cyrilzakka/clinical-trials huggingface dataset:
The Effect of Transcranial Direct Current Stimulation on Visual Attention in Mild Cognitive Impairment

Progressively causes the breakdown of cognitive functions and impairs quality of life for patients and their caregivers. In addition to memory impairment, visual attention is also compromised, even at the stage of mild cognitive impairment due to AD (MCI-AD). No treatment has been found for MCI-AD; therefore, attention has been drawn to non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), in order to enhance cognitive functions by modifying brain plasticity. In the current research, investigator aim to examine the long-term effects of the optimal multiple-session tDCS protocol in MCI-AD on visual attention including the transfer to an ecologically valid virtual environment and identify the neural underpinnings of tDCS-induced behavioral aftereffects using a combined tDCS/ MRI network-based approach.

Investigator will investigate the long-term effects of 10 active tDCS consecutive sessions using an optimized stimulation protocol as compared to a placebo stimulation on visual attention in the MCI-AD. A two-parallel-group, randomized, placebo-controlled design will be used. In addition, the cognitive transfer of tDCS will be evaluated. Repeated tDCS sessions will be performed in 10 consecutive sessions (2 weeks: Monday to Friday) over one preselected ROI together with ongoing visual attention training. During the stimulation, investigator will use the visual matching task. Before the repeated stimulation sessions, participants will undergo the neurocognitive examination. Behavioral examinations of the trained and untrained tasks (i.e. the transfer tasks) will be performed to assess the baseline performance. MRI protocol consisting of T1, T2, FLAIR, and fMRI during the task performance (visual matching task), resting state fMRI, and DTI sequences will be acquired before and after the whole 10-day stimulation protocol in order to search for active vs. placebo tDCS-induced changes in brain activation and resting state functional and structural connectivity and to identify neural correlates of behavioral changes. Behavioral assessment of the trained task and the transfer task will be repeated immediately after and again at a one-month follow-up visit after the end of the last stimulation session

Eligibility Criteria:
Inclusion Criteria:

* amnestic single or multi-domain mild cognitive impairment patients in accordance with diagnostic criteria (Albert et al., 2011)

Exclusion Criteria:

* psychiatric disorders, including major depression, major vascular lesions, and other brain pathologies detected by MRI that might present with cognitive decline
* a cardio pacemaker or any MRI-incompatible metal in the body
* epilepsy
* any diagnosed psychiatric disorder
* alcohol/drug abuse
* lack of cooperation
* presence of dementia.
Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects

The goal of this clinical trial is to test in height increment of alveolar bone and safety evaluation index.

The main question it aims to answer are:

• The safety and effectiveness of magnesium calcium silicate three-dimensional alveolar bone repair unit in the repair of periodontal bone defects Participants will be treated through Guided Bone Regeneration operation with calcium magnesium silicate three-dimensional alveolar bone repair unit.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old, healthy;
* Good oral hygiene, do not smoke;
* There is bone defect at the tooth extraction site, and it is planned to carry out implant repair after tooth extraction;
* There is at least one healthy adjacent tooth in the mesial and distal surface of the tooth extraction site;
* The residual height from the bottom of the extraction socket to the crest of the alveolar ridge is ≥ 3 mm, with at least one bone wall;
* Can understand the purpose of the trial
* Be willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trial
* Sign the informed consent form.

Exclusion Criteria:

* The affected tooth is in the acute inflammatory stage;
* Those who have bad habits such as smoking and drinking；
* Subjects who cause artifacts in oral imaging examination, such as the extraction site and its adjacent teeth are metal Dentures, porcelain teeth;
* Patients are allergic to ceramic implants;
* Those who have participated in other clinical trials in the past 3 months;
* The investigator estimated that the compliance was poor, or there were other factors that were not suitable for the test;
* Patients with a history of diabetes or abnormal blood glucose detection (fasting blood glucose ≥ 7mmol/L);
* Abnormal liver and kidney function (AST, ALT, creatinine ≥ 1.5 times ULN);
* Patients with serious endocrine and metabolic diseases;
* Have a history of tertiary hypertension;
* Have a history of osteoporosis;
* Those who are not suitable for surgery due to the history of malignant tumor or other serious diseases;
* People with a history of autoimmune diseases;
* Pregnant or lactating women;
* Mental disorders without autonomous behavior ability;
* Patients who are using steroids that interfere with calcium metabolism within 3 months before the signing of informed consent
TLR-9 Antagonism in Steroid Resistant Optic Neuritis

Although idiopathic steroid resistant optic neuritis is very uncommon, there is no established treatment protocol for such patients. Toll like receptors (TLRs) especially TLR-9 has been shown to play a role in the pathogenesis of optic neuritis. This small case series aims to determine whether immunomodulators directed specifically at TLR-9(i.e. TLR-9 antagonism)play any role in improving the visual function in such patients.


