cyrilzakka/clinical-trials huggingface dataset:
Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.

The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.

Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital
* American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)

Exclusion Criteria:

* Physical or developmental delays
* Psychiatric illness
* Current use of sedative or anticonvulsant medications
* Pre-existing renal disease (ranging from stage 2 \[mild\] to stage 5 \[end stage\])
* Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia)
* Pre-existing liver disease
* Pre-existing cerebral or neuromuscular disease
* Patient or family history of Malignant Hyperthermia
* Recent history of upper respiratory infection within last 7 days
* Regular use of analgesic medication
* Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation
* Other procedure scheduled in addition to tonsillectomy
* History of allergies to local anesthetics
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.

Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.

Eligibility Criteria:
Inclusion Criteria:

* Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.
* Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy

Exclusion Criteria:

* Previous surgical intervention to the shoulder joint understudy
* Tears of the subscapularis or labral pathology requiring surgical repair
* Shoulder instability either shoulder
* Unable to complete functional evaluations in either shoulder
Association of History of Concussion With Vestibular Impairment and Cognitive Function in Sports Athletes

This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports.

The association of a history of concussions with vestibular impairment and cognitive function in sports athletes is a significant area of research due to the potential long-term consequences of head injuries in contact sports.

Vestibular impairment refers to disruptions in the balance and spatial orientation system of the inner ear, which can result from head trauma. Cognitive function encompasses various mental processes, including memory, attention, and decision-making, which may be affected by concussions.

This study aims to examine how prior concussions relate to both vestibular impairment and cognitive function in athletes participating in sports. Researchers typically employ a combination of self-reported concussion history, clinical assessments of vestibular function, and standardized cognitive tests to evaluate participants.

Findings from such studies can provide valuable insights into the potential effects of concussions on athletes' balance, spatial awareness, and cognitive abilities. Understanding these associations can inform concussion management protocols, rehabilitation strategies, and preventive measures in sports settings.

Furthermore, this research may contribute to the development of targeted interventions aimed at improving vestibular rehabilitation and cognitive training for athletes with a history of concussions. By identifying and addressing these potential deficits early, athletes may reduce their risk of long-term complications and optimize their performance and well-being in sports.

Eligibility Criteria:
Inclusion Criteria:

* athletes actively involved in sports at age of 18 to 35
* active players in contact sports

Exclusion Criteria:

* Concussion other than sports
* History of recent fractures.
* Participants having neurological deficits
Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN)

Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.

PLAN is a multicentre, parallel-group, blinded, randomized controlled trial of 1,602 patients undergoing breast cancer surgery. Consented eligible patients will be randomized to receive an intravenous lidocaine: 1.5 mg/kg bolus with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room). Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution). Study medications will be prepared in blinded 50 mL syringes and labelled as per Regulatory requirements. Patients will follow up on the first 3 days after surgery, and at 3 and 12-months postoperatively to report on pain, analgesic consumption, functional, mood, and quality of life outcomes

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)

Exclusion Criteria:

1. Previous breast surgery within 6 months of index surgery
2. Undergoing any autologous flap procedure during index surgery
3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
4. Documented hypersensitivity or allergy to lidocaine
5. Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
7. Known cirrhotic liver disease
8. Pregnant
9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
Toward an Automated Method of Abdominal Fat Segmentation of MR Images

Subjects will undergo a brief magnetic resonance (MRI) scan. The resulting images will be used to compare two abdominal fat segmentation techniques. The first technique is already validated and in use. The second technique was recently developed and has not been validated. The hypothesis is that the second technique will be the faster and more reliable of the two.


Eligibility Criteria:
Inclusion Criteria:

* ambulatory
* cognitively sound

Exclusion Criteria:

* body mass index less than 18 or greater than 45 kilograms per square meter
Topical DHEA Against Vaginal Atrophy

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (non hysterectomized or hysterectomized)
* Women between 40 and 75 years of age
* Willing to participate in the study and sign an informed consent
* Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
* Women having a vaginal pH above 5
* Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

Exclusion Criteria:

* Undiagnosed abnormal genital bleeding
* Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
* The administration of any investigational drug within 30 days of screening visit
* Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
* Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Plaque Reduction Sesame-based Oil

The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:

• is there a difference in the plaque reducing effect of oil pulling with sesame-based oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.

Researchers will compare sesame-based oil against distilled water to see if there is a difference in the plaque reducing effect.


