cyrilzakka/clinical-trials huggingface dataset:
Registrational Trial to Compare Effectiveness of Two Digital Software Medical Devices as Adjunctive Oncology Treatment

This is a non-significant risk, double-blinded, randomized, registrational study to compare the effectiveness of two digital, software only, medical devices (SaMD) (attune™ and cerena™) in reducing cancer-related anxiety and depression symptoms when used adjunctively with multidisciplinary (medical, psychosocial) oncology usual care regimens for up to 10 weeks.

Study population will consist of up to 553 participants with stage I-III breast cancer or stage I-III NSCLC. The primary endpoint is percent improvement in anxiety symptoms at Week 10 and secondary endpoints of percent improvement in depressive symptoms will be assessed at Week 12.

An interim analysis for efficacy and futility will be conducted once 236 participants have completed the study.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III breast cancer or Stage I-III NSCLC who are currently in active treatment or have completed initial cancer directed treatments (surgery, radiation, chemotherapy) within the past 3 months;
* Are experiencing at least moderate anxiety (GAD-7 \>10) or mild-to-moderate depression (PHQ-8 score 5-11);
* Are fluent in English; and
* Have access to smartphone, or tablet capable of running iOS or Android software.

Exclusion Criteria:

* Previous history of cancer;
* \<2-yr survival prognosis as determined by treating clinician;
* Currently participating in investigative CBT trial for treatment of anxiety or depression;
* Participant is unable to complete training, has cognitive deficits, more severe psychiatric conditions, lack of access to internet accessible device or psycho-social conditions (e.g., other social conditions, that would interfere with adherence to self-directed care), such that in investigator's opinion the participant would be unable to complete the study;
* Recently completed use of Blue Note Therapeutics Covid Cancer Care Program or other Blue Note Therapeutics-sponsored study; and
* PHQ-9 Q9 response \>0 AND Columbia Suicide Severity Risk Scale (or equivalent) score of Category 2- "suicidal ideation" at screening.
Radiofrequency For Chronic Knee Pain Post-Arthroplasty

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

The purpose of this study is to evaluate whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain.

Chronic knee osteoarthritis (OA) is one of the most common diseases with increasing prevalence in advanced age. Knee OA results in movement restriction, sleep disturbance, and disability. Total knee arthroplasty (TKA) is employed often in the symptomatic treatment of knee OA. It has been estimated that 3.4 million TKAs will be performed in the year 2030 in the United States alone. Many studies report rewarding outcomes for patients, but other research shows there are many patients that remain dissatisfied post-arthroplasty.

As the prevalence of knee arthroplasty increases, so does the frequency of revisions. It has been found that 20% of patients reporting painful knee arthroplasties were not able to be diagnosed with a specific cause and were therefore referred to a pain specialist. Pharmacologic therapy and non-surgical interventions are often employed with minimal benefit to the patient's level of disability as indicated by clinical evidence.

Genicular radiofrequency ablation seems to be a safe, effective and minimally invasive therapy for chronic knee OA patients who have had a positive diagnostic block. No study has determined whether genicular radiofrequency ablation can relieve chronic post-arthroplasty knee pain. The investigators propose to examine the effect of genicular radiofrequency ablation in chronic post-arthroplasty knee pain in patients who respond positively to diagnostic nerve blocks.

Eligibility Criteria:
Inclusion Criteria:

* Study candidate must provide written informed consent.
* Must be ≥ 50 years of age at the time of consent
* Chronic knee pain despite total knee arthroplasty at least 6 months prior to consent
* Orthopedic evaluation indicating no further surgery is warranted
* Stable pain medication regimen for 30 days prior to baseline visit
* Knee pain is primary pain complaint

Exclusion Criteria:

* Acute knee pain
* Connective tissue disorders affecting the knee
* Serious neurologic or psychiatric disorders that would affect the outcome of the study as determined by the Principal Investigator
* Steroid or hyaluronic acid injections into the affected knee in the past 3 months
* Confounding pain conditions of the index leg that may affect medication requirements or study outcomes
A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease

