cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effect of M-TAPA and TAPB on Laparoscopic Cholesistectomy

Cholecystectomy is the most frequently performed abdominal surgery in developed nations, with laparoscopic cholecystectomy being recognized as the gold standard technique for treating gallstones.

The efficacy of TAP block for pain relief has been well-documented following laparoscopic cholecystectomy procedures. Recently, m-TAPA block has emerged as an alternative analgesic technique for abdominal surgeries.

This study aims to evaluate and compare the effectiveness of these two analgesic methods in managing postoperative pain after laparoscopic cholecystectomy.

Cholecystectomy is the most commonly performed abdominal surgery in developed countries, with laparoscopic cholecystectomy regarded as the gold standard technique for gallstone treatment.

Postoperative pain following laparoscopic cholecystectomy is influenced by several factors, making it a complex and predominantly visceral pain. These factors include phrenic nerve irritation due to CO2 insufflation, abdominal distension, port site incisions, the effects of gallbladder removal, and individual patient characteristics.

Regional analgesia has gained widespread acceptance from both patients and physicians, becoming a key component of multimodal analgesia techniques. The transversus abdominis plane (TAP) block has proven effective in reducing postoperative pain in surgeries such as hysterectomy, cholecystectomy, cesarean section, and colorectal procedures.

The Ultrasound (US)-guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) involves administering a local anesthetic to the underside of the perichondral surface. This technique provides effective analgesia for the anterior and lateral thoracoabdominal regions.

The purpose of this study is to compare the efficacy of US-guided M-TAPA block with TAP block for postoperative analgesia following cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of
* Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Combined Effects of Visceral Manipulation and Noble Technique on Post-partum Females With Diastasis Recti

Diastasis recti is characterized by an abnormal expansion of the gap between the medial sides of the rectus abdominis muscle and a lengthening of the linea alba (increased inter-recti distance). It is mainly caused by excessive intra-abdominal pressure. The abdominal muscles and connective structures expand from the growing uterus during pregnancy. Low back pain is a prevalent complaint that can result from various factors, including weakened core muscles and functional disability. The aim of the study would assess of combined effect of visceral manipulation and noble technique on Inter-rectal distance, low back pain and functional disability in post-partum females with diastasis recti.

A randomized controlled trial will be conducted in DHQ Hospital Toba Tek Singh. A nonprobability convenience sampling technique will be used. There will be 34 participants. Participants will meet with inclusion criteria and be divided into two groups A and B. In Group A 17 participants will receive visceral manipulation technique with noble technique for 30 minutes per session, three sessions per week for 6 weeks. While in Group B 17 participants will just receive noble technique exercises for 15 min per session, three sessions per week for 6 weeks. Participants will be assessed before and after treatment through; Digital nylon calipers for diastasis recti, NPRS for pain, and Quebec Back Pain Disability Scale (QBPDS) to assess LBP-related functional. Data will be analyzed during SPSS software version 21

Eligibility Criteria:
Inclusion Criteria:

* Age between 22 to 35.
* Primiparous women with vaginal delivery and an IRD of \>2 cm.
* Three to six months postpartum with the presence of diastasis rectus abdominis.
* Patients having moderate low back pain in NPRS.

Exclusion Criteria:

* Acute Malignancy
* Recent Abdominal or Pelvic surgery
* Having undergone spinal surgery in the previous six months
* Serious spinal pathology
* Serious cardiovascular or metabolic disease Pregnancy
* Herniation pain
Heart Disease and the Black Health Disadvantage

To utilize national population data sets prepared by the National Center for Health Statistics, to (1) examine the current Black disadvantage in cardiovascular (CV) health, (2) explore potential clinical and epidemiologic causes, (3) incorporate emerging knowledge of new risk factors and (4) compare trends in medical treatment and risk factors for the four sex-race groups.

BACKGROUND:

The Black health disadvantage remains a pressing public health issue in the United States. According to the Department of Health and Human Services 'Black and Minority Health Report', 65,000 excess deaths occur each year among Blacks when compared to the mortality experience of whites. Cardiovascular diseases make by far the largest contribution to this loss of life, accounting for over 30 percent of the excess. Despite improvements in CV mortality for all four major sex-race groups during the 1970's, the trends in heart disease in the United States began to diverge. A 50 percent slowing of the decline in coronary mortality occurred among Blacks from 1978-1986, compared to whites, and the gap in life expectancy between the races has widened. As noted in the 'Report', despite the widespread recognition of the importance of the problem, our knowledge regarding the causes of these differentials in CV disease was inadequate. To address this problem, the Report recommended support for 'innovative uses of current data' and 'cross-comparisons from different data sets', emphasizing the unique contribution population-based studies can make to 'understanding the health status and needs of minority populations'. Given the deterioration of the Black health status relative to the majority population, these recommendations took on new urgency.

