cyrilzakka/clinical-trials huggingface dataset:
Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures

The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.

This is a blinded, randomized controlled trial. Patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. If eligible and willing to participate, patients will be randomized to a "3 weeks post-operative restriction" or "6-week post-operative restriction" of activities group.

Currently, pelvic surgeons' recommendations for activity and lifting restrictions during post-operative period vary widely from 1 to 50 pounds (10). Given variation in literature and reasonable expectations for lifting restrictions, 20-pound lifting restriction was considered to be a reasonable and attainable expectation from patients. Both groups will be given an identical set of postoperative instructions which include refrainment from lifting anything over 20 pounds, avoid strenuous exercise, running, or perform high-impact aerobic activities during the restricted activity period. Depending on their random allocation, patients will follow these instructions either for 3 or 6 postoperative weeks. The activities which all patients will be allowed to do during their postoperative recovery include walking, using stairs and showering in both groups. All patient will be asked to refrain from sexual intercourse for 6 weeks consistent with current routine post op recommendations (6). Other than the time of activity restriction post op (heavy lifting, strenuous exercise, running, high impact exercise), patients will receive identical postoperative instructions otherwise.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age,
* Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence

Exclusion Criteria:

* • Patients who are unable to read, understand, or complete study documents in English or Spanish

  * Patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling
  * Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)
Dental Caries Management by Risk Assessment: Identification and Treatment of Risk Factors Among (IDF) Personnel

Our study is designed as an interventional prospective longitudinal study which examines the Israeli defense force personnel. The population of our study is composed out of the IDF personnel which will be randomly be subdivided into 2 different groups - one will be noted as the intervention group and the other will function as a control group. Each participant will be monitored for a period of 18 months.

On the intervention group, which includes a couple of hundreds participants, a thorough caries management by risk assessment plan will be conducted. The risk assessment will include the following criteria:

* Saliva check
* Plaque control
* Plaque acidity
* Diet - Frequency of carbohydrate intake
* Previous caries experience and present carious activity
* Others (prosthetic/orthodontic appliances, systemic diseases etc.)

After obtaining the data the patients will be categorized into 1 of 3 distinct risk level - low, medium, high. Each category will be treated according to a tailored treatment protocol:

* Dietary instructions
* Oral hygiene instructions
* Antibacterial therapy
* Fluorides
* Restoration
* Follow ups The control group will be treated according to standard protocol of treatment in the IDF dental clinics, which is based on removal the cavitated lesions, and lacks any reference to caries as a multifactorial infectious disease.

We assume that personalized treatment of the disease, based on identifying risk factors will lower the number of patients with active disease.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent

Exclusion Criteria:

* Pregnancy
* Available for 18 month follow-up
MiVacunaLA: an Intervention to Improve COVID-19 Vaccination Behaviors Among Latinos

The aim of this study is to determine whether a community-informed, linguistically and culturally tailored educational program delivered via mobile phone is effective in improving vaccination behaviors among Latino families. Thus we evaluate a community-based mobile phone intervention (mivacunaLA) to assess if there is an increase in vaccination rates among 12-17 year old children and willingness to vaccinate 2-11year old children who have not been previously vaccinated who reside in high-risk and low resourced neighborhoods in Los Angeles.

We conducted a community-based randomized clinical trial with a wait list control group among adult Latino parents or caregivers in East and South Los Angeles. Participants completed an online demographic and baseline survey and were randomly assigned to treatment or wait-list control. Based on their preference, participants received a weekly text message or email link twice a week for four weeks (Mon and Wed at noon). Twice a week messages consisted of a short text (\<160 characters) linking participants to a 2-3 minute video (Monday) and educational text (around 500 words in length. The material was divided into weekly topics regarding the coronavirus vaccine and other topics relevant to the Latino community. Participants were also directed to reliable websites where they could access additional information and links with instructions on where to get vaccinated. Upon completing the intervention, participants completed a 1-month follow-up survey.

Eligibility Criteria:
Inclusion Criteria:

1. self-identified as Latino/a,
2. were 18 years or older,
3. had at least one unvaccinated child of any age (17 or younger), and
4. had the means to receive messages and review educational material online, such as a text-capable mobile phone with internet access

Exclusion Criteria:

1. Unable to receive information via mobile text or computer.
2. Does not speak English or Spanish.
Pediatric Inguinal Hernia Repair: Are Muscle Relaxants Necessary? Endotracheal Intubation vs Laryngeal Mask Airway

In prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups. Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant. Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

In this prospective, safety-control study; children undergoing laparoscopic inguinal hernia repair using PIRS (Percutaneous Internal Ring Suturing) method will be randomly assigned into four groups.

