cyrilzakka/clinical-trials huggingface dataset:
Lung Cancer Screening by Artificial Intelligence Device

Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 1000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population.


Eligibility Criteria:
Inclusion Criteria:

Patients are eligible to be included in the study only if all of the following criteria apply:

1. Age 50-75 years old
2. Non-smoker (defined as less than 100 cigarettes in lifetime)
3. Having a first-degree family history of lung cancer
4. Physically fit for curative treatment if early-staged lung cancer is found
5. Able to provide written informed consent
6. Consent to follow up visits and follow up CT scan if indicated
7. Consent to blood taking for translational research

Exclusion Criteria:

Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study:

1. History of malignancy
2. Smoking history (defined as more than 100 cigarettes in lifetime)
3. Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss
4. Medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder
5. Pregnant ladies or ladies planning for conception
6. History of tuberculosis or interstitial lung disease
7. Pneumonia requiring antibiotic treatment within the last 12 weeks
8. CT thorax or chest performed within 2 years (including LDCT or CT coronary angiogram)
9. Unable or unwilling to provide written informed consent
Role of Pentoxifylline as an Adjuvant Therapy for Adult Patients With Major Depressive Disorder

This study aimed to evaluate the therapeutic benefits of pentoxifylline (PTX) in treatment of adult patients with MDD as it has anti-inflammatory and phosphodiastrase inhibition activities.

In this study, the investigators evaluated the potential antidepressant effect of PTX in adult patients with MDD. the investigators hypothesized that MDD patients taking add-on PTX would present greater amelioration of their depressive symptoms than patients taking add-on placebo. Furthermore, the investigators assessed the relationship between HAM-D score and several peripheral biomarkers as well as their role in diagnosis and therapeutic targets of MDD.

Eligibility Criteria:
Inclusion Criteria:

* Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).
* Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females
Safety-Enhancing Motor Vehicle Child Safety Seat

This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design.

A descriptive study will be conducted to determine whether human subjects are able to install the new feature of the prototype car seat correctly. Participants will be presented with the prototype car seat and a set of basic written instructions and labels to guide their installations. The percentage of participants who use the new feature and use it correctly will be reported. Any installation errors on other parts of the child seat (seat belt, lower anchors, top tether) will also be reported.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Be a care provider to a child who is up to 4 years of age
* Have installed a child safety seat in the last 2 years
* Able to lift and install a child safety seat into a vehicle
* English-speaking (because consent forms and explanation will be given in English)

Exclusion Criteria:

* Not meeting any of the above
Colonoscopy Outcome Database

The aim of this database is to keep routinely collected endoscopic data and outcomes in a single database which will enable the gastroenterology team to perform analyses to improve services and patient outcomes.

Colonoscopy is an invasive procedure that is currently performed for a variety of reasons that centre on the detection and treatment of bowel disorders. It is time-consuming and an expensive process to develop a skilled workforce that has both the skills and the resources to provide a satisfactory colonoscopy service to the general population. Colonoscopy is also an invasive procedure associated with some serious complications like bleeding and perforation. Endoscopy resources are limited by theater space, number of endoscopes and skilled workforce. With the introduction of bowel cancer screening programmes, colonoscopy capacity has been stretched to the limit, such that extremely long waiting lists are an increasingly growing problem.

The rationale for having the database in Portsmouth is because it is a large referral centre and already has an electronic hospital endoscopy reporting system. All useful information is already stored on this platform, but the relevant clinical information is not easy to analyse in the current format. Therefore, we plan to export relevant clinical information to a database to permit retrospective data analysis. There is no need to collect any prospective data as we can achieve the desired outcomes with the current information.The research database will facilitate definitions of clinical pathways to reduce the present burden of colonoscopy on the health care system.

Eligibility Criteria:
Inclusion Criteria:

* All patients' ≥18 years of age who underwent endoscopy at Portsmouth Hospitals NHS Trust, including repeat colonoscopies performed for surveillance purposes aged ≥18 in either males or females

Exclusion Criteria:

* Patients under 18 years age.
Congenital Transmission of Lineages I and II of Trypanosoma Cruzi

