cyrilzakka/clinical-trials huggingface dataset:
Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions

Background: Overactive bladder (OAB) is a common condition among postmenopausal women, requiring a multifaceted treatment approach that requires patient retention of information given to them in clinic. Recall of recommendations is a key component of compliance. Supplemental educational tools such as handouts and audiovisual information have been investigated for their ability to improve patients' recall of information and increase satisfaction with the clinical encounter.

Objective: To determine if a written list of seven management strategies for overactive bladder leads to improved immediate and delayed recall of these recommendations in postmenopausal women presenting with OAB compared to a traditional verbal discussion.

Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed (2-week) recall of seven OAB management strategies will be compared between two groups. The intervention group will receive a handwritten list during their verbal discussion of OAB treatment while the control group will receive standard care (verbal discussion only). Immediate and delayed recall will be assessed by a member of the study team who has been blinded to participants' group assignments.

Results: The results of this study may guide clinicians in the most effective mode of providing treatment recommendations to post-menopausal patients with OAB.


Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of overactive bladder
* post-menopausal

Exclusion Criteria:

* Pre-existing diagnosis of dementia or other cognitive disorders
* Patients with mixed incontinence
* Non-English speaking
* Patients with contraindications to taking vaginal estrogen or anticholinergic medications
Comparison of Two Methods of Transnasal Sphenopalatine Ganglion Block

The transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.

The objective of this study was to compare facial temperatures and visual analogue scale (VAS) between drip method and topical method of transnasal sphenopalatine ganglion block (SPGB).

The transnasal SPGB is administered to patients with facial or head and neck pain. In the transnasal approach, the drip and topical methods are frequently used. We compared facial temperatures and VAS after transnasal SPGB.

Medical records of 74 patients who visited the pain clinic and underwent transnasal SPGB were retrospectively reviewed. A total of 156 transnasal SPGB were performed. The patients were divided into the drip-method and topical-method groups. Facial temperatures were measured in six areas of the right and left forehead, maxilla, and mandible before and 30 min after completion of the transnasal SPGB. Temperatures were compared before and 30 min after SPGB in each group and between the two groups. VAS scores were compared at same times of SPGB in each group and between the two groups.

Eligibility Criteria:
Inclusion Criteria:

(1) age over 20 years ; (2) head and neck pain; (3) pain score \> 4 on the VAS in the head and neck; and (4) having undergone a transnasal SPGB and having had facial temperatures measured.

Exclusion Criteria:

(1) patients with a history of head and neck surgery, (2) treatment with a vasodilator or vasoconstrictor, (3) contraindication to treatment using a transnasal approach, (4) clinically significant systemic disease or any reduced organ failure, and (5) missing data.
LaGRA Trial in Laparoscopic Cholecystectomy

This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.

A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.

Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* ASA I, II or III

Exclusion Criteria:

* Patients that don't consent to be included
* Allergy to levobupivacaine
Impact of Parent's Presence in Neonatology

Every year 75000 new-born babies are hospitalized in neonatology yard in France with about 60000 born prematurely.

Studies showed that parents presence is good for the baby development , decrease the stress due to hospitalization.It's also efficient for the attachment between the baby and parents.

Although the team try to settle a good atmosphere to establish this link and let parents take their position,it seems that the time taken to stay with the baby is less moreover the night.

The aim of the study is to evaluate the time of presence to find tools to increase this time in the neonatotology yard


Eligibility Criteria:
Inclusion Criteria:

* every newborn baby hospitalized in neonatology yard

Exclusion Criteria:

* no french speaking parents
* duration of hospitalization less than 1 week.
A Study of Multiple Sclerosis Routine Clinical Practice: Impact on Adherence and Clinical Outcomes of Ofatumumab Treated Patients

This was a retrospective non-interventional study (NIS) of adult (≥18 years) multiple sclerosis (MS) patients on ofatumumab therapy in the United Kingdom (UK) using secondary data. UK MS centers with National Health Service (NHS) databases and/or homecare and pharmacy services prescribing ofatumumab were identified and recruited for study participation using a feasibility assessment exercise. The study index identification window spanned from 26 March 2021 to 30 June 2023 (or latest data available prior to start of study data extraction). The index date was defined as the first date ofatumumab was dispensed or injected within the index identification window. From index date, patients were followed up until death, up to 13 months after index date, loss to follow-up, or end of study index identification window (whichever came first).

