cyrilzakka/clinical-trials huggingface dataset:
Communication Coaching to Improve Patient and Clinician Satisfaction in Cardiology Encounters

The purpose of this study is to determine the effect of a clinician communication coaching intervention versus control on an objective measure of the quality of communication (primary outcome) and patients' perceptions of the quality of patient-centered care (secondary outcome), both overall and within Black and White patients.

The investigators propose a two-arm cluster randomized controlled design, in which the unit of randomization is the clinician. Up to fifty cardiology clinicians will be randomly assigned to either the coaching intervention or to a control condition. The investigators will recruit up to 50 clinicians to ensure that we have at least 40 clinicians with complete pre- and post-intervention measures. Although the unit of randomization is the clinician, the unit of evaluation is the patient: 10 patients per clinician who get cardiology care from the enrolled clinicians will consent to audio-recording of their encounters and to completing the surveys. Clinicians randomized to the intervention will obtain verbal consent from additional patients to audio-record the encounter for coaching. The intervention will be delivered in the clinic or via video-conference (Skype or Facetime), providing individual coaching and professional feedback on the communication behaviors encounters. The investigators will also measure Press Ganey scores by clinician pre- and post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older
* Must be able to read
* Must speak English
* Capable of providing informed consent
* Must be receiving continuity care from and enrolled clinician

Exclusion Criteria:

* Currently hospitalized
* Awaiting heart transplant
Influence of the COVID-19 Pandemic on Dutch Surgical Patterns of Care

The aim of this study is to determine the impact of the COVID-19 pandemic on the Dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the Netherlands during the year 2020.

The aim of this study is to determine the impact of the COVID-19 pandemic on the Dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the Netherlands during the year 2020. This was done by executing a nationwide prospective cohort study, under the name "Dutch COVIDsurg II Snapshot Study". This study was conducted in collaboration with the Dutch Institute of Clinical Auditing (DICA). For this study, the surgical audits for lung cancer surgery (DLCA-S), Upper gastrointestinal cancer surgery (DUCA), pancreatic cancer surgery (DPCA), hepatobiliary surgery (DHBA), colorectal cancer surgery (DCRA), hip fracture surgery (DHFA), aortic aneurysm surgery (DSAA), and bariatric surgery (DATO), were expanded with an additional COVID-19 survey, since August 2020. This survey focused on alterations in, or delay of treatment and diagnostics, perioperative outcomes, and specific COVID-19 related symptoms and complications during the COVID-19 pandemic. All academic-, general community-, teaching- and non-teaching hospitals in the Netherlands performing pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysmal or bariatric procedures were approached to participate in the Dutch COVIDSurg II Snapshot study. Patients who underwent surgery during the period January 1st 2018 until December 31st 2019, were included in the historical cohort. Patients who underwent a surgical procedure in the period January 1st 2020 until December 31st 2020 were included in the study group.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent pulmonary, upper gastrointestinal, pancreatic, hepatobiliary, colorectal, hip fracture, aneurysm or bariatric surgery
* Alle patients \>18 years
* Patients undergoing surgery during the period January 1st 2018 until December 31st 2020
* Hospital that performs the surgery has to participate in the study

Exclusion Criteria:

* none
Pictographic Education Handout on Tracheostomy Care

The goal of the study is to address the clinical problem of poor education outcome from the current practice of teaching tracheostomy care by providing them with a pictographic education handout to assist their learning. The study seeks to establish face validity and preliminary efficacy of a pictographic education handout with patients and identify factors associated with lower self-efficacy level on tracheostomy care.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Had a tracheostomy as part of head and neck cancer treatment, and who is not on mechanical ventilation
* His or her date of the related tracheostomy surgery was within the past 6 months
* Have received the discharge tracheostomy care education from the clinical nurse

Exclusion Criteria:

* Documented major physical or cognitive disabilities that would limit the ability to give informed consent or answer survey questions
Dynamic Navigation-Assisted Dental Implant Placement

Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach.

