cyrilzakka/clinical-trials huggingface dataset:
Training Listening Skills With the Inclusion of Cognitive Control

Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). As aging affects multisensory integration and cognitive control, these higher-order processes are likely to put accumulating constraints on listening as adults grow older. By training listening skills (not solely auditory skills), the investigators aim at improving overall communication and quality of life. Moreover, the investigators aim at freeing up cognitive resources in the listen task: the better one gets at a certain domain specific task, the less one needs to draw from other resources and, the more resources are free for another concurrent task. The interdisciplinary approach will inform us about ideal audiological rehabilitation or intervention approaches. Pre-posttests comprise behavioral measures to evaluate listening skills and transfer towards non-trained measures. The training is tablet-based and can be performed at home.

Goals of the study:

* Investigate transfer of listening skills to non-trained listening.
* To develop evidence-based guidelines for clinical audiological rehabilitation.
* Investigate if the inclusion of cognitive control frees up cognitive resources to use for another concurrent task.
* Inform about retention following listening training

All participants will be assessed 4 times, with a 4-week interval in between. Participants in the first arm will perform the training during the first two weeks. 4 weeks after training ended and 8 weeks after training ended, retention of training gains will be assessed. Participants in the second arm will perform the delayed training. This is to control for procedural learning effects. After 4 weeks they will start training for 4 weeks. After training retention of training gains will be assessed after 4 weeks. The third arm will start with active control training (listening to stories) for 4 weeks, followed by training for 4 weeks. After these 8 weeks, retention was measured 4 weeks later. Participants are randomly allocated to a group. The efficacy of training will be determined with a within-subject design (i.e. baseline session outcomes will be compared to the final session outcomes of the randomized control trial.

Eligibility Criteria:
Inclusion Criteria

* Clients who experience listening and communication difficulties.
* Clients must not undergo any audiological rehabilitation (auditory training/hearing aid fitting) during the study.
* Able to operate the training programme as an app on a tablet (e.g. clients have sufficient eyesight to see the exercises; clients must be able to operate the programme).
* At least 18 years old.
* Dutch-speaking, as all training material and counselling questions will be presented in Dutch.

Exclusion Criteria (all groups):

* Severely visually impaired
* Motorically impaired
* Cognitively impaired
Detecting Lung's Closing Pressure by Capnography

General anesthesia is associated with loss of pulmonary functional residual capacity and the consequent development of atelectasis and closure of the small airway.

Mechanical ventilation in a lung with reduced functional residual capacity and atelectasis increased the dynamic alveolar stress-strain, inducing a local inflammatory response in atelectatic lung areas known as ventilatory-induced lung injury. This phenomenon may appear even in healthy patients undergoing general anesthesia and predisposes them to hypoxemic episodes that can persist in the early postoperative period.

Lung recruitment maneuvers restore the functional residual capacity and, therefore, protect the lungs from lung injury. A key issue in this kind of treatment is detecting the lung's closing pressure in order to maintain the end-expiratory pressure above such a limit.

This is a prospective and observational study designed to measure the lung's closing pressure. The investigators will study 20 mechanically ventilated patients scheduled for mediastinoscopy surgery under general anesthesia.

Lung mechanics and capnography will be assessed during surgery. A slow pressure-volume curve will be automatically performed by the ventilator, and the small airway closing pressure will be determined as the inflection point in the alveolar slope of the pressure-CO2 and volume-CO2 curves. Then, a lung recruitment maneuver will be applied following a descending positive end-expiratory pressure trial to determine the lung's closing pressure. The investigator will see if the lung's closing pressure found with these two techniques is similar.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 17 years ole
* Programmed surgery

Exclusion Criteria:

* Pregnancy
* No programmed surgery
* Hemodynamic instability
* Severe COPD
* Acute respiratory infection
Ultrasound for Neuraxial Anesthesia

The patients will be allocated to 2 groups: the ultrasound group and the palpation group. Ultrasound detection of the puncture site will be performed to the patients of the one group (group U). The puncture site will be determined by palpation of the landmarks at the patients of the other group (group L). The main purpose of the study is to determine if the ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural anesthesia, increase the success and decrease the complication rate of these techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to determine accurately the depth of the epidural space.


Eligibility Criteria:
Inclusion Criteria:

* Surgery under spinal, epidural or combined spinal-epidural anesthesia.
* Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia.
* ASA 1-3.

Exclusion Criteria:

* History of lumbar spinal surgery.
* Low back pain at the time of anesthesia
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.


