cyrilzakka/clinical-trials huggingface dataset:
Comparison of Superior Hypogastric Plexus Block and Peritoneal Bupivacaine in Pain Management

Background: Laparoscopic hysterectomy is one of the most frequently performed major surgeries in nonmalignant gynecological diseases. Effective postoperative analgesia is associated with short hospital stays, early mobilization, reduced costs, and patient satisfaction. Intravenous administration of nonsteroidal anti-inflammatory drugs, paracetamol or opioids; epidural catheter placement; peritoneal local anaesthetic administration; and superior hypogastric plexus block (SHPB) are routinely employed methods for postoperative pain management following laparoscopic hysterectomy.

Methods: The study population comprised patients who underwent laparoscopic hysterectomy with or without oophorectomy for benign indications. A total of 94 patients were included in the study. Thirty patients received a superior hypogastric plexus block, thirty received intraperitoneal local anaesthetic spray, and thirty-four received intravenous analgesics.

Conclusion: In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted.

In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted. The findings indicated that the initial postoperative administration of analgesics occurred later in patients who received peritoneal local anesthetics and SHPB compared to the control group. In addition, VAS values at the first and third hours were found to be lower in the peritoneal local anesthetic and SHPB groups than in the control group. Postoperative pain experienced by patients following gynecologic surgery. It has been reported that approximately 75% of patients experience severe pain. Excessive opioid use in postoperative pain management and the potential for additional complications are also possible. One of the alternative methods to reduce postoperative opioid use is intraperitoneal bupivacaine administration.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent laparoscopic hysterectomy-with or without oophorectomy-
* ASA physical status I-II patients

Exclusion Criteria:

* women with known bupivacaine allergy, anxiety-depressive disorders, fibromyalgia, coagulopathy, eclampsia/preeclampsia, or those who were pregnant were also excluded.
* if they were younger than 18 or older than 65
* underwent epidural catheterisation and/or received additional pain management modalities
* prescribed preoperative antidepressants or gabapentinoids
Effects of Eccentric Training in the Rehabilitation of Patients Undergoing Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

This study aims to investigate the effects of eccentric training on the functional rehabilitation of patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R). Thirty-four participants undergoing ACL-R will be randomly assigned to two groups: the Conventional Training Group (CTG) and the Eccentric Training Group (ETG). Both groups will adhere to the same post-surgical rehabilitation program, commencing in the first week after ACL-R and continuing until the criteria for sports resumption are achieved. The rehabilitation program will be structured into four phases: immediate post-operative, preparatory, general acquisition, and specific acquisition. The key distinction between the groups lies in their exercise regimen: ETG will prioritize the eccentric phase of movement, whereas CTG will engage in conventional exercises, maintaining uniform load across both movement phases. Assessment procedures will be conducted at three intervals for all participants: immediately post-operative, at 12 weeks post-ACL-R surgery (before the initiation of the training protocol), and at 25 weeks post-ACL-R surgery (upon completion of the training protocol). The primary outcome measure will be the maximum isometric strength of knee extensors. Secondary outcomes will encompass functional status, maximum isometric strength of knee flexors, peak dynamic strength during leg press, quadriceps muscle atrophy, performance in jump tests, and psychological readiness.


Eligibility Criteria:
Inclusion Criteria:

- Individuals of both genders, aged between 18 and 40 years, scheduled for ACL reconstruction surgery during the data collection period.

Exclusion Criteria:

* Delay of more than 7 days after surgery to initiate the rehabilitation program proposed by the study;
* Presence of injuries related to the rupture of the ACL that hinder partial weight-bearing in the first week after surgery, either due to medical recommendation or the patient inability/disposition.
Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study

The overall objective of the Cholesterol Lowering via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome ACS (CLEAR ACS) study is to determine the efficacy, safety, and tolerability of bempedoic acid/ezetimibe (BA/E) in a contemporary and real-world population, enriched for older adults, women, and underrepresented racial/ethnic groups, of adults with a recent acute coronary syndrome (ACS) event independent of use of statin therapy before the ACS event.