All patients received implants in the right and left the side of their upper jaws via the random use of the navigation or the freehand approach. Positional deviations between the planned and placed implants were measured on a final tomographic image matched to the baseline.


Eligibility Criteria:
Inclusion Criteria:

* men and women aged \>18 years.
* Patients approving to participate in the trial and giving written consent
* must be able to open his/her mouth

Exclusion Criteria:

* Hemodynamically significant mitral valve stenosis
* Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
* Planned cardioversion (electrical or pharmacological)
* Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery, myocardial infacrtion)
* Known presence of atrial myxoma or left ventricular thrombus
* Active endocarditis
Effect of Sinovac on Survival in Intensive Care Unit

Effect of Inactivated COVID-19 Vaccine (Sinovac) on survival in intensive care unit, Single Center Experience

Turkey has started vaccinate healthcare professionals at 13 January 2021 by Sinovac vaccine and declared a step by step inclusion schedule The primary aim of the study is to compare clinical, laboratory and survival data of COVID-19 patients who were vaccinated at least 14 days before enrollment to the study with COVID-19 patients not vaccinated although they would have. The secondary aim is to compare age of enrolled patients to ICU due to SARS-CoV-2 infection with patients admitted to ICU before start of vaccination program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with covid 19 over the age of 65 who were admitted to the intensive care unit between 1 April 2021 and 15 May 2021

Exclusion Criteria:

* admissions to ICU due to reasons other than COVID-19, age younger than 65, continued admission at the end of enrolment date,
US-guided SAPB for Rib Fractures in the ED

The purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.

Patients with unilateral rib fractures in the Highland Hospital Emergency Department who agree to participate will be randomized 1:1 to either the control group or the experimental group. Those in the control group will receive the usual oral and/or IV pain medication as needed. The experimental group will receive an ultrasound-guided serratus anterior plane block. Numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. At time 60, patients who received the SAPB will receive sensory testing. Patients will be offered additional pain medication as needed at times 20, 40, and 60.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy.
* Written informed consent must be obtained from each patient prior to entering the study.
* Patients with moderate to severe pain (NRS 4 to 10) as a result of one or more rib fractures occurring at levels T2-T8, measured on a self-reported NRS.

Exclusion Criteria:

* Patient refusal
* Patients with significant pain from other injuries (as determined at the discretion of the treating physician)
* Patients deemed critically ill by provider
* Patients with decompensated psychiatric disorders
* Pregnant patients (positive urine or serum B-HCG)
* History of heart block or bradycardia
* History of uncontrolled seizures
* Patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine
* Patients with bilateral rib fractures
Determining Whether Intra-Arterial Carboplatin Causes Hearing Loss in Children

The purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent indicating awareness of the investigational nature of the protocol.
* Children with RB aged 3 months and older who are scheduled to receive their first dose of IA carboplatin chemotherapy.

  * Retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants

Exclusion Criteria:

* Children with known and documented preexisting hearing loss.
Prostaglandin E2 in Migraine Suffers Without Aura.

The hypothesis of this study is that Prostaglandin E2 (PGE2) induces headache and dilatation of brain vessels in migraine patients without aura.


Eligibility Criteria:
Inclusion Criteria:

* Patients with migraine without aura

Exclusion Criteria:

* Tension type headache more than x 3 per month
* Other forms for primary headache
* Headache 24 h before the day of the investigation
* Migraine 48 h before the day of the investigation
* Hypertension
* Hypotension
* Pregnant/nursing
* Daily intake of medication (except oral contraceptives and migraine rescue medicine during migraine attack)
* Cardiovascular or central nervous system (CNS) disease
* Drug/alcohol abuse
* Psychiatric disease
* Asthma or any other lung diseases
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in the treatment of endometriosis

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with endometriosis-associated pelvic pain

Exclusion Criteria:

* Pregnant or lactating women
* history or suspicion of hormone dependent tumor
* therapy resistant endometriosis
* need for primary surgical treatment
* any other conditions which forbid the participation.
Uterine Peristalsis in IVF

An observational prospective cohort study to evaluate the effect of uterine peristalsis at the time of embryo transfer on IVF clinical outcomes performed in Women's Health hospital, Assiut University, Egypt.

