cyrilzakka/clinical-trials huggingface dataset:
Knee Arthroscopy for Pain Control

This study aims to determine the effectiveness of an anterolateral genicular nerve block and portal anesthesia in controlling pain in the perioperative period after knee arthroscopy. Opioid consumption, the use of non-opioid medications, complication rate, and sleep quality will also be measured.

Orthopaedic surgeries are some of the most painful operations to recover from, especially when involving cruciate ligaments. Because of this, orthopaedic surgeons have worked to optimize postoperative pain management that provides the best relief. Opioids traditionally were the primary medication for pain control during the perioperative period, however, with the current opioid epidemic and opioids being the leading cause of accidental deaths in the United States, physicians have transitioned to multimodal pain control which has shown to provide better pain control. In cases involving knee arthroscopy, pain management options include variations of nerve blocks, medications, surgical techniques, and postoperative activity.

An anterolateral genicular nerve block has been proposed that focuses on decreasing postoperative pain in the lateral aspect of the knee by targeting the lateral retinacular nerve, the nerve to the vastus lateralis, and the articular branch of the nerve to the vastus intermedius. Adductor canal blocks and intraarticular injections are known methods of providing postoperative pain control, but due to their risks, they may be inappropriate for knee arthroscopy. An anterolateral geniculate nerve block targets sensory, terminal nerve fibers outside the joint capsule, theoretically avoiding the risks of large nerve irritation and chondrotoxicity. Postoperative portal injections are another form of analgesia provided after knee arthroscopy and have been demonstrated to be equally effective in controlling pain as intraarticular injections one hour postoperatively. Otherwise, portal injections in knee arthroscopy have not been extensively studied in the literature.

Patients will be sent home after surgery with a survey to be completed at 2, 4, 6, 12, 24, and 48 hours and 1 week. The survey will inquire about the period from the prior survey to the current survey and will evaluate pain via Visual Analog Score, opioid consumption, non-opioid medication use, sleep, and intervention complications. Patients will be called at 12 and 48 hours and 1 week as reminders to complete the survey.

Eligibility Criteria:
Inclusion Criteria:

* skeletally mature patients with indications for knee arthroscopy

Exclusion Criteria:

* include patients with previous knee surgery on the operative side
* opioid use within six weeks before surgery that is deemed to be chronic or excessive
* gabapentin use within six weeks before surgery
* diagnosis of chronic pain, fibromyalgia, or other somatosensory disorder(s)
* history of radicular pain or neuropathy in the operative limb
* patients with cancer
Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer

This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2) postoperatively in patients with high-risk renal cell carcinoma (RCC).

Patients with high-risk RCC have a dismal prognosis. To date, no effective adjuvant therapy exists for this patients category. We suggest that combination of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin-2 (IL-2) stimulate immune system from dendritic cells till cytotoxic T-lymphocytes step by step and eliminate residuary tumor cells.

This prospective, non-randomized, phase II trial assessed low-dose GM-CSF, IFN and IL-2 postoperatively in patients with high-risk renal cell carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* completely resected advanced high-risk RCC
* T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002) Patients must have recovered from any effects of surgery, which must have been - excellent performance status (Eastern Cooperative Oncology Group performance status of 0 or 1);
* adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL, hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and direct bilirubin 1.5 mg/dL; and forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing
* age 18 years and older

Exclusion Criteria:

* history or evidence of cardiac disease on ECG or autoimmunity
* prior systemic treatment for RCC
* history of invasive malignancy in the past 5 years or human immunodeficiency virus positivity
* positive pregnancy test
Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.

The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma in stomach
* Aged≥20 years and ≤80 years
* Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)
* Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria
* ECOG 0 (Eastern Cooperative Oncology Group)
* ASA score class I-III (American Society of Anesthesiologists)
* patient has given their written informed consent to participate in the study

Exclusion Criteria:

* Simultaneously combined resection of other organ
* Active other malignancy
* Expected to severe intra-abdominal adhesion due to previous abdominal operation history
* Uncontrolled co-morbidity
* Vulnerable patients
Coping Skills Training for Early Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the most common inflammatory arthritis and a major health problem. Medical treatments are now being used much earlier in the course of RA, but these treatments do not address the challenges of coping with the early stages of this disease. This study will determine whether a comprehensive coping skills training program can decrease pain, psychological disability, and physical disability in patients with early RA.