DESIGN NARRATIVE:

Several separate analyses were conducted of prevalence surveys, epidemiologic followup studies, hospitalization surveys and vital statistics. These separate analyses were subsequently combined into a comprehensive description of the clinical and epidemiologic determinants of the Black CV disadvantage, and its future trends.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
LifeWalker Upright Walker vs. Conventional Rollator Walker and Predicate Device

The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device.

The LifeWalker Upright is a walker that has been designed to address fall risk, slouching, and user confidence and comfort. The LifeWalker has adjustable armrests and handles that enable users to stand tall and look ahead, providing support and stability that is designed differently than conventional walkers. The LifeWalker Upright's design allows the user to walk within the walker. This allows people to walk inside the walker as opposed to behind the walker.

The purpose of this project is to evaluate if the LifeWalker Upright walker is improves walking and reports of pain compared to a conventional rollator and predicate walker device

Aim 1: Perform in-laboratory training on the Life Walker and testing to compare functional gait outcomes with the Life Walker compared to a conventional rollator and predicate assistive mobility device. We expect that participants will be able to walk longer and will perform more efficiently on measures of gait function when using the Life Walker.

Aim 2: Perform in-laboratory testing to compare self-reported pain with the Life Walker compared to a conventional rollator and predicate assistive mobility device. We expect that participants will report less pain because they will have a more efficient and upright posture when using Life Walker.

Aim 3: Perform in-laboratory testing to compare measures of quality of life with the Life Walker compared to a conventional rollator and predicate mobility device. We expect that participants will report better outcomes on quality of life measures because they will experience better self-esteem due to better mobility when using Life Walker.

Participants will first complete a series of gait testing. Gait testing will include the six minute walk test and the 10 meter walk test. In addition there will be hand and forearm load and grip testing using load sensors. Participants will also be asked to be videotaped during their training sessions. After all the testing is complete, participants will be asked to complete a set of self-report questionnaires. During each device session, participant heart rate, blood pressure and blood oxygenation will be measured. All of these procedures will be repeated with each device.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who use a walker due to back pain or adults (over 18) who use a walker for ambulation.
* Ages from 18 to 89 years old
* Medically stable for therapy

Exclusion Criteria:

* Patient weight exceeds 300 lbs
* Patient height is below 5'0" or exceeds 6'3"
* Inactive, physically unfit to fit into the device.
* Cognitive deficits or visual impairment that would impair their ability to give informed consent or to follow simple instructions during the experiments.
* Mini-Mental State Exam (MMSE) score below 17
* Pregnant women
* Co-morbidity that interferes with the study (e.g. stroke, pace maker placement, severe ischemia cardiac disease, etc.)
Impact of Darbepoetin Alfa on Exercise Tolerance and Left Ventricular Structure in Subjects With Symptomatic Congestive Heart Failure (CHF) and Anemia

The purpose of this study was to evaluate the effect of treatment with darbepoetin alfa on peak oxygen consumption (peak VO2) in subjects with symptomatic CHF and anemia.


Eligibility Criteria:
Inclusion Criteria: - Symptomatic CHF for at least 3 months - Reduced left ventricular ejection fraction - Stable heart failure medication - Peak VO2 less than or equal to 16 ml/kg/min - Hemoglobin concentration between 9.0 and 12.0 g/dL Exclusion Criteria: - Hypertension - Unstable angina pectoris or recent myocardial infarction - Likely to receive cardiac transplant - Unable to do cardiopulmonary exercise testing - Major organ transplant (e.g., lung, liver, heart) or renal replacement therapy (e.g., dialysis) - Recent or current treatment for malignancy - Systemic hematologic disease - Anemia due to acute or chronic bleeding - Recent Epogen® or darbepoetin alfa therapy - Recent blood transfusion
Diagnosis of PCL With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy

Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. However, imaging modalities for characterising PCL is a known clinical uncertainty since imaging is capable of detecting these lesions but may often not be able to distinguish malignant from benign lesions. Incorrect assessment of PCL can lead to fatal consequences because a malignant lesion may not be treated and a benign may be unnecessarily resected. The aim of this study was to assess the performance of endoscopic ultrasound with fine-needle aspiration (EUS-FNA) in the diagnosis of pancreatic cystic lesions compared to cross-sectional imaging modalities (CT/MRI). Our hypothesis is that EUS-FNA has a higher accuracy for diagnosing PCLs compared with cross-sectional imaging.


