rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Paravertebral Block for Mastectomy With Immediate Reconstruction
Status: Not yet recruiting

Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively.

The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18-70 years of age woman scheduled for unilateral mastectomy with immediate reconstruction  Exclusion Criteria:  Patients who will have an axillary dissection during surgery. Woman with severe hepatic insufficiency (Child Pugh Classification B and above24). Woman with kidney failure stage 4 and above25. Body mass index (BMI) > 40 kg/m2. Woman with an allergy to local anesthetics. Woman with a bleeding disorder in whom BPV is contraindicated. Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia. Woman with a single lung. Pregnant woman. - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Nebulized Salbutamol in Acute Renal Colic
Status: Not yet recruiting

A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic.

Research Summary:

INTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department.

METHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge.

AIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic.

PRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS).

SECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge.

PATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colic

INTERVENTION: Single dose of Nebulized Salbutamol 10mg.

CLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented.

OUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient with classical acute renal colic symptoms. Age ≥ 18 years and < 60 years Hemodynamically stable vital signs. Mentally competent patient who can understand and sign the consent form.  Exclusion Criteria:  Patients who are allergic to Salbuamtol. Renal disease or transplant. Patients with pervious myocardial infarction and PCI. Active peptic ulcer disease. Liver cirrhosis. Couagulopathy. History of asthma , urticaria, or other allergic-type reactions after taking NSAIDs. Patient with any other contraindications to use of NSAIDs. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult
Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
Status: Recruiting

A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient with aged between 18 - 75 years old Closed isolated fracture midshaft of clavicle within 9 days after the injury date  Exclusion Criteria:  After bracing, fracture displacement and/or shortening > 2 cm or fracture comminution > 3 fragments Segmental fracture Open fracture Impending open fracture (soft tissue compromise/skin lesion) Ipsilateral upper extremities fracture which disturbs clavicular bracing Floating shoulder which surgical treatment is indicated. Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing Pathologic fracture Patient has limitation for clavicular brace application Pregnant women - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism
Status: Recruiting

The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.

The main question it aims to answer is:

• whether adding Vitamin D to standard therapy has any additional benefits

Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.

Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients of all genders. Age more than 12 years Biochemically hypothyroid (overt & subclinical) Vitamin D level between 10-70ng/ml TC <250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl  Exclusion Criteria:  Known Atherosclerotic Cardiovascular Disease BMI>35kg/m2 History of Alcoholism (>14 units/day) History of Beta blocker intake Patient taking lipid lowering drugs - HealthyVolunteers: No - Gender: All - MinimumAge: 12 Years - StdAgeList: Child, Adult, Older Adult
Digital Physiotherapy Treatment for Patients With Subacromial Pain Compared to Usual Physiotherapy in Primary Care
Status: Not yet recruiting

The goal of this clinical trial is to test a digital treatment for patients with subacromial pain using the digital Shoulder Aid (diSAID) strategy. The participants in this study will be randomly assigned to digital treatment (diSAID) or to receive the treatment that is currently available in primary care, i.e. continue according to usual practice.

The main question this clinical trial aims to answer are:

- Can the diSAID improve shoulder function and reduce pain for patients with subacromial pain in primary care?

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  >18 years old Pain duration >2 weeks Lateral shoulder pain (C5 dermatome)  At least three positive tests as follows:  Painful arc External rotation resistance test Jobe's test Neer's impingement sign Hawkin's-Kennedy's impingement test  Exclusion Criteria:  Symptoms are related to a traumatic event in the last 6 months with suspected rotator cuff tear, dislocation or fracture. Clinical features of cervical radiculopathy Clinical features of Adhesive capsulitis The patient does not understand or can not read Swedish The patient has no access to BankID - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Epidural Oxycodone for Pain Management for Lower Limb Amputation
Status: Recruiting

The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age 18 to 65 years. Both sexes. American Society of Anesthesiologists (ASA) physical status II or III. Undergoing lower limb amputation. Under epidural anesthesia.  Exclusion Criteria:  Hypersensitivity to opioids. Cardiac arrhythmias. Acute asthma or other obstructive airways disease. Severe renal impairment. Pregnancy. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Trajectory of Frailty and Cognitive Dysfunction in Older Adults
Status: Not yet recruiting

To explore the heterogeneity of the development trend of frailty and cognitive function of older adults.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥60 years. Older adults with clear consciousness, ability of simple written and verbal communication. They volunteered to participate in this study, and signed an informed consent.  Exclusion Criteria:  A clear diagnosis of any type of dementia. There are neurological diseases that clearly lead to cognitive dysfunction, such as severe cerebrovascular disease, brain trauma, intracranial tumors, etc. They have been clearly diagnosed with mental disorders affecting cognitive function, including schizophrenia, depression, bipolar disorder, etc. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Older adults without clear diagnosis of any type of dementia, neurological diseases, and mental disorders that affecting cognitive function. - SamplingMethod: Non-Probability Sample
Construction of Multicenter Retrospective Registry Cohort Database for Gallbladder Cancer
Status: Not yet recruiting

