* AML patients, aged more than 18yrs and received chemotherapy (aggressive or palliative).

Exclusion Criteria:

* patients less than 18years old.
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices

This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative.

The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.

The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.

The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subject of legal age at the date of implantation;
* Subject implanted with one or more implants: FAST Screw, FAST Plate, Toe FAST and VEOFIX Screw between November 2021 and October 2022;
* Subject able to understand the information and instructions given by the investigator;
* Subject with a social security affiliation.

Exclusion Criteria:

* Vulnerable persons
* People with contraindications (including pregnant women)
Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer

Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
2. Cooperative and mentally stable patients .

Exclusion Criteria:

1. Hepatic patients .
2. Uncontrolled hypertension .
3. Uncontrolled diabetic patients with HbA1c\>8.5% .
4. Neurological disorders .
5. Musculoskeletal disorders that interfere with program .
6. Previous history or any sign of DVT .
The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.

In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo.

Study Design: Double-blind, randomized, placebo-controlled, parallel-group study.

Objective: To investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery on operative time, estimated blood loss and complications.

Summary of Background Data: Studies have shown that TXA reduces blood loss during major spine surgery. There are no studies on the effect of TXA in minor lumbar spine surgery on operative time, intraoperative and postoperative blood loss and complications.

Methods: We enrolled patients with ASA grades 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA or history of convulsion were excluded. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).

Eligibility Criteria:
Inclusion Criteria:

* patients referred to the Centre for Spine Surgery and Research in the Region of Southern Denmark with symptomatic, MRI-verified lumbar spinal stenosis or disc herniations
* low risk (American Society of Anesthesiologists, ASA, score 1-2) adult patients scheduled for elective primary decompression or/and discectomy over one to two vertebral levels (without fusion or instrumentation), willing to give informed consent.

Exclusion Criteria:

Not able to understand verbal and/or written Danish ASA score more than 2 Malignant disease Pregnancy Breast feeding

Contraindications to TXA:

Active thromboembolic disease Coagulopathy History of venous or arterial thrombosis Hypersensitivity to the active substance Disseminated intravascular coagulation Severe renal impairment History of convulsions ASA - American Society of Anesthesiologists score, TXA - Tranexamic acid.
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
* Subject met eligibility criteria of IDE study
* Subject agrees to complete study follow-up visits
* Subject provides written informed consent

Exclusion Criteria:

* Subject currently participating in another device or drug study
* Subject unable or unwilling to return for study follow-up visits
Study of Iodine Contrast Media Extravasation

The purpose of this study is to determine the best intervention after the extravasation of the iodinated contrast medium out of a vessel into the surrounding tissues.

The risk of intravenous extravasation of iodinated contrast media has a relatively low incidence, although the increase in requests for computed tomography scans where it can manage contrasts with a large volume, high osmolality, high-speed injection pumps and even with an added electrical load, has caused an increase in this risk and its complications.

When there is an extravasation of iodinated contrast medium, in most published recommendations and guidelines advise local conservative measures, but there is no consensus on whether cold or heat should be applied as the first intervention to minimize the consequences and favour a rapid resolution.

This study aims to evaluate the effectiveness of the application of heat in the extravasations of iodinated contrast, providing the necessary evidence to determine the best cure that can be applied in the current circumstances of administration, by injection pumps at high speeds and large volumes.

Eligibility Criteria:
Inclusion Criteria:

* Computed tomography procedure.
* Administration of the contrast medium with injection pump between 1,5 and 8 ml/s.
* Peripheral venous access in the arms or legs.

Exclusion Criteria:

* Administration of the contrast medium with central venous access.
* Renal insufficiency.
* Iodine allergy.
* Immediate acute complications.
Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection

Studies have demonstrated that the rate of change in stroke volume variation (SVV) can be used to determine the volume of body fluids during major abdominal surgery. Anaesthesiologists can use SVV as a guide for the appropriate administration of intraoperative fluids to improve postoperative prognoses. Liver surgery is a major abdominal operation, and the amount of blood lost is typically higher than that during other general abdominal surgeries. Blood loss is positively correlated with the intraoperative fluid infusion volume, and greater blood loss is associated with more postoperative complications. Additionally, comorbid liver disease or cirrhosis can increase the complexity of liver tumour resection, causing difficulty in assessing intravascular volume and determining the appropriate intraoperative infusion volume.


Eligibility Criteria:
Inclusion Criteria:

* We initially selected 118 patients who required hepatectomy.
* The physiological status of the patients was assessed in terms of American Society of Anesthesiologists scores I-III

Exclusion Criteria:

* Extreme body mass index (BMI)
* Age under 20 or over 75 years
* Emergency surgery
* Preexisting cardiac, hepatic, renal, or coagulation disorder; hyperthyroidism; and sinus arrhythmia.