cyrilzakka/clinical-trials huggingface dataset:
Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA

Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.

DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. DLB is like Parkinson's disease (PD), characterized by the accumulation of alpha-synuclein, which misfolds and aggregates within neurons in so-called Lewy Bodies; this assumably drives the neurodegeneration. A novel technique for the measurement of misfolded alpha-synuclein is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process as well as aid in identifying patients with prodromal DLB. This would enable earlier symptomatic relief and care and potentially promote the search for disease-modifying therapies, which is currently absent.

Objectives. The overarching objective of this project is to identify early clinical warning signs and biomarkers in prodromal DLB.

Method. Study 1: Exploratory cross-sectional case-control study of patients with olfactory dysfunction versus individuals without olfactory dysfunction assessing pathological alpha-synuclein by RT-QuIC and prodromal symptoms of DLB and Parkinson's Disease.

Study 2: Longitudinal follow-up in Danish registries on diagnosing PD and dementia.

Eligibility Criteria:
Inclusion criteria with patients iOD:

* Age 55 -75 years of age
* Slowly progressing and non-fluctuating iOD
* Able to give informed consent and to cooperate as evaluated by the PI

Exclusion criteria with patients iOD:

* Diagnosed with a neurodegenerative disease or major neurological/psychiatric condition.
* Anosmia/hyposmia caused by sino-nasal disease (including chronic rhinitis and allergy), after trauma, infection, congenial, olfactory dysfunction due to surgery, or toxins/drugs affecting the olfactory function.
* Olfactory dysfunction with response to systemic or local corticosteroids if tried
* Severe nasal cavity abnormalities or infections.
* Overt signs of dementia or PD
* Current alcohol or drug abuse
* Terminal illness
* Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.

Inclusion criteria controls:

* Age 55 -75 years of age
* Able to give informed consent
* Able to cooperate as evaluated by the PI

Exclusion criteria controls:

* Olfactory dysfunction on clinical test
* Overt signs of dementia or PD
* Severe nasal cavity abnormalities or infections.
* Current alcohol or drug abuse
* Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.
Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease

The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Liver biopsy proved CHB and/or NAFLD at baseline;
* Chinese
* Follow-up duration\>12 months

Exclusion Criteria:

* Other liver diseases;
* Secondary causes of hepatic steatosis;
* Alcohol abuse;
* Liver cirrhosis, cirrhosis related complications or HCC at baseline;
* Malignancy;
* History of liver transplantation
Light Emitting Diodes With a Continuous Spectrum of 430-780nm for Myopia Prevention

The purpose of this clinical trial is to evaluate the effect of light-emitting diodes (LEDs) with a continuous spectrum of 430-780 nm for lighting in the classroom on myopia prevention among children in Grades 2 and 3.

Myopia is a common condition that primarily arises in childhood and remains the most important cause of vision loss for children. Irreversible vision-threatening ocular complications such as posterior staphyloma, myopic maculopathy, and glaucoma may occur with a dramatically high risk once myopia progresses to high myopia. Considering the striking rapid increases in the prevalence of myopia and the premature age of myopia onset, myopia prevention is of extreme urgency and presents several challenges.

It has been proven with solid evidence that outdoor times has effects on myopia prevention, which may be attributed to outdoor light exposure. However, it is difficult to meet the required outdoor times (i.e., at least 2 hours/day) for school-aged children under such educational pressure, especially in China. The differences between the light outdoors and indoors in terms of the light spectrum provide some insights into research to find the alternative. The growth rate of the vitreous cavity in juvenile and adult tree shrews grown under red light with a wavelength of 628±10 nm was significantly slower than those grown under the normal fluorescent lighting group, and red light could induce a hyperopic shift in juvenile tree shrews, thus slowing down the development of myopia. Another experiment has also shown that the use of full-spectrum LED covering a continuous spectrum of 400-775 nm accelerated the recovery from form-deprivation myopia in chickens, and it is hypothesized that full-spectrum lighting may affect the choroid-scleral remodeling pathway, which is thought to be associated with myopia control.