Eligibility Criteria:
Inclusion Criteria:

Unilateral Steroid Resistant Optic Neuritis

Exclusion Criteria:

* bilateral optic neuritis
* Associated Systemic disease
* Prior treatment received
Examining Feasibility and Acceptability of Telemedicine for Substance Use Disorder (SUD)

The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via telehealth (Teletx) to help improve substance use and other related outcomes in SUD patients who are not receiving SUD care. We will examine feasibility and acceptability of these pilot psychosocial programs in a total of n=50 participants. The goal is to refine the programs to improve acceptability and feasibility and collect preliminary data for a future fully powered randomized controlled trial (RCT) in the future.

In addition to study sessions, participants that are enrolled in the study will complete surveys prior to, during, and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient care at Michigan Medicine in past year
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
* Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)

Exclusion Criteria:

* Inability to speak or understand English
* Conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
* Prior alcohol withdrawal seizures or delirium tremens (DTs). Those who are at-risk of complicated withdrawal (e.g., seizures, DTs) require greater medical attention and will be excluded and referred to their clinician for medical management.
Impact of a Biofeedback Intervention on Microbiome, Metabolome, and Clinical Outcomes in Pediatric IBD (Study 2)

This prospective, randomized, longitudinal, controlled study will enroll pediatric CD patients with inflammatory, non-stricturing, and non-penetrating disease type with mild/quiescent disease based on Pediatric Crohn's Disease Activity Index (PCDAI). Participants will be randomized to receive HRV biofeedback intervention daily for 12 weeks or to music relaxation therapy.

The inflammatory bowel diseases (IBD), which include Crohn's disease (CD) and ulcerative colitis (UC), affects 3 million Americans. In approximately 25-30% of patients, onset of these chronic diseases occurs prior to the age of 20. Despite medical advances in new therapies, the clinical remission rate on biologics is less than 50% and a significant number of patients will lose response to anti-TNF therapy over time. In addition, patients that require a change in therapy will have a lower response rate to a different biologic. Additional therapies and mechanisms that affect disease activity need to be investigated to identify complimentary treatments that can further impact remission rates without increasing side effects such as lymphoma.

Environmental factors, such as stressor exposure, can exacerbate mucosal inflammation. Patients with IBD report a lower quality of life, as well as increased anxiety and depression. Psychological interventions may improve disease activity. This study will test, using a randomized clinical trial (RCT) design, whether biofeedback intervention will attenuate disease activity. If efficacious, this study will provide a rationale for establishing biofeedback as a complimentary therapy to standard of care to ameliorate stress-induced increases in chronic inflammation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 8-17 years
2. Have inflammatory, non-stricturing, and non-penetrating CD with either mild/quiescent disease based on PCDAI or PGA
3. Live within a 2 hour drive of NCH

Exclusion Criteria:

1. Participants are excluded if they have ulcerative colitis, penetrating and/or stricturing CD, have a comorbid chronic illness, perianal disease, taking antibiotics within the last 3 months, psychological disorders that they are undergoing treatment or taking medication for at that time, presence of a heart rhythm or other abnormality of heart rhythm on screening EKG, or undergoing psychological treatments such as cognitive behavioral therapy, mindfulness, or biofeedback therapy at the time of enrollment.
2. Age and language are limited by the demands of the study (questionnaire completion
Study of Tomography of Nephrolithiasis Evaluation

This is a multi-center, randomized controlled trial of ultrasonography (ultrasound) compared to computed tomography (CT) for the initial emergency room evaluation of patients with suspected renal colic. The investigators will compare several measures of effectiveness including morbidity related to the patient's underlying disease, or complications related to delayed diagnosis, patient status regarding pain/missed days of work, and utilization of health care resources based on one of three study arms: ultrasound in the Emergency Department, ultrasound in Radiology or CT.

