cyrilzakka/clinical-trials huggingface dataset:
Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.

Pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. Pelvic floor physical therapy (PFPT) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. This randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.

The objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized noninferiority clinical trial. The hypothesis is that both interventions will improve incontinence-related quality of life and that home biofeedback will be noninferior to PFPT. Two specific aims will be investigated: 1) Determine the impact of both interventions on urinary incontinence-related quality of life measured by the change in score at 3-months on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF); 2) Determine patient impression of symptoms improvement (measured by the change in score at 3-months and 1-year on the Patient Global Impression of Improvement scale or PGI-I), overall pelvic floor symptoms (measured by the change in score at 3-months and 1-year on the Pelvic Floor Distress Inventory of PFDI) and changes in sexual function (measured by a change in score at 3-months and 1-year in the Female Sexual Function Index or FSFI). An additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3-months and 1-year among a cohort of women who elect for the standard of care without PFPT or biofeedback.

Eligibility Criteria:
Inclusion Criteria:

* following a vaginal delivery (primiparous or multiparous, spontaneous, forceps, or vacuum assisted)
* willingness to participate in PFPT or home biofeedback exercises
* access to a smartphone with Bluetooth capabilities
* positive screen for urinary incontinence between 4 and 8 weeks postpartum defined as patient report of any urinary leakage within the prior two weeks

Exclusion Criteria:

* multiple births or deliver at ≤34 weeks
* previous urinary incontinence or pelvic organ prolapse surgery
* self-identified pre-pregnancy pelvic floor disorder such as urinary incontinence
* fecal incontinence or chronic pelvic pain or if they have a history of prior PFPT
Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults

To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.

An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or over
* One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months
* Meets diagnostic criteria for Insomnia Disorder
* Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener
* Able to ambulate safely (with or without an assistive device)
* Able to follow study directions
* Able to communicate and follow study instructions
* English speaking

Exclusion Criteria:

* Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome)
* Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder)
* Lack of decision-making capacity, as documented in medical record
* Referred to institutional care and/or currently residing in a nursing home or other residential facility
A Double-blind Confirmatory Trial of Levetiracetam in Epilepsy Patients With Partial Onset Seizures

A double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

Epileptic patients who fulfill the following criteria are eligible for inclusion in the study:

* Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
* Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "Clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
* Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
* Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks

Exclusion Criteria:

The following patients are not eligible for inclusion into the study:

* Subjects who were diagnosed with status epilepticus within 3 months before screening
* Subjects with no partial seizures of which frequency was measured during the Baseline Period
* Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
* Subjects with a history of oral treatment with Levetiracetam (LEV)
A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer

The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.

Each subject will be followed from the time of enrollment for a minimum of 3 years and a maximum of up to 6 years or until death, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate adenocarcinoma
* Will receive a new intervention at the time of study entry, for the treatment of:

  * Biochemical failure after initial curative-intent surgery (radical prostatectomy) or radiotherapy (external-beam radiation therapy, brachytherapy, or both) and a PSA doubling time of one year or less or a confirmed PSA of ≥ 50 ng/mL (2 consecutive values) within 6 months prior to study entry; or
  * Castration-resistant prostate cancer; or
  * Metastatic prostate cancer at initial diagnosis of prostate cancer

Exclusion Criteria:

* Prior treatment of metastatic castration-resistant prostate cancer with systemic chemotherapy
* Life expectancy of \<1 year due to comorbidities
pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture

This study will collect data from patients undergoing an ERCP procedure with probe-based Confocal Laser Endomicroscopy for suspicion of bile duct cancer. the objective is to evaluate the diagnostic performance of pCLE for the diagnosis of indeterminate biliary stricture when associated with other diagnostic information (standard ERCP and tissue sampling).

This trial aims at evaluating the performance diagnosis of pCLE for the detection of bile duct cancer, in patients with indeterminate biliary stricture when associated with other diagnostic information.

The hypothesis is that ERCP with Cellvizio probe-based endomicroscopy improves differentiation of biliary and pancreatic duct lesions versus ERCP alone or ERCP with tissue sampling, by improving the sensitivity of detection and by providing a real-time diagnosis.

Direct measures of accuracy (sensitivity, specificity, etc.) in the differentiation of malignant versus benign biliary duct lesions will be compared for the combination of ERCP alone, endomicroscopy plus ERCP imaging, and ERCP plus endomicroscopy plus tissue sampling. These information will be reviewed retrospectively by a second physician.

