cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Different Methods for the Diagnosis of Primary Caries Lesions

According to the World Health Organization (WHO), dental caries is considered one of the major pediatric health problems worldwide, due to its high prevalence and incidence. Therefore, the early diagnosis of caries lesions is a fundamental procedure for building the treatment plan, aiming at prevention, minimal intervention and the promotion of oral health. The present study aims to evaluate, through a randomized and controlled clinical study, which is the best strategy for diagnosing primary caries lesions located in the interproximal region in individuals aged from 4 to 10 years. Diagnostic methods will be analyzed and compared: visual clinical examination using the International Caries Detection and Assessment System (ICDAS), iTero Element 5D System (intraoral scanner with NIRI technology) and bitewing radiography (BWX). All evaluations will be carried out by 02 examiners. The examiners will be trained and calibrated to use the visual and radiographic criteria, and also to use the iTero 5D intraoral scanner, following the manufacturer's guidance.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes who seek dental treatment at the Dentistry Clinic of Universidade Metropolitana de Santos.
* Be between 04 and 10 years old;
* Good general health;
* Present at least two tooth surfaces that can be included in the study.

Exclusion Criteria:

* Dental surfaces with proximal restorations;
* Surfaces with evident proximal cavities (marginal crest break);
* Absence of adjacent tooth (absence of proximal contact).
Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients

Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* ≥100 lifetime cigarettes.
* English-speaking.
* Report smoking ≥ 1 cigarette in past 30 days.
* Working smartphone.

Exclusion Criteria:

* Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
* Currently pregnant or breastfeeding.
Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

The purpose of this study is to investigate the genetic variants of clock and narcolepsy genes that determine the therapeutic effects of Stalevo® on the quality of sleep in patients with Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with PD in accordance with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria (Hughes AJ, et al. 1992).
2. Patients with PD who have wearing off phenomenon.
3. Patients with PD with Hoehn and Yahr stage 1-4.
4. Patients with PD who have sleep problems (PDSS score ≤120 or Epworth Sleepiness Scale(ESS) score ≥ 8).
5. Patients with PD who showed Montreal Cognitive Assessment (MoCA) score ≥15.
6. Patients with PD who have no major depression (Geriatric depression scale, GDS ≤ 24)

Exclusion Criteria:

1. Secondary parkinsonism
2. Parkinson-plus syndromes (multiple system atrophy, progressive supranuclear palsy, and corticobasal degeneration.
3. Patients with PD who have history of severe side effect of Stalevo®.
Evaluation Between Zirconia and Stainless Steel Crowns

Introduction and Research Problem:

The aim of this project is to evaluate and compare two full coronal restorations on primary posterior molars over a period of 3, 6 and 12 months in terms of restoration failure, marginal integrity, proximal contact, secondary caries, occlusion and gingival response. The restorations types are Stainless Steel Crowns (SSC) and NuSmile Zirconia Crowns (Nu/ZR).

Materials and Methods:

Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who need restorations will be screened for inclusion criteria till 120 teeth are recruited (60 teeth for SSC restorations and 60 for Nu/ZR restorations). Split mouth technique will be used to ensure equalizing variables for both groups, each patient will have side restored with SSC and the opposite side will be restored with Nu/ZR crowns.

Randomization will be done using Statistical Package for the Social Sciences (SPSS) software version 20.0 (Armonk, New York; International Business Machines Corporation (IBM Corp) for each age group separately with a uniform random variable generation. A simple descriptive statistics will be used for analysis and a T-Tests with Wilcoxon Signed-Rank will be used. Level of significance will be set at (α = 0.05) and level of confidence at (95%).


Eligibility Criteria:
Inclusion Criteria:

* Age group of 4-8 years
* Free of any systemic disease
* Cooperative patient
* At least two matched bilateral carious primary molars
* Minimal of two surfaces of caries in the targeted tooth
* Written consent obtained from the parent/guardian

Exclusion Criteria:

* Any subject that does not fall under the inclusion criteria were excluded.
A Trial Using ARV-471 or Anastrozole in Post-Menopausal Women With Breast Cancer Prior to Surgery

This trial is a Phase 2 neoadjuvant study evaluating ARV-471 or anastrozole in post-menopausal women with ER+/HER2- localized breast cancer.

This is a Phase 2, open-label, randomized, non-comparative proof of concept study of ARV-471 or anastrozole in participants with ER+/HER2- breast cancer amenable to definitive surgical resection. The main goal of this study is to evaluate the biological activity of ARV-471 and anastrozole, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal females ≥ 18 years
* Histologically or cytologically confirmed ER+ and HER2- breast cancer (per local assessment). ER and HER2 status must be documented:

  * ER+ disease, with ER staining of ≥ 10% of tumor cell nuclei by IHC per ASCO/CAP Guidelines (Allison 2020).
  * HER2- disease by either IHC or in situ hybridization per ASCO/CAP guidelines
  * Ki-67 score ≥ 5%, analyzed locally
* Clinical T1c-T4c, N0-N2, M0 breast cancer amenable to definitive surgical resection, without bilateral breast ductal carcinoma in situ or invasive breast cancer
* The primary tumor must be at least 1.5 cm by imaging
* ECOG performance status of 0 or 1 Willingness to undergo a screening biopsy, an on-treatment biopsy and surgical resection

Exclusion Criteria:

* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ
* Any of the following in the previous 6 months: Myocardial infarction; Severe unstable angina; Coronary/peripheral artery bypass graft; Symptomatic congestive heart failure (New York Heart Association class III or IV); Cerebrovascular accident; Transient ischemic attack; Symptomatic pulmonary embolism or other clinically significant episode of thromboembolism
* Any of the following in the previous 6 months: Congenital long QT syndrome; Torsade de Pointes; Sustained ventricular tachyarrhythmia and ventricular fibrillation; Left anterior hemiblock (bifascicular block); Ongoing cardiac dysrhythmias of NCI CTCAE ≥ Grade 2; Atrial fibrillation of any grade (≥ Grade 2 in the case of asymptomatic lone atrial fibrillation)
* QTcF \> 470 msec
* Active, uncontrolled bacterial, fungal or viral infection, including HBV, HCV, and HIV or AIDS-related illness
* Active inflammatory gastrointestinal disease, chronic diarrhea, known uncontrolled diverticular disease, or previous gastric resection or lap band surgery
* Cirrhosis meeting criteria for Child Pugh B and C
* Prior treatment for breast cancer including systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents
* Any live vaccines within 14 days of planned start of first dose of study drug.
* Major surgery (as defined by the Investigator) within four weeks of first dose of study drug
An Extension Study of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Able to comply with the study protocol, in the investigator's judgment
* Completion of Study GA30044 up to 48 weeks
* Acceptable safety and tolerability during Study GA30044 as determined by the investigator

Exclusion Criteria:

* Met protocol-defined treatment-stopping criteria during Study GA30044
* An adverse event in Study GA30044 that required permanent discontinuation of study drug
* In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
* Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor
Compensatory Movements With Axon-Hook and Greifer in Transradial Amputees

Upper limb amputees often report musculoskeletal pain due to exaggerated shoulder abduction movements. Previous studies on prosthetic hands showed that wrist orientation contributes to reduce shoulder compensatory movements. The hypothesis of this research is that prosthetic hooks may also provide better functional outcomes when offering wrist adjustments and a design that favors a good visualization of the grips. The objective of this study is to compare shoulder abduction, manual dexterity and satisfaction when using Axon-Hook and Greifer myoelectric hooks during repetitive tasks. Shoulder abduction and manual dexterity results are also compared with the sound side.

Depending on patient's expectations, different prosthetic solutions can be offered. If prosthetic hands, being at the same time functional and aesthetic solutions, are widely used, for some professional or leisure activities, myoelectric users will have a better functional response with a non-morphologic terminal device such as a hook.

Axon-hook and Greifer are two myoelectric hooks proposed by Otto Bock HealthCare. Greifer (Myobock system) has two movable strong hooks and a wrist that can be orientated medially or laterally. Axon-Hook (Axon-Bus system) has thin hooks for a good visualization of the grip, one being fixed for more precision, and a flexible wrist that can be orientated and locked in flexion and extension position.

Previous studies on myoelectric hands showed that functionalities of prosthetic components such as type of hand or type of wrist, have an influence on compensatory movements, which can explain musculoskeletal pains. The hypothesis of the study is that Axon-Hook may reduce shoulder abduction and improve patient satisfaction. No significant difference is expected regarding manual dexterity.

This randomized corossover trial compares shoulder abduction, manual dexterity and satisfaction while using Axon-Hook and Greifer. Shoulder abduction and manual dexterity results are also compared with the sound side.

Eligibility Criteria:
Inclusion Criteria:

* persons with trans-radial upper limb amputation
* persons whose amputation is acquired or congenital
* persons who regularily uses a myoelectric prosthesis and who controls it
* persons whose residual limb is stabilized, with a minimum time of six month since amputation
* persons whose profesional activity or life project justify or could justify the use of a myoelectric hook
* persons who gave their written consent to participate to the study

Exclusion Criteria:

* persons under 18 years of age
* pregnant woman
* persons unable to personnaly give their consent
* persons with psychic or linguistic inability to understand instructions for the test
* persons unavailable to comply with the entire study protocol
"Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON)

Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.

In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of oral squamous cell carcinoma
* Eligibility for surgical treatment
* Acceptance to be included in the study

Exclusion Criteria:

* Oral lesions other than oral squamous cell carcinoma
* Pregnant or breastfeeding patients
* Uncontrolled chronic diseases and/or conditions hindering the participation in the study
* Denial of inclusion in the study
Quality of Life After Transanal Total Mesorectal Excision Compared to Traditional Total Mesorectal Excision

The improvement in prognosis of rectal cancer through modern therapy modalities rises questions regarding quality of life (QoL) and functional outcomes. Evidence for long-term QoL and functional outcomes of transanal total mesorectal excision (taTME) is not provided in current literature. This study will compare short-term and long-term QoL and functional outcomes after taTME compared to traditional abdominal TME (laparoscopic, robotic, and open approach)

Quality of life and functional outcomes of patients undergoing taTME or abTME for stage I-III rectal cancer will be analysed. A retrospective propensity score-adjusted analysis of prospectively conducted data will be performed. The primary endpoint QoL will be assessed by the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30). Secondary endpoints are the functional outcomes according to the EORTC QLQ-C30 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* elective total mesorectal excision followed by reconstruction with anastomosis for primary rectal cancer

Exclusion Criteria:

* diagnoses other than rectal cancer
* recurrent rectal cancer
* partial mesorectal excision
* discontinuity resection (no anastomosis)
* incomplete TNM staging information
* metastatic cancer
* 30-day mortality
* lack of quality of life data
* patient decline
* age under 18 years
Hand Acupoint Stimulation to Treat Disorders of Consciousness

The purpose of this academic lead study is to explore the ideal stimulation strategies at Hand twelve jing-well points in patients with disorders of consciousness.


Eligibility Criteria:
Inclusion Criteria:

* Age: \> 18 years old
* From 7 to 90 days since brain injury
* Diagnosed in UWS or MCS as deﬁned by the two CRS-R assessments performed during the screening period
* Acquired cerebral damage of known etiology
* Intact hand skin
* Informed consent given by the legal surrogate

Exclusion Criteria:

* Unstable vital signs or life-threatening comorbidities
* Active implant (e.g., pacemaker, cochlear implant. . .)
* Epilepsy
* History of previous neurological disorder prior to the brain injury
* Documented pregnancy
* Deep sedation such as one caused by general anaesthetics (e.g., propofol) or a combination of central acting sedatives (e.g., benzodiazepines, opioids)
Salt Warning Label Restaurant Study

This between-subjects randomised controlled trial aims to test the effect of a menu featuring salt warning labels on perceived message effectiveness relative to a menu with no labels in a real-world restaurant environment. The study will also act as a pilot experiment for examining the impact of the salt warning label on food choice and subsequent salt intake in real-world conditions.

