cyrilzakka/clinical-trials huggingface dataset:
A Study on Vertebral Bone Strength by Micro-CT-Like Image

In this study, we use conditional generation adversarial network to enhance the resolution of MSCT images and obtain micro-CT-like images. Based on this, we measure the bone structure indexes of micro-CT-like images and analyzed the correlation between bone structure and bio-mechanical indexes.

In this study, we expect to collect 10 sets of vertebrae (between T6 and L5) from 10 formalin-fixed human cadavers. The study protocol was reviewed and approved by the local Institutional Review Boards.The collected specimens subject to normalized Micro-CT and MSCT image scanning, image reconstruction using standard algorithms, and bone structure observation using bone algorithms to obtain high-quality, standardized axial images. We will use a conditional generation adversarial network-based image mapping technique to train the mapping model between MSCT images and Micro-CT images, find the correspondence between the image information contained in each of MSCT and Micro-CT, and finally obtain high-resolution micro-CT-like images. After obtaining the Micro-CT-like images of the samples, we will segment and annotate the images (including different structures such as vertebral body, bone cortex) and train the Teacher-Student \& U-Net++ deep learning architecture to achieve accurate segmentation of vertebral body regions, and obtain cancellous bone regions of interest. Based on this, we will analyze the bone structure characteristics of each spatial region in the images, including the thickness, spacing, orientation and distribution pattern of bone trabeculae and other indicators. Ultimately, we will cut a standardized cubic sample from the vertebral cancellous bone , obtain the bio-mechanical performance index of this cancellous bone sample by mechanical experiments, and analyze the correlation between bone structure of Micro-CT-like images and bio-mechanical index.

Eligibility Criteria:
Inclusion Criteria:

* We will collect human formalin-fixed vertebral specimens provided by the Department of Anatomy, Peking University School of Medicine. The expected number of enrolled specimens is approximately 100 vertebrae (between T6 and L5) .

Exclusion Criteria:

* The vertebrae with significant compression fractures, bone neoplasms, or other causes of significant bone destruction.
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.

This is a multi-center, double-blind study that will evaluate 265 mg BID of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
* Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
* MMSE score at Screening of 22 to 30 (inclusive).
* CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.
* RBANS delayed memory index score ≤ 85.
* Evidence of progressive memory loss over the last 12 months per investigator assessment

Exclusion Criteria:

* Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI.
* Diagnosis of neurodegenerative disorder other than AD.
* Diagnosis of major depressive disorder (MDD) within one year prior to screening.
* Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit.
* History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation.
* History of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years).
* Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.
Psychotherapy Trial With Transgender Clients

Transgender and gender diverse (TGD) individuals are at an increased risk for mental health concerns, including anxiety, trauma-based distress, depression, self-harm, and suicidality. Quantitative and qualitative studies have shown that support appears to mediate mental health concerns, but to date, there have been zero psychotherapy studies focusing on transgender and gender diverse patients. The NIH has noted that TGD patients are considered to be a "health disparities population," indicating that there is considerable research to support prevention and reduction in mental health disparities for this population.

There are two aims to the current study-Aim 1: investigate the feasibility of conducting a psychotherapy randomized controlled trial for transgender and gender diverse populations, and Aim 2: longitudinally investigate the impact of minority stress interventions on well-being for transgender and gender diverse patients.

First, it is hypothesized that this study will demonstrate feasibility regarding recruitment of transgender and gender diverse patients and that patients from both groups will report treatment acceptability. We also hypothesize that patients will report more acceptability for treatments that are focused on minority stress interventions. It is hypothesized that individuals in both the Minority Stress Treatment (MST) group and Treatment as Usual (TAU) group will both show improvements in well-being, but that the MST group will demonstrate larger effects in outcomes.

No known published studies have focused on minority stress psychotherapy interventions for transgender and gender diverse populations. The findings from the proposed study will provide a multitude of information regarding longitudinal psychotherapy interventions focusing on minority stress that will inform future treatment manuals and larger, multi-site studies.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or older
* Fluent in written and spoken English
* Willingness to participate in pre/post/session-by-session assessments and 12 ----Individual psychotherapy treatment sessions
* Individual identifies as transgender, trans, or non-binary (or somewhere along the gender minority spectrum).

