cyrilzakka/clinical-trials huggingface dataset:
Metals and in Fetal Growth Restriction

Introduction: Intrauterine fetal growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in the uterus. Heavy metals important pollutants produced from anthropogenic activities, has been suggested to be embryotoxic and fetotoxic in a lot of studies. However, the causes of fetal growth restriction are little known and heavy metals merit further investigation. The investigators will be tested whether fetal growth restriction was associated with exposure to these metals/vitamins.

Methods: This study was designed to determine maternal plasma/urine/hair, cord plasma, placenta and breast milk tin (Sn), manganese (Mn), Vanadium (V), Magnesium (Mg), cobalt (Co), nickel (Ni), arsenic (As), chromium (Cr), cadmium (Cd), lead (Pb), mercury (Hg), antimony (Sb), aluminium (Al), zinc (Zn), copper (Cu), selenium (Se), iron (Fe), vitamin D, vitamin A, vitamin B12 and folate concentrations in women with FGR (n=55) compared to those of volunteer healthy pregnant women (n=55). These heavy metals concentrations measured using inductively coupled plasma-mass spectrometry were compared.

This observational case-control study will be conducted at the Department of Obstetrics and Gynecology, Cengiz Gokcek Public Hospital, Gaziantep, Turkey, between May 2020 and February 2021. The protocol was approved by the Ethics Committee for Clinical Research of Gaziantep University (reference no: 2020/131). The study strictly will be adhered to the principles of the Declaration of Helsinki. All subjects will be included in the study gave oral and written informed consent. FGR was defined as an estimated fetal weight (grams) less than the 10th percentile for gestational age. Hadlock I formula were used to calculating estimated fetal weight percentiles. Every woman in the study population will be undergone obstetric ultrasound/doppler examination and fetal-maternal assessment will be carried out. Then, this study will be determined maternal plasma/urine/hair, cord plasma, placenta and breast milk tin (Sn), manganese (Mn), Vanadium (V), Magnesium (Mg), cobalt (Co), nickel (Ni), arsenic (As), chromium (Cr), cadmium (Cd), lead (Pb), mercury (Hg), antimony (Sb), aluminium (Al), zinc (Zn), copper (Cu), selenium (Se), iron (Fe), vitamin D, vitamin A, vitamin B12 and folate concentrations in women with FGR (n=55) compared to those of volunteer healthy pregnant women (n=55).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women complicated with fetal growth restriction
* healthy pregnancy
* singleton pregnancy

Exclusion Criteria:

1. pregnant women with any systemic condition (such as chronic hypertension, renal disease and )
2. Women who have dyed their hair in the last 9 months
3. history of using any medication
4. Presence of gestational hypertension or gestational diabetes
5. drug user
6. patients who had fetal congenital abnormalities or genetic syndromes
7. multiple-gestation pregnancies
8. intrauterine fetal death
Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children

In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.

French multicentric study. 100 children, profound, congenitally deaf, aged between 10 months and 40 months, with indication of unilateral CI will be included. Randomization: 50 sequential at one year CI versus 50 simultaneous bilateral CI, their results compared. Main measures at 12 and 24 months: speech perception in silence and in noise. Other measures: sound localisation, oral language, vestibular impact, quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Deep bilateral congenital deafness.
* Age at the implantation: from 10 to 40 months, included.
* Criteria for indication of unilateral implantation (those considered by the HAS (2007))
* Deep bilateral deafness
* Threshold prosthetic equal or above 60 dB
* Intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the M.A.I.S. (72) below 15 with 2 apparatus)
* No medical nor radiologic contraindication
* Entitled child for welfare (excepted medical state aids)
* French spoken at home
* Agreement firms for the study by the two genitors

Exclusion Criteria:

* Neurologic and/or psychiatric known related disorders
* Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation.
* Progressive or acquired deafness
Telemedicine and Social Media for People Who Inject Drugs (PWID) in Greece

The current study seeks to address questions regarding internet and social media usage as well as telemedicine concept and knowledge, by conducting targeted focus group discussions (FGDs) and administering cross-sectional questionnaires among PWID in Greece. Further parameters, such as perceptions for high-quality healthcare access, confidentiality, privacy, and security, will also be explored.

