cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of LBBP

At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, you can choose to pace the heart in different parts. The atrium can choose the right atrial appendage, the atrial septum and the right ventricular side wall. The right ventricle can choose to be paced in the His bundle, right ventricular apex and ventricular septal outflow tract. The right ventricle can choose the pacing positions including left bundle branch pacing and left ventricular pacing via coronary vein. There are few studies comparing the long-term efficacy and safety of different pacing programs in daily practice. This study is to observe the short-term and long-term effects and safety of different parts of cardiac pacing, and compare the advantages and disadvantages of different parts of cardiac pacing.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.
* Patients who have the ability to understand the test and can cooperate with investigators.

Exclusion Criteria:

* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors
Teen Sleep Health Study

The objective of this project is to develop an effective, yet feasible strategy to extend school-night sleep duration of older adolescents.

The investigators are developing and testing a feasible behavioral intervention to increase school-night sleep duration by shifting the circadian system earlier and providing a time management plan for after-school activities in youngsters between 14 and 17 years and enrolled in high school. This study tests morning bright light and a school-night time management plan to facilitate earlier bedtimes to increase sleep duration. Circadian phase, sleep, neurobehavioral functioning and mood are measured before and immediately after the 2-week intervention and compared to a control group. Long-term effectiveness, adherence, and acceptability are also examined in a 3-week extension study. These data will provide evidence-based treatment strategies for delayed and sleep-restricted adolescents, and acceptability of and adherence to the treatment in this age group.

Eligibility Criteria:
Inclusion Criteria:

* 14- 17 years; enrolled in high school; lives in or near Chicago, IL

Exclusion Criteria:

-
EBUS-TBNA for Diagnosis of Mediastinal Lymphadenopathy

This study aims on the combinatorial results of cytology, histopathology and microbiology obatined by EBUS-TBNA for unselected mediastina lesions.

A number of studies have proved EBUS-TBNA to be useful for lymph node staging in lung cancer. The diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. This study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by EBUS-TBNA for unselected mediastina lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* mediastinal lymphadenopathy on Chest CT scan
* with a short-axis \> 10mm

Exclusion Criteria:

* patients intolerant to bronchoscopy exam
* unstable vital sign (Blood pressure, heart rate, breath rate)
The Development, Safety, and Feasibility of an Artificial Intelligence-Powered Platform (NodeAI) for Real-Time Prediction of Mediastinal Lymph Node Malignancy During Endobronchial Ultrasound Staging for Lung Cancer

Lung cancer is the leading cause of annual cancer deaths globally, more than breast, prostate, and colon cancers combined. The staging of chest lymph nodes (LNs) is a crucial step in the lung cancer diagnostic pathway because it aids in treatment decisions - whether a patient is a candidate for lung resection, chemotherapy, radiation, or multimodal treatments. Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) is the current standard for chest nodal staging for non-small cell lung cancer (NSCLC), and guidelines mandate that Systematic Sampling (SS) of at least 3 chest LN stations be routinely performed for accurate staging. Unfortunately, EBUS-TBNA yields inaccurate results in 40% of patients, leading to misinformed treatment decisions. This proportion is much higher in patients with Triple Normal LNs \[LNs that appear normal on computed tomography (CT) scans, positron emission tomography (PET) scans, and EBUS\], which have been found to have a \> 93% chance of being truly benign. This is because EBUS-TBNA is based on ultrasound, whose success highly depends on the skill of the person performing it (operator). When the operator makes an error, the entire procedure is jeopardized. This causes downstream delays in treatment due to repeated testing and ill-informed treatment decisions.

