cyrilzakka/clinical-trials huggingface dataset:
Examining the Impact of Transcranial Focused Ultrasound (tFUS) on Reward Neural Circuitry

The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity and emotions in healthy adults as a first stage toward understanding the predisposing brain mechanisms of underlying substance use disorders.

In a small pilot study the investigators propose to demonstrate feasibility of using tFUS to target the ventral striatum (VS) in humans by examining VS target engagement by tFUS in healthy human volunteers using a reward processing task that reliably activates the VS.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age
* No psychiatric history

Exclusion Criteria:

* Not between 18-35 years of age
* Has psychiatric history
* History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report)
* Mini-Mental State Examination (MMSE) score (cognitive state) \<24
* Premorbid North American Adult Reading Test (NAART) intelligent quotient (IQ) estimate\<85
* Visual disturbance: \<20/40 Snellen visual acuity
* Left/mixed handedness (Annett criteria)
* History of alcohol/substance use disorder (SUD) (all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (Structured Clinical Interview for Diagnostic and Statistic Manual of Mental Disorders , 5th Edition (DSM-5) (SCID-5)). Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals
* Magnetic resonance imaging (MRI) exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
* Unable to understand English
* Individuals with a positive pregnancy test will be excluded from the study and not undergo a computerized tomography (CT) scan or MRI scan
* Present or history of seizure disorder
Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis

The proposed Phase 1b study design was a randomized, placebo-controlled, double-blind, study to evaluate the safety and pharmacokinetics of oral BT-11 in active eosinophilic esophagitis.


Eligibility Criteria:
No patients enrolled
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma

This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy

This study will be conducted in 2 parts:

The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.

The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.

Eligibility Criteria:
Main Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
2. Tumor tissue positive for HPV16 or HPV52.
3. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.
4. Human leukocyte antigen (HLA)-A\*02:01 genotype.
5. Measurable disease as defined by RECIST v1.1.
6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
7. Anticipated life expectancy ≥3 months.
8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.

Main Exclusion Criteria:

1. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.
2. Active brain metastasis or leptomeningeal metastases.
3. History of other malignancy within 2 years prior to Screening.
4. History of organ transplant.
5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
6. History of active cardiac disease.
7. History of active pulmonary disease.
8. Active, known, or suspected autoimmune disease.
9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
12. Any serious medical condition or abnormality in clinical laboratory tests.
Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial

Our aim is to assess the clinical efficacy and the safety of fractional CO2 laser combined with topical tioconazole versus Q-switched Nd:YAG laser in the treatment of OM.


Eligibility Criteria:
Inclusion Criteria:

* • Age group \>18 years.

  * Patients of both genders.
  * Patients with OM any type.

Exclusion Criteria:

* • Pregnancy

  * Localized bacterial infection around the affected nail
  * Concomitant nails disease that causes nail dystrophy or discoloration such as psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis and treatment
  * Hypersensitivity to terbinafine
  * Intake of oral antifungal medication within the last 3 months or used topical antifungal medication within the last 2 weeks prior to the laser treatment
Static Stretching on Postural Sway and Plantar Pressures

Risk for falls has been associated with falls efficacy and postural balance. The objective was to compare the effects on the footprint and the stabilometry of the continuous stretch and the intermittent. Subjects were randomly assigned to an intermittent stretching protocol group or continuous stretch group both of them loading passive plantar flexor stretching. Static footprint and stabilometry were measured before and after both protocols.


Eligibility Criteria:
Inclusion Criteria:

* Non-trained individuals
* Healthy subjects

Exclusion Criteria:

* Previous surgery on the lower extremities
* Injuries
* Musculoskeletal conditions
Cellular Senescence and COVID-19 Long-Hauler Syndrome

The purpose of this study is to test if senescent cells and their secretome contribute to Long-Hauler Syndrome and if a clinical trial of senolytic drugs, which selectively eliminate senescent cells, should be initiated.


Eligibility Criteria:
Longhauler's Cohort -

Inclusion Criteria:

* Ability to give informed consent or LAR.
* At least 18 years old.
* Ability of subject or LAR to read and speak the English language.
* Positive PCR or antibody test within 12 months of initial study visit.
* Patient of the Long-Hauler Syndrome clinic and differential diagnosis of Long-Hauler Syndrome.

Exclusion Criteria:

* Any potential participant who refuses medical record review.
* Pregnant females.
* Incarcerated individuals.
* Inability to cooperate or any medical condition that, in the opinion of the investigator, interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.

Control Cohort -

Inclusion Criteria:

* Ability to give informed consent
* At least 18 years old
* Ability of subject to read and speak the English language

Exclusion Criteria:

* Known case of COVID-19.
* Any potential participant who refuses medical record review.
* Pregnant females.
* Incarcerated individuals.
* Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.

COVID-19 Control Cohort

Inclusion Criteria:

* Ability to give informed consent.
* At least 18 years old.
* Ability of subject to read and speak the English language.
* Known case of COVID-19.