For patients who consented to the use of their data, participating sites transcribed protocol required patient data from existing individual patient medical records into an electronic case report form (eCRF). The end of study was defined as the date of last data query resolution (i.e., all data had been recorded in the eCRF and all data queries resolved to allow database lock to occur). This ensured that all data was available to answer the research questions in the study.


Eligibility Criteria:
Inclusion criteria:

Patients were included in the study if they met all of the following criteria:

* Patient was prescribed ofatumumab within the UK approved marketing authorization
* Patient initiated ofatumumab via participating MS clinic with or without KC PSP
* Patients initiated ofatumumab during the index identification window
* Authorized to collect study data:

  1. Patient was alive at start of data collection and patient consented prior to start of their data collection or,
  2. Patient was deceased at start of data collection and a member of the patient's direct care team had a pre-existing right to access patient medical record
* Specifically for adherence analyses: Patients were required to have a minimum of 6 months of follow-up post index date available to make this assessment
* Specifically for clinical effectiveness analyses: Patients were required to have a minimum of 6 months look-back pre-index date and minimum 6 months follow-up post index date available to make this assessment.

Exclusion criteria:

Patients were excluded from the study if they met the following criteria:

• Patient prescribed ofatumumab outside the approved marketing authorization (i.e., under off-label prescribing) at any point within the patients record
Postoperative Effects of Propofol Versus Sevoflurane Anesthesia

Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.

Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.

Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 years
* Body Mass Index (BMI) 25-35 kg/m2

Exclusion Criteria:

* ASA physical status \> II
* Age \< 21 years
* Patients with Montreal Objective Cognitive Assessment (MoCA-B) score \< 24 points
* Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
* Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
* Patients on long-term use of sedatives or steroids, alcohol or drug abuse
* Allergy to any of the study drugs
Where's the Wif? Referent Selection and Retention

The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

The goal of the current proposal is to identify how digital media alters the mechanisms of word learning and subsequently impacts the lexical foundation on which a child's vocabulary is built. Specifically, the proposal aims to identify the impact of digital media on 1) the processes underlying real-time word learning, and 2) the processes of language generalization and vocabulary growth. Specific Aim 1 will use a novel word learning task to test children's ability to map and retain new words within and between digital media (2D images on a tablet) and real world objects (3D objects). Specific Aim 2 will probe children's novel label generalization abilities within and between 2D and 3D modalities using a novel noun generalization task. Further, individual differences in a child's prior technology experience will be measured and used to predict overall vocabulary as well as performance within and between each task. This Clinical Trial record is focused on Specific Aim 1.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 30 months old

Exclusion Criteria:

* diagnosed developmental delay or disorder
* exposure to more than 25% of another language
A Study to Assess COVID-19 Vaccination Immune Response in Multiple Sclerosis Patients Treated With Ofatumumab

This was a non-interventional, retrospective, observational cohort study involving the abstraction and review of pertinent data from medical records by participating physicians, who completed a customized electronic case report form hosted on the secure electronic data capture system.


Eligibility Criteria:
Inclusion criteria:

* Aged at least 18 years of age upon receipt of first COVID-19 vaccination.
* Fully vaccinated with any FDA-authorized COVID-19 vaccination.
* Diagnosed with MS.
* Receiving ofatumumab at the time of either (or both) of the following:

  1. Initial COVID-19 vaccination.
  2. Booster vaccination.
* Had a documented measurement of humoral response at least 2 weeks after completion of either (or both) of the following:

  1. Full COVID-19 vaccination course.
  2. Booster vaccine (among patients receiving ofatumumab at the time of the booster).