Over the past decade, the investigator has been conducting a series of research studies and trials: the development and validation of the Canada Lymph Node Score (CLNS) - a surgeon-derived semi-quantitative measure of LN malignancy; an Artificial Intelligence (AI)-based version of the CLNS to predict malignancy; and a fully autonomous AI that learned to predict malignancy directly from ultrasound images, to introduce AI to the decision-making pathway in NSCLC. This resulted in the creation of an AI-powered software to predict malignancy in mediastinal LNs of patients with lung cancer. The software is currently housed in cloud storage and its applications are latent - which means that LN images must be uploaded to the software, and results are received at a future time. In its current form, the software is not ready for clinical application due to this latency. In this project, the investigator aims to build a point-of-care device which will house the software (NodeAI) and deliver real-time results to the surgeon, and this device will be tested in a clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age diagnosed with suspected or confirmed NSCLC based on CT and PET scans that are referred for chest staging by EBUS-TBNA
* CT and PET scans completed

Exclusion Criteria:

* Patients with cN0 disease AND peripheral tumors AND tumors \< 2 cm in diameter (those do not require chest staging)
The Impact of a 3-day High-altitude Mountain Trek on the Emotional States of Children

The mood was influenced by many factors in children. Sport, such as high-altitude mountain trek activity was thought benefit for human's mood and health. The expedition therapy was more and more popular in many schools recently. However, as the investigators best knowledge, there was no article discuss the relation between the mood and high-altitude mountain trek activity such as benefit influence in children. So, the investigators conduct the study.

Method: Demographic data will be recorded. The Professor Yeh's mood questionnaires were used to record the mood status of before and after the 3 days high-altitude mountain trek activity.

Statistical analyses: Participants rated their emotional states (happiness, sadness, anticipation, and anger) on a Likert scale. Each variable will be presented as descriptive statistics. Student t test or other suitable statistical method(s) will be used to determine the correction among the variables with scores of mood status. The paired t test or other suitable statistical method(s) will be used to determine the correction among the scores of mood status before and after the mountain activity. A difference was considered statistically significant if the p value were less than 0.05. All statistical analyses will be performed using SPPS statistical software for Windows, version 14 or more updated version.


Eligibility Criteria:
Inclusion Criteria:

* Sixth-grade elementary students who participated in a 3-day, 2-night high-altitude mountain walking trek from the trailhead (2,140 m above sea level) to the summit of Xue Mountain (3,886 m above sea level)
* Subject who provide the written informed consent from participants and their legal guardians before the distribution of the questionnaires.

Exclusion Criteria:

* Not Sixth-grade elementary students.
* Not finish the 3-day, 2-night high-altitude mountain walking trek from the trailhead (2,140 m above sea level) to the summit of Xue Mountain (3,886 m above sea level)
* Subject who do not provide the written informed consent from participants and their legal guardians before the distribution of the questionnaires.
Association of Cognition With Functional Mobility in People With Alzheimer's Disease

This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.

Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility. Sociodemographic information of participants will be recorded. Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded. Functional mobility will assessed Timed Up and Go Test and 5 Times Sit\&Stand Test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
* Over 65 years old,
* Cases who could understand the instructions given in Turkish were included in the study,
* Having ambulation skill independently or with walking aid.

Exclusion Criteria:

* Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
* Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
* Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
* Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
A Collaborative Approach to Medication Reviews for Older Patients With Polypharmacy

In patients aged 65 years and older, polypathology is frequent and often associated with polypharmacy. This polypharmacy may be a source of iatrogeny due to pharmacokinetic interactions, enhanced sensitivity of older people to medication, or failure to adhere to the therapy. Since January 2018, French community pharmacists have been allowed by the Health ministry to perform medication reviews for people aged 65 years and over, who are being treated with more than 5 medications a day. the present hypothesis is that medication therapy management performed in collaboration with patients, general practitioners, and community pharmacists will lead to a reduction in medical events and inappropriate prescriptions.

This is a stepped-wedge cluster randomised controlled trial conducted in 9 regions of France. Each region represents one cluster with 7 community pharmacies located around the University Hospital associated with that cluster. In total, 63 community pharmacies will be enrolled, with each pharmacy including 20 patients over a 10 month-period. Over the life-time of the project, a total of 1260 patients will benefit from either the intervention or from a controlled pharmaceutical care according to the period of time they will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 65 or older suffering from long-term illness
* Patient aged 75 or older
* Living at home
* Having 5 medications or more per day for more than 6 months
* Being a regular patient of the community pharmacy involved in the study
* General practitioner of the patient agrees to participate to the study
* Patient being mentally and physically able to decide on his own to participate in the study
* Patient available by phone throughout the study

