cyrilzakka/clinical-trials huggingface dataset:
Preventing Alcohol Exposed Pregnancy Among Urban Native Young Women: Mobile CHOICES

Fetal Alcohol Syndrome Disorders (FASD) result in lifelong disability and are a leading cause of preventable birth defects in the US. Urban American Indian and Alaska Native (AIAN) young women are at high risk for alcohol exposed pregnancies (AEPs) which can cause FASD. In this project, the inverstigators will test the effectiveness of a culturally adapted mobile health intervention to prevent AEP, using social media to recruit AIAN young women from urban centers across the nation.

The proposed project builds on a prior NIAAA-funded project which used intensive community-based participatory research (CBPR) methods to adapt CHOICES, an evidence-based brief alcohol-exposed pregnancy (AEP) prevention intervention supported by the CDC, to American Indian Youth CHOICES (AIY-C). AIY-C contains features that make it highly amenable to mHealth approaches, including a framework for integrating diverse cultural teachings, few modules of short duration, and concrete opportunities for goal-setting and achievement. Innovative for this population is the plan to recruit young AIAN women from major urban areas in the US through social media-and to deliver AIY-C via mobile devices, increasingly ubiquitous among AIAN young adults. While social media recruitment and mHealth interventions are not new, only very recently have they been used with AIAN populations. The investigators will partner with urban AIAN organizations to guide us through social media recruitment strategies, mHealth intervention translation and implementation, and evaluation in urban AIAN settings. The investigators propose 3 specific aims: (1) Develop and pilot social-media-based recruitment strategies for urban AIAN young women; (2) translate AIY-C for mHealth delivery through an iterative and theoretically driven process and pilot the developed translated mHealth AIY-C intervention; and (3) recruit 700 (final N=525) urban AIAN young women using identified social media strategies, and conduct an RCT to rigorously evaluate the effectiveness of the mHealth translation of AIY-C for preventing AEP and FASD.

Eligibility Criteria:
Inclusion Criteria:

* Identifies as American Indian or Alaska Native (AIAN)
* Biologically female
* 16-20 years old
* Not pregnant
* Not living in tribal reservation or in an Alaska Native Village
* Live in an urban area that is at least 50,000 in population
* Not breastfeeding
* Has an email account
* Has a smart phone

Exclusion Criteria:

* Age 15 or younger, and 21 or older
* Biologically male
* Not AIAN
* Pregnant or breastfeeding women
* People who live on a tribal land or in communities with less than 50,000 in population
* Reside in the state of Alaska (until study obtains local IRB approval)
ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer

The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams.

The AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.


Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for radical radiotherapy.
2. Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.
3. Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.
4. Mental capacity to understand and consent to participate in the study.
5. Patients aged ≥18years.

Exclusion Criteria:

1. Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.
2. Patients receiving palliative radiotherapy
3. Patients aged \< 18years.
Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans

1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

Participants are screened for eligibility.

Study involves a 4.5 hour morning in the lab:

1. Participants come fasting
2. IV infusion and blood draws
3. Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 90 years
* Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)

Exclusion Criteria:

* Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
* Cerebrovascular disease (transient ischemic attacks or stroke)
* History of hypertension (BP\>140/90 or use of antihypertensive medications)
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
* Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose \>7mmol/L)
* Current smoker
* Previous history of preeclampsia
* Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.
Prevention of Injuries by an Exercise Program - a RCT

Overuse injuries are a major concern for physical active individuals. Study hypothesis is that an exercise programme based on known intrinsic risk factors can prevent overuse injuries in soldiers undergoing basic military training.

PURPOSE: Overuse injuries are a major concern for physical active individuals engaged in endurance type activities. This is especially true for soldiers during basic military training or subjects with a sedentary lifestyle taking up exercise to prevent disease, as they are vulnerable for sustaining an overuse injury. Contradictory to traumatic injuries, little is known about the prevention of overuse injuries using a training program. This study evaluates the preventive effect of a training program based on known intrinsic risk factors for the occurrence of anterior knee pain and shin pain in soldiers undergoing basic military training. We also evaluate the effect on physical performance.

METHODS: From December 2004 - March 2006 1000 soldiers undergoing basic military training divided into 24 platoons are cluster randomised into a prevention-training (PRE) group or a placebo-training (PLA) group. The PRE group will perform exercises based on known intrinsic risk factors namely strength, flexibility and coordination of the lower extremity, while the PLA group will perform exercises for the upper body. Both programmes consists of 5 exercises and will be performed 3 times a week during a 12 weeks period. All subjects will prospectively be examined by the same observer, who will be blinded to the allocation.

OUTCOME: primary outcome: reduction in anterior knee pain and shin pain.

Eligibility Criteria:
Inclusion Criteria:

* Basic military training in the Royal Danish Guards.
* Passed military medical board.