Women performing fresh or frozen embryo transfer who do not have any uterine abnormalities will be included in the study


Eligibility Criteria:
Inclusion Criteria:

* • Women undergoing embryo transfer during IVF cycles.

  * Age: between 20 and 40 years.
  * Have at least 1 good quality embryo at the time of transfer
  * Fresh or frozen-thawed cycles.
  * Any stimulation protocol in fresh cycles, or any endometrial preparation protocol for frozen-thawed cycles

Exclusion Criteria:

* • Women refusing to participate in clinical research.

  * Any uncorrected uterine abnormality, such as septum, myoma, adenomyosis, or polyp
  * Hydrosalpinx without prior disconnection or excision
Myofunctional and Respiratory Intervention on Phonation in Stroke

Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented in order to improve phonation outcomes.

Patients with stroke frequently present phonation difficulties. An intervention combining myofunctional and respiratory training is presented to improve phonation outcomes. Myofunctional therapy is based on exercise training program for the muscles around your face, mouth, and tongue. Respiratory muscle strength training focuses on increasing the force-generating capacity of the inspiratory and expiratory muscles. A combination of both may be of interest to improve phonation parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of chronic stroke (duration above 6 months).
* Age over 18 years

Exclusion Criteria:

* Communication or cognitive deficits that prevented them from following verbal commands.
Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections.

Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon.

Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion.

The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections.

In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by :

* the visual appreciation of the surgeon
* the fluorescence-based enhanced reality, after injection of ICG and digital process.

A series of peri-operative samplings will also be carried out. In any case, the resection will be performed according to the surgeon's appreciation.

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, from 18 years old
* Patient with sigmoid diverticulosis or diverticulitis
* Patient with colon malignancy
* Patient with rectum malignancy
* Patient with no contraindication to anesthesia and to colonic resection surgery
* Patient able to understand the study and to provide informed consent
* Patient affiliated to the French social security system

Exclusion Criteria:

* Patient undergoing emergency surgery
* Patient undergoing abdomino-perineal resection
* Patient undergoing colonic resection without anastomosis (Hartmann's colostomy)
* Patient with proven or unclear allergic reactions
* Pregnancy or breast-feeding
* Patient in exclusion period (determined by a previous study or in progress)
* Patient in custody
* Patient under guardianship
Safety Study of Increasing Doses of Combretasatin A1 Diphosphate (OXi4503) as Monotherapy in Subjects With Hepatic Tumor Burden

The purpose of this study is to determine the safety and tolerability of OXi4503 in subjects with relapsed or refractory carcinomas with hepatic tumor burden.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed carcinoma. Tumor must be relapsed or refractory to standard therapies, or have no acceptable standard therapy.
2. Measurable disease by RECIST criteria.
3. Subjects must be at least 28 days from other investigational therapy and at least 2 weeks after chemotherapy or radiation therapy.
4. Age 18 years or older.
5. Eastern Cooperative Oncology Group (ECOG) Performance Score of less than 1.
6. Life expectancy of greater than 12 weeks.
7. Hemoglobin greater than 10 g/dL.
8. Adequate hepatic function.
9. Adequate renal function.
10. Adequate bone marrow reserve.
11. Able to maintain potassium, calcium and magnesium levels within normal ranges.
12. Must be able to provide written informed consent.
13. All women of childbearing potential (WOCBP) must have a negative serum pregnancy test.
14. WOCBP and fertile men and their partners must agree to use an effective form of contraception during the study and for 90 days after the last dose of study medication.