Eligibility Criteria:
Main Inclusion Criteria:

* Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53
* Diabetes type 1 or 2
* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Main Exclusion Criteria:

* Presence or history of macular edema involving the center of the macula
* Any kind of neovascular growth in the study eye, including anterior segment neovascularization
* Arterial hypotension with systolic blood pressure \< 100 or diastolic blood pressure \< 60mmHg
* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (ULN) or bilirubin ≥ 1.5 ULN at screening, known ascites
* Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m\^2 at screening
* Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye
* Any prior intraocular steroid injection in the study eye
* Any prior grid or focal laser photocoagulation within 500 microns of the foveal center or any prior Pan-retinal photocoagulation (PRP) in the study eye
* Use of nitrates or Nitric oxide (NO) donors (such as amyl nitrate) in any form including topical; Phosphodiesterase 5 (PDE5) inhibitors, nonspecific PDE inhibitors within 1 week or less than 5 half-lives (whichever is longer) before first study drug administration
Anti-Inflammatory Agent in Sinusitis

To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving signs and symptoms of disease in patients with sinusitis.

This is a Phase 2a, single-center, randomized, placebo-controlled, double-blind study that includes 12 weeks of treatment with experimental drug anti-inflammatory agent or placebo TID administered orally.

All subjects will be ≥18 years, have sinusitis with persistent symptoms despite standard of care treatment, and have failed a course of steroids in the past.

Eligibility Criteria:
Inclusion Criteria:

1. Females must have a negative urine pregnancy test at screening unless documented to have a hysterectomy or be postmenopausal.

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Use of any investigational drugs within 30 days of screening.
3. Acute infection needing antibiotic treatment at screening.
Cholinesterase Activity and DeliriUm During Critical Illness Study

Delirium is a syndrome of acute brain dysfunction involving attention and cognition that affects up to half of older hospitalized patients and 50%-75% of critically ill ICU patients, such that millions of patients worldwide experience this acute threat to their health and well being every year. One-third to half of critical illness survivors struggle with a dementia-like disorder similar in severity to moderate-to-severe traumatic brain injury or Alzheimer's Disease, and the only proven risk factor that is potentially modifiable is delirium in the ICU. Despite the frequency and impact of delirium in the ICU, little is known regarding the biological mechanisms that lead to this form of organ dysfunction during critical illness. A widely held hypothesis proposes that inflammation is regulated by the cholinergic system, and that this interaction plays a pivotal role whether delirium developments in the setting of acute illness. Acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) are enzymes that hydrolyze the neurotransmitter acetylcholine. Changes in the activity of these enzymes, which can be measured in whole blood, reflect altered regulation of circulating acetylcholine. AChE and BuChE activities have promise as both predictors of delirium (when found to be low at admission) and biomarkers of delirium (when low during serial measurement). Neither of these biomarkers, however, have been studied in the ICU setting where delirium risk is the highest. The current investigation, therefore will be the first to determine the validity of circulating AChE and BuChE activities as biomarkers of delirium during critical illness and subsequent cognitive impairment after discharge. This study will measure whole blood AChE and butyrylcholinesterase BuChE activities within the framework of the ICU Delirium and Cognitive Impairment Study Group's ongoing clinical trials in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults (\>18 years of age) treated for acute respiratory failure (with mechanical ventilation or non-invasive positive pressure ventilation \[NIPPV\]) and/or shock (with vasopressors) in a medical and/or surgical ICU at Vanderbilt University Medical Center enrolled in an ICU Delirium and Cognitive Impairment Study Group's clinical trials. Exclusion criteria for the parent studies are summarized below. No additional exclusion criteria are required for this investigation.

Exclusion Criteria:

* Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
* Active substance abuse, psychotic disorder, or homelessness without a secondary contact person (which would make long-term follow-up difficult)
* Blindness or deafness (which would prevent assessment of the study's outcomes)
* Inability to obtain informed consent
Toothbrush Wear and Its Effect on Subgingival Inflammation Using Two Different Brushing Techniques

Toothbrush plaque removal, along with interproximal flossing, helps to maintain the oral cavity free from periodontal diseases and dental caries. Although techniques such as the Bass Technique (BT), the Modified Bass Technique (MBT) and the Modified Stillman Technique (MST) are taught to dental students, dental hygiene students, and dental assistants, there is little evidence to discern which technique is more effective in reducing or preventing gingival inflammation.

At Tufts University School of Dental Medicine (TUSDM), a modification of the Bass intrasulcular technique is advocated to many students. We call this modification of the Bass technique a Stationary Bristle Technique (SBT), which is an intrasulcular technique that maintains the toothbrush bristle ends essentially stationary on the tooth cervically and in the gingival crevice.

In this study, half of the participants were taught the Stationary Bristle Technique Group, while the other half were not be provided with instructions, but asked to brush as normal (non-interventional group) throughout the duration of the study.