T. cruzi has been divided into two main lineages: T. cruzi I (TcI) and T. cruzi II (TcII, including all non-TcI). TcI is predominant in Mexico and Central America, while TcII (non-TcI) is predominant in most of South America, including Argentina. In recent studies from Argentina, the risk of congenital transmission has been estimated to vary between 2.6 percent and 7.9 percent. By contrast, we know very little about the congenital transmission of TcI. It has been suggested that congenital transmission of T. cruzi is strain related, and there is an urgent need to know if TcI transmits differently than TcII (non-TcI). Our primary hypothesis is that congenital transmission rates are different for TcI versus TcII. Our secondary hypothesis is that the characteristics of T. cruzi infected mothers (e.g., age, parity, transmission in previous pregnancies) and their exposure to vectors are different in regions where TcI is predominant versus regions where TcII (non-TcI) is predominant. To test these hypotheses, we propose to conduct a prospective study to enroll at delivery 13,000 women in Mexico, 7,500 women in Honduras, and 10,000 women in Argentina. We will measure transmitted maternal T. cruzi antibodies in cord blood, and, if the results are positive, we will identify infants who are congenitally infected by performing parasitological examinations on cord blood and at 4-8 weeks, and serological follow-up at 10 months. We will also perform standard PCR, real-time quantitative PCR, and T. cruzi genotyping on maternal blood, standard PCR and T. cruzi genotyping on the cord blood of congenitally infected newborns, and serological examinations on siblings. We will estimate the exposure to vectors in the household. In addition, we will measure prenatal outcomes among infected and uninfected infants with seropositive mothers, and the birth weight of their siblings. The specific aims of this study are: 1) To determine the rate of congenital transmission of TcI compared to TcII (non-TcI); 2) To compare the T. cruzi infected mothers' characteristics and exposure to vectors in regions where TcI is predominant and regions where TcII (non-TcI) is predominant; and 3) To describe the birth outcomes of infected and uninfected infants born to TcI and TcII seropositive women.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years old or more, informed consent, live birth.

Exclusion Criteria:

* Women residing outside of the follow-up area.
Efficacy Trial of a Brief Parent-Based Adolescent Sexual Health Intervention

The purpose of this research study is to evaluate a brief parent-based adolescent sexual health intervention called Families Talking Together Plus (FTT+). FTT+ is based on an established intervention called Families Talking Together (FTT) and will enhance FTT by adding modules on human papillomavirus (HPV). The goal of the study is to evaluate whether FTT will help parents increase sexual health communication, delay adolescent sexual debut, and increase HPV vaccination. FTT will be delivered to parents of minority youth and will be delivered by student nurses.


Eligibility Criteria:
Age limit for parents: minimum = N/A (No limit); maximum = N/A (No limit) Age limit for children: minimum = 11 years; maximum = 14 years

Inclusion Criteria:

* Parent: resides with a child 11-14 years old who attends a participating community center, after-school program, or Boys and Girls Club (BGC)
* Parent: available for a face-to-face or small group session with the PI or student nurse within 2 months of consenting and assenting to participate in the study
* Parent: can read, write, and speak English or Spanish
* Child: between 11-14 years of age

Exclusion Criteria:

* Parent: Without primary custody of child
* Parent: Incarcerated
* Parent: Unable to attend a face-to-face session within 2 months
Phase 2 Study of ABX-EGF (Panitumumab) in Japanese Subjects With M-colorectal Cancer

The primary objective of this study is to assess the effect of treatment with ABX-EGF on best overall objective response rate by modified RECIST (confirmed complete or partial response) in Japanese subjects with metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic colorectal adenocarcinoma;
* Subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - Tumor expressing EGFr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells).

Exclusion Criteria:

* Subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment;
* Subjects who have prior EGFr targeting agents;
* Chemotherapy other than fluoropyrimidine (including oral agents such as UFT, TS-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy
Pain Sensitivity and Psychological Profile of Chronic Low Back Pain Patients

This study aims to characterize pain sensitivity and psychological profile of CLBP patients in comparison with pain free adults, and explore their predictive role on hypnosis outcomes, an effective intervention for pain control.

Chronic low back pain (CLBP) is a very prevalent condition, associated with high disability and financial costs. Pain sensitization and psychological status have been associated with symptom severity and treatment outcomes, but their prognostic value is not yet well established.

This is a Prospective Randomized Controlled Trial, with an experimental (hypnosis) and one control group (standard care), and 5 assessment points: baseline, post intervention, 1, 3 and 6 months follow-up. Participants will be 160 CLBP patients and 50 pain free adults, assessed on sociodemographic, clinical, pain, disability, psychophysical (Quantitative Sensory Testing) and psychological variables.

This work will contribute to a better knowledge of the mechanisms underlying CLBP and of the patient characteristics that can predict treatment outcomes after hypnosis. The findings have the potential to improve patient-targeted treatment approaches.