This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+) malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CD20+ B-cell lymphoma or B-CLL
* Refractory/relapsed CLL, FL, and DLBCL
* At least 1 measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension) with the exception of CLL
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy \>6 months

Exclusion Criteria:

* Prior use of any investigational antibody therapy within 6 months of study start
* Prior use of any anti-cancer vaccine
* Prior administration of rituximab within 3 months of study start
* Prior administration of radioimmunotherapy 3 months prior to study entry
* Central nervous system lymphoma
* History of other malignancy
* Evidence of significant, uncontrolled concomitant disease
* Abnormal laboratory values
* Patients with progressive multifocalleukoencephalopathy (PML)
* Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

This is a multicenter study designed to compare the effect of exenatide plus a lifestyle modification plan versus placebo plus a lifestyle modification plan on weight loss in non-diabetic, obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Have a Body Mass Index (BMI) \>= 30kg/m\^2

Exclusion Criteria:

* Have ever participated in this study previously, or any other study using exenatide (AC2993/LY2148568) or GLP-1 analogs
* Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start (this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry)
* Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of anti-diabetic medications for \> 3 months
* Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks of screening
* Used drugs for weight loss (e.g., Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Accomplia \[rimonabant\], Alli \[low-dose orlistat\], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
* Are actively participating in, or have participated in a formal weight loss program within the last 3 months
* Have a history of chronic use of drugs that directly affect gastrointestinal motility, including, but not limited to Reglan (metoclopramide) and chronic macrolide antibiotics
* Have been treated with any anti-diabetic medications within 3 months of screening
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study start
* Have had bariatric surgery
* Have had an organ transplant
Trial for Femoroacetabular Impingement Treatment

Femoroacetabular Impingement (FAI) describes a condition of the hip where additional bone results in the abutment of the femoral neck against the rim of the acetabulum. This gives rise to localised cartilage damage and pain, but also increases the risk of developing osteoarthritis. The purpose of this study is to compare the effectiveness of arthroscopic surgery versus physiotherapy and activity modification for the treatment of this condition.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients
* Age 18-60 years
* Clinical and radiological evidence of FAI
* Competent to consent

Exclusion Criteria:

* Prior hip surgery
* Established osteoarthritis (Kellgren-Lawrence \>/= 2)
* Hip dysplasia (Centre-Edge angle \< 20 degrees on radiograph)
* Completion of physiotherapy programme targeting FAI within past year
* Co-morbidities that mean surgical intervention is not possible/safe
* Contraindication to MRI
* Pregnancy
The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life

The research was carried out to determine the effect of acupressure and yoga applied to cope with PMS on premenstrual symptoms and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* have regular menstrual cycle

Exclusion Criteria:

* Has a psychiatric diagnosis,

  * Having any gynecological disease (anornal uterine bleeding, fibroids, ovarian cyst etc.)
  * Using contraceptive drugs,
  * With tissue deformity in its extremities, Any health problems that may prevent physical exercise
Point-of-Care Ultrasound in Primary Care

The purpose of this study is to evaluate reliability of Point-of-Care ultrasound evaluation performed by general practitioners.

The purpose of this study is to evaluate reliability of Point-of-Care ultrasound (POCUS) evaluation performed by general practitioners.

General practitioners who underwent predefined training in POCUS will perform ultrasound examination in outpatients meeting inclusion criteria. While this is observational study, result will not have an impact on the management of the patients.

Regardless of the POCUS examination, patients undergo a routine diagnostic process which is appropriate for the initial symptom. Imaging examinations will always be a part of this. This will serve as an expert control to evaluate the reliability of POCUS Each POCUS examination will also be recorded as a video loop, subsequently assessed by an expert in the POCUS and also used as an expert control.

The data will be analyzed by standard reliability testing.