The purpose of this study is to evaluate the effects of LEDs covering a continuous spectrum of 430-780 nm for lighting in the classroom (intervention arm) among students in Grades 2 and 3 compared with regular LEDs with a spectrum of 430-630 nm (control arm). Cluster randomization by class was chosen, and all classes in the same school and grade were equally and randomly assigned to the intervention or control arm, with follow-ups at 1- and 2-year. Vision acuity, ocular biometry, cycloplegic refraction, slit-lamp examinations, optical coherence tomography, optical coherence tomography angiography, and questionnaires will be performed at baseline and during the follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. All the students in Grades 2 and 3 from the 8 schools participated in a myopia surveillance program in Zengcheng District, Guangzhou, China.
2. Provision of consent and able to participate in all required activities of the study.

Exclusion Criteria:

1. Schools without Grade 2 or Grade 3.
2. Schools that only had one class in either grade.
3. Children who refused to accept cycloplegia and/or other examinations.
4. Children with ocular abnormalities and/or previous history of ocular surgery.
Chronic Cardiovascular Risk Outpatient Management in South Asians Using Digital Health Technology

This platform will enable investigation the cardiovascular risk reduction and the increase in participant engagement in their heart-healthy goals, through the use of virtual care/telemedicine with a digital platform that connects them to their own doctors, nurses, and dietitians.

The study will use telemedicine and the mobile health capabilities of smartphones to facilitate communication of medical goals set by the treating physician to the subject in between clinic visits, and to assess the daily medical and lifestyle change compliance of enrolled Stanford subjects and provide virtual health coaching, as needed, to subjects to achieve said goals. How patients comply with their specific medical and lifestyle goals all affect their cardiovascular health, yet largely go unmeasured. These can now be measured with a notification-based system in which subject-entered activity, medication compliance, and dietary reporting data will be collected, assessed, and trigger appropriate responses by the subject's Care Team, which includes their physician, nurse, dietitian, and assigned health coach. We aim to collect this subject-reported activity and cardiovascular care plan compliance data to provide much more quantitative data on type, duration, and intensity of daily activities and compliance with the medication regimens of enrolled subjects.

The study will compare anthropometric cardiovascular risk biomarkers testing at the initial visit and after 3 months, in subjects utilizing the HealthPals digital platform PLUS the standard SSATHI clinic visits, versus subjects receiving only SSATHI clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* adult smartphone users

Exclusion Criteria:

* Subjects who do not own a smartphone or cannot access their mobile health data
* Patients unable to read English, as the initial version of the research app will be in English
* Participants who are children (under 18 years old)
* Participants who are pregnant women
* Participants who are economically and educationally disadvantaged, decisionally impaired, homeless people, or employees of Stanford University will be excluded due to being of a vulnerable population.
* Participants who express active chest pain or shortness of breath in their first clinic visit and are clinically deemed to require an emergency room evaluation will be excluded
* Participants who have inability or unwillingness to use or connect to data services for app messaging
* Participants with an upcoming surgical procedure (for instance, a clinic visit as part of preoperative evaluation) that will significantly impair or block their ability to follow the chronic disease management program during the study period
* Participants who have pre-existing participation in another clinical research protocol.
The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant

under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

under GA, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Eligibility Criteria:
Inclusion Criteria:

* patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia

Exclusion Criteria:

* systemic disease interfere with bone healing enophthamous less than 2 mm
Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)

This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL patients.

After enrollment, patients in this study will be given Chidamide, Cyclophosphamide, Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008 classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell lymphoma and granuloma fungoides excluded）;
2. De novo peripheral T cell lymphoma patients;
3. Age 18-70 years old;
4. ECOG≤2；
5. Female patients not in lactation nor pregnancy, and no intention to concept during the study and 12 months thereafter. Male patients agree not to impregnate his partner during the study and 12 months thereafter;
6. The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable skin foci);
7. Willing to sign a written consent.