Exclusion Criteria:

* Under 18 years old
* Reports current, unmanaged psychotic symptoms or symptoms requiring immediate inpatient treatment (e.g., hallucinations, delusions, threatening immediate suicidal behaviors)
* Currently engaging in psychotherapy
* Cannot attend therapy on Tuesdays from 2-7pm
* Individuals who lack the capacity to provide consent will be excluded.
Telemonitoring and E-Coaching in Hypertension

Rationale: Hypertension is the most significant risk factor for cardiovascular disease and can be mitigated by lifestyle and medical management. Telemonitoring as a novel management approach to perform hypertension management at distance has been thriving but became indispensable during the COVID-19 pandemic. However, evidence of an effective implementation for telemonitoring remains to be elucidated.

Hypothesis: Telemonitoring with a smartphone application, which includes mixed automated services for a personal counselling program (PCP), on top of self-monitoring (SM) will lead to improvement of hypertension control rates, medication adherence and lifestyle behaviors and lower health care costs in patients with hypertension when compared to usual care.

Objective: To investigate the effects of PCP+SM on hypertension control rate and lifestyle behaviors as compared with usual care.

Study design: The study is a non-blinded randomized controlled clinical trial in adults with hypertension, in a multicenter hospital setting . We will randomize participants in a 1:1 fashion to the intervention group (PCP+SM), or to the control group (usual care).

Study population: 400 patients, patients, aged ≥18 years with hypertension (RR \>140/90) Main study outcome: hypertension control rate (%\<140/90mmHg) after 6 months (as measured by the SPRINT protocol)


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Hypertension (\>140/90)
* Have and use a smartphone or a partner/caregiver who is able to provide the necessary technical support
* Able to provide written informed consent prior to participation in the study

Exclusion Criteria:

* Current user of a blood pressure monitor apporoved by the Dutch Heart foundation in combination with the Luscii app
* Persistent atrial fibrillation as indicated in the electronic health record (EHR)
* Pregnant or planning to become pregnant during the study period
* Severe kidney disease, defined as estimated glomerular filtration rate \<30 per 1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or peritoneal dialysis)
* Unable to communicate (not language specific)
* Recent cardiovascular event (ischemic stroke, transient ischemic attack, myocardial infarction, coronary artery bypass grafting) in the past 3 months
* Diagnosis of dementia, psychosis as indicated in the electronic health record
* Life expectancy \<1 year, for instance in terminal cancer or NYHA III or IV heart failure
* Individuals requiring BP monitor cuff size larger than 42cm
* Patients with proven secondary cause of hypertension for which drug treatment is not first choice (e.g. excessive licorice use, proven renal artery stenosis etc)
Integrated Palliative Care With Nephrology Care

This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning.

Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Documented diagnosis of Chronic Kidney Disease stage IV or V
3. Speaks Spanish or English fluently
4. Provision of signed and dated informed consent form
5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.

Exclusion Criteria:

1. Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
2. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation, for example not being able to cognitively understand the questions or to provide informed consent.
3. Pregnant women.
4. Not fluent in either English or Spanish
5. Any urgent supportive/palliative care needs identified on screening interview.
Validation of Radio-induced Damage Biomarkers

The aim of this study is to confirm in humans the relevance and the kinetics of radio-induced bio-markers in plasma and urines, previously described at the preclinical stage.

The nuclear and radiologic risks monitoring is a major preoccupation for our society. During an accident, it is primordial to define the biologic dosimetry. The dose and distribution knowledge is crucial for the medical care. Indeed, Total Body Irradiation (TBI) and Partial Body Irradiation (PBI) do not have the same clinical outcome. A Total Body Irradiation induces an acute radiation syndrome with a Medullary Aplasia. A quick diagnostic would allow the optimization of the medical care.

Nowadays, the analyse of the chromosome with two centromeres is the current norm to estimate the radiation dose, but this technique is time consuming, and not adapted to an emergency situation, and to a large population.