Exclusion Criteria:

* Injury before start of intervention
Intervention to Reduce Bisphenol A Exposure in Women

The purpose of this study is to determine whether a 3-week intervention reduces urinary Bisphenol A (BPA) in women with obesity

The purpose of this study is reduce BPA exposure in women. The intervention is rooted in social cognitive theory, and is applied to environmental health.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>29.9
* Age 18-50 years
* Non-smoking
* English speaking

Exclusion Criteria:

* History of infertility
* Type 2 or Type 1 diabetes
* Cardiovascular disease, or any other metabolic disease/complication
* History of major psychiatric illness, drug abuse, or unsafe dieting practices
* History of bariatric surgery
* Pregnant women or women expecting or trying to become pregnant
* Participating in other studies
Prediction of Endotracheal Tube Depth by Using Deep Convolutional Neural Networks

Malposition of an endotracheal tube (ETT) may lead to a great disaster. Developing a handy way to predict the proper depth of ETT fixation is in need. Deep convolutional neural networks (DCNNs) are proven to perform well on chest radiographs analysis. The investigators hypothesize that DCNNs can also evaluate pre-intubation chest radiographs to predict suitable ETT depth and no related studies are found. The authors evaluated the ability of DCNNs to analyze pre-intubation chest radiographs along with patients' data to predict the proper depth of ETT fixation before intubation.

This was a retrospective, IRB-approved study using chest radiographs images obtained from Picture Archive and Communication System (PACS) at Chang Gung Memorial Hospital, Linkou branch, Taiwan.

A total of 595 de-identified patients' chest radiographs was obtained for this study. The inclusion criteria for this study are patients 18 years or older who were orotracheal intubated within November 2019 to October 2020 and had taken chest radiographs before and immediately after the intubation (\<24 hours). Both pre-intubation and post-intubation chest radiographs of a same patient were obtained. Clinical data including age, sex, body height, body weight, depth of ETT fixation were also recorded. All ETT tip to carina distance was manually measured by a same anesthesiologist from post-intubation films and documented. Lip to carina length of each patient can be calculated by adding ETT fixation depth and ETT tip to carina distance.

Pre-intubation chest radiographs (n=595) along with clinical data including age, sex, body height, body weight, and measured lip to carina length are collected for model building. For this study, 476/595 (80%) of those were used for training and 119/595 (20%) for validation randomly selected by AI model. In training process, images and related clinical data along with the measured lip to carina length are fed into and used to fit out AI model. Then, in validation process, the investigators evaluate the model accuracy and efficacy of predicting the lip to carina length with images and clinical data of those unforeseen cases.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* orotracheal intubated within November 2019 to October 2020
* had taken chest radiographs before and within 24hr after intubation

Exclusion Criteria:

* Bad chest radiographs quality that patients' carina can not be recognized
* Patient with bronchial insertions found in post-intubation films
* Nasal intubation
A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenicity.

This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* ECOG performance status of 0-1
* Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
* At least one measurable lesion according to RECIST v1.1.
* Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

Exclusion Criteria:

* Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
* Sensitizing EGFR mutations or ALK rearrangements
* Increased risk of bleeding determined by investigator based on radiographic / clinical findings
* History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
Draw-10: A Weekly Blood Draw Study to Understand the Biological Variability of Plasma pTau-217

This is an observational study that will serially collect 10 plasma samples over the course of 9 weeks from the same individuals to assess fluctuations in blood biomarker results.

Blood biomarkers offer a less invasive and cheaper method for identifying Alzheimer's disease (AD)-related changes. Already, blood biomarkers for AD are being adopted by clinical practice and their use will only expand in coming years. However, blood biomarkers are susceptible to fluctuations not yet well characterized. Such fluctuations, although rarely observed in current research settings, may influence the biological evaluation of dementia once implemented into routine settings. The study at present aims to identify how blood biomarkers fluctuate over a short period of time in the same individual and assess drivers of these fluctuations.

Eligibility Criteria:
Inclusion Criteria:

* able and wiling to provide informed consent
* Aged 50-80 years old at the time of signing study consent; participants aged 50-59 years will be no more than 20% of the total study population
* Has normal cognition or mild impairment at screening MoCA by a score of greater than or equal to 18; participants with a Montreal Cognitive Assessment (MoCA Test) score between 18-25 will be no more than 20% of the total study population
* able and wiling to fully comply with study procedures defined in the protocol
* Written and spoken fluency in English

Exclusion Criteria:

* Plans to begin any new treatment or is having surgery during the 9-week draw timeframe
* Currently enrolled in a clinical trial using an investigational drug
Dynamic Light Scattering and Keratoscopy for Corneal Examination

This pilot study will examine the usefulness of a new instrument called the Dynamic Light Scattering (DLS) device for documenting and monitoring changes in the cornea, the front part of the eye where contact lenses are placed. The DLS device uses a low-intensity laser similar to that used in supermarket checkouts to measure the cloudiness of the cornea. The results of this study may lead to further investigations using DLS to discover the cause of corneal clouding and to develop treatments to prevent it.

