cyrilzakka/clinical-trials huggingface dataset:
Post Operative Pain Management for ACL Reconstruction

Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.

The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.

Exclusion Criteria:

* Revision ACLR, worker's compensation, pregnancy, age\<18 years
A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects

The main objective is to study how astegolimab may behave in the body when injected subcutaneously into the abdomen, thigh, or upper arm in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body weight of ≥50 kg to ≤110 kg with body mass index (BMI) range 18.0 to 30.0 kg/m2 (inclusive) at screening

Exclusion Criteria:

* History of significant hypersensitivity or severe allergic reaction, including anaphylaxis, to any drug compound, food, or other substance
* Any immunization or vaccination 14 days prior to the Check-in (Day -1) or plans to obtain any immunization or vaccination within 30 days after the Check-in
* Any surgical procedure (except for minor surgeries) within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* Donation of blood from 30 days prior to screening through study completion or end of trial, inclusive, or of plasma from 2 weeks prior to screening through study completion or end of trial, inclusive
* History of immunodeficiency, including but not limited to, human immunodeficiency virus (HIV) infection
* History of active or untreated latent tuberculosis
* History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class 3 or 4 heart failure within 12 months prior to screening
* History or presence of clinically significant ECG abnormalities at screening or check-in (Day -1)
* Positive for Hepatitis B or Hepatitis C (HCV)
* Tattoo(s) or scarring at or near the site of injection (abdomen, front and middle thigh, or upper arm) or any other condition which may interfere with the injection site examination (as determined by the Investigator)
Feasibility Testing a shareD dEciSIon Making Intervention for People With Kidney failuRE, Their Relatives, and the Health Professionals in Kidney Services: a Pilot Randomized Controlled Trial Study Protocol

The aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together.

The objectives of this study is to pilot test an intervention aiming to accomplish shared decision making when deciding about end-of-life care preferences in people with kidney failure. The intervention consists of shared decision making consultations for adults with kidney failure their relatives and contact health professionals regarding end-of-life care planning supported by a patient decision aid. We will evaluate how adults, relatives and, health professionals implements the intervention and if the intervention is acceptable to the different stakeholders. The research question will investigate if the adults, relatives, and health professionals are experiencing the intervention as shared decision making and if they feel involved in the decision making process.

The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals. Randomization will be performed as block randomization with a 1:1 allocation.

Eligibility Criteria:
Inclusion Criteria:

* Adults with kidney failure on haemodialysis, peritoneal dialysis, or on conservative kidney management and their relatives will be considered for participation. Inclusion criteria will be adults ≥75 years of age, with an estimated glomerular filtration rate \<15, and not suited for a kidney transplant.

Exclusion Criteria:

* Adults who are cognitively unable to participate will be excluded from the research.
Objective Functional Outcome Measures in Orthopedic Surgery Using Advanced Tracking Technologies

The proposed project will address the measurement and ramifications of out-of-home mobility problems in various orthopedic disorders in an innovative way, using advanced tracking technologies.


Eligibility Criteria:
Inclusion Criteria:

* Unwillingness to sign informed consent.

Exclusion Criteria:

* Pregnancy.
Healthy Eating and Lifestyle for Total Health

The Dietary Guidelines for Americans provide recommendations for making better food and physical activity choices that promote health and help prevent disease. Yet, few Americans meet the Dietary Guidelines for Americans (DGA) and a large percentage are overweight.

The goal of the research was to examine the association between weight and the barriers and facilitators to meeting the DGA in a multi-site study using a cross-sectional survey. 836 caregiver-child dyads enrolled and completed the HEALTH study questionnaire across six sites among three race/ethnic groups participating in the HEALTH Study. Barriers and facilitators to meeting the DGA were assessed using a validated questionnaire which was developed specifically for the HEALTH Study. Heights and weights were measured. A series of bivariate regression analyses were conducted to examine the association between the caregivers BMI or the children BMI z-score and the barriers and facilitators to meeting the DGA, adjusting for appropriate covariates in the models. Path analysis was used to examine the relationship of caregivers and children barriers and facilitators to their relative BMI.

Eligibility Criteria:
1. Children in grade 5 and primary caregiver of a child in the 5th grade (the primary caregiver was defined as the person responsible for the health of the child and who has the most influence in what the child eats most days of the week)
2. Attend public school and caregiver to a child in a public school
3. Fell in one of three racial/ethnic groups (African Americans, Hispanics, White)

Exclusion Criteria:

1. Pregnant women were not recruited as their dietary intake was different because of pregnancy.
2. Children not attending 5th grade in public school.
3. Parents of children not attending 5th grade in public school
4. parents of children attending 5th grade in public school but who were not responsible for the health of the child and who did not have the most influence in what the qualified child ate most days of the week.
Inpatient vs Outpatient Management of Short Cervix

The presence of short cervix during pregnancy is a risk factor for preterm birth though in many cases women will eventually deliver at term or near term.