Gr 1: Endotracheal intubation and muscle relaxant, Gr 2: Endotracheal Intubation without muscle relaxant, Gr 3: Proseal Laryngeal Mask Airway without muscle relaxant, Gr 4: Proseal Laryngeal Mask Airway with subparalytic does muscle relaxant.

Apart from standard monitorization, all patients' intragastric pressures will also be monitored. Patients' age at presentation, gender, time of surgery, time of anesthesia, intragastric pressure, intraabdominal pressure, intraoperative findings and complications will be noted and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-18 years
* Diagnosed with inguinal hernia or communicating hydrocele
* Due to undergo laparoscopic inguinal hernia repair

Exclusion Criteria:

* Previous abdominal surgery
* Comorbidities that will effect surgical time, time under anesthesia, intragastric pressure and abdominal pressure
A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.

The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single National Health Service (NHS) centre in the United Kingdom (UK).


Eligibility Criteria:
Inclusion Criteria :

* Patient diagnosed with spasticity related to any cause except cerebral palsy.
* Patient initiated on treatment with either onaBoNT-A or aboBoNT-A during the study enrolment periods.
* Patient is an adult aged ≥18 years old at the time of the first BoNT-A injection for spasticity
* Patient has not received treatment with any type of BoNT-A 6 months prior to initiation of onaBoNT-A or aboBoNT-A. For patients with multiple courses of BoNT-A, separated by a gap of 6 months, only the first course will be evaluated in this study.
* Patient is being treated at Haywood Hospital at index date and during follow-up for up to 24 weeks post-index date, with medical records available for review.

Exclusion Criteria :

* Patient is participating in an interventional clinical trial of an investigational medicinal product for the treatment of spasticity at index date and/or during follow-up.
Autologous Stem Cells in Newborns With Oxygen Deprivation

The purpose of this study is to determine whether the plasticity of autologous intravenous application of cord blood stem cells would improve the clinical course of asphyxiated newborns.

When there is oxygen deprivation, more frequently in premature newborns, the brain and other organs suffer severe consequences. There is evidence that hematopoietic stem cells can help in this scenario by promoting the release of growth-enhancing factors that can help control the damage due to their "homing" capacity, which attracts them to injured sites.

Cord and placental blood have a high concentration of these stem cells, and because its obtention is relatively easy, it seems like a feasible treatment in perinatal hypoxia.

There are current clinical trials that use cryopreserved cord blood for these patients but, to do that, the stem cells have to be frozen and then thawed to be infused, losing a considerable amount of stem cells (almost half of them). We want to evaluate the same condition but infusing non-cryopreserved autologous cord and placental blood because we believe it can be more beneficial due to the greater amount of cells infused, the avoidance of the cryoprotection agent´s toxicity and the lower costs.

Eligibility Criteria:
Inclusion Criteria:

* Apgar \< 5 at 5 minutes
* Mixed or metabolic acidosis with a pH \<7.0 from umbilical cord blood sample
* Neurological manifestations compatible with Hypoxic-Ischemic Encephalopathy
* Any degree of organic/systemic affectation (cardiovascular, gastrointestinal, hematologic and/or respiratory)

Exclusion Criteria:

* Neurodegenerative, autoimmune or genetic disease
* Active infection at birth
* Informed Consent not signed
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
* Confirmed clinical diagnosis of insomnia disorder
* Males and Females between 2 and 17 years, inclusive.
* The sleep disturbance must not be a result of another medication.

Exclusion Criteria:

* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
* Indication of impaired liver function.
* Pregnant or lactating females.
* A positive test for drugs of abuse.
HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib

Now haplo stem cell transplant using bone marrow or peripheral blood is becoming more feasible with better regimens to prevent graft versus host disease (GVHD) like post transplant cyclophosphamide , tacrolimus, mycophenolate . Recently Bortezomib has also been shown to inhibit dendritic cells maturation and function and possesses a number of other favorable immunomodulatory effect that can prevent GVHD and help enhance immune reconstitution. this study is to assess the engraftment rate in patients with hematologic malignancies who need allogeneic stem cell transplant but do not have a suitable matched related or unrelated stem cell donor and will get T-cell replete HLA-Haploidentical allogeneic peripheral stem cell transplantation using post transplant Cyclophosphamide and bortezomib


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old patient lacking a matched related donor or unrelated donor but have a related haploidentical donor (\</= 7/8 allele match at the A, B, C, DR loci with a minimum match of 5/10 is required) is identified
* Candidate for stem cell transplant in a malignant hematological condition
* Karnofsky Performance Scale 0-1
* Available donor able to undergo a Peripheral blood stem cells collection
* Bilirubin \</= 1.5 mg/dl , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \</= 200 IU/ml for adults.
* Serum creatinine clearance \>/=60 ml/min (calculated with Cockroft-Gault formula)
* Diffusing capacity for carbon monoxide (DLCO) \>/= 45% predicted corrected for hemoglobin.
* Left ventricle ejection fraction \> 40%.
* Patient or patient's legal representative, parent(s) or guardian should provide written informed consent.