     Exclusion criteria:
* Received treatment with monoclonal antibodies to treat or prevent COVID-19 at any time between the first COVID-19 vaccination to within 6 months of the last COVID-19 vaccination (booster-inclusive).
LunG and Melanoma canceR pAtients coVId19 Disease (GRAVID)

This is a multi-centre study on lung cancer patients which experienced COVID-19. Information on clinical features, clinical course, management and outcomes will be collected for both, thoracic cancers and COVID-19 infection. Firstly, investigators will be registered in an online secure registry. After that, a protocol will be developed in order to collect clinical data for the research. It will also include I on the care organization or the perception of the patient and their family members.

The final stage will consist on retrospective data collection from patients. So, it is a retrospective study data collection, preceded by prospective data registry.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer
* Patients who have contracted COVID-19 infection

Exclusion Criteria:

* Patients diagnosed with lung cancer but no confirmation of COVID-19 infection.
WE Project: 2.0 Grassroots Wellness Coaching (Phase 2)

African American adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. The treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. The purpose of this research study is to find out about the feasibility and acceptability of using house chats (HC) as a model for a weight loss program in a real-world, community-based setting.

The pilot trial will utilize a cluster randomized controlled design to assess the feasibility, acceptability, and preliminary effectiveness of the house chat model as a grassroots approach to lifestyle intervention delivery in a community setting. Two wards will be randomly assigned to either intervention or a delayed intervention control. A total of 10 HCL will be recruited and trained across the two wards (5 in the intervention ward and 5 in delayed intervention ward). HCL will recruit members of their social network (N=80, \>18 years of age) to participate in a 12-week lifestyle intervention delivered via weekly group meetings in the HCL's homes. The primary goal is to understand the feasibility and acceptability of this novel approach to intervention delivery, and as such, process data on recruitment, training, fidelity of intervention delivery, and satisfaction with the sessions will be collected on a weekly basis. In addition, in-person assessment visits will take place at 0, 12 weeks (post-treatment) and 24 weeks (follow up) to determine the preliminary effectiveness of this intervention to promote positive changes on behavioral risk factors (physical activity and diet) and adiposity (weight and waist circumference). Satisfaction will be assessed in-person at 12 weeks (post-treatment) via surveys and an exit interview. In addition, The investigators will employ a mixed methods approach (process data, surveys, in-depth interviews with HCL and focus groups with participants) to assess factors that might promote and / or interfere with sustainability over long-term follow up to inform our future clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Resident of Petersburg, VA

Exclusion Criteria:

* Dx of type 1 diabetes mellitus
* Current treatment for cancer
* Medical conditions that may increase risk for participating in unsupervised
* Hospitalization for depression or other psychiatric disorder within the past 12 months
* Uncontrolled psychotic disorder or bipolar disorder
* Currently pregnant or lactating or planning to become pregnant within the study period
* Current involvement in a weight loss program or current use of weight loss medication
* Inability to speak and read English
* Planning to move from the Petersburg area within the study period
Excimer Laser Trabeculostomy Glaucoma Treatment Study

Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate POAG
* Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse
* Medicated IOP of \<=24 mmHg
* Unmedicated diurnal IOP of \>=22 mmHg and \<=34 mmHg
* Shaffer angle grade of III or IV
* CD ratio \<=0.8
* At least 45 years old

Exclusion Criteria:

* Closed-angle and secondary glaucomas
* Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery
* Cannot undergo medication washout in the study eye
* Diagnosis of degenerative visual disorders
* Non-study eye with BCVA worse than 20/80
* Known corticosteroid responder
* Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Development of a Robotic Minimally Invasive Pathway for Cochlear Implantation

Cochlear Implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon. The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics.

The ROSA robot coupled to the O-Arm scanner will guide the milling to the round window, whose path has been previously modeled, with the identification of the facial nerve. Milling will be done in 2 stages with a CT (computerised tomography scan) and electromyographic verification of the facial nerve. The insertion of the implant will be performed manually under endoscopic control. The preoperative and postoperative course of the patient will be identical.