Eligibility Criteria:
Inclusion Criteria:

Patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017, who underwent pancreas resection

Oral and written consent of patients examined

Exclusion Criteria:

None
Severe Head Trauma: Coagulation and CT-Scan Aggravation.

Retrospective, multicenter cohort study describing the biological, radiological and clinical criteria of patients managed for isolated severe head trauma between January 2016 and December 2018.

The objective of the study is to describe the evolution of CTscan lesions in patients with isolated Head Trauma between admission and re-evaluation after 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Patients informed and did not object to the collection of their medical data for the study
* Patient admitted in Trauma center between January 2016 and December 2018 severe head injury defined by a Glasgow Coma Scale (GCS) \< 9 AND/OR Abnormalities on the first brain CT-scan with pathological transcranial Doppler (Vd \< 25 cm/s and IP \> 1.25)

Exclusion Criteria:

* Abbreviated Injury Score (AIS) head and neck ≤ 3 AND/OR AIS out of head and neck \> 3
* Taking drugs that interfere with hemostasis, such as anticoagulant or antiplatelet antiaggregants in preventive or curative doses;
* Patients under guardianship
* Patients still alive at the time of data collection AND opposed to the collection of their data
Multi-omic Approach to Cancer Diagnosis: the Italian Network of Excellence for Advanced Diagnosis (INNOVA)

The INNOVA project aims to create an advanced multidisciplinary diagnostic platform to support the Italian healthcare system and translational research. In this context, WP7, coordinated by the Pascale Institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.

The study is multicentric, observational, non-interventional, and both prospective and retrospective.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in the study
* Age \>18 years
* Performance status (PS) 0-1
* Availability of biological samples for multi-omic profiling
* Availability of radiological images for radiomic assessments
* Patients with metastatic disease, i.e., stage IV (except for melanoma, where stage II/III patients eligible for adjuvant therapy may also be considered)
* Patients eligible for targeted therapy and/or immunotherapy
* Patients with aggressive neoplasms, including melanoma, non-small cell lung carcinoma (NSCLC), colon carcinoma (BRAF-mutated, MSI), triple-negative breast cancer, ovarian cancer, and cholangiocarcinoma.

Exclusion Criteria:

* Previous line of immunotherapy or targeted therapy
* Previous radiotherapy at the sites of the most recent diagnostic biopsy
* Most recent diagnostic biopsy performed \>24 months before enrollment
* Absence of measurable lesions
* Presence of active or untreated brain metastases or leptomeningeal carcinomatosis
Longitudinal MR Imaging of Pulmonary Function in Patients Receiving Thoracic Radiation Treatment

The purpose of this study is to determine whether magnetic resonance imaging (MRI) using inhaled hyper polarized xenon-129 (129Xe) gas, and conventional contrast can help visualize impaired lung function and detect changes over time in patients receiving treatment as well as those who don't. 129Xe is a special type of xenon gas and when inhaled during MRI may be able to show areas of abnormal thickening of parts of the lungs. These images combined with images taken with injected contrast agents or other special types of MRI such as conventional proton (1H) MRI may provide a better way to look at lung structure and function. The ultimate goal is to predict the degree of radiation-induced lung injury that will develop in a given patient for a given treatment plan. The investigators anticipate that these images will provide more specific information about lung disease than standard lung function tests. The use of 129Xe MRI is investigational. Investigational means that these tests have not yet been approved by the US Food and Drug Administration and are only available in research studies like this one. In addition, standard MRI with contrast is not typically done as standard of care for monitoring changes due to thoracic radiation therapy, therefore, its use in this study is also considered investigational.

Healthy volunteers are being asked to participate in this study because to develop a database of functional images that are representative of healthy lungs.