Eligibility Criteria:
Inclusion Criteria:

age ≥ 18 years contractual capability the presence of ≥ 10 teeth, community periodontal index of treatment needs (CPITN) grade 1 or 2

Exclusion Criteria:

missing consent community periodontal index of treatment needs (CPITN) grade 0, 3 or 4 pregnancy or breastfeeding systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment mental and behavioral disorders that impede (verbal) communication allergy against sesame(oil) intake of antibiotics 6 months prior to or during study duration intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone) infectious diseases (e.g. HIV, hepatitis B or C) fixed orthodontic appliances ongoing oil pulling or mouth rinsing adult guardianship insufficient nasal breathing
Evaluation of a Shared Decision Making Portal for Pediatric Asthma

This pilot intervention study will test the feasibility and acceptability and explore the outcomes of a primary care-based shared decision making (SDM) electronic medical record (EMR)-based portal that provides education, elicits and tracks patients/families' treatment concerns and goals, assesses symptoms and asthma control over time, and provides decision support to clinicians and families.


Eligibility Criteria:
Inclusion Criteria:

* Parents/legal guardians of children aged 6-12 with persistent asthma, currently receiving chronic maintenance therapy, cared for at a study practice, with consistent access to a computer with an internet connection where they feel comfortable accessing MyChart (patient portal)
* Clinician at study site

Exclusion Criteria:

* parents non-english speaking
* child's primary care provider at the time of enrollment is a pediatric resident
* not meeting inclusion criteria
An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Have received at least 3 prior lines of therapy, including a proteasome inhibitor \[PI\] and an immunomodulatory agent \[IMiD\] OR have disease that is double refractory to a PI and IMiD
* More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
* Have detectable disease measured by a specific protein in your blood and/or urine
* Must consent to bone marrow aspirate or biopsy.

Exclusion Criteria:

* Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia
* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation
* Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C
* History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply
Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD)

The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention.

The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and (ii) to investigate the effect of screening followed by randomisation to intervention with consultations based on cognitive therapeutic principals to reduce anxiety in patients with ICD or usual care.

Screen-ICD is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.

The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy. The intervention consists of three steps: 1. The intervention begins with a consultation with a nurse aiming at uncovering anxiety using the Hamilton anxiety scale and exploring how life with an ICD is perceived, 2. Based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided and 3. After each session participants are asked to fill out the HADS questionnaire. When the patient scores below the cut-off value two times in a row, sessions will end. Each patient can have a maximum of 15 sessions.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Have had ICD implantation
* Speaks and understands Danish
* Scores 8 or more in the HADS-A questionnaire
* Gives written informed consent

Exclusion Criteria:

* Scores 11 or more in the HADS-D questionnaire and the depression score exceeds the anxiety score.
Modified Otago Exercise Program on Balance Performance

Fall is a common problem encountered by elderlies. In Hong Kong, the prevalence rate of falls among elderlies aged above 65 years old ranged from 18%-29%, standing at approximately one-fifths of the total elderly population. Falls pose huge threats to the physical and psychosocial health of the elderlies as they are often accompanied by serious injuries such as bone fracture and post-fall syndrome, decreased confidence in walking, and social exclusion.

Otago Exercise Program (OEP) was a tailor-made home-based fall prevention program of community-dwelling elderlies. It comprises of 3 main components: 5 lower limb strengthening, 12 balance retraining and walking exercises. Regarding on its effectiveness, multiple studies revealed that OEP and modified version of OEP (mOEP) brought significant improvements on perceived, static and dynamic balance, lower limb strength, quality of life and functional capacity of healthy elderlies and those with various health conditions such as chronic illnesses, osteoarthritis, stroke and hemiplegia.

The delivery method of OEP and mOEP has been limited to have elderlies following the instructions and illustrations of a printed booklet. Currently, there are only two proposed effective forms of mOEP: video-instructed and Exergames. Our study attempts to establish a new home-based exercise option incorporating mOEP with video, music and lyrics. It helps to increase the exercise motivation of elderlies, hence their physical performance.