Exclusion Criteria:

* Patient refuses to participate
* Patient without a family doctor
* Patient whose family doctor refuses to participate in the study
* Patient who does not understand French, or dependant on someone else to manage his medication
* Resident of a nursing home
* Patient placed under guardianship
* Uncertainty of the pharmacist about patient reliability
* Patient having benefited from a medication review in the previous 12 months
* Patient already included in another study
Remediation of Working Memory in Schizophrenia

The primary aim of the study is to test the efficacy of a novel cognitive remediation intervention that targets working memory-related functions. To accomplish this goal, 80 volunteer patients with schizophrenia will be enrolled and randomized to either a cognitive remediation condition that targets working memory or a computer skills training intervention that teaches computer applications. In both conditions participants will receive computer training three times a week for 4 months. The investigators hypothesize that patients who receive the cognitive remediation intervention will demonstrate significantly greater change on neuropsychological measures of working memory and executive abilities than patients who receive the computer skills course. In addition, the investigators hypothesize that the intervention-induced cognitive change will be associated with concurrent improvements in functional capacity and psychosocial functioning in the community. A second study goal is to examine the stability of the intervention-induced changes in cognition. Cognition and psychosocial functioning will be reassessed 4 and 8 months after treatment termination to examine the stability of treatment effects and to assess whether a less intense maintenance training (once a week sessions) provides any additional benefit to participants. Lastly, this study will examine in an exploratory manner whether there are individual differences in treatment response. The Val158Met polymorphism of the COMT gene has been found to be associated with working memory and prefrontal dysfunction in schizophrenia. The study will test whether the COMT polymorphism is predictive of response to cognitive remediation.


Eligibility Criteria:
Inclusion Criteria:

* Veterans with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder
* No hospitalizations in the previous 4 weeks
* No antipsychotic medication changes in the previous 4 weeks
* Age 18-60
* Does not meet DSM-IV criteria for substance dependence in the previous 6 months or substance abuse in the previous month

Exclusion Criteria:

* History of clinically significant head injury or neurological disease
* Poor comprehension of the English language
* History of diagnosis of mental retardation or pervasive developmental disorder
* Unable to give informed consent
Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD

This study will evaluate the clinical efficacy of using earlier fast-track services compared to the standard of care in a clinical setting to improve retention in care and virologic suppression for patients who are initiating a dolutegravir-based antiretroviral therapy regimen.

With current approaches to HIV care, patients generally do not qualify for expedited services until they have been in care for 6 to 12 months. Once they have achieved an undetectable viral load and/or high adherence, patients qualify for expedited services with fewer clinic visits. The problem with this approach is that it's time-intensive early in ART care, when attrition rates are highest. A potential solution to this problem is to provide earlier fast-track care for patients on dolutegravir-based regimens with viral suppression. This strategy is feasible due to the high potency and rapid declines in viral load with dolutegravir-based regimens.

We will compare a strategy of early fast-track care (8 to 12 weeks, for patients with viral suppression) versus standard initiation of fast-track care (after 6 months in care, with viral suppression). All participants will receive the same ART regimen, the combination regimen of Tenofovir Disoproxil Fumarate-Lamivudine-Dolutegravir.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of positive HIV status (test conducted at GHESKIO)
* Age ≥18 years of age
* Eligible for TLD regimen, according to Haitian Ministry of Health guidelines
* Initiate ART within 3 days prior to enrollment
* Lives in Port-au-Prince metropolitan area
* Ability and willingness to give written informed consent
* Use of reliable contraception (for women of childbearing potential);
* Physician-confirmed WHO Stage 1 or 2 disease

Exclusion Criteria:

* Not ART-naïve (history of ART for any duration in the past)
* World Health Organization Stage 3 or 4 disease;
* Pregnancy or breastfeeding at the screening visit;
* Planning to become pregnant during the study period;
* Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician;
* Creatinine clearance (CrCl) \<50 within 1 month prior to study entry;
* ALT and/or AST\> 5X upper limit of normal (ULN) within 1 month prior to study entry;
* Planning to transfer care to another clinic during the study period
COVID-19: A Pilot Study of Adaptive Immunity and Anti-PD1