Eligibility Criteria:
Inclusion Criteria:

* Patient with abdominal pain in the right upper quadrant (will be indicated for the abdominal ultrasound) or patient with dyspnoea (will be indicated for lung ultrasound) or patient with suspected deep vein thrombosis (will be indicated for compression ultrasound testing)
* Signing of informed consent to participate in the study

Exclusion Criteria:

* Age \<18 years
* Refusal of ultrasound examination by patient
* Any circumstance that prevents ultrasonographic examination (eg allergy to ultrasonographic gel, skin lesions that do not allow safe examination, etc.)
Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans

While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.

The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.


Eligibility Criteria:
Inclusion Criteria:

* Infants and children from 0 to 17 years old
* Having had meningitis or meningococcal purpura fulminans between 2010 and 2021
* Delay ≥ 1 year between the date of diagnosis of meningitis or purpura meningococcal fulminans and the date of inclusion in the study (signature of the informed consent)
* The holders of parental authority have read and understood the information letter and their express consent has been obtained
* Patient affiliated to a social security system (Social Security or Universal Medical Coverage)

Exclusion Criteria:

* refusal to participate
Impact of the Residual Gastric Volume in Laparoscopic Sleeve Gastrectomy's Failure

Obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. The surgical management of this illness consists in different techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the residual gastric volume.

The aim of the present study was to determine whether the residual gastric volume is involved in Laparoscopic Sleeve Gastrectomy's failure.

This study can be done in three steps:

1. From a prospective database, patients are selected if they were operated by Laparoscopic Sleeve gastrectomy at least two years before.
2. these patients are convoked by their surgeon, who proposed them to participate at this study. During this consultation, the BAROS score is calculated by the surgeon and reported in the case report form of the patient.
3. After checking the possible contraindication, a gastric computed tomography volumetry is done and the residual gastric volume is calculated by two independent radiologists.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* laparoscopic Sleeve gastrectomy performed two years before
* surgery performed in the digestive surgery department of the Amiens University Hospital

Exclusion Criteria:

* pregnancy or breastfeeding
* death of the patient or lost of follow-up
* patient under legal or administrative protection
* contraindication to the volumetry (pregnancy, technical impossibility)
The Effect of Nasal Cannulae During the First 2 Hours Postoperative in Patient Undergoing Thoracotomy

At our institute,during the first 2 hour postoperative, we used to give supplement oxygen via face mask in patient having lung resection surgery. After then if the patient is fine, we'll replace the face mask with nasal cannular untie the next morning. We hypothesized that oxygen mask can be replace by nasal cannular without any hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* age \>/= 18 years old
* Patient undergoing lobectomy or pneumonectomy or wedge resection
* ASA 1-3
* Preoperative oxygen saturation \< 95 %

Exclusion Criteria:

* Cannot communication
A Self-management Based Survivorship Intervention for Chinese Cancer Survivors

This study, using a sequential multiple assessment randomized controlled trial (SMART) approach, will evaluate a cancer survivorship care intervention on physical symptom distress, weight management, self-efficacy in managing cancer and health-related quality of life among Chinese patients recently completed curative cancer treatment.

This study, using this SMART approach, will assess the effect of a cancer survivorship care intervention on physical symptom distress, self-efficacy in managing cancer, weight management and health-related quality of life among Chinese patients recently completing curative cancer treatment. First, the investigators will test the effect of a one-off, multidisciplinary team face-to-face assessment (namely, the cancer survivorship clinic) with personalized advice on symptom management, lifestyle modification and anxiety management in reducing the case prevalence of symptom distress, increasing the proportion meeting the weight management criteria, and improving self-efficacy and health-related quality of life among cancer survivors in post-treatment survivorship, in comparison to those receiving skills-based pamphlets for symptom management and lifestyle recommendations. Secondly, this study aims to explore if a step-up targeted personalized intervention is more effective for patients who continue to have symptom distress and/or not to meet the weight management criteria if patients have attended cancer survivorship clinic (i.e. the embedded adaptive intervention) in comparison to those receiving skills-based pamphlets.

