louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00484172: Genomic Search for Childhood Obesity Genes-A Pilot Study
Official title: Genomic Search for Childhood Obesity Genes-A Pilot Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2007-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2-8 years old

Brief summary: The purpose of this study is to screen a pediatric population (ages 2-8) for genes associated with childhood obesity.

Detailed description: The incidence of childhood obesity has been growing at an epidemic rate for the past several years, in part due to the lack of understanding of mechanisms at a molecular level. This study will screen a healthy general pediatric population age 2 to 8 for potential genes associated with childhood obesity using whole genomic gene arrays. Patients with BMI values equal to or greater than the 85th percentile will be compared to patients with a BMI below or equal to the 15th percentile. The INSIG2 gene will be specifically studied because of its identification in several populations of obese subjects. The differences in gene expression of the 2 groups will then be used to identify new genes for investigation in childhood obesity.

Eligibility criteria: Inclusion Criteria:

* Ages 2-8, predominately Caucasian to minimize population stratification

Exclusion Criteria:

* Chronic diseases (diabetes, cancer, etc) and known syndromes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Merlin G Butler, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01746472: Study of the Diffusion of a Smoking Cessation Application Through an Online Network
Official title: Online Social Networks for Dissemination of Smoking Cessation Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use and Dissemination of Smoking Cessation Intervention
Cessation of Smoking
Lead sponsor: Truth Initiative
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 11413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Effective evidence-based interventions exist for smoking cessation delivered over the Internet, but consumer acceptance and adherence remains low. Scalable and efficient mechanisms to disseminate these interventions online are needed, and existing online social networks provide a potential mechanism. This is a proposal for a randomized, factorial trial of the dissemination of an evidence-based intervention through the massive Facebook social network, with the goal of determining intervention characteristics that drive viral spread.


Eligibility criteria: Inclusion Criteria:

* Facebook user
* Age 18 years or older
* Entered UbiQUITous Facebook Application
* Confirms smoker status
* U.S. resident

Exclusion Criteria:

* Non-smoker
* Under 18 years old
* Non-U.S. resident
* Non-Facebook advertisement point of entry

Primary outcomes:
measure: Reproductive rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Truth Initiative
state: District of Columbia
Study officials:
affiliation: Truth Initiative
name: Amanda L Graham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cobb NK, Jacobs MA, Saul J, Wileyto EP, Graham AL. Diffusion of an evidence-based smoking cessation intervention through Facebook: a randomised controlled trial study protocol. BMJ Open. 2014 Jan 21;4(1):e004089. doi: 10.1136/bmjopen-2013-004089.
Clinical trial NCT05477472: Low Dose St John's Wort for Depression
Official title: Observational Study of the Efficacy and Tolerability of Low-dose Phytotherapy Using the Example of St John's Wort (Hypericum Perforatum)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Lead sponsor: Ceres Heilmittel AG
Sponsor class: INDUSTRY
Collaborators: name: University of Zurich
First posted: 2022-07-28
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of outpatient physicians which are used to the therapy of major depression with CERES St John's Wort mother tincture

Brief summary: This observational study observes the routine use of low-dose St John's Wort herbal mother tincture in patients with major depression. It measures intensity of depression at the beginning of St Johns Wort and after 6 weeks and evaluates tolerability and compliance.

Detailed description: Herbal medicine is widely used, and high-quality evidence shows their efficacy and tolerability for specific disorders. Most of the studies, however, is conducted with standardized, relatively high dosed dry extract preparations, while other preparations such as tinctures are widely used as well. The aim of this observational study ist to document real-live use of the use of a low-dose herbal medicine preparation (a mother tincture) of St John's Wort (Hypericum perforatum), to compare depression intensity at the beginning and after 6 weeks of therapy using the Hamilton Depression Scale 17, and to evaluate tolerability and compliance. Finally, the results will be compared with results of randomized controlled trials examining high dosed dry extract preparations of St John's Wort for major depression.

Eligibility criteria: Inclusion Criteria:

* diagnosis of mild or moderate depression according to ICD-10 or DSM-IV
* new start of CERES St John's wort mother tincture

Exclusion Criteria:

- at the same time as St John's wort mother tincture started, other antidepressive therapy

Primary outcomes:
measure: Hamilton Depression Scale 17
timeFrame: Change at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kesswil
country: Switzerland
facility: CERES Heilmittel AG
state: Thurgau
Study officials:
affiliation: University of Zurich
name: Natalie Kalbermatten, cand. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04468672: Eating Behaviors in Shift Workers
Official title: The Interaction of Shift Work and Food Environment on Eating Behaviors and Appetite
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Shift Work Type Circadian Rhythm Sleep Disorder
Eating Behavior
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a mixed design with two participant groups (between-subject), day and night workers, each being exposed to 4 levels of food portion size (within-subjects factor)
Primary purpose: TREATMENT

Brief summary: This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.