The aim of the study is to establishing a standardized clinical information database for patients with malignant tumors of gallbaldder. Based on the database, real-world clinical research on the diagnosis and treatment of biliary tract tumors is about to be carried out, and a high-standard cohort research foundation is laid for precision therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Sign informed consent, have good compliance, and be willing to accept follow-up and provide blood samples Age 18-74 years old, gender is not limited Clinical diagnosis of gallbladder cancer, including unoperated patients preliminarily diagnosed as gallbladder cancer according to the results of imaging examinations and laboratory tests, or pathological examination of patients treated with surgery confirmed as malignant tumors of the gallbladder. The primary tumor is located in gallbladder floor, gallbladder body, gallbladder neck or gallbladder duct. Karnofsky performance score greater than 50.  Exclusion Criteria:  Patients with gallbladder cancer, gallbladder cancer foci are not primary lesions. Patients with gallbladder cancer, combined with serious central nervous system diseases, respiratory diseases, autoimmune diseases, chronic renal insufficiency and other diseases, long-term use of immunosuppressants, combined with serious uncontrolled infections. Patients with gallbladder cancer, who also have active cardiovascular and cerebrovascular diseases, have cerebrovascular accidents, myocardial infarction, unstable angina pectoris, or grade II. or above congestive heart failure according to the standards of the New York Heart Association, and require serious arrhythmias requiring drug treatment. Patients with gallbladder cancer, women of childbearing age who have a positive blood pregnancy test or have not had a pregnancy test, pregnant or breastfeeding women. The patient is participating in other therapeutic clinical trials where treatment measures cannot be clarified or treatment information cannot be collected . - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 74 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients with gallbladder cancer diagnosed by pathology, and combined with clinical manifestations and imaging results, the first diagnosis and discharge were diagnosed as patients with gallbladder cancer. - SamplingMethod: Probability Sample
Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy
Status: Recruiting

Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Over 18 years of age Voluntarily sign informed consent The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor, lung cancer, breast cancer, stomach cancer, colorectal cancer, glioma, esophageal cancer, liver cancer, bile duct cancer, cervical cancer, prostate cancer, bladder cancer and other malignant tumors Need to be treated with immune checkpoint inhibitors ECOG PS Score: 0/1.  Exclusion Criteria:  There are contraindications to immunotherapy Combined with other tumors (basal cell or squamous cell skin cancer that has been cured, and cervical cancer in situ removed) External) Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose > 1.5 × ULN), and mental illness. At the investigator's discretion, those who was not considered to be suitable for participation in the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Cancer patients who need to accept immunotherapy - SamplingMethod: Probability Sample
Uses of Titanium Nail in Pediatric Fractures
Status: Recruiting

The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient Age ( 4 - 16 ) Years old. Both sex included . Simple or compound fractures (Grade I). Isolated fracture in the limb. Severely displaced fracture (Angulated). Recent and old distal radius fractures  Exclusion Criteria:  Ages below 4 years or above 16 years. Associated with other fractures in the same limb. Compound fractures ( Grade II,III). Comminuted or Pathological fractures. - HealthyVolunteers: No - Gender: All - MinimumAge: 4 Years - MaximumAge: 16 Years - StdAgeList: Child
Supporting Our Caregivers In ADRD Learning (SOCIAL)
Status: Not yet recruiting

Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.

The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.

Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years or older English fluency and literacy Meeting criteria for being a caregiver (e.g., family or friend of a care recipient who provides unpaid care) Must live with and care for an individual with ADRD Must have been in a caregiver role for more than 6 months Must provide an average 4 hours of supervision or direct assistance per day for the are recipient Perceived Stress Scale-4 (4-item) version >=6 Had managed 1 or more behavioral symptoms in past month  Exclusion Criteria:  Recent change in psychotropic treatment for depression or anxiety Use of mindfulness apps or any meditation (more than 60 min/week in past 6 months) Involvement in another clinical trial for caregivers, a score >= 4 on the Portable Mental Status Questionnaire (PMSQ) No stated concerns or distress related to care recipient's disruptive behaviors Involvement in another clinical trial for caregivers - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO
Status: Not yet recruiting

The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Age ≥ 18 years old VA-ECMO or VV-ECMO was accepted after cardiac surgery. The ECMO treatment team believes that systemic anticoagulation is needed Sign the informed consent form  Exclusion Criteria:  The researchers believe that there are other causes of active bleeding that are not suitable to participate in this study. Long-term use of anticoagulants before establishment of ECMO Antiplatelet drugs were used before the establishment of ECMO Severe liver insufficiency Connective tissue disease There is a history of allergy to heparin or nemolastat mesylate. Pregnant Previous diagnosis of heparin-induced thrombocytopenia Expect to die within 48 hours ECPR - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
GAIN Project: Gastric Cancer and Artificial Intelligence
Status: Not yet recruiting

Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.

The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  All >60 years-old patients undergoing upper-gastrointestinal (GI) endoscopy for selected indications in Italian areas at high-risk of gastric cancer (Lombardia, Emilia Romagna, Veneto, Friuli-Venezia Giulia).  Exclusion Criteria:  contraindications to upper-GI endoscopy. contraindications to biopsy. active upper-GI bleeding or urgent upper-GI endoscopy. patients with previous upper-GI surgery involving the stomach. patients who were not able or refused to give informed written consent. - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - StdAgeList: Adult, Older Adult
Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients
Status: Recruiting

The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Subjects waiting for Elective Cardiac Surgery (CABG, Cardiac Valve Operation, Congenital heart anomaly surgery, aortic surgery, etc.) Subjects over the age of 18 Patients with type 2 diabetes  Patients with prediabetes  HbA1c 5.7% or more fasting blood glucose 100 mg/dL or more 2 hours 75g-OGTT 140 mg/dL or more  Exclusion Criteria:  Emergency surgery patients Patients performing co-operation other than cardiac surgery Patients with type 1 diabetes Total Pancreatectomy patients Patients with high surgical severity (STS score of 8 or more or EURO score of 5 or more) Patients who do not consent to the study  Severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion)  Cases where severe weight gain and severe edema occur after surgery Cases where the surgery time is significantly longer than average Cases where cardiopulmonary bypass is used more than once during surgery Others who are deemed unsuitable for research progression at the researcher's discretion - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult