cyrilzakka/clinical-trials huggingface dataset:
Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets

The study is a single-arm, open-label study to explore the salivary concentration of Cetylpyridinium Chloride Buccal Tablets after single-dose administration in Healthy Subjects

Primary Objective: To observe the concentration of the investigational product in the saliva of healthy subjects.

Secondary purpose: To observe the safety of the investigational product in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have fully understand the objective, character, methods and potential adverse reactions of the trial, voluntarily participate in the study, and sign the informed consent form before enrolled into the study.
2. Healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male to female.
3. Subjects who had no parenthood plan from the signing of the informed consent form to one month after completing study, and agreed to take effective and appropriate contraceptive measures voluntarily by themselves and their partners during this period.
4. Subjects those who be able to communicate well with investigators, and be able to understand and comply with the requirements of this study.

Exclusion Criteria:

1. Allergic to any ingredients of this product or excipients (sucrose, Hypromellose, Carbomer 934P, Tartrazine aluminium lake, menthol,Magnesium octadecanoate, Povidone K 30)
2. Pregnant or breastfeeding women
3. Participants with abnormal salivary secretion, such as patients with xerostomia and diabetic dry mouth
4. Usage of oral stimulants, salivary gland stimulants, other treatments or saliva substitute treatment that may affect salivary gland secretion within 7 days before screening
5. Those who cannot tolerate venipuncture or have a history of haemorrhage or needle fainting
6. Those who on special diet, who cannot comply with the standard diet of the study center, who have difficulty swallowing, who are lactose intolerant, or who have galactosemia or glucose/galactose absorption disorders
7. Those who indicated as abnormal with clinical significance in screening laboratory examination, physical examination, vital signs or electrocardiogram inspection based on judgement of clinical study doctor.
8. The subjects may not be able to complete the study following protocol due to other reasons or investigators judge that they are not suitable participants.
Artificial Intelligence-Guided Radiotherapy Planning for Glioblastoma

The ARTPLAN-GLIO study aims to evaluate the feasibility and effectiveness of integrating artificial intelligence in personalized radiotherapy planning for glioblastomas. On the basis of previous work by our group, where a predictive model was developed from radiological characteristics extracted from MR images, this project will evaluate the use of tumor infiltration probability maps in radiotherapy planning.

Currently, radiotherapy treatment uses margins defined by population studies, without considering the individual characteristics of the patients. Although 80% of recurrences occur in peritumoral areas close to the surgical margins, treatment volumes are not customized owing to the lack of techniques that distinguish between edema and infiltrated tumor tissue.

Our recurrence probability maps address this limitation and could improve radiation planning. In this study, the volumes and doses of radiotherapy were adjusted according to the predictions of the model, with a focus on high-risk areas to optimize local control and reduce toxicity in healthy tissues.

Survival results will be compared between patients treated with personalized AI-guided radiotherapy and a historical cohort with standard treatment. In addition, the safety of the approach will be evaluated by adverse event analysis. Finally, an accessible online platform with the potential to transform glioblastoma treatment and improve patient survival will be developed to implement this predictive model.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent diagnosis of IDH wild-type glioblastoma, grade 4 according to the Central Nervous System Tumors classification of the World Health Organization of 2021.
* Ability to undergo MRI studies.
* Performance status with Karnofsky Performance Status (KPS) ≥ 60.
* Life expectancy ≥ 12 weeks.
* Laboratory results within the following ranges, obtained in the 14 days prior to enrollment:

  * Leucocitos ≥ 3,000/µL.
  * Absolute neutrophils ≥ 1,500/µL.
  * Plaquetas ≥ 75,000/µL.
  * Hemoglobin ≥ 9.0 g/dL (transfusion is allowed to reach the minimum level).
  * Glutamic-oxaloacetic transaminase (SGOT) ≤ 2 times the upper limit of normal.
  * Bilirubin ≤ 2 times the upper limit of normal.
  * Creatinina ≤ 1.5 mg/dL.
* Women of childbearing age must present a negative pregnancy test ≤ 14 days prior to enrollment.
* Ability to understand and sign the informed consent.
* Willingness to refrain from other cytotoxic or noncytotoxic therapies against the tumor during the protocol.

