cyrilzakka/clinical-trials huggingface dataset:
Imaging Analysis Following Periodontal Surgery

This is a single centre, randomised, single-blind, parallel-group clinical trial that aims at evaluating the use of imaging (2D and 3D) in obtaining geometric and thermometric changes of postoperative healing patterns and comorbidities (facial swelling, oedema and inflammation) following two routine surgical procedures performed for the treatment of periodontal (gum) disease.

A surgery in a posterior sextant will be performed per patient. The surgical procedures being compared for their post-operative healing patterns are:

1. Simplified Papilla Preservation Flap (SPPF) which is a conservative flap aiming at preserving the tissues between teeth.
2. Resective Periodontal Flap with Osseous Recontouring (RPFO) which is a conventional surgery which involves hard and soft tissues resection.

Geometric (3D) surface imaging and thermal (2D) surface imaging will be used to assess the post-operative healing patterns and comorbidities (facial swelling, oedema and inflammation) following either of the surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy males and females ≥ 30 years of age.
2. Participants must be willing to read, and sign a copy of the "Informed Consent Form" (ICF) form after reading the, "Patient Information Leaflet" (PIS), and after the nature of the study has been fully explained.
3. Participants must present with clinical and radiographic evidence of periodontitis, with one interdental area of Periodontal Pocket Depth (PPD) ≥6mm, Bleeding On Probing (BOP), and Clinical Attachment Level (CAL) ≥6mm in any posterior sextant of their mouth (excluding third molars and the distal aspect of the second molars), or multiple sites (≥9) with PPD ≥5mm, BOP, and CAL ≥5mm.
4. Participants must have completed a course of non-surgical periodontal therapy within 2 years prior to study commencement and have had maintenance including subgingival debridement within 6 months prior to assessment for eligibility.

Exclusion Criteria:

1. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases e.g. cardiovascular disease or AIDS.
2. Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
3. History of alcohol or drug abuse.
4. Self-reported pregnancy or lactation.
5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of the data.
Supportive Care Mobile Application for Patients With NSCLC

This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.

This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services.

The research study procedures include:

* A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing
* Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms)
* Data collection from participants medical records

After completing a baseline study questionnaire, participants will be randomized into two (2) study groups:

* Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services.
* Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app.

Participants will be in this research study for 12-14 weeks.

It is expected that about 120 people will take part in this research study.

The sponsors of this study are the National Comprehensive Cancer Network (NCCN) and AstraZeneca Pharmaceuticals. NCCN is a non-profit alliance of leading cancer centers across the United States, and AstraZeneca Pharmaceuticals is a global bio-pharmaceutical company. These two sponsors are together providing funding and oversight for the conduct of this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record)
* Eastern Cooperative Oncology Group Performance Status = 0-3
* Plan to receive oncology care at one of the participating study sites
* Ability to read and respond to questions in English

Exclusion Criteria:

* Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures
Naturalistic Sleep Assessed by Wearable Devices in Parkinson Disease

The cardinal motor features of Parkinson's disease (PD) include bradykinesia, rest tremor, and rigidity. Though non-motor features have been recognized for centuries, only recently has the prevalence and impact of non-motor symptoms become the focus of intense study. Disturbances of sleep are among the most common non-motor manifestations of PD; approximately two-thirds of PD patients experience sleep dysfunction of some kind. Given that sleep contributes to the regulation of many physiological processes, sleep disturbance has a significant impact on quality of life in PD, and places high strain on caregivers. Though numerous symptomatic therapies exist, the treatment of sleep disorders in PD is limited by a lack of adequately powered, randomized studies providing high quality evidence. Although deep brain stimulation (DBS) is primarily used to treat PD motor symptoms and reduce the need for dopaminergic medications, several studies have shown that DBS provides benefit for non-motor symptoms, including sleep disturbance. Few studies have used an objective measure to assess the impact of DBS on sleep in PD, and none have done so by studying sleep in the home environment. Existing studies have largely been limited to a single night of sleep recording in a sleep lab. Furthermore, no studies have assessed sleep both on and off medication, before and after DBS implantation. This study will enroll patients undergoing evaluation for DBS implantation. Sleep will be assessed before DBS implantation, both while patients continue their usual medication regimen and while withholding medications. After DBS implantation and programming, sleep will again be assessed with stimulation on, both while continuing medications and subsequently while withholding medications.


Eligibility Criteria:
Inclusion Criteria:

Research subjects must be willing and able to do the following:

* Be able to learn to use and maintain a wristband-style sleep monitor
* Wear a wristband-style sleep monitor for two weeks
* Be able to learn to use and maintain a headband sleep monitor
* Wear a headband sleep monitor for two weeks
* Log daily routine events, such sleeping, eating, and medication regimens for the two-week study period
* Withhold dopaminergic medications after 5:00pm for three consecutive nights

Exclusion Criteria:

Subjects will be excluded if they:

* Carry a diagnosis of dementia (e.g., Parkinson's Disease Dementia or Dementia with Lewy Bodies)
* Currently use or recently (within past 30 days) used a sedative-hypnotic agent for sleep (e.g., Zolpidem, Suvorexant, Eszopiclone)
* Fulfill criteria or carry a diagnosis of a circadian sleep-wake rhythm disorder, as defined by the International Classification of Sleep Disorders, Third Edition
Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.