Primary objectives:

* To measure the PME of a menu featuring salt warning labels relative to a menu with no labels
* To measure label awareness, perceived knowledge gain, and perceived influence of the label on food choice

Secondary objectives:

* To identify whether there is an effect of the salt warning label on:

  * Food choice (label/no label)
  * Total salt selected
  * Total salt intake
* To examine support for the introduction of a salt warning label policy in the UK


Eligibility Criteria:
Inclusion Criteria:

* Are a UK resident
* Are aged 18 years and above
* Are fluent in English
* Eat an out-of-home meal at least once a month on average
* Have no dietary allergies
* Are not vegan
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 12 to 65 years
* Severe hemophilia A defined as \< 1% FVIII:C
* \>/= 150 days of previous treatment with FVIII in lifetime
* Currently receiving on-demand or any type of prophylaxis treatment regimen with any FVIII product
* No history of or current FVIII inhibitors

Exclusion Criteria:

* Presence of another bleeding disease that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B)
* Low platelet count, abnormal kidney function, or liver disease
* Received treatment with immune suppressing drugs within the last 3 months prior or requires treatment during the study. (Some drugs for hepatitis C, Human immunodeficiency virus (HIV), and steroids are allowed)
* Receiving or has received other experimental drugs within 3 months prior to study entry
* Allergy to Factor VIII or hamsters or mouse protein
Phase I Study of WX-037 Alone and in Combination With WX-554 in Solid Tumours

The purpose of this study is to test the safety of escalating doses of the novel PI3K inhibitor WX-037 and to explore its effectiveness in combination with WX-554 which targets mitogen activated protein kinase (MEK1 and MEK2). Preclinical evidence indicates that these two novel compounds could provide targeted inhibition of both pathways to block tumour growth.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced, metastatic and/or progressive solid tumors for whom there is no effective standard therapy available (for part 2 in addition patients for whom their PI3K pathway is deregulated)
* Evaluable or measurable disease
* Has normal organ function; is no greater than 2 on the ECOG performance scale
* Negative hCG test in women of childbearing potential

Exclusion Criteria:

* History of diabetes requiring daily medication or history of grade 3 or more fasting hyperglycemia
* Patients with major surgery, radiotherapy, or immunotherapy within 4 weeks of starting the study
* Clinical significant, unresolved toxicity from previous anti-cancer therapy
* Patients who previously received a MEK inhibitor (for combination part only)
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs
* Known medical history of retinal vein occlusion, intraocular pressure greater than 21 mm Hg or patient considered at risk of retinal vein thrombosis (combination part only)
* Known HIV positivity or active hepatitis B or C infection
* History of clinically significant cardiac condition
A Study of YM178 in Subjects With Symptoms of Overactive Bladder

This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with symptoms of overactive bladder for at least 12 weeks before the study
* Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
* Subject with an average frequency of micturition of 8 or more times per 24-hour period
* Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
* Subject having provided written informed consent by him/herself

Exclusion Criteria:

* Subject having stress urinary incontinence as a predominant symptom
* Subject with transient symptoms suspected for overactive bladder
* Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
* Subject complicated with bladder tumor/prostatic tumor or with the historical condition
* Subject confirmed to have a post-void residual volume of \>=100ml or with a clinically significant lower urinary tract obstructive disease
* Subject with indwelling catheter or practicing intermittent self-catheterization
* Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
* Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
* Subject with uncontrolled hypertension (indicated by sitting SBP \>=180mmHg or DPB \>= 110mmHg)
* Subject with a pulse rate \>= 110bpm or \<50 bpm