cyrilzakka/clinical-trials huggingface dataset:
Desktop Versus Mobile Data Collection in Clinical Trial

Paper-based data collection for prospective clinical trials is associated with a poor quality of data collection. This typically involves missing or wrong data entry or a low recruitment rate, mainly due to the cumbersome and uncontrolled data collection.

Electronic data collection is associated with improved quality of data entry in the cases of Electronic Patient Records (EPR) and patient handover among doctors during night and day shifts. However, a comprehensive direct comparison between web-based desktop personal computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.

The purpose of this prospective trial is to compare the users' experience with the web-based desktop PC and mobile data collection (iPad) tools.

The investigators designed a prospective randomized controlled trial where doctors from several randomly selected hospitals will use either a desktop PC or mobile (iPad) data collection tool. A validated user experience evaluation instrument will be used at the beginning, during interim analysis and at the end of the trial.

The desktop-based data collection is built on Drupal, a renowned open source content management system (CMS). The same CMS will be used with a special interface designed for iOS/iPad. Both data collection platforms will be used in parallel to a prospective clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Room doctors
* Surgeons
* Agree to participate in the trial
* Provide informed consent
* Have basic information technology literacy
* Agree to receive brief training of the platform

Exclusion Criteria:

* Clinicians and health care professionals not part of this trial
* Lacking of basic information technology literacy
Impact of Covid-19 Pandemic on Management of Head and Neck Cancers

Since its emergence in late December 2019, the SARS-CoV-2 coronavirus has spread rapidly, causing a global health crisis. The disease caused by this highly contagious respiratory virus is called COVID-19. At the beginning of August 2020, there were more than 194,000 confirmed cases in France - including approximately 16,000 cases in the Hauts-de-France area - and more than 30,300 deaths.

Cancer patients are generally susceptible to respiratory infections, and CoV-2-SARS is no exception. Early Chinese studies reported a higher rate of CoV-2-SARS infection in people with cancer (or a history of cancer) than in the general population, with more severe forms and with an increased risk if surgery or chemotherapy is performed in the month prior to infection. The purpose of this study is to describe the management modalities of patients with H\&N (Head and Neck) cancer during the COVID-19 pandemic in the Maxillofacial Surgery Department of CHU Amiens-Picardie.


Eligibility Criteria:
Inclusion Criteria:

* patient diagnosed with cancer of the upper aero digestive tract
* patient benefiting from a medical consultation
* patient benefiting from a multidisciplinary consultation meeting for treatment decision between 01/03/2020 and 28/02/2021.

Exclusion Criteria:

* patient diagnosed with cancer other than upper aero digestive tract cancer
* patient whose treatment decision was made before 01/03/2020 (date considered as the beginning of the epidemic at the CHU Amiens-Picardie).
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep Sedation

The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years;
* Expected to require deep sedation ≥8 hours;
* Requirement for deep sedation (a Narcotrend index between 13 and 64).

Exclusion Criteria:

* Body mass index (BMI) \<18 or \>30 kg/m2;
* Acute severe neurological disorder and any other condition interfering with RASS assessment;
* Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
* Heart rate less than 50 beats/min;
* Second- or third-degree heart block in the absence of a pacemaker;
* Unstable angina;
* Acute myocardial infarction;
* Left ventricular ejection fraction less than 30%;
* Contraindicate or allergic to study drugs;
* Moribund state;
* Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2;
* Alcohol abuse;
* Myasthenia gravis;
* Expected to have a general anesthesia within 8 hours;
* Pregnancy or lactation.
Decreasing Physician Burnout With Professional Coaching

The goal of this randomized control trial is to learn if professional coaching can help reduce physician burnout among physicians at UCLA. The main aims of the study are:

* To reduce burnout among physicians with professional coaching
* Improve work satisfaction and engagement, sense of self-efficacy and social support with professional coaching
* Determine the efficacy of one-on-one professional coaching and small group professional coaching combined with behavioral interventions/activities in reducing physician burnout and comparing these groups to one another and to a delayed-entry (control) group

Participants will be randomly assigned into one of three groups:

* Intervention Group 1: One-on-one coaching (N=30). Six one-on-one coaching sessions via Zoom with one of two private professional coaches every other week for 3-4 months.
* Intervention Group 2: Coach-facilitated group sessions and coach-guided activities/behavioral interventions (N=30). Six small-group coaching sessions via Zoom with one of two private professional coaches and three physician participants in each group, every other week for 3-4 months.
* Delayed-Entry Group 3 (N=30): No intervention during duration of study period. Note: once participation in the pilot study has been completed for Groups 1 and 2, physicians participating in Group 3 will be offered to participate in six one-on-one sessions with a private professional coach over a 3-4 month period.