While there are proven treatments such as cerclage and progesterone that can improve pregnancy outcomes, many women are advised to limit their activity, are put on bed rest, or admitted to hospital for inpatient management. Presently, there is no evidence that hospital admission of women with short cervix is beneficial and prolongs the pregnancy.

The investigators propose to examine whether inpatient management results in comparable outcomes to outpatient management for women with short cervix.

Preterm birth, defined as the birth of a baby at less than 37 weeks' gestation, is a significant burden to society that is on the rise. Although many risk factors contribute to preterm birth, a short cervix is a well-established risk factor.The most common management for short cervix in Canada is vaginal progesterone, cervical cerclage, and hospital admission. Evidence suggests that vaginal progesterone and cervical cerclage improve outcomes, but there is very limited research on hospital admission or its efficacy. Due to the increased risk of preterm birth associated with cervical length ≤15 mm, some patients are admitted to hospital for observation even though labour is not imminent. The role of inpatient versus outpatient management is unclear and has not been explored. Hospital admission or modified activity has not been shown to improve pregnancy outcomes however, due to the increased risk of preterm birth, many women with short cervix are admitted for inpatient management.

This project's objective is to examine whether inpatient or outpatient care results in similar pregnancy outcomes for women with short cervix.

This is a multi-centre, non-inferiority randomized controlled trial in women with a singleton pregnancy and isolated short cervix (SC) (≤1.5cm by transvaginal scan (TVS)) at 23-28 weeks at Sunnybrook Health Sciences Centre (SHSC) and North York General Hospital (NYGH), in Toronto, Ontario, Canada. The intervention involves randomizing women to either inpatient or outpatient management and examining whether gestational age at delivery in women with SC (≤1.5cm by TVS) is comparable between arms. The investigators hypothesize that there will be no difference in the preterm birth rate and gestational age at delivery between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy between 23 weeks 0 days - 28 weeks 6 days gestational age
* SC (≤1.5cm) determined by TVS
* Vaginal progesterone treatment
* Cervical dilatation of ≤1cm
* Located within 45 minute drive from recruitment site (Sunnybrook Health Sciences Centre or North York General Hospital)

Exclusion Criteria:

* Multiple pregnancy
* Preterm premature rupture of membranes (PPROM), vaginal bleeding, infection, high blood pressure (defined as 140/90 mm Hg or higher)
* Regular uterine contractions or active labour
* Vaginal bleeding
* Cervical dilatation of \>1cm
* Fetal anomalies
Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections

Introduction Ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. Despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. Music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels.

Objective This study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety.

Methods This is a randomized, prospective, single blind, clinical trial. Patients will be divided into two groups. Group A patients will listen to classical music during the procedure (intervention). Group B patients (control), will not listen to music during the procedure. All other aspects of the procedure will be the same for both groups. To analyze the impact music therapy, patients will fill in the STAI anxiety questionnaire and will be evaluated with the pain visual analogue scale (VAS) before and after the injection procedure.

Expected results Subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. Less pain perception is also expected.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 18 years old.
* Patients must have been prescribed an intravitreal injections of an anti-VEGF drug.
* Subjects must have undergone at least one previous intravitreal injection.
* Patients must fully understand the procedure and the project they will be participating in and agree on signing the informed consent.

Exclusion Criteria:

* Patients with a psychiatric diagnosis with the need to take anxiety medication.
* Patients that before the intervention took medication to relax, such as benzodiazepines or anxiolytics.
* Subjects with hearing difficulty.
INTUIT Hip Fracture Outcome Study

The primary objective of this study is to characterize patients' course of recovery in the year following the initial surgery for unstable intertrochanteric hip fractures treated with the InterTAN intramedullary hip screw device. This will be done by collecting patient outcome measures of health related quality of life and functional status including return to normal gait. Secondary objectives are to document any adverse events associated with the procedure, and to analyze differences in recovery due to differences in age, gender, co-morbidities, nutrition, residence and ambulation status, and use of mobility aids.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral unstable intertrochanteric hip fracture without other lower extremity fractures.
* Community and household ambulators with or without assistive devices.
* Age 50 years or greater.

Exclusion Criteria:

* Stable intertrochanteric hip fracture.
* Bilateral or two or more lower extremity fractures.
* Non-functional ambulators or non-ambulators.
* Age less than 50 years.
Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease

Home palliative care needs are often under-recognized in patients with End-Stage Renal Disease (ESRD). This pilot study is designed to evaluate the feasibility and acceptability of an initiative to enhance referrals to Penn Home Palliative Care compared with usual care among hemodialysis-dependent ESRD patients admitted to a Penn hospital. Results will inform a future pragmatic trial comparing the effectiveness of home palliative care compared with usual care among ESRD patients. Evaluating the effectiveness of home palliative care services is critical to determine whether increasing access to these services would improve patient-centered outcomes for these high-need patients.