RA is a serious and complex disease that taxes patients' coping resources. Patients with RA must cope with pain and with major life stresses, including disruptions in their health, work, family, and marital functioning.

Recognition of the morbidity and mortality associated with RA has increased interest in early interventions. Rapid disease progression during the first few years of RA taxes patients' coping efforts. Those who cope well with the early stages of RA can maintain an active and rewarding lifestyle. Those who do not may become depressed, decrease physical activity, and develop a sedentary, restricted lifestyle that contributes to long-term disability and overdependence on family and friends.

This study will evaluate the effectiveness of early coping skills training (CST) to enhance self-efficacy, prepare patients to cope with future pain, and prevent the development of behaviors that may increase long-term psychological distress and physical disability. The comprehensive CST intervention combines traditional CST with CST components tailored to rheumatoid arthritis patients. It is designed to teach traditional coping skills such as attention diversion, cognitive restructuring, and changes in activity to control and decrease pain.

Participants will be randomized to one of three study groups: 1) comprehensive pain coping skills training; 2) arthritis education; or 3) standard care. Study participants assigned to the comprehensive CST and the arthritis education groups will be asked to attend ten weekly, 80-minute treatment sessions. These ten sessions will be followed by a series of six biweekly follow-up telephone calls.

Study participants in the arthritis education group will learn about the nature and treatment of rheumatoid arthritis as well as the benefits of exercise and joint protection. Study participants in the standard care group will continue to receive care from their rheumatologists but will not participate in any treatment sessions.

Measures of pain, disability, pain coping, and self efficacy will be collected during evaluation sessions before and after the treatment phase. Participants attend 5 evaluation sessions and will be followed for 18 months.

Eligibility Criteria:
Inclusion Criteria

* Meet at least 4 of the 7 criteria for RA classification based on the 1987 American College of Rheumatology criteria
* Onset of RA symptoms within 2 years of study entry

Exclusion Criteria

* Known organic disease that significantly affects function
* Rheumatic disorders in addition to RA that significantly affect function
Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety

Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT) has proven to be effective when administered in live-sessions. The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of hypochondriasis
* At least 18 years old
* Able to read and write in swedish
* Computer access

Exclusion Criteria:

* Drug abuse
* Concurrent severe depression
* No serious somatic illness
* Previous treatment with CBT for hypochondriasis
A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

The study will last approximately 4-5 years. Screening is required within 35 days prior to enrollment. For each participant, the total duration of the clinical trial will be about 69 weeks including screening.

Eligibility Criteria:
Inclusion Criteria:

* Have had an established diagnosis of UC of ≥3 months in duration before baseline.
* Have moderately to severely active UC as assessed by the UC disease activity score.
* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).
* Are on a stable dose of certain oral UC medications (including corticosteroids).
* Must meet contraception requirements.

Exclusion Criteria:

* Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.
* Have experienced a thrombotic event within 24 weeks before baseline.
* Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.
* Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.
* Have a history of certain adenomas, dysplasia's, or malignancies.
A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear

Biomechanical and clinical success of the superior capsule reconstruction (SCR) using fascia lata (FL) grafts has been reported in treating irreparable rotator cuff tear. Human dermal (HD) allograft has been used successfully for SCRs; however, the clinical comparative study between FL and HD have not been reported.


Eligibility Criteria:
Inclusion Criteria:

* Patients with irreparable rotator cuff tears
* Underwent superior capsule reconstruction using fascia lata allograft with human dermal allograft
* At least two years follow-up

Exclusion Criteria:

* reparable rotator cuff tears
* underwent partial repair or reverse total shoulder arthroplasty
First Postoperative Day Review After Uneventful Phacoemulsification

The purpose of this randomized trial was to examine the value of the review on the first postoperative day after uneventful phacoemulsification cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

Exclusion criteria were the following:

i) intra-operative complications, such as posterior capsule rupture, vitreous loss, lost nucleus, zonule dehiscence and wound leak,

ii) inadequate social support for overnight care at home,

iii) severely limited visual potential in the fellow eye,

iv) uveitis or ocular trauma,

v) severe systemic diseases limiting activity,

vi) patients with learning disability or dementia.
Real World Observational Study of Sotatercept for Pulmonary Hypertension

The purpose of this study seeks to describe the real world initial experience with sotatercept in the treatment of pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or greater who are being treated with sotatercept in the Mayo Pulmonary hypertension clinic.

