louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03485651: Natera Ovarian Cancer Detection Assay
Official title: Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Adnexal Mass
Keywords: adrexal mass
ovarian cancer
fallopian tube cancer
peritoneal cancer
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-02
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who present with an adnexal mass on imaging and meet the eligibility criteria. Up to 300 total participants may be enrolled in the study, or until samples from at least 100 malignant cases have been collected.

Brief summary: The purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. The study will collect blood, tissue, and health information from these individuals.


Eligibility criteria: Inclusion Criteria:

* Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging
* Must be planning surgical resection or biopsy
* Must be treatment naïve
* Must be 18 years or older
* Able to understand and sign a written informed consent document
* Able to provide 40mL of blood (at least 20mL) for each blood draw

Exclusion Criteria:

* Prior removal of either ovary for any reason
* Currently pregnant
* Blood transfusion within 3 months of study enrollment
* History of bone marrow or organ transplant
* Prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer.
* A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia

Primary outcomes:
measure: Compare ctDNA from benign ovarian masses and confirmed ovarian cancers
timeFrame: Up to 60 months or 5 years
Secondary outcomes:
measure: Determine the relationship between quantity of ctDNA and standard prognostic criteria
timeFrame: Up to 60 months or 5 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06623851: Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers
Official title: Effectiveness of Digital Versus Conventional Impression on Discomfort and Dental Anxiety in Preschool Children (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Anxiety
Keywords: Dental impression
Digital impression
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 66
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression.

Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning.

Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch.


Eligibility criteria: Inclusion Criteria:

* Children with scores of 3 or 4 during preoperative assessments according to the Frankl Behavioral Rating Scale.
* No previous dental experience.
* Patient's parents signed an informed consent before participating in the trial.

Exclusion Criteria:

* Any physical or mental disability, or psychological problems.
* Children with temporomandibular joint or periodontal discomfort

Primary outcomes:
measure: Change in child discomfort
timeFrame: intraoperative
measure: Change in dental anxiety
timeFrame: intraoperative
Secondary outcomes:
measure: Gag reflex
timeFrame: post procedure
measure: Assessment of level of child cooperation
timeFrame: intraoperative
measure: procedure time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03613051: Assessment of Movement Skills in Autism Spectrum Disorder
Official title: Assessment of Movement Skills in Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Movement Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children from age of 3 years to 18 years with autism not having other brain disease

Brief summary: this study is to explore the degree of impairement in movement skills in children with autistic spectrum disorders

Detailed description: Motor impairments in neurodevelopmental disorders specifically autism spectrum disorder (ASD) , are prevalent and pervasive . However ,sensori-motor development and self-care activities such as bathing, dressing, eating and toileting, remain little explored in comparison to the other areas of development. Some children with ASD have difficulty mastering self-care skills, which we will call daily living skills .

Eligibility criteria: Inclusion Criteria:

* all children with autism from the age of 3 years to 18 years

Exclusion Criteria:

* children less than 3 years , children with neurodegenerative disorders or cerebral palsy

Primary outcomes:
measure: assessment of motor skills in autism spectrum disorders through Movement Assessmet Battery for Children test ( M-ABC) , using checklists' method .
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Craig F, Lorenzo A, Lucarelli E, Russo L, Fanizza I, Trabacca A. Motor competency and social communication skills in preschool children with autism spectrum disorder. Autism Res. 2018 Jun;11(6):893-902. doi: 10.1002/aur.1939. Epub 2018 Mar 1.
citation: Purpura G, Fulceri F, Puglisi V, Masoni P, Contaldo A. Motor coordination impairment in children with autism spectrum disorder: a pilot study using Movement Assessment Battery for Children-2 Checklist. Minerva Pediatr. 2020 Feb;72(1):22-29. doi: 10.23736/S0026-4946.16.04633-8. Epub 2016 Oct 12.
Clinical trial NCT01165151: Impact of Group Size in Weight Loss Interventions
Official title: Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Weight Loss
Keywords: obesity
weight loss
group size
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2010-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.