Exclusion Criteria:

* Known Longhauler's syndrome/Post-COVID
* Any potential participant who refuses medical record review.
* Pregnant females.
* Incarcerated individuals.
* Inability to cooperate or any medical condition that interferes with the evaluation of the study objectives or increases the subject's risk by participating in the study.
Assessment of Prognosis Using Peripheral Blood Circulating Tumor DNA in Patients With Cervical Cancer

This observational study is conducted to assess the value of using peripheral blood ctDNA to detect dynamic changes in HPV and genetic variants in predicting the prognosis of patients with locally advanced cervical cancer, as compared with traditional imaging and tumor markers.

The goal of this study is to assess the prognostic value of ctDNA HPV and gene variant clearance in peripheral blood.

Two cohorts will be enrolled: operable group and radical chemoradiotherapy group.

After enrollment, patients will receive standard treatment and follow-up strategy. Peripheral blood samples will be collected from 2 cohorts of patients before treatment and at different time points after starting treatment. Baseline surgical or puncture tissues will be also obtained.

Peripheral blood ctDNA and baseline tissues will be tested for HPV copy number based on ddPCR and genetic variation based on next-generation sequencing (NGS).

Finally, the correlation of ctDNA HPV and genetic variation clearance with patients prognosis and its value for recurrence monitoring compared to traditional tumor markers and imaging examination will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with initial diagnosis, operable locally advanced cervical cancer, FIGO stage IB2/3-IIA1/2 or initial diagnosis, receive radical chemoradiotherapy locally advanced cervical cancer, FIGO stage IIB-IVA
* Not receiving systemic treatment
* Pathological diagnosis: cervical squamous cell carcinoma
* Aged 18-70 years
* ECOG PS: 0-1
* Patients volunteer to participate in this study and sign the informed consent, with good compliance, and cooperate with the acquisition of tissue samples and blood samples

Exclusion Criteria:

* Patients diagnosed with other malignancies within 5 years
* Patients had received previous systemic antitumor therapy
* In the judgment of the investigator, the patients had other factors that might have caused the study to be discontinued
Online Adaptive Radiation Therapy for Rectal Cancer

In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. Diagnose with rectal cancer;
3. T3-T4 or N+, and no distant metastasis
4. Neoadjuvant chemoradiotherapy intended;
5. Surgery is expected after neoadjuvant therapy;
6. ECOG score 0-2, expected to lie in the treatment bed for at least half an hour;

Exclusion Criteria:

1. With contraindications to rectal MRI;
2. Received surgery, radiotherapy or chemotherapy for rectal cancer;
3. History of pelvic radiotherapy.
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to 36 months ) were selected, randomized to two groups \[Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600\], adults in each group will be vaccinated with two doses of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively,21 days apart.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age from 6 months to 35 months ;
* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
* Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
* Axillary temperature ≤37℃.

Exclusion Criteria:

* Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
* Low platelet or bleeding disorder do not allow vaccination into the muscle;
* Have damaged or lower immunological function;
* Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
* Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

Exclusion Criteria for doses 2

* Have serious anaphylaxis or high fever, convulsion during first dose;
* Have any circus of Exclusion Criteria after Eligible for study;
* Have serious adverse event which related to previous vaccination;
* Withdrawal and Discontinuance Criteria;
* Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
* Vaccinated with any other vaccine（except DTP）;
* Stop observation determined by investigator owing to occurring serious adverse event.
Hearing Aid Impact on Chronic Tinnitus Patients Evaluated by Resting State PET.

Using resting state positron emission tomography (PET), our goal was to analyze the metabolic and functional neural changes that occur after 6 months of effective hearing aid (HA) use. Besides, we correlate those changes with behavioral results. Patients with chronic tinnitus and untreated sensorineural hearing loss were tested pre-HA fitting, and at 6 months post-HA fitting.

Subjects are selected as they are enrolled in the Tinnitus Research Group between January 2014 and September 2018. The study was approved by the local medical ethics committee for research at the Medical School of University of São Paulo - protocol number 611.174 in April, 2014.

All the procedures were performed after medical evaluation and a complete tinnitus evaluation protocol, which included somatosensory assessment, self-related questionnaires for tinnitus and hearing: Tinnitus Handicap Inventory (THI), Hearing Handicap Inventory for Adults (HHIA), and , for anxiety and depression symptoms: Generalized Anxiety Depression Scale (GAD-7) and Patient Health Questionnaire (PHQ-9), and for neck pain (Neck Disability Index, NDI). The subjects of this study were also blood tested for pregnancy and diabetes, which may interfere on fluorodeoxyglucose (FDG)-positron emission tomography PET acquisition.

All subjects underwent hearing and tinnitus evaluation, counseling and hearing aid fitting.

To prescribe and verify acoustic response, we used the HA fitting protocol recommended by the National Acoustics Laboratories (NAL), named NAL NL-2 (NL-non linear) FDG-PET measurements were obtained at baseline (prior to HA fitting) and after 6 months of HA use.