Eligibility criteria: Inclusion Criteria:

* Work \~ 8-hour shifts during day or night on 3 or more consecutive days of the week
* BMI 19-35 kg/m\^2
* Age 20-55 years of age
* Metabolically healthy
* Weight stable over previous 3 months
* Lives in New York City area

Exclusion Criteria:

* Pregnant or less than 1 year postpartum at time of study
* Smoking
* History of drug or alcohol abuse
* Rotating shift work
* Habitual sleep duration of more than 6 hour per night
* Obstructive sleep apnea
* Transmeridian travel
* Type 2 diabetes
* Cardiovascular disease
* Hypertension
* Participation in diet or weight loss program in the 3 months prior to enrollment
* Psychiatric or sleep disorder
* Food allergies or intolerances
* Dislike of or unwillingness to eat test foods

Primary outcomes:
measure: Food intake
timeFrame: 24-hours intake period
measure: Energy intake
timeFrame: 24-hours intake period
measure: Energy density consumed
timeFrame: 24-hours intake period
Secondary outcomes:
measure: Appetite-regulating hormones
timeFrame: 2-hours measurement period
measure: Hunger and fullness
timeFrame: 24-hours measurement period
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Faris M Zuraikat, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Marie-Pierre St-Onge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05676372: Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC
Official title: The Role of the Peritoneal Microenvironment in the Pathogenesis of Colorectal Peritoneal Carcinomatosis: Single-cell Transcriptomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peritoneal Metastases
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Flemish institute of biotechnology (VIB)
First posted: 2023-01-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CRS+HIPEC

Brief summary: Single cell transcriptomics of CRC PC samples

Detailed description: Research methodology

Before inclusion of patients, patients will be screened for the presence of hepatitis B, hepatitis C and HIV to ensure researcher safety. During cytoreductive surgery, a total of five samples of tumoral tissue will be acquired. Three of those samples will be utilized for ScRNASeq analysis, and two samples of a macrometastasis will be snap frozen and cryopreserved.

Single-cell RNA-Sequencing analysis We will comprehensively catalog the stromal cell types in the microenvironment of colorectal cancer peritoneal metastases utilizing single-cell RNA sequencing (scRNAseq) on three samples (one of which should preferably originate from the omentum majus, to encompass milky spots) acquired from surgical waste material of patients undergoing cytoreductive surgery. After sample prelevation, samples will be transported as soon as possible while cooled and submerged in 10% PBS to the VIB facilities, where single cell suspensions will be made according to standard protocols. After cell selection by FACS (CD45+ and live/dead stain, to ensure a 50/50 mix of immune and stromal cells) and library prep, ScRNASeq will be performed.

Single cell sequencing analysis will allow us to identify cell clusters that by usage of marker genes will be assigned to different known cell lineages. After annotation of data, a "landscape" of the composition of the tumor stroma will be acquired.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing CRS+HIPEC for PC of colorectal origin

Exclusion Criteria:

* Previous HIPEC/PIPAC

Primary outcomes:
measure: Single-cell transcriptomics
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: UZ Ghent
name: Wim Ceelen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06066372: Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis
Official title: Application of Machine Learning Models to Reduce Need for Diagnostic EUS or MRCP in Patients With Intermediate Likelihood of Choledocholithiasis- A Prospective, Open Label, Diagnostic Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Choledocholithiasis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with suspected choledocholithiasis satisfying either ESGE or ASGE risk stratification criteria of intermediate likelihood of choledocholithiasis will be prospectively enrolled from AIG Hospitals, Hyderabad

Brief summary: Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

Detailed description: The current guidelines for suspected choledocholithiasis are aimed to reduce the risk of patient receiving diagnostic ERCP and reduce the risk of post ERCP adverse events. In this process there is apparent increase in number of patients in the intermediate likelihood group requiring EUS or MRCP. This can increase the health care utilization and cost of care for intermediate likelihood patients. The field of artificial intelligence in clinical medicine is evolving rapidly. The use of artificial intelligence based machine learning model is not adequately studied for prediction of choledocholithiasis. Machine learning predictive model can help in stratifying heterogenous intermediate likelihood group to reduce need for EUS or MRCP in selected subgroup of patients.

Eligibility criteria: Inclusion Criteria:

• Individual 18 years or older with a suspected choledocholithiasis satisfying either ASGE or ESGE risk stratification criteria of intermediate likelihood undergoing EUS or MRCP

Exclusion Criteria:

* Patients having co-exiting disease of pancreato biliary system other than gall stones and choledocholithiasis which include chronic pancreatitis, biliary stricture, pancreatobiliary malignancy, portal biliopathy
* Patients having underlying chronic liver diseases
* Pregnancy and breast feeding
* Previous history of cholecystectomy

Primary outcomes:
measure: Development of machine learning algorithm to predict choledocholithiasis
timeFrame: One year
Secondary outcomes:
measure: 1. Compare diagnostic accuracy of EUS or MRCP with machine learning algorithm
timeFrame: One year
measure: 2. To validate machine learning algorithm
timeFrame: One Year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04924972: FACE-Q in Blepharoplasty
Official title: Face-Q Patient-Report Assisted Subjective and Objective Evaluation of Upper Eye Lid Blepharoplasty Outcomes Using Different Suturing Techniques: A Randomized Observer and Patient-Blinded Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatochalasis of Upper Eyelid
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ninety patients will be enrolled in the study. Eligibility will be assessed at the first visit based on inclusion/exclusion criteria.