These presumptive diagnoses will be compared against a 12-month follow-up confirmed histopathologic endpoint (an initially-benign pathologic diagnosis will be confirmed by a 12-month follow-up). Secondary objectives include collecting patient management recommendation. Yet, effective management recommendation is left as the discretion of the physician.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \> 18 years of age
* Indicated for ERCP for indeterminate bile duct stricture
* Referral patients with indeterminate biliary stricture coming in for first ERCP procedure at referral institution or
* Patients who had previous non-diagnostic tissue sampling (brushing biopsies or EUS-FNA) taken during a previous ERCP or EUS-FNA for an indeterminate biliary stricture
* Willing and able to comply with study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

* Subjects for whom ERCP procedures are contraindicated
* Known allergy to fluorescein dye
* Patients suffering Primary Sclerosing Cholangitis or chronic pancreatitis.
* Patients with post-transplant stricture
* If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
Buprenorphine Maintenance for Opioid Addicts - 1

The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence.


Eligibility Criteria:
Please contact site for information.
Neuroendocrine Dysfunction in Traumatic Brain Injury: Correlation With Cognitive Dysfunction and Repair

Traumatic Brain Injury (TBI) is a neurologic disorder cuased by physical trauma to the brain. Neuroendocrine abnormalities in these patients have been reported, including central hypogonadism within hours of the insult and eventual recovery of the hypothalamic-pituitary-gonadal axis with recovery of cognitive function to baseline. This pilot study will measure hormonal level of neuroendocine function at the time of TBI and various time points during recovery.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects having had a recent traumatic brain injury.

Exclusion Criteria:

* Currently receivng sex steroids, glucocorticoids, or have an inability to complete the neurobehavioral assessment.
Dapagliflozin for Long COVID Syndrome

This is a randomized, placebo-controlled study. Patients with long COVID will be randomized to receive dapagliflozin or placebo for 12 months.

This is a multi-centre, randomized, placebo-controlled trial (Figure 4). We will randomly assign patients with long COVID to 12 months of dapagliflozin 10 mg or placebo daily. The 10 mg daily dose of dapagliflozin was used in large clinical trials (44,48) and is the Health Canada approved dose for heart and kidney disease. Additionally, this dose was used in the MRI study of body composition (58) and the RCT in patients with acute COVID-19 (54).

Eligible patients with long COVID will be recruited from post COVID programs or advertisement through-multi-media. A total of 192 participants will be enrolled and this is anticipated to take 3 years. Participants will be followed for the entire duration of the study. Based on a study duration of 5 years (3-year recruitment, 2-year follow-up), patients will be followed for a median of 3.5 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and willing and able to provide informed consent
* Patients with a history of positive COVID-19 test (polymerase chain reaction or rapid test) or have been diagnosed with COVID-19 by a health care provider.
* New or persistent symptoms at least 12 weeks from infection and present for at least 8 weeks that is not explained by an alternative diagnosis (64).
* Women of childbearing potential (WOCBP) who, if sexually active, are willing to use to use at least one highly effective methods of contraception throughout the study.

Exclusion Criteria:

* History of diabetes
* Prior heart failure
* Weight loss treatment with glucagon-like peptide-1 receptor agonists (e.g. liraglutide, semaglutide)
* Pregnancy or planned pregnancy in the next 12 months. We will ask WOCBP about the possibility of pregnancy at the time of screening and if so, then pregnancy testing will be offered. If testing is declined in this instance, then they will be excluded from the study.
* Women who are breastfeeding
* Severe renal impairment (eGFR\<30mL/min1.73m2)
* Known history of allergy or hypersensitivity to dapagliflozin

Exclusion for optional MRI portion of the protocol:

- Any contraindication to MRI
A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:Key Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy.
2. No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
3. Participants whose tumours are PD-L1 TPS ≥ 1%.
4. At least one measurable lesion per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization.
6. A life expectancy of at least 12 weeks.
7. Adequate organ and bone marrow function.

Exclusion Criteria:Key Exclusion Criteria:

1. Active second malignancy.
2. Uncontrolled or clinical significant cardiovascular disease.
3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
4. Active infection requiring systemic therapy within 2 weeks of randomization.
5. Active hepatitis B or hepatitis C virus infection.
6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
7. Known allergy to SKB264 or pembrolizumab or any of its components.
8. Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):

   1. Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibody, anti-CTLA-4 antibody, etc.), checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), any treatment targeting the immune mechanism of tumors such as immune cell therapy;
   2. Therapy targeting TROP2.
   3. Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
9. Major surgery within 4 weeks prior to randomization or expected major surgery during the study.
10. Pregnant or lactating women.
Concussion Active Rehabilitation

In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.

Specific Aims:

To compare the risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort after an acute concussion.