This is a double-armed, randomized clinical trial. The primary aim of this study is to compare whether a Stationary Brushing Technique (SBT) is more effective in the reduction of gingival inflammation than permitting people to brush the way they normally do without instruction (Non-Stationary Brushing Technique).

Gingival inflammation is evidenced by the percentage (%) sites with Bleeding on Probing (BoP). The primary time-point will be at 4 weeks.

The amount of toothbrush bristle deformation at 4 weeks, 12, and 16 weeks of brushing with a SBT and with a NSBT will also be evaluated. 3. The secondary evaluation of BoP will be at the 12 and 16 week time-point.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age
* Subjects must have at least 20 teeth
* Subjects must have had a professional dental prophylaxis done in the 3 months prior to the beginning of the study
* Subjects exhibiting 10% or greater BoP at the baseline examination

Exclusion Criteria:

* Subjects wearing fixed orthodontic appliances (including lingual retainers or Invisalign®)
* Subjects who smoke (=more than 0 cigarettes a day)
* Subjects who received antibiotic treatment during the month prior to the beginning of the study
* Subjects who have cervical probing depth (PD) greater than 3mm
* Subjects diagnosed with periodontal disease at any site as defined bleeding on probing with cervical probing depths greater than 3 mm and loss of cervical attachment.
* Subjects who are currently pregnant (self-report).
Invasive Revascularization or Not in Intermittent Claudication

Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting\> 10% of individuals\> 65 years. A recent Swedish Health Technology Assessment Report identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.


Eligibility Criteria:
Inclusion Criteria:

* Patient with intermittent claudication (typical symptoms and ABI \<0.9) seeking treatment
* Significant aortoiliac- and/or femoropopliteal lesion.
* Age 30-80 years

Exclusion Criteria:

* Invasive treatment contraindicated because of severe intercurrent disease.
* Two or more failed vascular reconstructions in the same leg.
* Employees unable to work because of intermittent claudication.
* Need for open reconstruction below the tibioperoneal trunc.
* Thromboembolic etiology (popliteal artery aneurysm; cardiac emboli)
* Other disease severely affecting walking performance.
* Body weight \> 120 kilograms.
* Age \<30 or \> 80 years.
Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures

This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.

At present, there is no standard of care nor consensus for the proper management of repaired vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter removal. In the past, extension of time with catheterization has been tried, with patients becoming fully healed by the time of catheter removal. However, some patients who are discharged with a fistulous leak later return at follow up completely dry, with a closed and healed fistula. This study will compare, in a prospective, randomized manner, extension of catheterization vs no intervention, to see if in such patients extending catheterization will improve their likelihood of complete fistula healing.

Eligibility Criteria:
Inclusion Criteria:

* Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test

Exclusion Criteria:

* HIV infection,
* concomitant bladder stone(s),
* one or more ureters outside of the bladder,
* urethrovaginal fistula,
* multiple fistulas (more than one),
* dye leak / fistulous leak present at end of surgical procedure,
* radiation-induced fistula,
* fistula caused by cancer or infection (such as lymphogranuloma venereum),
* continence procedures being performed (such as pubovaginal sling),
* rectovaginal fistula,
* pregnancy,
* fistula breakdown of greater than 2cm identified on postoperative dye test.
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
* Been treated for early breast cancer with standard of care duration of trastuzumab.
* Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

* Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
* History of heart disease.
* Corrected QT (QTc) interval \>0.45 seconds
* History of gastrointestinal disease with diarrhea as the major symptom.
Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.

This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years (for MS patients, 18-55 years); both genders eligible.
* Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS).
* Anticipated survival of ≥ 12 weeks as judged by the researcher.
* Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
* Provides written informed consent.

Exclusion Criteria:

* History of solid organ transplantation.
* Malignant tumor within the last two years.
* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
* Primary immunodeficiency (congenital or acquired).
* Severe cardiac disease.
* History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
* Allergic constitution or a history of severe allergies.
* Pregnant or breastfeeding women.
CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

This prospective cohort study enrolls subjects who experience carbon monoxide (CO) poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments and short and long-term outcomes in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through various ways and the association between complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.

This prospective cohort study enrolls subjects who experience CO poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments, including hyperbaric oxygen therapy (HBO), therapeutic hypothermia (TH), and additional drugs, and short and long-term outcomes, such as neurocognitive sequelae or mortality, in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through a variety of ways, such as magnetic resonance image (MRI), computed tomography (CT), ultrasound, and laboratory test, and the association between various complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.

Eligibility Criteria:
Inclusion Criteria:

* Acute CO poisoning

Exclusion Criteria:

* Declined to enrollment in the study