Background:

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.

Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of advanced emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist \& inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted \& experiencing \< 30% or 300 mL improvement using bronchodilator; total lung capacity \> 110% predicted; residual volume \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or\> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* significant comorbidity
Outcomes in MEasurement-Based Treatment

The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Diagnosis of major depressive disorder
* Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days
* Primary depression management is performed by the primary care provider
* Capable of self-management (i.e., taking medications and independently responding to follow-up contacts)
* Able to provide informed consent to participate
* Sufficient ability as judged by the physician to read, understand and complete survey instruments written in English and phone interviews spoken in English

Exclusion Criteria:

* History psychotic disorder or bipolar disorder
* Diagnosis of current postpartum depression
* Diagnosis of bereavement less than 8 weeks duration
* Currently pregnant
* History of suicide attempts or current suicide plan
* Need for psychiatric hospitalization at enrollment visit
* History of adjunctive treatments including electroconvulsive treatment (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), or deep brain stimulation (DBS)
Association Between Post-operative Anemia and Mortality After Valvular Heart Surgery

The investigators aimed to evaluate whether postoperative anemia can predict 1-year mortality after valvular heart surgery independent of preoperative anemia. Patients who underwent valvular heart surgery were divided into four groups according to whether or not they had preoperative and postoperative anemia. Postoperative one-year mortality, as well as overall mortality and a composite of death and heart failure requiring hospitalization, was investigated according to the groups, adjusted by confounders.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System.

Exclusion Criteria:

* patients who underwent only pulmonary valve surgery
* those with missing hemoglobin values at 2months after the surgery, due to loss of follow up or death.
Weekly Versus no Routine Ventilator Circuit Changes in NICU

The purpose of this study is to determine incidence of ventilator-associated pneumonia compared between weekly and no routine ventilator circuit changes in neonatal intensive care unit

Parents were received informed consent. Enrolled neonates was randomly assigned to 2 groups as 7-day ventilator circuit change and no change group by computerization with allocated of concealment. The investigation team opened the next sequentially numbered study pack, which was stored in the neonatal unit. The assignment sequence was generated with balance within random block sizes of 4. Stratification according to birthweight was done before randomization to control for differences in patient populations. Patient characteristics were recorded as gestational age, sex, birthweight, underlying disease, date of intubation, date of extubation, duration of mechanical ventilator, reintubation, length of hospital stay, parenteral nutrition, medication (H2-blocker, PPI, narcotic drugs), transfusion and oral immune therapy. Laboratory data and radiographic data were recorded. Both groups received similarly care as the nurse was assigned to take care of patient in ratio 1-2 patients: 1 nurse, new disposable circuits were use in both groups and the VAP prevention protocol and the endotracheal suctioning protocol which followed by an American Academy of Respiratory Care (AARC) clinical practice guidelines were performed in both groups.

When the VAP was suspected the radiographic data were reviewed by two pediatric radiologists on the day of diagnosis, 3 days prior to the diagnosis and/or 2 and 7 days after diagnosis to confirm diagnosis of VAP if there is different in the results, the consensus must be made.

Eligibility Criteria:
Inclusion Criteria:

* All neonates who admitted at neonatal intensive care unit (NICU) and required ventilator support with both intubated at time of neonatal resuscitation and within the NICU as indicated

Exclusion Criteria:

* Patient was extubated or died within 2 calendar days of endotracheal intubation
* Pneumonia was diagnosed before intubation
* Outborn who was intubated before referred
* Parents declined to participate
* Incompatibility of disposable circuits and ventilator
* Chromosome abnormality or moribund
Does Nesiritide Provide Renal Protection

This project evaluates whether nesiritide, human recombinant brain natriuretic peptide, confers renal protection during cardiovascular surgery by attenuating the inflammatory response.