Participants will complete several surveys that assess for burnout, work engagement and satisfaction, sense of social support and isolation, and areas of worklife) before the start, upon completion of the intervention and again at 6 months upon completion of the sessions for the delayed-entry group.

Each group also received coach-guided activities/behavioral interventions during coaching sessions. These activities will be sent by coaches to participates throughout the 3 month period and include, but are not limited to: Wheel of Life, visioning exercise, one page miracle: core values, purpose, and goals, buckets and mental models.


Eligibility Criteria:
Inclusion Criteria:

* Actively practicing UCLA department of medicine physicians who had at least two years of employment at UCLA

Exclusion Criteria:

* Current or anticipated (in the next 6 months) participation in one-on-one or group coaching provided by a professional coach
Feasibility of an Activity Regimen in Patients With Advanced Stage Lung Cancer

The investigators will evaluate the feasibility of implementing a low-intensity, patient-centered activity regimen (PCAR) that prioritizes education and communication over a 12-week period in advanced stage lung cancer patients. The primary outcomes will include number of patients increasing their overall step count over the study period and adherence to step count recommendations. Secondary outcomes will include quality of life (QoL), dyspnea, and depression scores before and after the intervention as well as a patient feedback questionnaire (to guide further interventions). The goals are to increase overall step count and obtain adherence of \>50% of participants. The investigators will also assess whether the physical activity regimen influences markers of inflammation and glucose control and novel markers of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic evidence of advanced non-small cell stage lung cancer (NSCLC)
* Approval of the treating clinician
* Adult patients (age \>21 years) willing to wear a FitBit® device (FitBit, Inc., San Francisco, CA)
* Access to a smartphone, agree to receive twice/daily text messages for 12 weeks (including any costs), and willingness to download the FitBit application to their smartphone.
* Low activity level as judged by a brief physical activity questionnaire (i.e., \<150 minutes/week of moderate-intensity exercise, \<75 minutes/week of vigorous aerobic exercise, or an equivalent combination).

Exclusion Criteria:

* Memory impairment (as judged by the treating clinician)
* Communication impairment (as judged by the treating clinician)
* Treating clinician's request not to alter physical activity
* Physical inability to safely walk (as judged by the treating clinician)
Real-world Experience of ICIs Plus Chemotherapy for Advanced ESCC.

This study is a multi-center, non-interventional study. Clinicopathologic, treatment , outcome and efficacy data will be collected from medical records in metastatic esophageal squamous cell carcinoma (ESCC) patients.

This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected in metastatic esophageal squamous cell carcinoma (ESCC) patients who were treated with ICIs as 1st line treatment at approximately 26 institutions. The patients should have received at least 1 cycle of anti-PD-1 immunotherapy with or without radiotherapy. Based on these data, overall survival (OS), progression free survival (PFS) from start of 1st line treatment and the role and efficacy of radiotherapy for these patients will be assessed.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18, had an Eastern Cooperative Oncology Group performance status score of 0-3; Patients had unresectable or recurrent disease that precluded esophagectomy or definitive chemoradiation, or distant metastatic disease; Patients had received no previous systemic therapy (patients who had progressed ≥6 months after \[neo\]adjuvant therapy or definitive chemoradiation were eligible); Patients accepted at least one cycle of anti-PD-1 immunotherapy as 1st line treatment, combined chemotherapy was allowed.

Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.