Eligibility Criteria:
Inclusion Criteria:

* Elderlies in community dwellings aged 55 or above
* Communicable \& able to follow command
* Self-reported sufficient visual \& auditory ability to follow the actions in video
* HK-MoCA 5-Min Protocol: No cognitive impairment
* Able to access electronic devices, such as smartphones, computers, televisions with network, Digital Video Disc/Compact Disc player

Exclusion Criteria:

* History of severe medical conditions that hinders physical ability, such as heart diseases and neurological disorders
* History of lower limb fracture in recent 1 year
* History of joint replacement and any cardio-thoracic surgeries
* Self-reported visual \& auditory impairment
* Users of walking aids other than sticks, tripods or quadripods
Effect of Light Color Temperature Applied During Breastfeeding on Mother's Stress, Anxiety, Peace and Breastfeeding Motivation

Breastfeeding is an important condition for the health of the mother and the baby, which is the most difficult for mothers after birth. Since it is an important practice for both the mother and the baby, the evaluation and reduction of the mother's stress factors can help the hospital to regulate the lighting of the breastfeeding room. In addition, setting the light color temperature to a more appropriate kelvin can make a positive contribution to the hospital in terms of costs. For this purpose, when researchers look at the literature, we have not come across a randomized controlled study examining the effect of the light color temperature applied during breastfeeding on the mother's stress, anxiety, peace and breastfeeding motivation. Researchers' purpose is to determine the effect of the light color temperature applied during breastfeeding on the mother's stress, anxiety, peace and breastfeeding motivation.


Eligibility Criteria:
Inclusion Criteria:

* Mothers who have given birth for the first time,
* being 18 years of age and older,
* volunteering.

Exclusion Criteria:

* Being a mother who has given birth to more than one child,
* having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding disorders),
* receiving psychiatric treatment (pharmacotherapy or psychotherapy),
* having a disease that prevents vision.
Effects of Anti-PD1 Adjuvant Checkpoint Blockade Immunotherapy on Atypical/Dysplastic Nevi

This study will examine the impact of anti-programmed cell death 1 (PD1) therapy given in the approved adjuvant therapeutic regimens upon the morphologic, histopathologic, molecular and immunologic as well as genomic features of atypical/dysplastic nevi (A/DN) in patients with a prior documented melanoma of Stages IIB, IIC, IIIA, IIIB, or IIIC and concurrent presence of two or more atypical nevi.

Given the established efficacy of anti-PD1 therapy as an adjuvant treatment in both advanced nodal and earlier stage deep primary node negative melanoma, this study hypothesizes that anti-PD1 therapy may provide a basis for effective therapeutic prevention. To study if anti-PD1 therapy can help prevent the development of melanoma, this study will examine its effects upon atypical/dysplastic nevi, which are well established as non-obligate pre-cursor lesions that are markers of increased risk of melanoma. This single agent, adjuvant study will evaluate the impact of adjuvant anti-PD1 therapy on morphology, histopathology, immunologic/molecular features, and gene expression of atypical/dysplastic nevi present in patients with stage IIB-III melanoma. This study aims to determine if anti-PD1 therapy will increase CD8 T cell responses to melanoma antigens, resulting in immune surveillance and anti-tumor immune responses within A/DN. It postulates that in response to anti-PD1 therapy, the aggregate pigmentation of total nevi including atypical/dysplastic nevi and benign melanocytic nevi will decrease with a measurable morphologic response. This study also asserts that there will be histopathologic changes within A/DN including increased density of immune infiltrate and increased presence of regression features. Increased anti-tumor immune response measured by increased CD8, IFN-y, and PD-1 expression within nevi is anticipated, along with a decrease in genes involved in pathways of melanomagenesis, pigmentation, and inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have at least two atypical nevi of ≥ 4 mm diameter.
2. Subjects must have a current documented history of melanoma.
3. Subject must be ≥ 18 years and if female of childbearing potential, must agree to practice effective contraception per institutional SOC if sexually active.
4. Subjects will have been deemed candidates for adjuvant therapy with single agent anti-PD1 therapy.
5. Subjects must give written informed consent to participate in this study with consent signed and dated prior to entry into trial.

Exclusion Criteria:

1. Patients with non-malignant diseases or indications that would preclude the administration of anti-PD1 therapy such as significant immune suppression or active autoimmune disease requiring disease modifying, immunosuppressive therapy, will be ineligible.
2. Patients who have previously received anti-PD1 therapy
3. Patients with history of other active, non-melanoma cancers
4. Patients who are receiving other anti-neoplastic therapy.
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels \< 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.

Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* ≥ 18 years of age and weight at least 40kg
* Two plasma HIV RNA levels \< 50 copies/mL during the qualification and screening period
* Patients receiving a PI and ≥ 2 NRTIs

Exclusion Criteria:

* Pregnancy or breastfeeding
* Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
* Active AIDS-defining opportunistic infection or disease
* Proven or suspected acute hepatitis within 30 days prior to study entry