Exclusion Criteria:

1. T lymphoblast lymphoma;
2. Bone marrow infiltrated with lymphoma cell ≥25%；
3. NT/T cell lymphoma;
4. Granuloma fungoides;
5. Severe impaired liver/ renal function (ALT, Bilirubin or creatinine \>3 times the normal maximum);
6. Uncontrolled infection;
7. Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥ level 2);
8. With other tumors;
9. With other condition that cause the patient unable to sign the written consent;
Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.


Eligibility Criteria:
Inclusion Criteria:

* Men and women \>/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)

Exclusion Criteria:

* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
* More than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of PE to randomization
* Calculated creatinine clearance (CLCR) \< 30 mL/min
* Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
* Active bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin
* Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
Utilization of PTNS During Office-Based Cystoscopy

This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has been shown to improve quality of life and symptom control in multiple urological conditions based on shared neuroanatomical structures between the genitourinary system and the tibial nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in minimizing patient discomfort during cystoscopy to develop a larger randomized control trial in the near future.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients undergoing routine office-based cystoscopy by a urology provider

Exclusion Criteria:

* Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration
* Patients undergoing cystoscopy due to concern for urologic injury
* Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition
* Patients who perform clean intermittent catheterization
* Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology
* Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy, simple prostatectomy)
* Patients with a history of interstitial cystitis/chronic pelvic pain
* Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours
* Patients with a history of urethral stricture disease
A BCT Intervention for an Hourly Activity Habit Among Caregivers for Persons With AD/ADRD

This 12-week trial will test the efficacy of a personalized, multi-component, personalized text-message delivered behavior change technique (BCT) intervention to encourage habitual hourly physical activity among care providers of persons with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) via the key mechanism of behavior change (MoBC) of automaticity.

The main question it aims to answer is whether a multi-component, personalized BCT intervention to increase habitual walking of \>250 steps/hour will lead to successful development of habitual hourly walking among 50% of caregivers.


Eligibility Criteria:
Inclusion Criteria:

* Identify as a caregiver (formal/paid or informal/unpaid) for persons with Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD)
* Age \>=18 and \<=85
* Speak English or Spanish as primary language
* Self-report low levels of physical activity or walking

Exclusion Criteria:

* Individuals who self-report having been informed by a clinician it is medically or physically unsafe to engage in a walking intervention
* Does not own or cannot regularly access a smartphone capable of receiving text messages or accessing the internet
* Does not own or have access to an email address
* Lives outside the United States
Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer

This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.

This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436. Drug infusions will last approximately 2 hours. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436 will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).
* Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination.

A metastatic site must be biopsy proven

* Life expectancy ≥3 months.
* Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.
* Female Age ≥18 years.
* Stable brain metastasis is permitted. This is not considered measurable disease.

Stable brain metastasis is defined as no change on CT scan or MRI for minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks

* A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age \< 55 or with no menses for \< 1 year
* Screening laboratory values as follows:

Total bilirubin ≤1.5 times upper limit of normal (ULN). Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times ULN.

Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. Absolute neutrophil count \>1,500 cells/mm3. Platelet count ≥100,000 plt/mm3. Hemoglobin ≥ 8 g/dL. Non-diabetic

Exclusion Criteria:

* Pregnant or breast-feeding
* ECOG Performance Status greater than 2
Evaluation of the Periodontal Status After the Treatment of Palatally Impacted Canines Using Acceleration Procedures

Impacted canine causes many problems for patients, such as damage to the adjacent teeth roots, effects on gingival tissues, aesthetic problems, difficulty, and prolonged orthodontic treatment duration. Therefore, solutions to accelerate the movement of impacted canines with the help of surgical procedures to reduce treatment time will be investigated, such as intra-operative alveolar perforations and piezocision. We also aimed to evaluate periodontal changes associated with such accelerating procedures compared with the conventional traction method.