Regarding FDG-PET images, a within-subject analysis was performed by comparing pre-treatment and post-treatment group using paired-t-tests.

Eligibility Criteria:
Inclusion Criteria::

1. chronic perception of tinnitus for more than 6 months;
2. THI score greater than 38;
3. bilateral and symmetric hearing loss not exceeding 70 decibels (dB) hearing threshold;
4. no previous experience with HA. -

Exclusion Criteria:

1. unilateral, mixed or conductive hearing loss;
2. pulsatile or myoclonic tinnitus;;
3. anxiety and depression detected by GAD-7 and PHQ-9;
4. significant visual, motor or cognitive deficits;
5. pregnant women and diabetic patients
6. history of drug abuse -
Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)

To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.


Eligibility Criteria:
Inclusion Criteria:

* Sonographers and cardiologists at CSMC Echocardiography Lab
* All transthoracic echocardiogram studies performed in the CSMC echocardiogram lab

Exclusion Criteria:

* transthoracic echocardiogram studies not able to be measured by sonographers in run in period
Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments

The goal of this retrospective single-center chat review is to establish the efficacy and safety of a single dose of intravitreal faricimab (Vabysmo®) injection in patients with neovascular age-related macular degeneration (AMD), who were previously treated with aflibercept (Eylea®) and had persisting intraretinal or subretinal fluid despite frequent treatments.


Eligibility Criteria:
Inclusion criteria

* Presence of neovascular age-related macular degeneration (AMD) in the study eye
* \>50 years of age
* Previous intravitreal anti-VEGF treatment with aflibercept (Eylea®) or with aflibercept and ranibizumab (Lucentis®) in the study eye
* Minimum of 6 monthly aflibercept injections
* Persisting intraretinal or subretinal fluid or both, despite at least 3 consecutive monthly aflibercept injections in the study eye before switching to faricimab

Exclusion criteria

* Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye
* Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye
* Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch
Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data

This project focuses on researching chronic rhinosinusitis in patients, employing image processing techniques and molecular biology methods to jointly determine the research objectives:

1. Investigating heterogeneity.
2. Developing an intelligent assessment model.
3. Creating a visual tool for diagnosis and prognosis.

1. Investigating the heterogeneity of chronic rhinosinusitis: the project will utilize high-throughput information from various sources such as radiology, pathology, and proteomics to gain insights into the multi-dimensional and big data aspects of chronic rhinosinusitis. By analyzing this data, the study aims to identify and understand the different subtypes with more precise and personalized treatment approaches.
2. Developing an intelligent assessment model: using artificial intelligence algorithms, the project will analyze multi-omics data gathered from the research. The goal is to establish an intelligent assessment model that can accurately interpret the data and provide valuable insights into chronic rhinosinusitis.
3. Creating a visual tool for diagnosis and prognosis: the project seeks to integrate multi-omics information to establish an AI model for typing and prognostic prediction. By achieving these research objectives, this project aspires to enhance the understanding of chronic rhinosinusitis and contribute to the development of more precise, personalized, and effective treatment strategies for patients suffering from this condition.

Eligibility Criteria:
Inclusion Criteria:

1. oral glucocorticoid, and intranasal steroid spray and steroid irrigation treatment were discontinued at least 3 months and 1 month before surgery, respectively;
2. without acute asthma episode or acute upper airway infection within 1 month before surgery;
3. not under allergen immunotherapy or biologic treatment.

Exclusion Criteria:

1. fungal sinusitis;
2. antrochoanal polyps;
3. cystic fibrosis, vasculitis, primary ciliary dyskinesia, or immunodeficiency;
4. odontogenic maxillary sinusitis;
5. patients with history of craniocerebral trauma or sinonasal tumours.
6. insufficient CT quality (e.g., metal artifacts, motion artifacts, and lack of intact CT scan of sinuses);
7. slice thickness more than 2.5 mm.
8. women must not be pregnant, or breast-feeding;
9. patients with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis;
10. patients with emotional or mental problems are excluded;
11. patients unsuitable for inclusion based on judgement of researchers are excluded;
Surveillance Modified by Artificial Intelligence in Endoscopy (SMARTIE)

Evaluation of an artificial intelligence system for polyp detection (CADe)

We aim to evaluate the artificial intelligence system ENDOMIND that supports endoscopist in detection of polyps during surveillance endoscopy for colorectal cancer. 1070 patients out of 6 gastroenterologic practice are randomized 1:1 for conventional surveillance colonoscopy vs. surveillance with AI support. Primary endpoint is Adenoma detection rate.

Eligibility Criteria:
Inclusion Criteria:

* indication CRC surveillance endoscopy
* indication post-polypectomy surveillance endoscopy
* positive fecal immunochemical test in patients \>=50 years

Exclusion Criteria:

* reasonable suspicion of inflammatory bowl disease
* reasonable suspicion of familiar polyposis Syndrome
* Patient after radiation/resection of colonic parts