The study's aim is to access the feasibility, acceptability and accessibility of social media and telemedicine as methods to obtain healthcare, in order to improve linkage-to-care among Greek substance users. Underserved populations, such as people who inject drugs (PWID) have limited access to healthcare and a potential solution to expanding healthcare access points is telemedicine. For the past decade, the investigators have studied the efficacy of a facilitated telemedicine model for hepatitis C virus (HCV) treatment integrated into opioid treatment programs (OTPs) for PWIDs. The investigators have achieved high rates of HCV resolution and high patient-satisfaction through facilitated telemedicine. The investigators now seek to explore whether this same intervention might be feasible and acceptable in Greece. The first step is to capture and explore the current knowledge, experiences, believes, perceptions and attitudes of PWID in Greece regarding internet and social media usage and telemedicine concept, through targeted Focus Group Discussions (FGDs) and administration of cross-sectional questionnaire. The perceptions for high-quality healthcare, confidentiality, privacy and security matters will also be explored as well as further relevant attributes.

Eligibility Criteria:
Inclusion Criteria for the FDGs:

* \>18 years old
* PWID
* Willing and able to provide informed consent and participate
* Fluent in Greek spoken language
* Internet access

Inclusion Criteria for the cross-sectional questionnaire:

* \>18 years old
* PWID
* Willing and able to provide informed consent and participate
* Fluent in Greek spoken language

Exclusion Criteria for FGD and cross-sectional questionnaire:

* \<18 years old
* Unable/unwilling to consent
* Legally incompetent
Phase III Trial of Vinflunine Plus Best Supportive Care vs. Best Supportive Care in Patients With Transitional Cell Carcinoma (TCC) of the Urothelial Tract

The purpose of this clinical research study is to learn if patients who receive vinflunine plus best supportive care live longer than patients who receive best supportive care alone. This study will also investigate patient benefit, safety and whether or not vinflunine shrinks or slows the growth of the cancer.


Eligibility Criteria:
Inclusion Criteria:

* Bladder cancer
* Progressed after 1st line platinum-chemotherapy
* \>= 18 years old
* Adequate hematologic, hepatic \& renal function

Exclusion Criteria:

* CNS disease
* Moderate neuropathy
* More than 1 previous chemotherapy
A Study of Teduglutide in Japanese People With Short Bowel Syndrome

The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.


Eligibility Criteria:
Inclusion Criteria:

* All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.

Exclusion Criteria:

* None
Exploring Beliefs and Behaviors About Weight Loss in Couples

This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behavior related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet).

This study explores among couples in which both members are obese how the use of mental contrasting along with implementation intentions influence intentions and behaviors related to weight loss (eating healthy and exercise), actual weight loss, as well as potential reasons (i.e., mediators) why these changes may occur (e.g., social support, changes in beliefs about weight loss, confidence in being able to eat healthy and diet). In mental contrasting procedures, people first imagine a desired future (e.g., eating healthy) and then reflect on the current negative reality (e.g., I snack too much). This process makes people aware of changes needed in the present to obtain future positive outcomes, and thus aids in increasing goal commitment and goal pursuit. In implementation intention procedures, individuals form "if-then" statements about how they will enact their goals in their everyday lives. Implementation intentions are highly effective at helping individuals achieve health behavior change. Recent studies suggest that the combined use of mental contrasting and implementation intentions produce more behavior change than either technique alone (e.g., diet) In this study, investigators test whether these procedures vary in their effectiveness when couple members are instructed to focus on themselves versus the relationship, the latter intended to instill a communal coping mindset (i.e., that losing weight is an issue that needs to be addressed as a couple enacted through mutually cooperative behaviors).

Eligibility Criteria:
Inclusion Criteria:

* Married couples or couples living as married
* living in the same household for at least six months
* both members of couple are obese (BMI \> 30).
* must be 18 years or older
* can read and write in English
Nudging Provider Adoption of Clinical Decision Support

The central hypothesis of this proposal is that the addition of a theory-informed "nudge" to a clinical decision support (CDS) tool will address identified behavioral barriers to use and significantly improve adoption by providers. Nudges are applications of behavioral science, defined as positive reinforcement and indirect suggestions that have a non-forced effect on decision making. This study will use a behavioral theory-informed process to develop a new CDS tool that includes a nudge that addresses barriers to adoption.

The research team developed and pilot tested two CDS tools for pulmonary embolism (PE) risk stratification in the Emergency Department (ED). One of the tools incorporated two behavioral theory-informed nudges in the user interface. The research team's objective was to pilot test the tools to demonstrate feasibility as well as examine preliminary efficacy of the nudges on provider adoption of the tool. This cluster non-randomized controlled trial took place between September 20th, 2021 and March 3rd, 2022 in two EDs that are a part of a large academic health system in the New York City metropolitan area. All ED providers (physicians, physician assistants and nurse practitioners) seeing patients for the evaluation of PE during this time were included in the trial. The EDs were chosen based on their comparable size and acuity levels.