Exclusion Criteria:

Patients who are prior exposure to immune-mediated therapy.
Quality of Medical History Taking and Diagnostic Accuracy

This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy

Diagnostic errors are a relevant health-care problem. As medical history taking is usually the first step in a patient's assessment its quality is most likely a first and important barrier against diagnostic errors. There are, however, only limited data on the association of the quality of medical history taking and diagnostic accuracy.This prospective randomized simulator-based single-blind trial aimed to investigate the effects of initial cues and history taking skills on diagnostic accuracy. 198 medical students (135 females) were given the task to assess a patient presenting with simulated acute pulmonary embolism. Participants were randomized to six versions of the scenario differing only in the initial cues, i.e. in the reply of the patient to the initial question about the reason for his visit. In three of six versions, initial cues were restricted to thoracic symptoms (chest pain, dyspnoea, or combination of both). In the remaining three versions, initial cues consisted of thoracic and extra-thoracic (leg pain, immobilization) symptoms. The primary outcome was diagnostic accuracy. The mannequin was equipped with a speaker in its head that broadcasts the voice of a remote operator (experienced physician) allowing verbal interaction of the participants with the "patient". The "patient" did not speak unless asked and responded to all participants' questions during history taking according to a pre-defined checklist.

Eligibility Criteria:
Inclusion Criteria:

* 4th year medical students participating in voluntary simulator-based workshops

Exclusion Criteria:

* decline to give written informed consent
Comparative Study of Intestinal Color Ultrasound and Capsule Endoscopy in Monitoring Crohn's Disease

The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and at the third month of treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.

The disease activity index under intestinal color ultrasound was evaluated by SUS-CD, and the disease activity index under capsule endoscopy was evaluated by CECDAI. Active lesions under intestinal color ultrasound were defined as SUS-CD ≥ 1, and active lesions under capsule endoscopy were defined as CECDAI ≥ 3.9. All subjects underwent intestinal color ultrasound and capsule endoscopy at baseline and 3 months after treatment. To compare the correlation between SUS-CD and CECDAI before and after treatment, and to compare the role of intestinal color ultrasound and capsule endoscopy in monitoring Crohn's disease in small intestine.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients diagnosed with Crohn's disease according to the 2019 European Guidelines for Crohn's disease;
* 2.At the time of inclusion, there were active lesions under color ultrasound or capsule endoscopy;
* 3.Voluntarily sign an informed consent form.

Exclusion Criteria:

* 1.Patients with contraindications for capsule endoscopy;
* 2.In the judgment of the investigator, it is not suitable to participate in this study.
Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel

Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to sign the informed consent
* Male and female subjects ages 18 - 90 at the time of surgery
* Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)

Exclusion Criteria:

* Inability to comply with follow-up requirements
* Known or presumed substantial rotator cuff disorders
* Subjects with an active or suspected latent infection in or about the shoulder
* Subjects with instability (surgically or non-surgically addressed)
* Subjects presenting with posttraumatic avascular necrosis
* Need for glenoid bone grafting
* Pregnant subjects
Effects of Selective Laser Trabeculoplasty

Primary objective is to evaluate the effect of selective laser trabeculoplasty (SLT) on the diurnal intraocular pressure variation in open-angle glaucoma patients (OAG).

This is a prospective observational study of OAG patients undergoing selective laser trabeculoplasty at the University of Kentucky Chandler Medical Center. The patients will be recruited over 12 months. Study will include 3 visits: pre-laser visit, visit for laser treatment and post-laser visit. All visits will occur within a 3-month period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have the diagnosis of open angle glaucoma
* Subjects who are able to speak and understand English and provide meaningful written informed consent,
* Subjects who are willing and able to comply with all testing and requirements defined in the protocol and willing and able to comply with all required study visits.

Exclusion Criteria:

* Subjects with previous laser treatment or intraocular surgery,
* Subjects with history of ocular inflammation and with history of previous ocular trauma.
A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.


Eligibility Criteria:
Inclusion Criteria:

* bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
* English speaking

Exclusion Criteria:

* Score less than 21 on the MoCa (Montreal Cognitive Assessment)
* Evidence of conductive or retrocochlear pathology
Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Strontium-89 may relieve bone pain caused by prostate cancer. Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth. Combining doxorubicin and strontium-89 with celecoxib may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying celecoxib together with doxorubicin and strontium-89 to see how well they work compared to doxorubicin and strontium-89 alone in treating patients with progressive androgen-independent prostate cancer and bone metastases.

