cyrilzakka/clinical-trials huggingface dataset:
Low-Intensity Physical Therapy for Prevention of Pre and Postpartum Urinary Incontinence

The purpose of this study is to determine if pelvic exercises can reduce the occurrence of urinary incontinence (involuntary loss of urine) before and after delivery. We would also like to see if performing pelvic exercises before birth has an effect on labor and/or delivery, and if there are any specific characteristics for developing urinary incontinence during pregnancy and after delivery.

The studies investigating physiotherapy for prevention of urinary incontinence during and after pregnancy used intensive pelvic floor muscle training. While physical therapy appears to be effective in preventing urinary incontinence, extensive physical therapy is too costly to be implemented as a preventive measure for the general population. Thus, we want to asses if non-intensive pelvic floor therapy decreases the urinary incidence of incontinence during pregnancy and postpartum. We propose a prospective randomized controlled trial to obtain baseline data on the effect of non-intensive pelvic floor muscle training of urinary incontinence in primigravid women.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous, pregnant women, 18 years or older
* Less than 20 weeks gestation
* Able to give consent and who are willing to participate

Exclusion Criteria:

* Multiparous women
* Women presenting after 20 weeks gestation
* History of urinary incontinence
* Mentally impaired women and women who have neurological impairment affecting ability to perform pelvic floor muscle training
Improving Wisely - Polypharmacy

This is a randomized controlled trial that uses an audit and feedback intervention to alert primary care physicians who are outliers in one or more metrics related to high risk prescribing of participants' outlier status. Primary care physicians will be randomized to the intervention or control arm, except in California, where all outliers will be notified. The investigators will evaluate the impact of the intervention on prescribing patterns.

The investigators have developed five different metrics related to low-value (and/or high risk) prescribing habits based on guidelines. The five metrics are listed below. The investigators are using 100% capture Medicare claims data to evaluate the prescribing habits of all US primary care physicians who prescribed to ten or more Medicare patients. A patient is attributed to the primary care physician who prescribed the patient the most medications that year.

The investigators have calculated the mean, median, and standard deviation for each of the five metrics based on data from 2016. All primary care physicians who are two or more standard deviation above the mean of a given metric are considered outliers. In each state (excluding California), half of the outliers while be randomly assigned to the intervention group and half will be assigned to the control group, using a random number generator. Those outliers who are assigned to the intervention group will receive a cover letter signed by a members from the Physician Engagement Council (PEC), which is composed of physicians from the Society of General Internal Medicine (SGIM) which explains the study. Participants will also receive a report of participants' status as an outlier which shows in both text and graphic representation, how participants compare to participants' peers. These communications will be sent by mail. The control group will not receive any communication. All outliers in California will receive the intervention.

Brief summary of metrics:

* Metric 1: Average number of concurrent medications per older patient, by physician
* Metric 2: Proportion of older patients who received at least one medication that is a designated high-risk medication in older patients, by physician
* Metric 3: Proportion of older patients with concurrent use of multiple central nervous system-active medications, by physician
* Metric 4: Proportion of older patients with chronic use of benzodiazepine sedative hypnotic medications, by physician
* Metric 5: Proportion of older patients with concurrent use of opioids and benzodiazepines, by physician

Eligibility Criteria:
Inclusion Criteria:

* Primary care physician
* Must be the primary care physician for at least ten Medicare patients

Exclusion Criteria:

* None
Effect of Alveolar Minute Ventilation on Respiratory Gas Heat Content

This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy).

This is a single site, prospective, non-blinded, non-randomized, noninterventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy). Each patient will serve as their own control. The study will enroll adult patients without cardiac or respiratory illness. It is designed to evaluate the effect of the ventilatory pattern (tidal volume, rate) on respiratory heat loss measured using the VQm™ monitor during standard intra-operative clinical care that requires positive pressure ventilation (PPV)

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18 years
* scheduled for an elective surgical procedure with an anticipated duration of more than 2 hours requiring general anesthesia and positive pressure ventilation using an endotracheal tube
* patient status ASA 1, 2 or 3
* no significant cardio-vascular or respiratory disease
* supine surgical position

Exclusion Criteria:

* Adults unable to give primary consent
* age less than 18 years
* pregnancy
* prisoners
* pre-existing cardiac or pulmonary disease
* infusion of inotropic drugs
* positive end expiratory pressure (PEEP) requirements \>8 cm H2O
* increased intra-abdominal pressure (e.g. planned surgical pneumoperitoneum or ascitis)
* intra-operative patient position other than supine
Comparison of the Immediate Effects of Lower Extremity Static Stretching Exercises on Vertical Jump

The aim of this study is to compare the immediate effects of lower extremity static stretching exercises on vertical jump in sedentary individuals based on gender.