Eligibility Criteria:
Inclusion Criteria:

* Medical doctors, nurse practitioners and physician assistants working full time at Huntington Hospital and Long Island Jewish Valley Stream

Exclusion Criteria:

* Does not meet the inclusion criteria
Exploring the Role of the GABAergic Modulation in Pain Transmission in Human

Neuropathic pain affects about 7% of the general population in European countries. Meta-analyses indicate that only a minority of neuropathic pain patients has adequate response to drug therapy and management of neuropathic pain is still an unmet medical need. New insights into the contribution of defined subtypes of GABAA receptors (GABAARs) to the different clinical effects of benzodiazepines, including analgesia, have suggested that α1-sparing selective benzodiazepines, such as N-desmethylclobazam (NDMC), may be a new realistic alternative for the treatment of neuropathic pain. Results from our previous study in healthy volunteers assessing the antihyperalgesic and sedative effects of benzodiazepines on a UVB-induced pain model of central sensitization showed that, at the time of maximum effect, clobazam and clonazepam antihyperalgesic effect was greater than placebo by respectively 15.7% (95% CI 0.8 - 30.5) and 28.6% (95% CI 4.5 - 52.6), p\<0.05. Moreover difference in sedation (VAS), as compared to placebo, was only significant for clonazepam 26.3mm (95%CI 15.0-37.7), p\<0.001. Our preclinical data also demonstrate that, in recombinant receptors, NDMC has a better α2- over α1GABAARs activity ratio than clobazam and diazepam. And, unlike diazepam, NDMC caused no or modest sedation at antihyperalgesic doses in two strains of wild-type mice. In addition NDMC α2/α1 in vitro activity profile and long term clinical experience from its marketed parent compound (clobazam) make it an advisable clinical candidate for further proof-of-concept assessments in human. Therefore the Geneva University Hospitals have manufactured a new chemical entity and initiated a drug development program for NDMC starting with this proof-of-concept phase 1b randomized double-blind crossover (4 arms) study that will assess the analgesic and sedative effects of NDMC 20mg and 60mg compared to clonazepam 1.5 mg or placebo on a UVB-induced erythema pain model in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male subject, age between 18 and 50 years old
* Caucasian
* Type 3 skin phototype (white skin that can tan gradually and burns moderately)
* Non smoker or moderate smoker (\< 10 cigarettes/day)
* No clinically abnormal findings on history and/or on physical examination
* Positive minimal erythema dose (MED) determination

Exclusion Criteria:

* Any active significant illness
* Current or past history of drug and alcohol abuse or current intake of more than 3 glasses of alcohol a day or more than 21 glasses of alcohol per week
* Psychotropic drug intake during the last month
* Sun allergy or any skin disease
* Any regular drug intake
* CYP2C19 poor metabolizer (phenotype)
Assessment of Safety and Satisfaction Toward COVID-19 Vaccines.

This is a cross-sectional, web-based online survey done with the use of a Google Form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the COVID-19 vaccine.

* A cross-sectional study was conducted. The subjects participating in the study are residents in Egypt.
* An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).
* The questionnaire comprised two categories of inquiries. The first is demographic data of the subject. The second is questions about COVID-19 vaccine-related data, such as whether had taken the vaccine or not, the type of vaccine administered, side effects encountered from the vaccine , if got enough information regarding the vaccine and where obtain the vaccine information from and if reluctant to taking the vaccine and the reasons for hesitancy. All participants were permitted to terminate the survey at any time of the study.

Eligibility Criteria:
Inclusion Criteria:

* all adults (age ≥ 18 years) complete the questionnaire were considered eligible to participate in the survey.

Exclusion Criteria:

* Incomplete questionnaires were excluded from the final analysis.
Masticatory Function in the Differential Diagnosis of Stage IV Periodontitis

This is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context Stage IV periodontitis from other stages of periodontitis. The index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. The reference standard is a full periodontal and functional assessment performed by a trained and calibrated specialist.

This is a pilot diagnostic accuracy study. Data are derived from a cross-sectional study based on a convenience, quota sample of patients referred for dental care to the reception clinic of the Prince Philip Dental Hospital or at the Institute of Advanced Dentistry, the University of Hong Kong between October 2020 and May 2021. The study will be conducted in accordance with the current revision of the Declaration of Helsinki. Informed consent will be obtained from all participants prior to enrollment in the study. This study will follow the Standards for Reporting Diagnostic Accuracy (STARD) guidelines. To limit bias, separate calibrated examiners performed the index test (chewing gum test) and the periodontal examination used for periodontitis stage and grade diagnosis (reference standard).