Healthy volunteers and patients with corneal clouding or opacification 18 years of age and older may be eligible for this study.

Participants will have a standard eye examination, including a check of visual acuity and eye pressure. The retina will also be examined and photographs of the cornea may be taken. For the DLS test, the subject sits in front of the device and looks at a yellow-green target while the cloudiness of the cornea is measured. Subjects will be tested four times. The entire procedure takes less than 30 minutes.

Corneal disease and injuries are the leading cause of visits to eye care clinics in the US today. These diseases are also some of the most painful eye disorders. Two important areas for research on the cornea are 1) to explore and understand the molecular basis of corneal transparency and 2) to analyze the molecular nature of corneal inflammation and wound healing. We have developed a new clinical device to understand molecular changes that occur in the lens, called Dynamic Light Scattering (DLS) device. Studies have shown its potential in the detection of the earliest changes occurring in the cataract, and have also shown good test retest reproducibility of the system. We now would like to apply this technique to study changes that occur in corneal opacification. In this pilot project, we would like to study the normal cornea in young and older persons (volunteers) as well as cloudy, opaque corneas. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various corneal disorders caused by trauma, infections, and dystrophies, as well as those caused by systemic or inherited disorders.

Eligibility Criteria:
INCLUSION CRITERIA:

Individuals greater than or equal to 18 years of age.

Controls:

Control subjects must have normal, clear corneas as determined by slit lamp biomicroscopy and central corneal thickness less than 0.55 mm centrally.

Patients:

Patients with corneal clouding and opacification.

EXCLUSION CRITERIA:

To be eligible, participants must not satisfy the criterion below:

Individuals who cannot cooperate or keep still for the DLS measurements.
Post-transition Clinical and Socio-professional Future in Adult Patients With Recurrent Multifocal Chronic Osteitis

Chronic Recurrent Multifocal Osteomyelitis (CRMO) is a rare autoinflammatory bone disease in children. Studies evaluating the quality of life of patients with CRMO are small and heterogeneous. A better understanding of the impact of the disease on the quality of life of adult patients with CRMO beginning in childhood would allow better long-term management of these patients. Our study aims are to assess the clinical and socio-professional outcomes of adult patients who started CRMO at pediatric age.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patient with a CRMO with pediatric-onset disease (\> 18years)
* Patient who was informed and agreed to participate in this study

Exclusion Criteria:

* Patients with Monogenic auto-inflammatory disease associated with osteolytic bone lesions (e.g. interleukin-1 receptor antagonist deficiency)
* Patient with Majeed syndrome
* Patient without sufficient imaging data to confirm the presence of one or more inflammatory lesions
* Patients with incomplete data.
* Patients placed under legal protection, guardianship or curatorship
Thyroid Dysfunction in Patients With Major Psychiatric Disorders

Thyroid dysfunction in major psychiatric disorders in psychiatric patients admitted to psychiatric unit of assiut university hospital

Thyroid hormones play a key role in the development, metabolism and functioning of many organs and have a profound influence on the human brain and behaviour. the coexistence of thyroid insufficiency with mental disorders was recognized . Mental disorders accounted for 6 of the 20 leading causes of disability worldwide for the most productive section of the population.Thyroid diseases can present with various neuropsychiatric manifestations which include mood, anxiety, psychotic, and cognitive disorders.Thus, thyroid function tests are routinely checked in psychiatric patients, While dealing with neurocognitive or neuropsychiatric manifestations,thyroid disorders should be ruled out by appropriate thyroid function tests which include Thyroid-stimulating hormone (TSH), free T3, free T4 and reverse T3.Multiple studies on the prevalence of thyroid dysfunctions on psychiatric patients in different populations were done and reported .the presence of thyroid dysfunction in patients with schizophrenia-spectrum disorder as well as mood disorders .Mental disorders merge highly with thyroid disease.Bio-psycho-social medical model are important for treatment of mental disorders associated with thyroid dysfunction .Till now, there is no literature on the rates of thyroid dysfunction among psychiatric patient in our population in assiut university hospital which can be helpful in the proper management of the cases.

Eligibility Criteria:
Inclusion Criteria:

* patients with major psychiatric disorders admitted to psychiatric unit of neuropsychiatry department of Assiut university hospital in Egypt.

Exclusion Criteria:

* pregnant or lactating females
* Patients on estrogen therapy or contraceptive
* Patients on carbamazepine, oxcarbazepine, phenytoin
Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State

To assess the relative bioavailability of dapagliflozin and metformin from the two FDC formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in healthy subjects in a fasted state.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* Glucosuria at screening
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* Presence of edema on physical exam
* History of diabetes mellitus
* History of heart failure
* History of renal insufficiency
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
* Estimated creatinine clearance (ClCR) of \< 80 mL/min using the Cockcroft Gault formula
* History of allergy or intolerance to metformin or other similar agents