Exclusion Criteria:

* Adults lacking capacity to consent
Application of Magnetic Resonance Fat-Free Imaging

Magnetic resonance imaging (MRI) is presently the best study for assessing the size and extent of the patient's sarcoma. Many sarcomas contain fat that can interfere with the accuracy of sarcoma detection. The investigators have developed a new MRI method that can suppress all the fat signals in the patient's tumor and this may improve the investigators' ability to see the patient's sarcoma. The purpose of this study is to determine if the investigators' new fat-free imaging methods provides them with images that are better than, equal to, or worse than those images obtained by standard MRI methods. This study may help the investigators develop a more accurate MRI examination.

In addition, we will perform the same scans on 4 volunteers who have no history of sarcoma. Scanning volunteers will allow us to optimize the imaging technique by 1.) Determine the best combination of pulse-sequence and magnetization transfer technique to obtain the greatest contrast and 2.) Determine the parameters of repetition time (TR), echo time (TE) and magnetization transfer time and power in order to reduce overall image acquisition time while optimizing image quality. Honing this technique on volunteers will allow us to decrease scan time and potential discomfort for patients.

Eligibility Criteria:
Inclusion Criteria:

* Participant is capable of providing verbal consent.
* 18 years of age or older.
* Participants will belong to one of the following two categories:
* Patient with a known or suspected soft tissue sarcoma of the extremity or trunk who is/will be scheduled for an MRI scan as part of their routine care, -OR--
* Volunteer with no history of sarcoma.
Activation Intervals Effects on Non-surgical Maxillary Expansion in Adults

OBJECTIVE: To evaluate the effects of different time intervals activations on the non-surgical maxillary expansion in adults. Methods: This study will include two groups, 10 adult patients each (mean age 20-35) with maxillary transverse deficiency and unilateral or bilateral crossbite. In the first group, the expansion is going to be activated every four days. In the second group, activation will occur every eight days. The primary outcomes are transverse dimension, the buccal cortical bone formation, and the upper premolar and molar labial inclination. Dentoalveolar changes will be evaluated using CBCT images and digital models.


Eligibility Criteria:
Inclusion Criteria

* Presence of transverse maxillary deficiency unilateral or bilateral in which the maxillary cusps of at least two premolars and/or maxillary molars occluded on the central fossa of the antagonist's teeth
* The needs of maxillary expansion for the correction of their malocclusion
* Age range from 20 to 35
* Non-gingivitis or untreated caries at the start of orthodontic treatment
* Probing depth less than 4mm across the entire dentition
* Gingival index ≤ 1
* Plaque index ≤ 1

Exclusion Criteria:

* Increased Monson curve
* Patients with systemic disease
* Patients with congenital anomalies
* Medicated patients (long term use of antibiotics, Phenytoin, cyclosporine, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers)
* Pregnancy
* Poor oral hygiene for more than two visits
* Radiographic evidence of moderate to severe bone loss
* Current periodontal disease
* Patients who smoke
* Individuals with inadequately treated endodontic problems in the study area.
Short-term Survival in Patients With Severe Alcoholic Hepatitis Treated With Steroid Versus Pentoxifylline

Alcoholic hepatitis represents one of the more serious forms of alcoholic liver disease. Critically ill patients with alcoholic hepatitis have high morbidity and mortality rate. Because of data suggesting that the pathogenic mechanisms in alcoholic hepatitis involve cytokine release and the perpetuation of injury by immunologic process, corticosteroid has been extensively evaluated in the treatment of alcoholic hepatitis. Although there are discrepancies in literature as several randomized trials and meta-analyses have reached contradictory results, corticosteroid for a subset of patients with severe alcoholic hepatitis, defined as a discriminant function ≥ 32, who also have no concomitant gastrointestinal bleeding, active infection, renal failure, and pancreatitis, has been recommended. This latter point emphasizes the important of meticulous selection to avoid the side effects of corticosteroid. Thus, the beneficial effects seems confined to a highly selected minority group in which the inhibitory effect of corticosteroid on liver inflammation is not outweighed by side effects such as weakened defense against infection, anti-anabolic effects, and possible ulcer-promoting effects causing gastrointestinal bleeding, which may be deleterious in these critically ill patients.