Eligibility Criteria:
Inclusion Criteria:

* patients eligible for cochlear implantation in CHU Amiens
* patient more than 18 years old.

Exclusion Criteria:

* malformation or significant antecedent of mastoidectomy
Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)

IBD patients have a higher risk of oral diseases that affect the oral mucosa, the teeth and the tooth supporting tissues. These conditions are often associated with pain, bleeding and impaired masticatory function which may have an impact on the oral health-related quality of life (OHRQoL). However, few studies have investigated the self-evaluation of oral quality of life in IBD patients. The rare existing studies focus on very specific patients (elderly patients, patients with stomas) and do not use validated tools for the evaluation of OHRQoL. We also lack data on the effect of treatments such as immunosuppressants and type of IBD on OHRQoL. The aim of this study is to (i) compare oral quality of life in a cohort of IBD patients versus non-IBD patients and (ii) explore potential factors that influence oral quality of life in IBD


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* With Crohn's disease or ulcerative colitis
* Able to understand and answer the questions asked

Exclusion Criteria:

* Unable to understand and/or answer questions
* Not willing to participate in the study
Remimazolam and Propofol Anesthesia in Elderly Patients

Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.

A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.

The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II patients over 65 years old undergoing general anesthesia

Exclusion Criteria:

* cardiac surgery
* neurosurgery
* liver surgery
* uncontrolled hypertension
* bronchial asthma
* body mass index ≥ 30 kg/m2
* severe heart, liver, kidney disease
Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF)

Vitamin K antagonists (VKAs) are used to reduce the risk of stroke (cerebral vascular dysfunction) in AF patients. However, VKAs interact with drugs/food and the drug level is influenced by worsening of renal function, liver congestion or hemodynamic alterations in acute decompensated heart failure (ADHF). New oral anticoagulants (rivaroxaban, apixaban, dabigatran) are alternatives to VKA, such as warfarin. In post hoc analysis of ROCKET AF trial, 63.7% patients had HF and treatment-related outcomes were similar in patients with and without HF (Circulation HF. 2013; 6:740-7). So rivaroxaban 20 mg daily (or 15 mg daily in patients with creatinine clearance 30-49 mL/min) was safe in nonvalvular AF patients with HF. However, the clinical effect and safety of rivaroxaban were largely unknown in acute decompensated heart failure (ADHF) patients with atrial fibrillation (AF).

ROAD HF-AF is the exploratory study to assess the change of surrogate markers (hsTn, d-dimer) when treated with rivaroxaban vs. warfarin and to strengthen the basis for future biomarker-based therapy in ADHF patients


Eligibility Criteria:
Inclusion Criteria:Hospitalized patients with a primary diagnosis of ADHF with AF One of the following criteria and LVEF ≤ 40% (at least 1 year before admission or admission)

1. dyspnea at rest
2. tachypnea; a respiratory rate \> 20/min
3. rales
4. pulmonary edema on chest X-ray

Exclusion Criteria:

1. History of increased bleeding risk (like ROCKET AF exclusion criteria)
2. Contraindication to anti-coagulation therapy
3. ACS diagnosis
4. Hospitalization plan for PCI, coronary artery bypass graft surgery, other cardiac invasive interventions (e.g. catheter ablation, pacemaker, CRT, ICD implantation)
5. Currently on dual anti-platelet therapy (aspirin + ADP receptor antagonist) or single antiplatelet therapy with a novel AP (e.g. Ticagrelor, Prasugrel)
6. Cardiogenic shock (systolic blood pressure, SBP, \< 80 mmHg)
7. Patients with CrCl \< 30 ml/min using creatinine-based CKD-EPI equations
8. Elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis
9. Uncontrolled hypertension (SBP \> 180 mmHg)
10. Allergy, adverse drug reaction, hypersensitivity to rivaroxaban or warfarin
11. Life expectancy \< 6 months (e.g. metastatic malignancy)
12. Pregnancy, or women of childbearing age
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

Exclusion Criteria:

* Inability to provide consent