This is a multi-center, randomized controlled trial of ultrasonography compared with computed tomography (CT) for the evaluation of patients with suspected urolithiasis. The study will be conducted at 15 large urban Emergency Departments (EDs), reflecting geographic, socioeconomic, racial and ethnic diversity, and include academic medical centers as well as safety net hospitals. The patients will be randomized to one of three arms: 1) ultrasound in the Emergency Department (ED), 2) ultrasound in radiology or 3) CT in radiology. The investigators will then collect precise and unbiased data on a comprehensive range of outcomes that will allow assessment of effectiveness, safety, accuracy and cost between patients randomized to one the three groups. Taken together, these measures are intended to provide the basis for a valid comparison of imaging of patients with suspected urolithiasis seen in the ED. The results of this trial could lead to a change in clinical practice that is associated with both improved patient outcomes and reduced cost. Broad stakeholder involvement from within radiology, emergency medicine and several subspecialty communities has been sought to ensure the strategic completion of study aims and to help rapidly disseminate the results of the study into clinical practice. This will create a collaborative network of EDs willing to act as a laboratory for studying the comparative effectiveness of diagnostic testing. As a result, the proposed trial will demonstrate the feasibility of conducting Randomized Control Trials (RCTs) of imaging that incorporates measurements of outcomes that can be expanded to additional imaging tests in the future.

Eligibility Criteria:
Inclusion Criteria:

* men or women = or \>18 but \<76 years of age presenting with acute renal colic
* Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones.

Exclusion Criteria:

* children \< 18 years old
* elderly patients \> or = 76 years old
* pregnancy or planning pregnancy
* Morbid obesity (\>285 pounds in men, \>250 pounds in women)
* patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected).
* history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)
Next-Generation-Sequencing Approach to Neutropenic Sepsis

The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER in neutropenic patients with FN is to provide further evidence of the efficacy of an NGS-based approach for detecting bloodstream infection in neutropenic patients.

The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER (Platform for digital pathogen diagnostics from Noscendo GmbH) in neutropenic patients with FN (Febrile neutropenia) is to provide further evidence of the efficacy of an NGS (Next-generation seqzencing)-based approach for detecting bloodstream infection in neutropenic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed consent
* Neutropenia defined as \<500 ANC (Absolute neutrophil Count)/µl or \<1000 WBC (White bloddcell Count)/µl if ANC is not available
* Fever (with an onset \< 24h) or Sepsis (with an onset \<24h) Patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection.

Exclusion Criteria:

* Age \< 18 years
* Refusal or inability to give consent Inability to give informed consent if no acceptable patient representative is available
* Patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time
* Death is deemed imminent and inevitable
Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure

Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety and perioperative pain during oocyte puncture


Eligibility Criteria:
Inclusion Criteria:

* Patient having an oocyte puncture as part of a medically assisted procreation procedure
* Surgical procedure planned in the operating theatre under local anaesthesia at the Clinique Mutualiste La Sagesse
* Patient capable of receiving and understanding information about the study and giving written informed consent.
* Affiliated to a social security system

Exclusion Criteria:

* Patient's refusal to participate in a study
* Patient having an oocyte retrieval as part of an oocyte donation
* Unbalanced epilepsy.
* Hearing and/or visual impairments that contraindicate the use of the virtual reality headset.
* Patient with a poor understanding of the French language.
* Medical indication to carry out the oocyte puncture under general anaesthesia
* Drug allergy or hypersensitivity to PARACETAMOL - IBUPROFEN or NEFOPAM prescribed during the pre-medication.
* Patient under legal protection
Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

The purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due to osteoarthritis of the knee or hip.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee
* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
* Discontinued all analgesic therapy at Screening
* For women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Ability to ambulate

Exclusion Criteria:

* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
* Requires regular (more than 2 doses per week) use of opioid or opioid combination products to control OA pain of the knee or hip
* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Significant difficulties swallowing capsules/tablets or unable to tolerate oral medication
* Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening
Echocardiographic Findings and 30-days Outcomes for Intraventricular Conduction Delay in Patients Undergoing Elective Surgeries

The purpose of this study is to investigate the type of the cardiac disease using transthoracic echocardiography in patients whose preoperative electrocardiography shows the intraventricular conduction delay.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged over 20 yrs who are scheduled for surgery under the general anesthesia and whose preoperative electrocardiography finding is intraventricular conduction delay.