The study was conducted on 10 female (Group 1) and 10 male (Group 2) university students. The vertical jump height (VJH) of the individuals who agreed to participate in the study was measured with a wireless jumping platform. After the initial evaluations, lower extremity static stretching exercises targeting the M. Gastrocnemious and M. Hamstring muscles were applied to the participants in both groups. The VJH of the participants was re-evaluated immediately after the application. Both pre-post evaluations and female-male comparison evaluations will be performed for the statistical analysis of the data.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being between the ages of 18-25

Exclusion Criteria:

* Having balance problems for any reason
* Having a history of lower extremity surgery
* Having a musculoskeletal problem within the last year
* Doing regular exercise within the last year
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery

The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).

Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from 40 to 88 years old
* Scheduled to undergo unilateral cataract surgery

Exclusion criteria:

* Combined surgery
* Previous intraocular surgery
A Study of Two Vismodegib Regimens in Participants With Multiple Basal Cell Carcinomas

This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Participants with multiple basal cell carcinomas, including participants with Gorlin syndrome, with at least 6 clinically evident basal cell carcinomas at the time of randomization, of which 3 measure 5 mm or more in diameter and are considered target lesions. All other lesions are considered to be non-target lesions
* Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Adequate renal and hepatic function and hematopoietic capacity
* Women of childbearing potential must agree to use contraception as defined by protocol during treatment and for at least 9 months after completion of study treatment
* Male participants with female partners of childbearing potential must agree to use contraception as defined by protocol during treatment and for 2 months after completion of study treatment

Exclusion Criteria:

* Inability or unwillingness to swallow capsules
* Pregnant or breastfeeding women
* Any metastatic basal cell carcinoma
* Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
* Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study
* Known or suspected alcohol abuse
* One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization

The study is a single-centre, randomized, active controlled, open label clinical trial. The primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after CTO-PCI (chronic total occlusion - percutaneous coronary intervention)

The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used in both arms at the approved doses and for the approved duration therapy of 1-year. The secondary hypothesis will test the role of ticagrelor/clopidogrel alone and together with ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is tested in the second randomization. The angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, older than 18 years old.
* Written informed consent obtained.
* Patients with stable angina pectoris (Canadian Cardiovascular Society (CCS) Class 1, 2, 3 or 4) or patients with documented silent ischemia by stress test during the last year.
* Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year.

Exclusion Criteria:

* Women who are pregnant or women of childbearing potential who do not use adequate contraception.
* Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
* Participation in other studies.
* Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
* Planned cardiac surgery or major non-cardiac surgery.
* The subject has a history of bleeding diathesis or coagulopathy.
* The subject suffered disabling stroke within the past year.
* Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction, which, in the judgment of the Investigator, may affect the patient's ability to complete the study.
* History of malignancy, except in patients who have been disease-free \>5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
* Inability to provide informed consent
An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer

This observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. The treating physician has decided to treat the patients with Avastin (bevaci zumab) in combination with chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be collected for 72 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Female patients over 18 years of age
* Histologically confirmed Advanced Epithelial Ovarian Cancer
* Confirmed ascites prior to surgery
* Residual disease after surgery
* Patients are chemotherapy naïve or have received only one prior line of treatment for their disease
* International Federation of Gynecology and Obstetrics (FIGO) stage IIIb or IV disease
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2
* Patients must meet treatment eligibility requirements according to treating physician and Summary of Product Characteristics (SmPC) criteria for Avastin plus chemotherapy.

Exclusion Criteria:

* Pregnancy or lactation
* Low grade tumors, since this does not necessarily requires systemic treatment. Complete surgical resection
* Uncontrollable hypertension
* Unexplained bleeding
* Known hypersensitivity to any components of bevacizumab
* All contraindications specified in the respective Summary of Product Characteristics (SmPC) and/or local labelling of Avastin and the corresponding chemotherapy must be adhered to by the physician.
Live and Interactive Fitness Training Program (Vivo Knee OA)

Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.