The CLEAR ACS study is a prospective, virtual, electronic health record (EHR)-based, randomized, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial (PCT) embedded within Kaiser Permanente Northern California's fully integrated and learning health care delivery system. The EHR will be screened in real-time for potentially eligible participants across all Kaiser Permanente Northern California hospitals using validated diagnostic and procedural codes, disease registries, laboratory values, pharmacy dispensing information, and sociodemographic data sources. Eligible patients that provide informed consent will be randomized in a 1:1 allocation ratio to an initial 12 weeks of blinded bempedoic acid/ezetimibe (BA/E) vs. matching placebo followed by a 12-week open-label extension phase where all patients will receive open-label, unblinded bempedoic acid/ezetimibe.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age \>18 years
* Able to provide informed consent
* A documented recent ACS event (i.e., defined as up to 14 days post-discharge from an index hospitalization for a non-ST-elevation MI \[NSTEMI\] or ST-elevation MI \[STEMI\] necessitating urgent and/or emergent percutaneous coronary intervention \[PCI\] and/or coronary after bypass graft \[CABG\])
* At least 6 months of continuous health plan membership and prescription drug benefit prior to enrollment
* A registered e-mail address with Kaiser Permanente in order to obtain electronic consent (eConsent) for study participation

Exclusion Criteria:

* Receipt of BA/E on or within 3 months before the day of enrollment
* A history of hypersensitivity to BA/E
* Women who are pregnant or planning to become pregnant and/or breastfeeding mothers
* A diagnosis of gout and/or previously known laboratory-confirmed hyperuricemia (serum uric acid \>8.0 mg/dL)
* A history of tendon disorders or tendon rupture
* Current and/or planned treatment with simvastatin/pravastatin, cyclosporine, fibrates, and/or bile acid sequestrants (to avoid drug-drug interactions)
* A known life-limiting diagnosis (e.g., stage D heart failure, severe liver disease, end-stage kidney disease \[ESKD\] requiring chronic dialysis or an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, metastatic cancer and/or actively receiving systemic chemotherapy)
* Institutionalized and/or receiving palliative care
* Non-English speaking
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology

Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output. Infants with the syndrome generally undergo a staged surgical approach in view of an ultimate Fontan procedure. Although long-term survival in patients with HLHS and related single ventricle physiology has improved markedly with advances in medical and surgical therapies, a growing number of infants will ultimately require heart transplantation for end-stage heart failure due to several potential disadvantages include a negative effect on right ventricular function, arrhythmia, additional volume load via regurgitation from the nonvalved shunt, and impaired growth of the pulmonary artery.

Risk factors for poor outcome of heart transplantation with HLHS and single ventricle physiology are older age at transplantation and previous Fontan operation. New strategies are needed to improve the underlying transplant risks proper for the Fontan failure patients.

Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved cardiac function in patients with ischemic heart disease. In this trial, the investigators aimed to test the safety and feasibility of intracoronary injection of autologous cardiac progenitor cells in patients with HLHS and related single ventricle anomalies and that could improve ventricular function at 3 months' follow up.

Autologous cardiac progenitor cells are isolated from patients' own cardiac tissues obtained during palliative shunt procedure. Patients will receive 0.3 million/kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

Eligibility Criteria:
Inclusion Criteria:

* Infants with hypoplastic left heart syndrome and related single ventricle anomalies undergoing first to third palliative shunt surgeries will be recruited into the study.
* Patients between 0 and 6 years of age are eligible if written informed consent can be obtained.

Exclusion Criteria:

* Cardiogenic shock
* Eisenmenger syndrome
* Uncontrollable arrhythmia
* Severe chronic diseases
* Infections
* Cancer
* Unwillingness to participate
Natural History of the Progression of Choroideremia Study

The objective of this natural history study is to gain a better understanding of the progression of choroideremia (CHM) and add to the knowledge base for this rare disease.