Exclusion Criteria:

* Patients who are planning cardiac surgery
* Patients who has chest wall disease
* Pregnancy
Expanded Access for Relatlimab

This is an expanded access designed to provide access to Relatlimab for eligible participants.


Eligibility Criteria:
Establishment and Clinical Validation of New Technologies for Accurate Screening of Colorectal Cancer Based on Multi-omics

Background:

The current screening techniques for colorectal cancer include colonoscopy, fecal occult blood, and high-risk factor questionnaires. However, the colorectal cancer screening technology that has been widely used at present cannot take into account sensitivity and specificity, and the tumor detection rate is low.

The purpose of research:

1. Build a new type of population colorectal cancer precision screening technology program;
2. Improve the detection rate of colorectal cancer in the population by new methods (compared with the existing domestic advanced technology) by ≥20%, and improve the specificity of colorectal cancer screening by ≥15% without significantly reducing the sensitivity.


Eligibility Criteria:
Inclusion Criteria:

Age: 40-74 years old

Exclusion Criteria:

1. Combine severe disorders to make it unsuitable for colonoscopy
2. Combine other tumors
3. Mental and behavioral abnormalities do not cooperate with the screener
4. Researchers believe that other reasons are not suitable for enrollment
A Study of LY3337641 in Japanese and Caucasian Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3337641 in healthy Japanese and Caucasian participants. The study will also investigate how the body processes LY3337641 and the effect of LY3337641 on the body. The study will last up to 4 weeks for each participant. Screening may occur within 28 days prior to first dose of study drug.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy Japanese or Caucasian
* Body mass index (BMI) 18.0 - 32.0 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the QTc analysis or have Fridericia-corrected QT interval (QTcF) \>450 milliseconds (msec) for males and \>470 msec for females
* Have had symptomatic herpes zoster within 3 months of screening
* Have active or latent tuberculosis (TB) based on a positive medical history, examination, and/or TB test results.
* Have received live vaccine(s) within 1 month of screening or intend to during the study
* Are immunocompromised
* Have a history of constipation or have had acute constipation within 3 weeks prior to admission
PCR Cycle Threshold Values and COVID-19 Outcomes

This is a retrospective observational study. The study will use high quality, reliable data that has already been collected for the ISARIC 4C COVID-19 study in order to analyse the relation between predictor variables (laboratory polymerase chain reaction \[PCR\] cycle threshold \[Ct\] values) and outcomes for COVID-19 disease within a hospitalised population.

Currently, in the United Kingdom, the recommended method for diagnostic testing and screening for COVID-19 is quantitative (real-time) reverse transcription polymerase chain reaction (PCR) analysis of viral RNA extracted from upper respiratory tract samples. A positive result indicates that SARS-CoV-2 RNA has been detected with a cycle threshold (Ct) value of less than 38 cycles of amplification (n.b. this is a locally agreed value, which is based on analysis of proficiency testing performance and other local testing data. Cycle threshold (Ct) values inversely correlate to the amount of target nucleic acid in the sample. Thus, a lower cycle threshold (Ct) value indicates a greater amount of target nucleic acid in a sample i.e. a higher viral load.

A recent scoping literature review has revealed only a handful of published studies to date that explore an association between cycle threshold (Ct) values and disease severity or clinical outcome in patients infected with the SARS-CoV-2 virus. The majority of these studies have been conducted in China with small patient sample sizes. Thus, a larger-scale study which explores the relationship between viral load and disease severity is required; indeed, the World Health Organization (WHO) has recently highlighted this as an area which needs further research.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (aged 18 years and over) patients presenting to UHNM with confirmed SARS-CoV-2 infection AND who are enrolled onto the ISARIC COVID-19 study.
2. Patients who have undergone an initial diagnostic or screening test for SARS-CoV-2 (from an upper respiratory tract sample) AND a cycle threshold (Ct) value is available on the UHNM laboratory database.

Exclusion Criteria:

1. Paediatric patients (under 18 years).
2. Patients without a PCR Ct result on the UHNM laboratory database
3. Patients without confirmed SARS-CoV-2 infection
4. Patients who were not enrolled in to the ISARIC COVID-19 study