OBJECTIVES:

* Compare time to prostate-specific antigen progression in patients with progressive androgen-independent prostate cancer and bone metastases treated with doxorubicin and strontium chloride Sr 89 with or without celecoxib.

OUTLINE: This is a randomized study. Patients are stratified according to extent of bone metastases on bone scan (\> 20 lesions vs ≤ 20 lesions) and quality of response (i.e., decline of the prostate-specific antigen from baseline) to prior induction chemotherapy (≥ 80% vs \< 80%). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive doxorubicin IV over 30 minutes on days 1, 8, 15, and 22 and strontium chloride Sr 89 IV on day 1. Patients also receive oral celecoxib twice daily in the absence of disease progression.
* Arm II: Patients receive doxorubicin and strontium chloride Sr 89 as in arm I.

PROJECTED ACCRUAL: A total of 70 patients (35 per treatment arm) will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of androgen-independent prostate cancer

  * Osteoblastic metastases
  * No predominant visceral metastases
* Progressive disease after response to prior induction chemotherapy (prostate-specific antigen decline of at least 50% from baseline after 16 weeks of treatment)
* No symptomatic lymphadenopathy (i.e., scrotal or pedal edema)

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Adequate physiologic reserves

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* No prior radionuclide therapy

Surgery

* Not specified

Other

* No more than 3 prior cytotoxic treatments
* More than 6 months since prior celecoxib or rofecoxib
A Study to Assess the Anti-Emetic Efficacy of Ginger in Children and Adolescents Receiving Chemotherapy

Ginger root powder is found to be significantly effective,when given as an add-on therapy in reducing chemotherapy induced nausea and vomiting in children and adolescents receiving chemotherapy.

It is very cost effective and as compared to the other add-on therapy drug like aprepitant.

Cisplatin is a chemotherapeutic agent with high emetogenic potential. High doses of Cisplatin (120 mg/m2) induces nausea and vomiting in 90 % of patients. More than 60% of patients experience nausea and vomiting even if they are getting the conventional anti emetic medications.

Children and adolescents with cancer are using complementary and alternative medicine (CAM) to relieve symptoms, reduce side effects of treatment, and cope with the emotional aspects of having a life-threatening illness. Parental decisions about using CAM should be based on studies of efficacy and safety .

Ginger is already used in traditional folk medicine to treat nausea and vomiting.Additionally, ginger's ability to block 5-HT3 receptors and its free-radical scavenging action in the gut suggests that it may be beneficial for reducing both the prevalence and severity of chemotherapy induced nausea and vomiting.

Ginger is an easily available and cost effective substance in Indian scenario; (1gm costs less than one rupees). A dose of 1-2 gm of ginger is found to have favourable effects in reducing the incidence of nausea and vomiting. There are not much side-effects of ginger have been established so far, except mild stomach upset, increased burping and nausea seen in very few patients after the ingestion of ginger. Ginger is a widely available,affordable and acceptable natural substance which is to be included as an additional treatment option for chemotherapy induced nausea and vomiting which will significantly improve the health, compliance with treatment and quality of life of patients receiving chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a histologically confirmed diagnosis of Osteosarcoma/ Malignant Fibrohistiocytoma of bone that is currently being treated with chemotherapy with high emetogenic potential chemotherapeutic agent(Cisplatin at a dose 120mg/m2 ; Adriamycin 75 mg/m2)
* Age group : 8-21 yrs.
* Weight : greater than or equal to 20 kg and less than 40 kg in Category 1
* Weight : greater than or equal to 40 kg and less than 60 kg in Category 2
* Patients who are willing to participate in study.
* Patients or their parents who can understand Hindi or English.

Exclusion Criteria:

* Patients of age \<8 yrs or age \>21 yrs.
* Weight \< 20 kg and greater than or equal to 40 kg in Category 1
* Weight \< 40 kg and greater than or equal to 60 kg in Category 2
* Patients receiving chemotherapy with drugs other than Cisplatin.
* Patients receiving a dosage of chemotherapy with Cisplatin\<120 mg/m2.