Patients with palatally impacted maxillary canines will be treated using fixed appliances assisted by some surgical procedures. The effects of this treatment approach on the periodontal status will be assessed using periodontal measurements.

There are two groups :

1. conventional treatment group
2. minimally-invasive corticotomy-assisted treatment group Patients will be allocated to the two groups randomly. Data will be collected using periodontal variables.

Eligibility Criteria:
Inclusion Criteria:

1. Age of patients: 18-28 years.
2. Palatal or Mid-alveolar impacted canine.
3. There is no previous orthodontic treatment.
4. Healthy periodontal tissues and good oral health (i.e., the Plaque Index is less or equal to 1 according to Loe and Silness(1963).
5. The patient does not take any drug that may interfere with the tooth movement (Cortisone, NSAIDs ...).
6. Mild or no crowding on the upper jaw.
7. No history of previous trauma to the maxillofacial region or surgical interventions.

Exclusion Criteria:

1. Any systemic diseases that would affect tooth movement
2. Antidepressant prevents oral surgery
3. Any congenital syndromes or cleft lip and palate cases
4. Bad oral health
5. Previous orthodontic treatment
SSRIs vs. TCAs for Depression in ALS Patients

Depression is seen in 9-11% of ALS patients and adequate and proper treatment is needed. In this study, ALS patients will be screened for depression using self-reported multiple choice questionnaire. Patients who fulfill the criteria for depression based on this screening tool will be evaluated by psychiatrist before inclusion in the study. The investigators will also measure quality of life and functional status by simple questionnaires. The patients will be allocated into two treatment groups to receive either TCA or SSRI for 12 weeks. Patients will be evaluated every 4 weeks and phone calls will be made in between the visits if needed to assess about efficacy and any side effects. If any patient reports having suicidal thoughts on any of these phone calls or clinic visits, he/she will be immediately sent to the ER for appropriate management. The investigators will repeat the questionnaires in the clinic visits, and use them in the data analysis to look for any improvement and to compare the two medication classes used in this study. This data may be used later on to do larger studies and help to make standard recommendations in treating depression in ALS patients.

This study is a 12-week, open-label, non-randomized, pilot clinical intervention trial. This is investigator initiated study.This trial will be done at St Louis University ALS clinic. ALS patients will be screened for depression using Beck depression inventory (BDI-II) scale. A mental healthcare provider will evaluate the patients scoring 19 or above, before inclusion in the study. Quality of Life (QOL) assessment by questionnaire (McGill) and ALS functional rating scale (ALS-FRS) measurement will be done at the baseline. Then these patients will be allocated into two treatment groups to receive either TCA or SSRI medication for 12 weeks based on the clinical judgment (non-randomized). Patients will require clinical encounters every 4 weeks and telephone encounters in between the visits to assess the effectiveness of medication and tolerability of the side effects if any. If any patient endorses active suicidal ideation on any of these assessments, he/she will be immediately sent to the ER for appropriate management. At 4, 8 and 12-week clinic visits, repeat BDI, QOL and ALS-FRS measurement will be done on each patient from both groups and used in the data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of definite or probable ALS
* Informed and written consent for enrollment in study
* Gender: both male and female
* Age: 25-80 years
* BDI score 19 or above
* Depression diagnosis by mental health provider

Exclusion Criteria:

* History of psychotic disorder, premorbid bipolar depression
* ALS-FRS score \< 26
* Cognitive impairment
* Currently on SSRIs or TCAs. However if for some reason they are off their treatment, then they can be enrolled in the study after a washout period of 30 days.
* Currently on other antidepressants such as monoamine oxidase inhibitors (MAOIs), selective norepinephrine re-uptake inhibitors (SNRIs) etc.