Eligibility Criteria:
Inclusion Criteria:

* Cantonese- or Mandarin-speaking Chinese patients diagnosed curable cancer
* have completed primary and adjuvant treatment within the past six months

Exclusion Criteria:

* Patients diagnosed with metastatic cancer
Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)

This study will test an investigational drug, theophylline, in children with pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt Clinical Research Center.

Study measures will be done at baseline and during a 24h infusion of IV theophylline. Theophylline levels will be drawn to ensure therapeutic dosing and to monitor for toxicity. Measures include laboratory values, response to PTH infusion and resting energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

1. Age 10 to 21 years old
2. English proficiency
3. Clinical and genetic diagnosis of PHP1a

Exclusion Criteria:

1. Use of a PDE inhibitor in the past 30 days
2. History of a seizure disorder unrelated to hypocalcemia
3. History of a cardiac arrhythmia (not including bradycardia)
4. History of hepatic insufficiency
5. AST or ALT \>2x upper limit of normal
6. Total bilirubin \>1.5 x upper limit of normal (unless patient has a diagnosis of Gilbert's syndrome and no other causes leading to hyperbilirubinemia are identified)
7. Congestive heart failure
8. Cigarette use in the past 30 days
9. Alcohol use within the past 24 hours
10. Current pregnancy
11. Untreated hypothyroidism (defined as free T4 level \< 0.6 ng/dL or TSH \>10 mcU/mL)
12. Active peptic ulcer disease
13. Fever \>101 degrees in the past 24 hours
14. Current use of medications known to effect theophylline levels (listed below)
15. Severe sleep apnea requiring BiPAP

Drugs with clinically significant drug interactions with theophylline:

* Allopurinol
* Cimetidine
* Ciprofloxacin
* Clarithromycin
* Enoxacin
* Ephedrine
* Erythromycin
* Estrogen
* Flurazepam
* Fluvoxamine
* Lithium
* Lorazepam
* Methotrexate
* Midazolam
* Pentoxifylline
* Propranolol
* Rifampin
* Sulfinpyrazone
* Tacrine
* Thiabendazole
* Ticlopidine
* Troleandomycin
* Verapamil
Opt-in vs. Opt-out for Breast Cancer Screening

This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening.

This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different outreach strategies in improving adherence to breast cancer screening via mammography.

Average risk female Veterans who are due for breast cancer screening (defined as aged 45-75 with no previous history of bilateral mastectomy, not under hospice care, and alive at the time of screening) will be identified through administrative data.

Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 2 and 4) to the following interventions:

Arm 1: Automated phone opt-in message Intervention Type: Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Arm 2: Opt-out scheduling Intervention Type: Consult automatically sent and Veteran called to schedule screening

Randomization will be stratified within arms by prior screening status (prior screener vs. never screener).

The study's primary outcome of interest is screening completion at 100 days post randomization. The study's secondary outcome of interest is screening scheduling at 100 days post randomization. Subgroup analysis aim 1 will explore whether the differences in breast cancer screening completion between investigational groups varies according to the Veterans' race/ethnicity. Subgroup analysis aim 2 will explore whether the differences in breast cancer screening scheduling between investigational groups varies according to the Veterans' race/ethnicity. Enrollment in the trial will occur between March 1, 2022 and August 31, 2022.

Eligibility Criteria:
Inclusion Criteria:

* female Veterans aged 45-75
* assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available
* due for breast cancer screening (have not had a mammogram in the last 12 months)

Exclusion Criteria:

* must not be any indication of current receipt of hospice care
* no record of recent death in the administrative data
* not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment.
* not have a personal history of bilateral mastectomy.
The Safety and Effectiveness of Transcatheter Aortic Valve Raplacemet in Intermediate Risk Patients With Bicuspid Aortic Stenosis

Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Severe, calcific bicuspid aortic stenosis.
2. Heart team agrees the patient has a risk of operative mortality and has an STS \<8 and \>3.
3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.

Exclusion Criteria:

1. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
3. Severe aortic regurgitation (\>3+).
4. Severe mitral regurgitation (\>3+).