Exclusion Criteria:

* Presence of pacemakers, neurostimulators, cochlear implants, metal in ocular structures, or work history that compromise safety in MRI.
* Significant medical illnesses that may compromise tolerance to treatment, at the discretion of the investigator.
* History of invasive cancer in the last 3 years, with few exceptions.
* Active infections or serious intercurrent illnesses.
* Previous treatments with cytotoxic, noncytotoxic, experimental agents, or cranial radiation therapy.
* Maximum radiation target volume (GTV3) greater than 65 cc.
Physical Activity and Sports for People With Visual Impairments

Purpose of this study was to assess the relationship between the visual impairment degree and the level of children's fundamental motor skills, balance and bilateral coordination.

The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants legal guardians, were given the written informed consent form after the detailed written explanation of the risk and benefits resulting from participation in this study. Static balance was assessed using the portable AccuSway-Optimized (ACS-O) by AMTI stabilographic platform (ACS Model). The study participants performed the both feet 30 second, single 10 second left and right-leg stance with eyes open (EO), and both feet 30 second, left and right-leg stance with eyes closed (EC). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted approximately 2 hours after a meal, in a sports outfit, in a specially designated room.

The functional assessment of locomotor skills will utilize the "locomotion" subtest, which is part of the Test of Gross Motor Development, Second Edition (TGMD-3) battery. In the selected "locomotion" subtest, the following movement tasks (locomotor skills) are assessed: Run, Gallop, Hop, Horizontal Jump, Skip, Slide.

The subtest 4 "Bilateral Coordination" of the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) was used in this study. The BOT-2 is an individually administered test that includes goal-directed activities to measure a wide range of motor skills in individuals aged 4 to 21 years. Participants performed seven items:

1. Touching Nose with Index Fingers - Eyes Closed
2. Jumping Jacks
3. Jumping in Place - Same Sides Synchronized
4. Jumping in Place - Opposite Sides
5. Pivoting Thumbs and Index Fingers
6. Tapping Feet and Fingers - Same Sides Synchronized
7. Tapping Feet and Fingers - Opposite Sides

Eligibility Criteria:
Inclusion Criteria:

* written consent form,
* visual impairment (diagnosed)
* intellectual norm.

Exclusion Criteria:

* nervous system disorders,
* structural changes within the musculoskeletal system
* and intellectual limitations.
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.

To ensure the extra drop does not interfere with antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal injection before and after the application of the extra eye drop. Patients will be randomized to undergo additional topical analgesia during intravitreal injection vs. the standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the additional topical analgesia does not interfere with antisepsis.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing intravitreal injection who do not have active eye infections
* greater than 18 years of age

Exclusion Criteria:

* patients younger than 18 years of age
* patients with active eye infections
The Impact of PDD During TURB for NMIBC

The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour.

Patients will be randomised to:

* Transurethral resection of the bladder (TURB) with a standard white light tecnique
* TURB with the PDD tecnique using the study drug Hexvix

Non-muscle invasive pT1 high-grade (HG) bladder cancer (NIMBC) represents a challenge for the urologists due to its aggressive behavior, with a marked tendency to recur after transurethral resection of the bladder (TURB) and even progress to muscle-invasive disease. To limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process, international guidelines strongly recommend a re-TURB to be performed within 2-6 weeks from the first resection in all pT1HG tumors. However, not all the published literature agrees on the value of re-TURB wich is also an invasive and morbid procedure, requires a general or locoregional anesthesia and, like all surgical procedure, it is not free of risks and complications. There is, therefore, an unmet need for improving the quality and completeness of TURB which may have an impact on the necessity of Re-TURB. It has been confirmed that fluorescence-guided biopsy and resection (photodynamic diagnosis-PDD) are more sensitive than conventional procedures for the detection of malignant tumours, particularly for CIS. PDD is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml).To date, no randomized controlled trials (RCTs) have been conducted aiming to compare the completeness of TURB with PDD compared to TURB with standard white light (WL).

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent per Good Clinical Practice and national regulations
* Age ≥ 18 years
* Patient planned for TURB for \>1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.

Exclusion Criteria:

* Patients with history of recurrent NMIBC
* Patients with visible incomplete resection during primary TURB
* Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC
Study of Self or Clinic Administration of DepoProvera

Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for many women. However, difficulty in access may cause many women to discontinue use, often without the use of another effective method of contraception, thereby leaving them vulnerable to unintended pregnancy. This study will randomly assign women who present for contraceptive services to two groups: self or clinic administered SC DMPA. The participants will be followed for one year to compare continuation rates, acceptability, cost effectiveness, evidence of skin changes, and need for continued support between the two groups.