To determine if active rehabilitation compared to routine care reduces the risk of PCS for high-risk patients.

This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 8-18 years old with an acute concussion diagnosis will be eligible. All patients will receive pedometers to monitor their activity levels. If the patient is in the control group the patient will receive standard concussion management per the treating ED physician. Patients in the active rehabilitation group will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers.

One to five days after the ED concussion diagnosis a trained research coordinator will call all subjects to reinforce the management plan.

28 to 32 days post ED concussion diagnosis, research assistants will contact subjects via email or phone call to complete the concussion symptoms inventory.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with an acute concussion within 48 hours
* Patient greater than 8 and less than 19 years old

Exclusion Criteria:

* Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include ADHD/ADD)
* Cognitive delay
* GCS \< 14
* positive findings on head CT
* Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)
Comparing AlloDerm and DermACELL in Breast Reconstruction

This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.

The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.

Eligibility Criteria:
Inclusion Criteria:

* Female patients over the age of 18
* May be undergoing either therapeutic or prophylactic mastectomy
* Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders

Exclusion Criteria:

* Patients who wish to avoid the use of ADM in their reconstruction
* History of radiation of the breast
* Unilateral mastectomies
* Direct to implant breast reconstruction (not utilizing a tissue expander)
Observational Study Evaluating the Potential Impact of Procalcitonin Testing on Care of Stemcell Transplant Recipients

An observational study in evaluating the clinical impact of procalcitonin on the care of Stem cell transplant recipient and its performance as an adjunct in the diagnosis and prognostication of Infectious processes

The overall goal of this project will be to provide new insights into the use of biomarkers in surveillance for infectious processes in Stem Cell Transplant recipients by evaluating the added impact of procalcitonin testing on detection of infectious processes

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-95 years with Multiple Myeloma (MM) undergoing stem cell transplantation

Exclusion Criteria:

* None
Low-dose IL-2 Plus IFN-alpha Immunotherapy as Adjuvant Treatment of Renal Carcinoma.

The aim of this study is to compare the efficacy (in terms of event-free survival and overall survival) of an adjuvant therapy with IFN-alpha plus low-dose of IL2 vs a wait-and-see program in patient with radically operated renal cell carcinoma.

For pts with non-metastatic RCC, no standard adjuvant treatment exists. Immunotherapy (IT) using IFN and/or IL2 is effective in metastatic disease setting. Low and chronically repeated doses of IL2 plus IFN induce a persistent stimulation of the immune system with no relevant toxicity.

Surgically treated RCC pts were randomized to the following arms: A) low-dose IT; B) control arm. IT consisted of a 4-week cycle of s.c. IL2 (5 days/wk, 1 million UI/sqm bid d 1,2 and 1 million UI/sqm x 1 d 3,4,5) + IFN (1,8 million UI/sqm d 3,5 of each week). Cycles were repeated every 4 months for the first 2 years and every 6 months for the remaining 3 years. Each patient received 12 cycles in 5 years. Inclusion criteria were as follows: histological diagnosis of RCC, age \<75 yrs, radical or partial nephrectomy within the past 3 months, pT1 (diameter of T \> 2,5 cm), T2, T3 a-b-c; pN0-pN3, M0; good cardiac and renal function and no autoimmune disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis histologically confirmed of renal cells carcinoma (every histotype);
* Age \< 75 years
* Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months
* Patient classified as T1 (with diameter \> 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy
* Absence of distant metastases;
* Written informed consent

Exclusion Criteria:

* Tumor diameter equal or less than 2,5 cm;
* Previous chemotherapy or ormonotherapy o immunotherapy;
* Renal insufficiency \>3 mg/dl);
* No symptomatic arrhythmias or autoimmune disease
Follow-up Study of the Effectiveness of Virtual Reality Therapy in Patients With Stroke

High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy. High intensity motion improves engine function and quality of life in a neurologist. With special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of STROKE participants. The investigaters randomly select participants who only perform the rehabilitation treatment have performed. The other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment. The investigaters assess the condition and quality of life of the patients. (EQ5-D, Barthel index, MRS test) The ivestigaters examine the functional movement and equilibrium variables of patients. (6MWT, Berg balance test, postgraduation) After that, participants are undergoing a 4-week intensive rehabilitation treatment. All participants are in post stroke. Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test). Functional tests show progress 6MWT, Berg balance test and postural control testing with posturography. The results are compared and evaluated among the groups. The expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity. Patients were followed for 2 years and participated in a follow-up study every six months.


Eligibility Criteria:
Inclusion Criteria:

• post stroke

Exclusion Criteria:

* Sever heart problem
* sever demeanor
* alcoholism
* drug problems