Exclusion Criteria:

* Adult who has a suitable related or unrelated donor or cord units available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation
* HIV positive; active hepatitis B or C
* Patients with active uncontrolled infections.
* Liver cirrhosis
* Uncontrolled central nervous system involvement by tumor cells
* Positive Beta Human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
* Inability to comply with medical therapy or follow-up
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Eligibility Criteria:
Inclusion Criteria:

* Parts A, B, C, and D: 60 years of age or older
* Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
* Treatment-naive patients with CD30-expressing PTCL (Part F)
* Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
* Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:

  * A CIRS score of 10 or greater
  * Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
* Measurable disease of at least 1.5 cm as documented by radiographic technique
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

Exclusion Criteria:

* Symptomatic neurologic disease compromising IADLs or requiring medication
* History of progressive multifocal leukoencephalopathy
* Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
* Concurrent use of other investigational agents
* Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
* History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
* Part D only:

  * Received any prior immune-oncology therapy
  * History of known or suspected autoimmune disease
  * Prior allogeneic stem cell transplant
  * History of cerebral vascular event within 6 months of first dose of study drug
  * Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
  * Known history of pancreatitis
* Parts D, E, and F only:

  * Known cerebral/meningeal disease related to the underlying malignancy
  * Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis

This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey.

The elderly population is the fastest growing segment of the dialysis population. A vascular access is required to perform dialysis and current guidelines support arteriovenous fistulas (AVFs) over arteriovenous grafts (AVGs) as the preferred vascular access for dialysis. However, the preferred choice of vascular access in the elderly is unclear. Older adults have higher rates of complications from AVF placement compared to AVG placement. Placement of a dialysis access and the procedures subsequently required to achieve and maintain access functionality could result in further declines of function in this already frail population and potentially reduce quality of life. High burdens of cardiovascular disease, heterogeneous life expectancy and variable health goals may make the ideal choice of vascular access different in the elderly population than the general dialysis population.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 years or older
* Referred by nephrology provider for vascular access for hemodialysis (HD)
* Able and willing to provide informed consent

Exclusion Criteria:

* Patient is not a candidate for an AVF per surgeon
* Congestive heart failure (CHF) as defined by ejection fraction (EF) \< 20%, history of heart transplant, history of ventricular assist device
* Known central venous stenosis
* Metastatic cancer or active cancer receiving chemotherapy
* Multiple Myeloma
* Vein mapping with arterial diameter ≤ 2mm and vein diameter ≤ 2.5mm or presence of stenosis or thrombosis in the draining vein
* arterial flow velocity of ≤ 40ml/min
Study Evaluation Tazocin Intervention

This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted or transferred to ICU/Pulmonary units
* Patients of either sex, 18 years of age or older

Exclusion Criteria:

- Patients who stay in units less than 48 hours will not be enrolled.
PRESENCE 2: Predicting Sedentary Entertainment Choices and Effects

The purpose of this study is to determine whether playing motion-controlled video games produces low caloric intake and higher caloric expenditure than watching TV or playing traditional video games.

The purpose of this study is to investigate differences in behaviors and emotions during TV watching and video game playing. Participants will be randomized to either watch TV, play traditional button-based video games, or play motion-based video games for one hour while palatable snack foods and sugar-sweetened beverages are provided within easy reaching distance. Both energy intake as well as energy expenditure during a one-hour period will be measured. All three conditions will be optimized to resemble typical in-home conditions as much as possible.

An additional goal of this study is to provide insight into the possible pathways by which TV and video games differentially affect intake and expenditure. Distraction from the real world (also called presence or engagement) will be analyzed to determine if a) these variables differ across groups and b) if these variables explain differences in energy intake and/or expenditure. The TV group will watch TV shows using Netflix streaming service, which will allow them to choose from a variety of popular shows without viewing commercials. As the investigators are primarily interested in satiety and hand occupation effects, the lack of commercials will allow us to eliminate food advertisements as a causal factor.

Finally, the third major goal of the study is to investigate how young adults choose screen-based media. In the two video game arms, participants will be allowed to choose to play any of 10 provided games, and in the TV group, participants will be able to choose from hundreds of options. Choices of game/program, time spent on each game/program, and psychological reactions to each game will be measured and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35 years old

Exclusion Criteria:

* Not at least a novice video game played (defined as having played games once or twice within the last year)
* Has pre-existing medical condition that precludes physical activity
* Is unable to find transportation to the study center
* Does not agree to be videotaped during the experiment
* Does not agree or is unable to fast for two hours prior to the experiment
* Is pregnant or nursing
* Weighs more than 300 pounds (required by one of the game controllers)