Unintended pregnancy remains a worldwide problem in both developed and developing countries. In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6 million women annually are at high risk of becoming unintentionally pregnant because of a gap in contraceptive use, and disadvantaged women are more likely to have more difficulty than others with continuous method use. Multiple strategies have been explored and implemented to increase the effective usage of contraception, including promoting the use of longer acting reversible contraceptives.

Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting is possible. The acceptability of self administered DMPA has also been reviewed, with favorable outcomes; however, the actual intervention has not been studied.

This study will recruit women presenting for abortion or contraceptive services at the Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special Gynecology Services who desire DMPA for contraception. Women will be randomized to two groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary objective of this study is to compare the continuation rates of SC DMPA between the self and clinic administration groups at 6 months. Secondary outcomes include participant satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method continuation or discontinuation, evidence of persistent skin changes following administration of SC DMPA, and need for continued clinical support.

Eligibility Criteria:
Inclusion Criteria:

1. age greater than or equal to 18 years
2. seeking DMPA for contraception
3. English or Spanish speaking
4. consistent access to a working telephone
5. availability for follow up for one year

Exclusion Criteria:

1. suspected or continuing pregnancy
2. undiagnosed vaginal bleeding
3. known or suspected breast cancer
4. acute liver disease
5. known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
6. desire for pregnancy within one year
Treatment of Popliteal Aneurysms With VIABAHN Stent Graft in Elective Surgery

This multicentric, prospective study will evaluate the medium-term outcomes of patients implanted with GORE VIABAHN® stent grafts for popliteal artery aneurysms in scheduled elective surgery with the registry of the Research in Vascular Surgery University Association (AURC)


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old at time of treatment
* symptomatic or asymptomatic popliteal artery aneurysm needing surgery
* scheduled elective surgery

Exclusion Criteria:

* life expectancy of \<1 year
* thrombotic occlusion of popliteal artery
* intolerance to antiplatelet drugs (antiaggregants)
* known allergies to GORE VIABAHN® stent graft materials/composition
* emergency surgery
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia

This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant adults (≥ 18 years old) with suspected CABP admitted to the hospital for parenteral antibiotic therapy.
* All patients will have a creatinine clearance (CrCl) \>50 ml/min.

Exclusion Criteria:

* pregnant or nursing patients,
* allergy to penicillin/cephalosporin antibiotics,
* allergy to fluoroquinolones,
* renal or hepatic failure, or have received an antimicrobial in past 96h.
* Patients who require antibiotics other than the study drugs will also be excluded.
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay

This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.


Eligibility Criteria:
Inclusion Criteria:

1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
2. DNA extracted from PB specimens no more than 7 days
3. DNA stored at -15°C to -30°C up to 5 years
4. Donor Age: ≥ 18
5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:

   1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
   2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)
6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

Exclusion Criteria:

1. PB specimens that have been frozen prior to extraction
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants

This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring.


Eligibility Criteria:
Inclusion Criteria

* Non-smoker for at least six months
* Healthy, as judged by the Investigator
* Women of non-childbearing potential (WONCBP) who are not pregnant or lactating
* Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug

Exclusion Criteria

* History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis)
* A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities
* Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing
* Participation in an investigational drug or device study within 90 days prior to screening
* Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment
Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series

This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is heavily implicated in the regulation of mood and affect, and has been suggested to be involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by improved regulation of mood and affect. Improvements in important areas of comorbidity might allow for better response to intensive treatment for AN and BN, and reduce relapse rates after such treatment. The DMPFC may be a more appropriate target for compared to the Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in the past. Our initial preliminary pilot work has noted unexpected and significant improvements in some core ED symptoms (bingeing and purging) and in important areas of comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have allowed some treatment resistant patients to either complete intensive treatment or be successful in maintaining their progress post intensive treatment. Subjects will receive up to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via psychometric measures, and pre and post fMRI.


Eligibility Criteria:
Inclusion Criteria:

Patients will be included if they:

* Are voluntary and competent to consent to treatment.
* Have met DSM-5 diagnostic criteria for Anorexia Nervosa or Bulimia Nervosa, over the last 6 months at minimum

Exclusion Criteria:

Patients will be excluded if they have:

1. Past or current neurological illness
2. Comorbid schizophrenia
3. Current suicidal intent or plan
4. Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)
5. Pregnancy.