Eligibility criteria: Inclusion Criteria:

* Adults (at least 21 years-old)
* Health insurance coverage with Capital Health Plan (CHP)
* Body mass index BMI between 30-45 kg/m2

Exclusion Criteria:

* BMI is less than 30 kg/m2 or greater than 45 kg/m2
* Weight loss \> 10 pounds in past 6 months
* Acute or chronic illnesses for which weight loss is contraindicated
* Unwilling or unable to give informed consent
* Unwilling to accept random assignment
* Unwilling or unable to travel to CHP clinic for assessments and groups
* Likely to relocate out of the area in the next 12 months

Primary outcomes:
measure: change in weight from baseline to month 12
timeFrame: 12 months
Secondary outcomes:
measure: adherence to treatment protocol
timeFrame: 12 months
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT05122351: Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Official title: Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Analgesia in Patients With Open Inguinal Hernia Surgeries
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

Detailed description: Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

Eligibility criteria: Inclusion Criteria:

* 50 patients with ASA grade I to II, posted for open inguinal hernia surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.

Exclusion Criteria:

* Patient refusal
* Patient with significant neurological , psychiatric or neuromuscular disease.
* Pregnancy or lactating women.
* Suspected Coagulopathy .
* Morbid obesity.
* Known allergy to some medications .
* Septicaemia and local infection at the block site .
* Alcoholism .
* Drug abuse

Primary outcomes:
measure: Analgesia in Patients with Open Inguinal Hernia Surgeries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
citation: Rab M, Ebmer And J, Dellon AL. Anatomic variability of the ilioinguinal and genitofemoral nerve: implications for the treatment of groin pain. Plast Reconstr Surg. 2001 Nov;108(6):1618-23. doi: 10.1097/00006534-200111000-00029.
citation: Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM. Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):381-6. doi: 10.1097/AAP.0000000000000121.
Clinical trial NCT00511251: Analysis of Induced Sputum and Lung Biopsies by SEM: a Tool to Identify Source of Exposure of Workers to Hazardous Dust
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Exposed Population
Keywords: IS-SEM
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-08-03
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.

Detailed description: Abstract

Background: On the last few years there is a rise in the public awareness of the danger potential that lies in the exposure to hazardous dust in different professions. The examination of induced sputum has been used from the early eighties to research and diagnose inflammatory lung diseases. We assess here patients with lung disease and occupational history, in order to undergo work up to assess hazardous dust exposure.

Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.

Methods: 40 patients referred with occupational history were included. For 24 of them SEM analysis was done in induced sputum (IS) together with questionnaires and in 11 among them the SEM analysis was done both from lung tissue (TS) and IS. In addition 11 lung biopsies from patients with occupational history were scanned by SEM and compared to 10 biopsies from patients with no occupational history.

Eligibility criteria: Inclusion Criteria:

* Occupational exposed workers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TASMC
name: Fireman Elizabeth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05637151: Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Official title: Different Effects of Delayed Cord Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrahepatic Cholestasis of Pregnancy
Keywords: Intrahepatic cholestasis during pregnancy
neonatal bilirubin
bilirubin
ICP
neonatal jaundice
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.

Method:This observational prospective cohort study included a total of 200 pregnant women at 37-40 gestational weeks. Among them, 100 pregnant women with intrahepatic cholestasis of pregnancy were divided into 50 cases of immediate cord clamping group （ICC in pregnant women with ICP）and 50 cases of delayed cord clamping group（DCC in pregnant women with ICP）, and 100 normal pregnant women were also divided into 50 cases of immediate cord clamping group （ICC in normal pregnant women）and 50 cases of delayed cord clamping group（DCC in normal pregnant women）. The bilirubin levels of neonates in each group were compared.


Eligibility criteria: Inclusion Criteria:

1. The pregnant woman is born at a gestational age of 37-40 weeks;
2. The pregnant woman has a single child;
3. Regular obstetric examination durinv pregnancy with complete obstetric examination data was diagnosed as intrahepatic cholestasis of pregnancy(ICP).