This will be a randomized, prospective blinded pilot study comparing nesiritide to placebo in patients undergoing aortic arch, ascending aorta, aortic valve or mitral valve surgery with baseline GFR 30-90ml/min. Patients were randomized to either placebo or nesiritide (administered prophylactically starting in the operating room prior to incision at 0.01 mcg/kg /minute with no bolus and continued for 48 hours).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery on their aortic arch, ascending aorta, or having aortic valve or mitral valve surgery
* Baseline MDRD (modification of diet in renal disease) calculated GFR (Glomerular Filtration Rate) 30-90 ml/min.
* Signed Informed Consent

Exclusion Criteria:

* Age \<18 or \>80
* Ejection Fraction \<30%.
* Presence of endocarditis or other infection.
* Presence or anticipated use of an intra-aortic balloon pump.
* History of an organ transplant.
* History of an adverse reaction to nesiritide.
* Surgery performed without cardiopulmonary bypass.
* Receiving Aprotinin
* Dopamine administered in doses \<5 mcg /kg min.
* Women of child bearing potential or pregnant or breastfeeding.
* Participation in any other investigational trial
* Jehovah Witness
* Bleeding Disorder
* Active Endocarditis
Prevention of Falls and Injurious Falls Among Elderly People

The aim of this study is to describe and analyse the effects of multifactorial trial on the incidence of falls and injurious falls and on different risk factors of falling among the home-dwelling aged.

The aims of the study:

1. To implement a program for the prevention of falls and injurious falls.
2. To describe the structure and activities of the fall prevention program implemented among the aged who are living in their own home, have at least moderate cognitive abilities, have fallen during previous 12 months and are 65 years of age or older. A further aim is to describe the frequency of participation according to age, gender, residence, health and physical condition.
3. To describe the effects of prevention on primary risk factors of falling such as muscle strength, balance, eye sight, medications, depression and home hazards in relation to age, gender, health and physical condition.
4. To describe and assess the effects of prevention on the incidence of falls and injurious falls.
5. To assess the effects of prevention on physical, cognitive and psychosocial functional abilities, quality of life and use of health and social services and deaths.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* home-dweller
* having fallen at least once during the previous 12 months
* at least moderate cognitive abilities (MMSE over 17)
* able to walk 10 metres independently

Exclusion Criteria:

* MMSE under 17
Over 2000 Epidural Anesthesias for Percutaneous Nephrolithotomy - a Retrospective Analysis

Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. In most of the centers, the PNL is done under general anesthesia (GA) that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. In our Department the procedure is usually performed under epidural anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL over the last decade in the Medical University of Warsaw Urology Department

Percutaneous nephrolithotomy is a renal lithiasis endoscopic treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. The PNL is usually two staged. It begins in the lithotomy position for cystoscopic placement of ureteral catheter and retrograde pyelography and, subsequently, a patient is placed mainly in the prone position for percutaneous access and stone removal. This position offers more options for puncture.

In most of the centers, the PNL is done under GA, that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. Other complications, including blood transfusion, nausea and vomiting or fever, are more often observed after the general then after the regional anesthesia; the cost of general anesthesia is also higher. The regional anesthesia that can be performed independently for the PNL includes spinal, epidural or combined spinal-epidural blocks. A segmental epidural block is better than spinal anesthesia in terms of hemodynamic stability, postoperative analgesia, patient's satisfaction and reduced incidence of postoperative nausea and vomiting. For epidural anesthesia it takes longer to act than for spinal one but it allows avoiding the motor block so the patient can change the position from lithotomy into prone himself with a little assistance. The position of a patient should not be changed rapidly right after the spinal anesthesia has been performed, due to the risk of too high anesthesia level and hemodynamic complications.

The aim of the study was to evaluate the epidural anesthesia performed for PNL over the last decade in the Medical University of Warsaw Urology Department.

Eligibility Criteria:
Inclusion Criteria:

* PNL procedure

Exclusion Criteria:

* no PNL procedure
The Effect of Watching Short Videos on Preoperative Anxiety

Preoperative anxiety is a common issue observed in pediatric patients prior to endoscopic procedures, and it can negatively affect the patient's overall experience. The aim of this study is to evaluate whether watching short videos on platforms such as YouTube Shorts, Instagram Reels, or TikTok has an impact on preoperative anxiety levels in pediatric endoscopy patients.

The study was designed as a prospective randomized trial. Patients aged 6-12 years undergoing endoscopy and/or colonoscopy in the pediatric endoscopy unit will be divided into the video and the control groups. Patients will be taken to the preoperative preparation unit, where those in the video group will watch short videos of their choice on a phone/tablet for 20 minutes under the supervision of their parents. The control group will receive standard preoperative preparation. Anxiety levels will be assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) at six different time points: upon entry to the pre-procedural preparation room (T1), upon exiting the pre-procedural preparation room (T2), in the procedure room (T3), upon entry to the recovery unit (T4), at the 15th minute in the recovery unit (T5), and upon exiting the recovery unit (T6). Additionally, the indication for the procedure (e.g., celiac disease, Crohn's disease, ulcerative colitis), history of prior endoscopy/colonoscopy, oxygen saturation (SPO2%), heart rate (HR), mean arterial pressure (MAP) during the procedure, and the duration of monitoring in the recovery unit will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 5-12 years undergoing endoscopy and/or colonoscopy, classified as ASA I-II

Exclusion Criteria:

* Patients under 5, over 12, or with ASA score \>2
* Epilepsy