Newer understanding of the role of the role of TNF-α expression and receptor activity in alcoholic liver injury has prompted to an examination of TNF inhibition as an alternative to corticosteroid for severe alcoholic hepatitis. Pentoxifylline, a nonspecific TNF inhibitor, recently has been demonstrated in a randomized trial to improve survival in the therapy of severe alcoholic hepatitis. In particular, the survival benefit of pentoxifylline appears to be related to a significant reduction in development of hepatorenal syndrome. These results are promising, and support the need to further evaluate the potential of this new therapeutic avenue.

There is a need for head to head comparison of corticosteroid and pentoxifylline in severe alcoholic hepatitis. At the time the current study was designed (2008), corticosteroid was first-line treatment for severe alcoholic hepatitis. This study was designed to demonstrate that the effect of pentoxifylline was similar (i.e., not inferior) to that of prednisolone, an active form of prednisone. The aim of the present study was thus to compare the effects of pentoxifylline and prednisolone on the short-term mortality.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Severe alcoholic hepatitis (discriminant function ≥ 32 points), Must be able to swallow tablets.

Exclusion Criteria:

* Gastrointestinal bleeding Bacterial infection HBsAg positivity Acute pancreatitis
Muscle Function After Intensive Care

Final objective of critical care is no longer only survival. The role of medical and paramedical teams should also be to restore functional capacities, autonomy and quality of life. What has been call "intensive care unit - acquired weakness" (ICU-AW) is associated to acute and long term increased mortality, prolonged ICU and hospital stay, prolonged duration of mechanical ventilation, altered quality of life in survivors and increased health-related costs. In order to target efficient secondary prevention and early rehabilitation, prompt identification of muscle weakness is crucial. Several methods, aiming to assess muscle mass, muscle strength or physical function, are described. Manual muscle testing using the Medical Research Council (MRC) scale is still the most commonly utilized tool to diagnose ICU-AW (MRC \<48/60). Dynamometry is an objective alternative and one of the most accurate clinimetric tool to assess muscle strength. Literature is overflowing with insufficiently standardized dynamometry data. Using the investigator's published standardized protocol of quadriceps strength (QS) assessment, this observational study aim to describe physical performances of CC patients and thus to define the weakest ones, by comparing them to surgical and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Collaborative ICU patients with length of stay \> 48h
* Surgical patients scheduled for colorectal surgery
* Healthy subjects

Exclusion Criteria:

* a score \> 1 or \< -1 on the Richmond Agitation and Sedation Scale (RASS)
* coma
* total hip or knee arthroplasty in the dominant limb
* unauthorized support on the dominant leg
* open wound located at the ankle's anterior face of the dominant leg
* pre-existing myopathy or polyneuropathy
* para- or tetraparesis, para- or tetraplegia
* refusal.
Whey-Based Partially Hydrolyzed Formula Versus Polymeric Formula On Undernourished Neurologically Impaired Children: Open-labelled Randomized Study

Purpose: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. This study aimed primarily to compare the efficacy of whey-based partially hydrolyzed formula (WPHF) versus isocaloric polymeric formula on the nutritional status reflected by growth parameters and feeding tolerance in undernourished children with neurological impairment (NI). The secondary aim was to follow up on the changes in these parameters after using WPHF for 3 and 6 months

This prospective open-label randomized study was conducted over 6 months on children with NI aged 2- 6 years. Patients were divided into two groups: one group received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines (group I), the second group received 50% of their caloric requirements as WPHF, and the other 50% standard nutritional feeding according to ESPGHAN guidelines (group II). At the start of the study, detailed clinical and nutritional history was recorded for all children in the two groups. Anthropometric measurements were measured, and the Z score was calculated for all parameters. Symptoms of feeding intolerance and frequency of chest infections were assessed and reported. These parameters were reassessed after 3 months and 6 months of nutritional intervention and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged from 2-6 years
2. undernourished children with NI (1 or more of the following signs for identification of undernutrition in the studied children:

   * weight for age z score \<-2,
   * triceps skinfold thickness \<10th centile for age,
   * mid-upper arm fat or muscle area \<10th percentile for age,
   * faltering weight
   * failure to thrive.
   * physical signs of undernutrition such as decubitus skin problems and poor peripheral circulation

Exclusion Criteria:

* NI due to metabolic diseases