This is an open-label, controlled, single-centre pilot study of nivolumab in adult patients with COVID-19. This clinical study aims to evaluate efficacy of anti-PD1 antibody in relation to viral clearance and its safety.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 by RT-PCR for SARS-CoV-2
* Clinically stable with disease severity defined as mild or moderate (mild disease is defined as symptoms with or without lung infiltrates on chest X-Ray or CT imaging; moderate disease is defined as lung infiltrates with evidence of type 1 respiratory failure)
* Asymptomatic patients may be enrolled if patients have obvious radiographic changes on chest or CT radiography deemed to be related to COVID-19

Exclusion Criteria:

* Active cancer, rheumatological and autoimmune conditions
* Transplant recipients, or patients on active immunosuppressants
* Chronic organ impairment, or documented or suspected concomitant infections (including chronic viral hepatitis B and hepatitis C) other than SARS-CoV-2
* Lactating mothers and women who are pregnant or intending to become pregnant
* Acute respiratory distress syndrome, evidence of myocardial injury, disseminated intravascular coagulopathy, organ failure, hemophagocytosis, shock, respiratory distress, or need for mechanical ventilation, AICU admission, or high flow oxygen therapy
SMA Flow Patterns in Neonatal Transfusion

This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in premature neonates. These changes will be measured in relation to feeding, before and after a blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing enterocolitis (NEC) - a condition with significant mortality and long term morbidity. Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for planning, studying and implementing risk avoidance and minimization strategies.

Hypothesis: In preterm neonates the anticipated physiologic post-prandial increase in each SMA flow and intestinal perfusion is blunted post transfusion. This is worse in SGA infants and/or in the presence of a PDA.

Questions: 1) Does PRBC transfusion alter postprandial SMA flow increases and intestinal oxygenation indices in preterm infants receiving enteral feeds? 2) Is there a difference in postprandial SMA flow and intestinal perfusion changes in recently transfused SGA infants compared to AGA infants, and in those with and without a PDA? Primary Outcome: Post-prandial SMA flows changes before and after PRBC transfusion.

Secondary outcomes: Pre-post prandial changes in near-infrared spectroscopy (NIRS)-measured intestinal oxygenation parameters before and after PRBC transfusion.

Eligibility Criteria:
Inclusion Criteria:

* Prematurity (\<34 completed weeks of gestation at birth)
* Need for PRBC transfusion
* Feeding at least 30ml/kg/day at the time of transfusion

Exclusion Criteria:

* Neonates previously diagnosed with gastrointestinal problems such as NEC, intestinal perforation or atresia.
* Infants receiving continuous feeds or less than 30ml/kg/day
* Major congenital or chromosomal abnormalities or infants unlikely to survive
* Skin disruption precluding application of sensors
Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery

The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.

In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery

Exclusion Criteria:

* non robot-assisted surgery
Study About the Effect of Doxycycline and Acetylcystein in the Treatment of CD-associated Fistulae

The investigators will study whether local instillation of Doxycycline and Acetylcystein results in fistula closure in CD patients.


Eligibility Criteria:
Inclusion criteria:

* fistulizing CD
* CD \< 6 months
* at least one insufficient fistula closure try

Exclusion criteria:

* CDAI \> 200
* Abscesses
* CRP \> 100
A Study of Indinavir Taken With or Without DMP 266

The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).

In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows:

Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks, patients may switch the NRTI portion of their regimen if they meet a treatment failure criterion. After the completion of the 24-week period, patients have the option to continue on open-label DMP 266 and indinavir.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* CD4+ cell count of at least 50 cells/mm3.
* HIV RNA level of at least 10,000 copies/ml by reverse transcriptase polymerase chain reaction (RT-PCR, Amplicor test kit) at screening.
* Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

* DMP 266.
* Other nonnucleoside reverse transcriptase inhibitors.

Required:

One or two NRTIs (except ZDV and d4T in combination) for a minimum of 8 weeks, within 12 weeks prior to screening.