To evaluate the diagnostic accuracy of masticatory function assessment for Stage IV periodontitis, logistic regression analyses will be conducted in univariate analyses and the area under the receiver operating characteristic curve (AUROC), diagnostic odds ratios (DORs), sensitivity, specificity, positive predictive values and negative predictive values will be calculated.

Multivariate logistic regression models will be applied to develop a screening algorithm for Stage IV periodontitis diagnosis including the masticatory function assessment and other candidate predictors. A backward stepwise selection method will be used (p = 0.05 for inclusion in model; p = 0.05 for removal from model). The standard nomenclature for interpreting low, moderate and high levels of accuracy will be based on sensitivity and specificity as well as the AUROC values: low level = sensitivity or specificity \<60%, AUROC ≤ 0.70; moderate level = sensitivity or specificity ranging from 60% to 79%, AUROC ranging from 0.71 to 0.90; high level = sensitivity or specificity ≥ 80%, AUROC\>0.90

Eligibility Criteria:
Inclusion Criteria:

* Periodontitis subjects reporting for care at reception clinic of dental hospital

Exclusion Criteria:

* presence of temporomandibular disorders,
* subjects undergoing orthodontic treatment
* less than 12 teeth;
* subjects having received periodontal treatment in the previous 12 months;
* subjects having received antibiotic medication in the previous 3 months
The Association Between Microplastics and Macrogenomics and Metabolomics in Gastric Cancer

The aim of this study was to identify and quantify microplastics in blood, stool, and tumor surgical specimens from gastric cancer patients by analyzing the nature, type, and abundance of microplastics using laser direct infrared (LDIR) spectroscopy, scanning electron microscopy (SEM), and pyrolysis-gas chromatography-mass spectrometry (Py-GC/MS). Meanwhile, combining macro-genomic and metabolomic techniques to explore the association between microplastics and host microbiota and metabolic profiles, and to reveal the potential effects of microplastics on gastric cancer incidence and development will provide new insights into the relationship between microplastic contamination and gastric cancer, as well as an important scientific basis for future public health strategies and cancer prevention and control measures.

This This study is planned to collect blood, cancer and paracancer tissues, and stool samples from 20 patients with gastric cancer, 2 gastric cancer tissues (at least 1cm\^3 each), 2 gastric paracancer tissues (at least 1cm\^3 each), 2 venous bloods (5ml each), and 1 stool (at least 10g each) from each patient. Samples will be collected from December 2024 through November 2025, with an expected total of 140 samples. Sample collection, transportation, and storage are described in IV.2. \& 3. Samples will be analyzed for the type, nature, and abundance of microplastics by Laser Direct Infrared Spectroscopy (LDIR), Scanning Electron Microscopy (SEM), and Pyrolysis-Gas Chromatography-Mass Spectrometry (Py-GC/MS), which is expected to detect microplastics such as polyamides, polyethylene terephthalate (PET), and polyvinyl chloride (PVC). At the same time, blood and tissue samples will be metabolomically assayed using NNR-IVD technology and macro-genomic sequencing will be performed to explore potential associations between microplastics and microbiota and metabolic pathways in gastric cancer patients. By analyzing the distribution characteristics of microplastics in gastric cancer patients and their relationship with microbial communities and metabolic pathways, this study will reveal the impact of microplastics on the tumor microenvironment and further understand their role in gastric cancer development and progression.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old;
* diagnosed with gastric cancer by pathology before surgery and not receiving chemotherapy, radiotherapy or immunotherapy;
* no history of other gastrointestinal diseases;
* complete clinical data and basic information;
* willing to participate in this study and sign an informed consent form.

Exclusion Criteria:

* Patients receiving neoadjuvant radiotherapy or chemotherapy;
* patients with other malignant tumors other than gastric cancer;
* patients with incomplete or unclear pathological data;
* individuals who are not willing to participate in the study.
Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

The aim of the study is to improve the results of related transplantation of the right liver lobe by verifying the general predictors of the development of hemostatic system disorders and optimizing a comprehensive program for thrombohemorrhagic complications preventing.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years and up to 70 years;
* Signed informed consent for inclusion to the study;
* End stage liver cirrhosis.

Exclusion Criteria:

* Pregnancy;
* Extrahepatic factors influencing systemic hemostasis;
* Concomitant hematological diseases affecting the hemostatic system;
* Severe concomitant disorders.