This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Are willing and able to provide informed consent for participation in the study.
* Have a clinical phenotype and confirmed genetic diagnosis of CHM.
* Have active disease clinically visible within the macular region.
* Are willing and able to undergo ophthalmic examinations once every 4 months for up to 20 months.
* Have a BCVA better than or equal to 6/60 (20/200; decimal 0.1; LogMAR 1.0; 34-38 ETDRS letters) in at least one eye.

Key Exclusion Criteria:

* Have a history of amblyopia in the eligible eye.
* Have any other significant ocular or non-ocular disease/disorder in the eligible eye which, in the opinion of the investigator, may put the subject at risk because of participation in the study, influence the results of the study or influence the subject's ability to participate in the study.
* Have participated in an interventional research study in the past 6 months.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intravenous Dexamethasone for Ropivacaine Axillary Block

Prospective monocentric double-blind controlled randomised trial Aim is to assess prolonged postsurgical analgesia by intravenous dexamethasone versus intravenous placebo, after ultrasound guided axillary brachial plexus block


Eligibility Criteria:
Inclusion Criteria:

* ASA 1,2 et 3
* surgery under axillary brachial plexus block
* aged \>18 years
* signed information consent

Exclusion Criteria:

* impaired coagulation
* contraindication to regional anesthesia or technical impossibility
* opioids or pain killers abuse or addiction
* steroids consumption in the past 6 months
* dementia or under administrative supervision
* delay of surgery to short to allow regional anesthesia
* pregnancy and breastfeeding
* allergy and contraindication to dexamethasone or ropivacaine
* anticipated bad observation of treatment
* patient enrolled in another trial
Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment

The occurance and clinical course of human papillomavirus (HPV)-induced lesions is largely determined by the nature of the cellular immune defense generated. Even tough both genital warts and vulvar intraepithelial neoplasia (VIN) are HPV-associated genital lesions they differ in their risk of malignant progression. Imiquimod (IMQ) is a topically applied Toll-like receptor (TLR) 7 agonist that has been approved for the treatment of superficial (pre-) carcinomas of the skin (basal cell carcinomas, actinic keratosis) and HPV-associated lesions (genital warts). It acts by activation of the immune system exerting anti-tumor and anti-viral properties. The aim of the study is to evaluate the mechanisms of IMQ treatment and to analyze the differences in HPV-affected and non affected tissue at cellular and molecular level as determined by immunofluorescence stainings and real time PCR, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with histologically proven Vulvar Intraepithelial Neoplasia 2/3 and/or anogenital Condyloma acuminata
* Age 18-50
* Informed consent

Exclusion Criteria:

* Malignancy
* Pregnancy
* Therapeutic Immunosupression
* Severe systemic dermatologic disease
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial

Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection

It is much more important in Japan than Western to improve the prognosis after stroke because the prevalence and mortality rate of stroke in Japan is about 3-4 times as those of acute myocardial infarction. Investigators will study whether immediate statin treatment after the onset of stroke is beneficial on the neurological protection since most of previous studies with statins just showed the preventive effects from onset of primary or recurrent cerebral infarction.

Eligibility Criteria:
Inclusion Criteria:

* the Informed consent will be acquired by the document.
* Age: 20 years of age or older.
* Gender: unquestioned
* hospitalization, outpatient: hospital
* Patients by MRI at the time of hospital transport, it has been confirmed diagnosed with cerebral infarction
* ingestible in within 24 hours after admission In the study treatment period, patients that can be defined treatment in this clinical study implementation plan

Exclusion Criteria:

* patients with a history of hypersensitivity to the treatment agent of the present study
* Patients acute hepatitis, chronic hepatitis acute exacerbation, liver cirrhosis, it is believed that the liver cancer, liver function jaundice or the like is reduced, or a biliary obstruction
* Patients suspected of being pregnant or pregnant
* Patients in the administration of the cyclosporine or telaprevir
* patients with moderate or severe renal impairment (SCr ≧ 2.5mg / dL or eGFR \<30mg / dL)
* Patients who received a diagnosis of acute coronary syndrome within 6 months
* valvular disease, atrial fibrillation, patients with atrial thrombus
* Patients familial hypercholesterolemia
* patient admission NIHSS score is greater than or equal to 3 is more than 20 or before the onset mRS score
* patients with other doctors deemed inappropriate
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation

The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

The purpose of this study is to assess the Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation.