Eligibility Criteria:
Inclusion Criteria:

* 55-85 years of age
* Diagnosis of Osteoarthritis within the prior 6 months
* Symptomatic OA defined as self-report:

  * Pain in the knee(s) on most days of the month
  * Difficulty with at least one of the following because of knee pain:

    * walking ¼ of a mile
    * climbing stairs
    * getting in and out of a car, bath, or bed
    * rising from a chair
    * or performing shopping, cleaning, or self-care activities
* Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
* Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
* Ambulatory and community-dwelling
* Sedentary or insufficiently active as measured by the PAVS
* Access to Wi-Fi in defined exercise space
* BMI of 20-34.9 kg/m2
* Document medication specific to OA and knee pain
* Willing and able to provide consent

Exclusion Criteria:

* Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
* Diagnosis of dementia
* Inability to complete ≥1 ADLs without assistance.
* Knee surgery in the past 6 months
* Severe osteoporosis T-score \< -3.5
* No concurrent enrollment in physical therapy for knee pain
* No concurrent enrollment in the Intermountain Arthrofit program
* Under the age of 55 or ≥85
* Asymptomatic OA
* Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
* KL Grade 1 or 4
* BMI above 34.9 kg/m2 or ≤20 kg/m2
* Participation in formal strength training more than 30 minutes a week in the past 6 months.
* PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.
* Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
* Symptomatic or severe coronary artery disease; peripheral vascular disease
* Untreated hypertension
* Active cancer other than skin cancer
Bioimpedance for Ortho Trauma

Patients with high-energy extremity trauma will undergo imaging with an EIT device in the Emergency Department, Operating Room, Orthopaedic Clinic, and In-patient hospital rooms. The EIT device is an electrical impedance tomography system.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* High energy closed extremity fracture
* Provision of informed consent

Exclusion Criteria:

* Metatarsal fractures
* Injury to both lower extremities precluding contralateral imaging
* Presence of an implanted electronic device (e.g. pacemaker, vagal stimulator, deep brain stimulator) or electrodes or electrical wires.
* Currently pregnant, potentially pregnant, or lactating women
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients

The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.

This is a prospective, single-center, open label single arm study, conducted in two phases: up to 6 healthy subjects (Phase 1) and up to 16 chronic heart failure (CHF) patients (Phase 2).

After being informed about the study, requirements and potential risks, consenting patients will be enrolled and undergo 3 procedures (each procedure up to 3 (±1) hours operation), with 4-10 days between each procedure.

All patients will be followed up for 7 (±2) days from final procedure.

Eligibility Criteria:
Inclusion Criteria:

Phase 1: Healthy subjects:

1. Age ≥ 18
2. Subject has been informed on the nature of the study and has provided informed consent
3. Subject is capable of meeting study requirements

Phase 2: CHF Patients:

1. Age ≥ 18 and diagnosed with CHF
2. Subject has 2 or more score for pitting edema
3. Subject is taking diuretic medications at home
4. Subject has been informed on the nature of the study and has provided informed consent
5. Subject is capable of meeting study requirements

Exclusion Criteria:

Phase 1: Healthy subjects:

1. Subject is enrolled to another clinical investigation that might interfere with this study
2. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
3. Subject has no known sensitivity to Neoprene

Phase 2: CHF Patients:

1. Subject is enrolled to another clinical investigation that might interfere with this study
2. Subject is admitted to the hospital for acute decompensated or acute heart failure
3. Subject has any known lower body skin problems (open wounds, ulcers)
4. eGFR\<15 ml/min/m2
5. Subject with severe peripheral arterial disease
6. Subject is pregnant or planning to become pregnant within the study period, or lactating mothers
7. Subject has known sensitivity to Neoprene
Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only

RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma.

PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.

OBJECTIVES:

Primary

* Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).

Secondary

* Determine predictive factors of relapse and survival of patients with stage 1, 2A, or 2B neuroblastoma without NMA who have undergone surgery only.

OUTLINE: This is a nonrandomized, multicenter study.

Patients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray periodically for up to 5 years. All other patients undergo additional therapy and follow-up according to national standards. Patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed neuroblastoma or ganglioneuroblastoma
* Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:

  * Stage 1
  * Stage 2A or 2B meeting 1 of the following criteria:

    * With or without N-myc amplification
    * No evaluation of NMA
    * Symptomatic spinal cord compression
  * Stage 3\*
  * Dumbbell syndrome with clinical signs of spinal cord compression\*
* NOTE: \*These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment
* Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy
* No metastases within 1 month of diagnosis

  * No skin metastases by clinical examination and MIBG scan
  * Normal liver by CT scan or ultrasonography
  * Normal chest X-ray (in case of nonthoracic primary site)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Prior steroids allowed
* No prior chemotherapy