Eligibility Criteria:
Inclusion Criteria:

* persistent or recurrent low back pain lasting over 3 months

Exclusion Criteria:

* pain due to other causes (e.g. fibromyalgia, fracture)
* back surgery in the previous 6 months or planned in the following 6 months
* debilitating organic, psychiatric or neurological conditions (e.g. cancer, schizophrenia, dementia)
* disability compensation or litigation related to CLBP
* unavailability to commit to the hypnosis sessions.
CLEAR Care Companion Application

Hospital readmissions are common after major cancer surgery, leading to poorer patient outcomes, increased mortality and additional costs. In this study, Clinical and Engineering Approaches to Readmission (CLEAR) Care Companion Application, investigators aim to utilize a smartphone application that tracks concerning postoperative symptoms and provides educational interventions to determine if this can minimize delays in communication between patients and medical providers, increase patient satisfaction with the care received, and reduce or lessen the severity of readmissions.

Patients complete clinically meaningful questions and validated questionnaires pertaining to physiological and psychological symptoms that serve as early indicators of readmission, with the aim to improve experience by empowering patient to be active participants in their recovery, identify complications early to minimize morbidity and reduce overall readmissions.

The study has the following three objectives: (1) Assess patient engagement with the CLEAR Care Companion application for patients that have undergone radical cystectomy (2) Measure patient experience with the application and its effect on satisfaction with overall care (3) Evaluate the effect of the application on case complexity (readmission intensity) and overall readmission rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a radical cystectomy with reconstruction through GU Oncology Clinic
* Patient at the University of Michigan (Michigan Medicine)
* Access to compatible smartphone or tablet device

Exclusion Criteria:

* Non-English speaking patients
* Patients without access to a smart phone or tablet with internet capacity
Management of Uncontrolled Hypertension (HTN)

In this study, investigators will compare chronotherapy to ABPM. Data collected will include hypertension drug therapy regimen prior to and during the study, timing of medication administration, and dose, along with the patient's office blood pressure values prior to study and one month after modification in therapy. This will enable us to explore whether it is a practical endeavor to implement ABPM as a routine process for all uncontrolled hypertension patients or whether ABPM does not seem to provide considerable value over shifting the timing of drug administration.

Investigators propose to conduct a pilot study to determine whether the incorporation of Ambulatory Blood Pressure Monitoring (ABPM) as routine procedure in clinic for uncontrolled hypertension influences how anti-hypertensive drug therapy is modified or if simply shifting the dosing of anti-hypertensive medications to night time achieves similar results. Investigators will enroll 20 participants with uncontrolled hypertension, who are prescribed 3 anti-hypertensive medications at maximum dose. All twenty patients will undergo 24-hour blood pressure monitoring with ABPM at baseline and one month after change in therapy has been initiated; ten of the patients will be randomized to receive a shift in dosing schedule of anti-hypertensive medication to night-time without utilizing their ABPM results while the remaining ten will receive modifications in therapy based on their ABPM results and dipping status. The results of this study will assist in assessing the feasibility and benefits of the incorporation of ABPM into the routine management of hypertension.

Eligibility Criteria:
Inclusion criteria

1. Age ≥ 18 years
2. Blood pressure of \>130/80 mmHg
3. Currently receiving 3 anti-hypertensive agents, one of which is a diuretic, for at least six weeks

Exclusion criteria

1. Vulnerable populations

1. Pregnant women
2. Prisoners
3. Cognitively impaired persons
4. Economically and/or educationally disadvantaged
5. Human fetuses and neonates
6. Patients who work night-shift
7. Children
8. Conditions with visual field deterioration (Anterior Ischemic Optic Neuropathy, Glaucoma, Optic Nerve Disorders)
Effect of Light Level on Stress, Anxiety, Psychological Well-being in Pregnant Women

To determine the effect of light level on stress, anxiety and psychological well-being in pregnant women. This research was planned as a single-blind, randomized controlled experimental type study by comparing separate groups as experiment-placebo control. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), and State-Trait Anxiety Inventory (STAI). The effect of two different amounts of light on pregnant women will be evaluated.

To determine the effect of light level on stress, anxiety and psychological well-being in pregnant women. This research was planned as a single-blind, randomized controlled experimental type study by comparing separate groups as experiment-placebo control. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), and State-Trait Anxiety Inventory (STAI). The effect of two different amounts of light on pregnant women will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* being in the last trimester of pregnancy,
* volunteering.

Exclusion Criteria:

* Having any problems that prevent you from communicating
Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food

The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests:

   1.1 No finding deviating from normal and of clinical relevance

   1.2 No evidence of a clinically relevant concomitant disease
2. Age ≥18 and Age ≤50 years, BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
3. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation of more than 100 mL within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range and of clinical relevance
* History of any familial bleeding disorder