The new genetic techniques could permit the quick radiation dosimetry diagnosis. The research of early exposition bio-markers seems to be of a major interest. These bio-markers would allow to rapidly define the radiations perceived by an exposed subject, before the apparition of the symptoms, and by the way, to conduct to a therapeutic strategy more adapted to the patient.

In this purpose, the present study will need blood and urines samples of patients totally or partially exposed to radiations, according to their usual medical care.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* For the group A:

Patient suffering from a malignant blood disease requiring a whole-body radiation, without (or prior to) a concomitant chemotherapy, according to the following protocol: 2x2 Gray per day, during 3 days.

* OR For the group B:

Patient with one (or more) pelvis metastasis requiring radiation therapy without concomitant chemotherapy, according to the following protocol: 4 Gray per day for 5 days.

Exclusion Criteria:

* More than 70 years old,
* Subject presenting abnormal blood count (grade 3),
* Person with a not controlled chronic illness,
* Subject presenting an abnormal hepatic assessment (grade 3),
* Subject having already received ionizing treatments,
* Subject reached HIV, hepatitis C or any other progressive infectious diseases,
* Pregnant women or nursing mothers,
* Person under protection of justice or unable to give consent.
Structural Problems in Brainstem and Cervical Spine Cord in ME/CFS

A case control study on patients with ME/CFS and healthy controls on prevalence of cervical obstructions, Cerebro spinal fluid (CSF) pressure and laboratory findings.

50 patients and 50 healthy controls will undergo clinical exams and blood test of inflammatory and other findings as well as magnetic resonance imaging (MRI) with spectroscopy. The patients will undergo csf -sampling and measurements of CSF pressure.

Eligibility Criteria:
Inclusion Criteria:

Diagnose Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) according to Canada Consensus Criteria from 2003

Exclusion Criteria:

Bleeding abnormality Contraindication to Magnetic Resonance Imaging MRI Pregnancy
Effect of Low Level Laser Therapy in Accelerating Tooth Movement For Dental Crowding Cases

26 participants from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. In the experimental group, a low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth. Control group will undergo typical orthodontic treatment with the laser device applied the same manner but without being turned on (to get the placebo effect for pain reduction effect). This procedure will be repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the end of the leveling and alignment stage.

The long time needed for orthodontic treatment is considered one of the biggest obstacles which make patients refuse to undergo treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. It also combined commonly with pain, which reducing patient acceptance and cooperation with treatment.

Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of root resorption.

A recent systematic review states that low level laser therapy has shown efficiency in accelerating orthodontic tooth movement, but there is a need for more studies to determine the best protocols regarding energy and frequency. A review of the literature shows that there is no randomized controlled trails evaluating its efficiency in accelerating orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between (16 - 24) years.
2. Moderate crowding (3 - 5) mm in the anterior region of the maxillary dental arch with an irregularity index of (7 mm or more) mm according to Little Index with an indication to extract upper two premolars.
3. All upper teeth are existed (except for third molars).
4. Patients have not undergone previous orthodontic treatment.
5. Patients have not undergone any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, ...).
6. Patient with good oral hygiene (Plaque Index less than 1).

Exclusion Criteria:

1. Any medical condition affecting orthodontic tooth movement.
2. Bad oral hygiene (Plaque Index greater than 1).
3. Any peri-apical lesions developed during treatment.
4. Patient lack of commitment toward follow-up appointments.
ENDmetriosis and Reserve Ovarienne

Endometriosis is the ectopic implantation of endometrial glands and stroma, and can be ovarian and peritoneal (superficial or deep). There are 4 stages in endometriosis according to severity, and the stage is established on the basis of intra-operative observations. The AFSr classification is currently most used (I-IV,minimal, mild, moderate, severe). Most associated with endometriosis are subfertility and pelvic pain.

In the surgical management of deep endometriosis, the issue of fertility is pivotal. There is a higher rate of infertility in a population of women with endometriosis as compared to the general population, even though the mechanisms are not yet elucidated. Patients with deep endometriosis can be referred to the surgeon for subfertility, but even when they are referred for chronic pain, future fertility considerations are taken into account in the planning of the surgery, as the patients are often young.