Eligibility Criteria:
Inclusion Criteria for Patients:

1. Patient scheduled to undergo thoracic RT at Duke University to a dose of at least 20 Gy
2. Willing and able to give informed consent and adhere to visit/protocol schedules

Exclusion Criteria for Patients:

1. Subject is less than 18 years old
2. MRI is contraindicated based on responses to MRI Screening questionnaire
3. Subject is pregnant or lactating
4. Respiratory illness of a bacterial or viral etiology within 30 days of MRI
5. Subject has any form of known cardiac arrhythmia
6. Subject does not fit into 129Xe vest coil used for MRI
7. Subject cannot hold his/her breath for 15 seconds
8. Subject deemed unlikely to be able to comply with instructions during imaging
9. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Inclusion/Exclusion Criteria for Healthy Volunteers

1. Subject meets all criteria above but does not have a clinical diagnosis of respiratory disease.
Effect of Nusinersen on Adults With Spinal Muscular Atrophy

Observational study of adult patients with spinal muscular atrophy types 2 and 3 receiving nusinersen

Observational study to assess effects of nusinersen on motor function in adult patients with spinal muscular atrophy who are both ambulatory and non-ambulatory. Subjects will receive standard of care with nusinersen intrathecal injection and undergo baseline and every 6 month motor assessments and pulmonary function testing during the first two years of treatment with nusinersen.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed 5q SMA
* ability to access intrathecal space for nusinersen injection

Exclusion Criteria:

* Renal impairment
* thrombocytopenia
* inability to access intrathecal space by CT or flouro guided injection
Comparison of Surgical Site Infection Rate Between Primary, Delayed Primary and Vacuum Assisted Closures.

The objective of the study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.

The objective of this study is to compare infection rates between primary, delayed primary and vacuum assisted closures in contaminated and dirty/infected laparotomy wounds.

Social, demographic, surgical, postsurgical and medical variables were registered. A descriptive analysis expressed as total and percentages, medians and interquartile ranges. Comparison between groups was made using the Kruskal-Wallis, U-Mann Whitney or Chi-squared as appropriate. A p value of less than 0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Laparotomy wound classified as class III or IV according to CDC's Criteria for Defining a Surgical Site Infection.

Exclusion Criteria:

* Patient refusal to participate in the trial
Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome

The purpose of this study is to determine the ability of acute exercise to regulate fat metabolism in muscle of overweight and obese people compared to lean people.

After being informed about the study details and possible risks and benefits, 15 overweight/obese and 15 lean participants gave written informed consent and were then screened and enrolled in the study. All participants then gave a muscle sample and ate a calorically controlled breakfast. Participants completed \~1 hour of cycling exercise on a stationary bike and gave a second muscle sample 4 hours after eating breakfast.

Eligibility Criteria:
Inclusion Criteria:

* healthy males that completed a physical examination with a State Licensed M.D. or D.O. within the past 2 years and completed a physical activity readiness questionnaire (PARQ), the International Physical Activity Questionnaires (IPAQ) and and a medical history questionnaire prior to the study

Exclusion Criteria:

* any participants that had not had a physical examination by a State Licensed M.D. or D.O. within the past 2 years
* persons not considered "healthy" (with any previous medical diagnoses) or not medically cleared by a M.D. or D.O. to perform physical activity/exercise
* persons who are regularly physically active
Sand Play vs. Cuff Training: Visual-Motor Skills in Autism

This study compares Image-Sand Play Therapy and Tabletop Training with Weighted Cuffs for improving Visual-Motor Integration (VMI) in children with autism. A 12-week randomized controlled trial will be conducted at Tanzeem-ul-Nisan, Faisalabad. Beery VMI will assess outcomes. Data will be analyzed using SPSS-23. Non-probability conventional sampling will be used. Sessions occur twice weekly.

This study compares the effectiveness of Image-Sand Play Therapy and Tabletop Training with Weighted Cuffs in improving Visual-Motor Integration (VMI) in children with autism.

Methods: A randomized controlled trial will be conducted with children diagnosed with autism from Tanzeem-ul-Nisan, Faisalabad. Participants will be randomly assigned to either intervention group. Both therapies will run for 12 weeks, with two sessions per week.

Image-Sand Play Therapy: Creative sand tray play guided by a therapist.

Tabletop Training: Structured tasks with weighted cuffs for proprioceptive input.

Assessment Tool: Beery VMI

Sampling: Non-probability conventional sampling

Data Analysis: SPSS version 23, using baseline, mid, and post-intervention scores to compare effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-8 yrs

  * A diagnosed by Autism
  * Guardian of child patients signed the informed consent
  * Both gender male and female

Exclusion Criteria:

* Complication of serious medical disease

  * Children and parents who cannot comply with the research
  * Surgical procedures performed in the year prior to the study
  * Poor medical conditions preventing participation