Brief summary: The aim of this study is to assess the effect of two different suturing techniques in patients undergoing bilateral upper eyelid blepharoplasty on the results of the FACE-Q Eye Module questionnaire for measuring patient-reported outcomes as well as on the blinded objective assessment by two experienced surgeons using the same questionnaire.

We aim to investigate the differences of the 2 most common techniques of skin closure with running cutaneous or subcuticular Nylon (6-0 Prolene) sutures in upper blepharoplasties and their effect on postoperative complications and scar formation. Besides the functional outcomes (visual field) and objective postoperative results, we aim to measure the patients' satisfaction using the FACE-Q Eye Module as a comprehensive, procedure- and disease-specific patient-reported outcome instrument.


Eligibility criteria: Inclusion criteria

* Women and men between 18-99 years
* With bilateral dermatochalasis and resulting visual field restriction
* Willingness and ability to comply with regular visits
* Signed informed consent form

Exclusion criteria

* Any disease affecting wound closure/healing such as diabetes, connective tissue disease or non-medically induced bleeding disorders, known autoimmune disease, known tendency for hypertrophic scars or keloids;
* Untreated hypertension or metabolic syndrome,
* Smoker
* Asymmetric brow ptosis,
* Previous surgery on the eye lids
* Sequelae after facial nerve palsy
* Allergy or adverse reaction to any substance or material used.
* Active or chronic eyelid inflammation

Pregnant or breast-feeding women:

Women of childbearing potential (18-50) are not excluded form this study. Breastfeeding or pregnant women are however excluded, as bilateral upper eye lid blepharoplasty can be easily postponed.

Primary outcomes:
measure: Overall patient satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: FACE-Q eye module: individual questions
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT02250404: Molecular Signatures of Relapse in Tissue Samples From Patients With Small Cell Lung Cancer Who Are Receiving Cisplatin and Etoposide
Official title: Pilot Study of the Identification of the Molecular Signatures of Relapse in Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Small Cell Lung Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects seen at USC Norris Comprehensive Cancer Center and at LAC USC Medical Center with histologically confirmed small cell lung cancer will be recruited for this trial.

Brief summary: This pilot research trial studies molecular signatures of the return of cancer after a period of improvement (relapse) in tissue samples from patients with small cell lung cancer who are receiving or planning to receive cisplatin and etoposide. Studying samples of tissue from patients with small cell lung cancer in the laboratory may help doctors learn more about the changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer relapse.

Detailed description: PRIMARY OBJECTIVES:

I. To collect and analyze small cell lung cancer (SCLC) tumor DNA and ribonucleic acid (RNA) from 3 human patients before and after relapse to identify the molecular signatures of relapse.

OUTLINE:

Previously collected tissue samples are analyzed via RNA sequencing and DNA methylation at baseline. Patients also undergo collection of tissue samples for analysis at relapse.

Eligibility criteria: Inclusion Criteria:

* Any patient seen at Norris or County with histologically confirmed SCLC, with tissue in the Norris Cancer Center Tumor Repository
* Patients must be undergoing or about to start first line treatment with cisplatin and etoposide
* Patients may not have a second malignancy

Primary outcomes:
measure: Change in tumor tissue molecular profiles
timeFrame: Baseline to up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County-USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Barbara Gitlitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03048604: BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
Official title: A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Nyxoah S.A.
Sponsor class: INDUSTRY
First posted: 2017-02-09
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).


Eligibility criteria: Main Inclusion Criteria:

* Body mass index ≤32 kg/m2
* Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments.
* Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour

Main Exclusion Criteria:

* Unable or incapable of providing informed written consent
* Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires
* Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Primary outcomes:
measure: Safety (Incidence of serious device-related adverse events)
timeFrame: 6-months post implantation
measure: Performance
timeFrame: 6-months post implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Hollywood Private UWA Centre for Sleep Science Facility
state: Perth
city: Paris
country: France
facility: La Pitié Salpêtrière - Paris
city: London
country: United Kingdom
facility: Royal National Throat, Nose and Ear Hospital - London
Study officials:
affiliation: La Pitié Salpêtrière, Paris
name: Valérie Attali, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eastwood PR, Barnes M, MacKay SG, Wheatley JR, Hillman DR, Nguyen XL, Lewis R, Campbell MC, Petelle B, Walsh JH, Jones AC, Palme CE, Bizon A, Meslier N, Bertolus C, Maddison KJ, Laccourreye L, Raux G, Denoncin K, Attali V, Gagnadoux F, Launois SH. Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea. Eur Respir J. 2020 Jan 9;55(1):1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.