It is now well documented that ovarian cystectomy is deleterious with regards to the ovarian reserve, and more so in endometriomas than in any other type of benign cysts. The ovarian reserve is the functional potential of the ovaries, reflecting the quantity and quality of remaining follicles. Studies have also relied greatly on the measure of serum anti-mullerian hormone (AMH) to evaluate the effect of cystectomy on ovarian reserve, as AMH is currently the most reliable marker to assess ovarian reserve. A significant difference was found between AMH before and following cystectomy in several studies. The deleterious effect of deep endometriosis surgery which comprises a wide dissection and adhesiolysis of the pelvis in many cases, even when no cystectomy has been performed, is therefore not entirely ruled out. To the best of our knowledge, there are no studies on the effect of deep endometriosis surgery, apart from ovarian surgery, on ovarian reserve.

Our center is very active in the laparoscopic surgical treatment of deep endometriosis, with more than 200 cases every year. The objective of this trial is to assess the effect of deep endometriosis surgery on the ovarian reserve, whether a cystectomy is performed or not, by measuring serum AMH before and after surgery, at 6 months and 1 year post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* female patient between 18 and 38 years
* endometriosis stage III or IV in the AFSr classification
* laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis)
* written informed consent

Exclusion Criteria:

* previous adnexectomy or adnexectomy during surgery
Gastric Ultrasound in Paediatric Anaesthesia

Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric contents. It has been previously reported that bedside two-dimensional ultrasonography can be a useful tool for anesthesiologists to determine gastric contents and volume in adults and children.

In this prospective study, preoperative qualitative ultrasound assessment of gastric contents is performed for each children admitted for emergency surgery, in order to plane in case of empty stomach an intravenous or inhalation technique induction rather than an rapid sequence induction.


Eligibility Criteria:
Inclusion Criteria:

* Children aged from 0 to 18 years old
* Parental consent

Exclusion Criteria:

* Gastric tube contraindication
* Parental refusal
BASIS Optimization

The objective of the BASIS R34 pilot study is to test the impact of eBASIS in a randomized controlled trial (RCT). Consistent with IMPACT's IQM, the study tests effects of eBASIS on treatment fidelity and youth outcomes, compared to a digitally delivered control (N=32 clinicians; 96 clients). A well-established EBP (Cognitive Behavioral Therapy Plus), will be a focus of the investigation, which eligible participants will already be signed up to receive.

Although evidence-based practices (EBPs) have been extensively developed, they are not widely used in school settings, where up to 80% of youth receive mental health services. This results in reduced impact on youth mental health. The project aims to test the online version of efficient and effective strategy called BASIS to improve the quality of EBP by focusing on individual-level processes, complementing organizational change approaches.

The strategy applies the Theory of Planned Behavior (TPB) to influence key provider behaviors, such as attitudes, subjective norms, and perceived behavioral control, which are central to EBP adoption and fidelity. Preliminary trials on BASIS found significant changes in key theory of planned behavior mechanisms (e.g., attitudes, perceived behavioral control, and social norms) and more engagement in post-training consultation among school school-based clinicians, supporting implementation of evidenced-based social-emotional-behavioral practices. By addressing the intrapersonal mechanisms driving provider decisions, the study aims to improve implementation outcomes in school settings.

The objective of this pilot study is to test the impact of the optimized eBASIS in a randomized controlled trial (RCT). Consistent with IMPACT's IQM, the study tests effects of eBASIS on treatment fidelity and youth outcomes, compared to a digitally delivered control (N=32 clinicians; 96 clients). A well-established EBP (Cognitive Behavioral Therapy Plus), will be a focus of the investigation, which eligible participants will already be signed up to receive.

Eligibility Criteria:
Inclusion Criteria:

* Mental health provider who spends 2 hours or more providing supports in school setting
* Registered to receive CBT+ training from the WA State EBP Initiative

Exclusion Criteria:

* None