Eligibility Criteria:
Inclusion Criteria:

* Be an adult (18 years of age or older) hospitalized at one of two study hospitals
* Digital signature of ESRD (N18.6) within the last 12 months with an inpatient hemodialysis order
* Patient resides in the five-county area surrounding Philadelphia which is served by the Penn Home Palliative Care services.
* Appropriate for home palliative care, defined as:

  (i) Existing home care eligibility/referral for home care OR (ii) Severe protein malnutrition (E43, E44) OR (iii) Non-ambulatory status determined by a flowsheet completed by nursing on hospital admission with three ambulatory options: (1) non-ambulatory, (2) ambulates with assistance, or (3) ambulates independently. If this information is missing from the electronic health record, the determination will be made using one of the three following options: (1) overall prior home mobility assessment "complete dependence on all aspects," or (2) ambulation or functional transfers domains indicate "dependent," or (3) wheelchair mobility domain was completed (with any non-null/non-empty value).

Exclusion Criteria:

* None
Combined Effects Of Diaphragm Strengthening And Accessory Muscles Stretchings In Asthma Patients

Asthma is a multifactorial and chronic inflammatory disease in older patients affecting many people worldwide with high cost of pharmacological treatment and physiotherapy interventions. It is characterized by a variety of symptoms including airway inflammation, bronchial hyper-responsiveness, and transient and reversible airway obstruction. Typical clinical features include wheezing, coughing, resting and/or exertional dyspnea, and chest tightness. Lung hyperinflation affects ability to inspire and increases the work of breathing.

Long and short acting corticosteroids and leukotriene are considered effective pharmacological interventions while inspiratory muscle training, incentive spirometry, purse lip breathing, and diaphragm strengthening are considered effective physiotherapy interventions for asthma patients. To find the combined effects of diaphragm strengthening and accessory muscle stretching on chest expansion, pulmonary function, dyspnea and exercise capacity in asthmatic patients. A randomized controlled trial will be conducted at Gulab Davi teaching Hospital Lahore through convenient sampling technique on 40 patients which will be allocated through concealed opaque envelop into Group A and Group Pretreatment values of pulmonary function and chest expansion will be recorded. And patient's perception of exertion through Modified Borg's rating of perceived exertion (RPE) and HRQOL for quality of life will be assessed before and after treatment. Group A will be treated with diaphragm strengthening and Group B will be treated with diaphragm strengthening and accessory muscles stretching. Treatment evaluation will be done after 4 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age group of 40-65 years
* Both male and females
* Phase-2 asthma patients
* Patients hemodynamically stable

Exclusion Criteria:

* Patients having pulmonary tumors
* Patients of Having cough and sputum
* Patients having TB and emphysema
* Patients with pneumonia, pneumonectomy or other lungs surgical procedures
Gut Microbiota And Radiotherapy

A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC
* Age 18 years old or older
* Patient capable of giving informed consent

Exclusion Criteria

* Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
* Active infection with oral temperature \>100°F
* Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
* Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
* Confirmed or suspected HIV, HBV or HCV
* Chronic constipation (bowel movements less frequent than every other day)
* Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated)
* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
* Patients on anti-diarrheal medications
* Patients on probiotics
Personalized Radiation Therapy for GBM

The study is a pilot study to estimate the efficacy of personalized dose-escalation radiation therapy in patients with glioblastoma, as measured by estimating the median of progression-free survival. Toxicity, patterns of recurrence, and overall median survival will be measured as secondary endpoints. Adverse events will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven WHO Grade IV glioblastoma, after gross-total or near-total resection, who are undergoing definitive chemoradiation as part of their treatment regimen
* Age 18 or older
* Ability to give signed informed consent
* Karnofsky Performance Status (KPS) at least 70

Exclusion Criteria:

* Placement of Gliadel wafers
* Participation in another investigational trial
* Active treatment of another malignancy
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit

The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the laboratory from a combination of a patient's own cells and other materials can be used to form a conduit to safety allow urine flow from the kidneys to outside the body after radical cystectomy in patients with bladder cancer.

The NUC under investigation is a regenerative medicine product comprised of the patient's own smooth muscle cells, procured from a fat biopsy. Tengion has developed appropriate culture conditions to reproducibly generate the necessary quantities of SMC in vitro from autologous adipose tissue biopsies. The NUC is produced at Tengion's Good Manufacturing Practices (GMP) qualified clinical production facility. In this process, smooth muscle cells (SMC) obtained from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4 weeks. At the end of this process, the SMCs are seeded onto the surface of a biodegradable PGA/PLGA mesh scaffold to form the NUC. The NUC is shipped to the investigative site for surgical implantation. Over time, the NUC should facilitate the regeneration of urinary tract tissue.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 - 80 years of age
* Patients undergoing radical cystectomy for treatment of bladder cancer clinically staged as no greater than T2, N0
* Indicated and agreed between physician investigator and patient to have an incontinent conduit as the diversion mechanism of choice post cystectomy

Exclusion Criteria:

* History of other cancer within the past 5 years (except non metastatic prostate or non melanoma skin cancer)
* Evidence of cancer metastasis
* History of any pelvic radiation or non-pelvic radiation within past 5 years
* Debilitating cardiac or pulmonary disease
* Expected need for chemotherapy within 3 months post cystectomy
* Life expectancy less than 2 years