Our study was set up with several group with EGFR mutant, ALK fusion, ROS1 fusion, RET fusion, BRAF mutation, NRG1 fusion, MET alteration, KRAS mutation, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histologically or cytologically confirmed, Stage IV NSCLC.
4. Oncogenic mutations confirmed by an accredited local laboratory, including EGFR, ALK, ROS1 etc.
5. ECOG 0-1.
6. Predicted survival ≥ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.

Exclusion Criteria:

The patient did not match from the Inclusion Criteria.
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.


Eligibility Criteria:
Inclusion Criteria:

* Low Grade Glioma \& Low-Grade Glioma Extension: a relapsed or progressive LGG with documented known activating BRAF alteration.
* Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.
* Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.
* Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.
* Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria

Exclusion Criteria:

* Participant's tumor has additional previously-known activating molecular alterations.
* Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.

Other inclusion/exclusion criteria as stipulated by protocol may apply
An Uneven Terrain Surface to Improve Locomotor Robustness in People With Amputation

To attain high levels of mobility, people with lower limb amputation must build both the skill and the confidence to rely on their prosthesis in the environments that they will encounter in daily life. The purpose of this research is to determine whether practicing walking on an uneven terrain surface, specifically designed to present a modest, manageable disturbance to walking, can improve balance, locomotor flexibility (i.e. the ability to adapt walking to different walking contexts) and balance confidence, to a greater extent than walking on level ground alone. This preliminary study aims to determine whether uneven terrain walking is feasible and acceptable in the target population, and also to establish preliminary efficacy.

The long-term focus of this research is to investigate an uneven terrain training paradigm as an intervention to improve locomotor skill and confidence in lower limb prosthesis users; specifically to determine whether by inducing step-to-step variability in a safe environment, through training on an uneven terrain surface, individuals may develop more adaptable gait, and greater confidence in their mobility. We hypothesize that inducing a manageable level of variability into walking patterns during training will lead to greater balance, locomotor flexibility, and balance confidence. The surface has shallow contours that alter foot-ground interactions at each step, disrupting habitual movement patterns.

The aim of this study is to establish feasibility, acceptability and preliminary efficacy of the uneven surface as a mobility training tool for lower limb prosthesis users. Ambulatory lower limb prosthesis users will attend a biomechanics laboratory on two occasions, during which they will complete walking practice sessions on a flat surface and on an uneven surface. A crossover design will be employed, with walking surface order randomized across participants. Preliminary efficacy will be established based on functional tasks and self-efficacy questions administered before and after the sessions on each day. Feasibility and acceptability will be established based on feasibility study objectives from Orsmond \& Cohn's feasibility framework.

Eligibility Criteria:
Inclusion Criteria:

* lower limb amputation at ankle level or above
* properly fitted with a walking prosthesis, used regularly for home and/or community ambulation
* good socket fit assessed by a score of 7-10 on the socket fit comfort score (Hanspal et at., 2003).
* able to walk for two minutes at a time with or without an assistive device
* willing to travel to the test site two times for training and testing.

Exclusion Criteria:

* leg/foot ulcer/sore or other conditions that cause pain during weight-bearing
* cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
* unilateral or bilateral upper limb absence or loss at the wrist and above
* diagnosis of cognitive disturbances
* allergy to medical adhesives
* women who are pregnant or think they may be pregnant
* acute illness
* dizziness on the day of testing
Effect General and Regional Anesthesia on Glycocalyx

Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.

The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.

Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.

Eligibility Criteria:
Inclusion Criteria:

Adult patients ASA 2-3 undergoing elective total knee replacement surgery

Exclusion Criteria:

None