Exclusion Criteria:

1. Uncontrolled CNS metastases.
2. No other active malignancies.
3. Poorly controlled hypertension.
4. Recent history of serious cardiovascular conditions.
5. Recent history of CVA, TIA, or intermittent claudication.
6. Current anticoagulation therapy.
7. History of cardiac arrhythmias.
8. Abnormal ECG findings.
9. Subjects who require concomitant medications which cause QTc prolongation.
10. Major surgery within 30 days of treatment, or minor surgery within 7 days of treatment.
11. Uncontrolled, clinically significant active infection.
12. Subjects who are pregnant or lactating.
13. Subjects with any other intercurrent medical condition.
14. Subjects with a history of solid organ transplant or bone marrow transplant.
Lipiflow Versus Warm Compresses in Parkinson's Disease

The LipiFlow System (TearScience, Morrisville, NC) is an in-office FDA approved treatment for meibomian gland dysfunction. It relieves meibomian gland obstruction through the use of heat and pulsatile pressure. A recent study has observed that a single treatment with the LipiFlow system can decrease dry eye symptoms and objective findings of meibomian gland dysfunction for 1 year. We aim to see if the Lipiflow System will be beneficial in patients with Parkinsons disease who may have difficulty performing normal meibomian gland dysfunction treatment.

Objectives To determine whether a single treatment with thermal pulsation relieves dry eye symptoms (primary objective) and improves objective findings of meibomian gland dysfunction in patients with Parkinsons disease.

Methods and Measures

Design

* Randomized, controlled trial
* Patient eyes will be randomized to either receive a single thermal pulsation treatment the FDA-approved Lipiflow thermal pulsation system or to use traditional eyelid hygiene or to use traditional eyelid hygiene

Eligibility Criteria:
Patients with Parkinsons disease and dry eye attributed to meibomian gland dysfunction

Inclusion Criteria:

* Medical diagnosis of Parkinsons disease
* \> 18 years-old
* Reported dry eye symptoms within 3 months of baseline examination with a Standard Patient Evaluation for Eye Dryness (SPEED) score ≥ 6 at baseline visit
* Evidence of meibomian gland obstruction (based on a total meibomian gland secretion score of ≤ 12 for 15 glands of the lower lid)
* Willingness to stop dry eye medications including antibiotics, non-steroidal and anti-inflammatory drugs, and corticosteroids for 2 weeks prior to treatment and during the duration of the study

Exclusion Criteria:

* Active intraocular inflammation
* Ocular surface abnormality that could potentially compromise corneal integrity in either eye
Improvement of Periprocedural Guidewire Management for Cardiac Catheterization (PTCA)

Periprocedural management of guidewire placement and removal in patients needing cardiac catheterization by use of marking of the access site and removal procedure due to a graduated scheme

Before elective cardiac catheterization, patients undergo an ultrasound-guided marking of the bifurcation of the common femoral artery in order to access the vascular complication rate compared tho those of non-marked patients.

Concerning the removal of the guided wire, patients will be treated due to a graduated scheme taking care of different risk levels. This procedure should improve clinical routine, but the efficacy and safety have to be assessed. Depending on the risk level, the guide wire will be removed either by an ambulance officer or emergency medical technician, assistant personal of the cardiac catheterization operating room or by a physician specialist in intensive care. Both methods should lead to quality assurance.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiac catheterization or PCI or emergency interventions

Exclusion Criteria:

-
The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children.

Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals.

Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure.

Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population


Eligibility Criteria:
Inclusion Criteria:

* Age 0 - 18 years
* Attending La Timone Paediatric Hospital for OFC
* Social insurance
* Parents and if possible child have received information and signed the consent form

Exclusion Criteria:

* Patients not receiving an OFC
* Lack of social insurance
* Inability to understand the study information
* Unwilling to participate
Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans

The purpose of this study is to determine if individuals with diabetes are at increased risk of hearing impairment or tinnitus (the perception of ringing or noises in the ears or head). An important goal of this research is also to obtain a better understanding of possible interactions between hearing disorders and other chronic conditions, such as diabetes. Participation in this research will be for a few hours only, to be scheduled at the participant's convenience and according to the testing schedules of the different clinics involved.


Eligibility Criteria:
Any participants over 21 years of age and under 80 who do not have an end-stage disease