Exclusion Criteria:

1. Pregnancy complicated with medical and surgical diseases, such as thyroiddysfunction and chronic hypertension;
2. Insufficiency of vital organ function or complicated tumor;
3. Pregnant women with other pregnancy complications besides ICP, such as preeclampsia, etc.

Primary outcomes:
measure: the neonatal bilirubin values
timeFrame: 2-4 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Ying Hua
role: STUDY_DIRECTOR
References:
Clinical trial NCT01644851: Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function
Official title: Cognitive Training for PTSD: Effects on Cognitive, Emotional, and Brain Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorders
Keywords: veterans
neuropsychology
neuroimaging
attention
working memory
inhibition
magnetic resonance imaging, functional
trauma
stress
anxiety
emotion
prefrontal cortex
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas
First posted: 2012-07-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine the effects of computer-based training in executive functioning compared to word games on cognitive and emotional aspects of combat-related PTSD.

Detailed description: Many posttraumatic stress disorder (PTSD) patients either choose not to complete or do not achieve optimal response to current first-line behavioral and pharmacologic treatments. Neurocognitive research points to the potential of novel treatments targeting dorsal prefrontal function and inhibition, attention, and working memory processes. This study investigates effects of computer-based training in executive functions compared to word games on cognitive and emotional aspects of combat-related PTSD. Paper-and-pencil questionnaires, interviews, computer-administered testing, and magnetic resonance imaging will be complete before and after the intervention. Results from this pilot study will provide information concerning feasibility and treatment potential of cognitive training for PTSD.

Eligibility criteria: Inclusion Criteria:

* combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn

Exclusion Criteria:

* enrolled in other active treatment protocols
* current substance abuse or dependence
* current suicidal ideation
* diagnosis of a neurological disorder
* history of moderate to severe traumatic brain injury

Primary outcomes:
measure: Neural activity in prefrontal regions during cognitive and emotional processing measured by functional magnetic resonance imaging.
timeFrame: change from baseline to after 6 weeks of training
Secondary outcomes:
measure: Cognitive functioning as measured by neuropsychological assessment.
timeFrame: change from baseline to after 6 weeks of training
Other outcomes:
measure: Clinical PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).
timeFrame: change from baseline to after 6 weeks of training
Locations:
city: Kansas City
country: United States
facility: Univesity of Missouri - Kansas City
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Robin Aupperle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00512551: DNA Array Analysis of Patients With Cervical Cancer
Official title: A Pilot Study of Early Changes in DNA Array Expression Following Chemo-Radiation Treatment of Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervical Cancer
DNA Array Analysis
Gene Expression
DNA
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-08-07
Enrollment: 18
Sex: FEMALE
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 with cervical cancer already scheduled to begin radiation therapy.

Brief summary: The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation. Researchers will study a large number of genes located in tumor material to learn this information.

Detailed description: Patients in this study are already scheduled to begin radiation therapy. Researchers will get tumor cells by taking two biopsies of the cervix. The first biopsy of the cervical tumor will be done before any treatment is given. The second biopsy will be performed about 48 hours after the radiation treatment has begun. They will then study the cells in the lab with a new technique for studying gene expression called DNA array, as well as human papillomavirus (HPV) analysis, quantification of apoptosis levels, hematoxylin and eosin staining, and storage of tissue for future research.

The patterns of gene expression in the biopsies will be compared with the success of radiation treatments.

Some of the material will also be stored and used in the future for other research projects.

This is an investigational study. A total of 18 patients will take part in this study. All will be enrolled at UTMDACC.

Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed cervical cancer: clinical Stage IB -IIIB
2. Invasive pure squamous cell carcinoma
3. Planned treatment with concurrent cisplatinum/5-fluorouracil chemotherapy and pelvic radiation

Exclusion Criteria:

1. Previous cervical cancer treatment including but not limited to transvaginal cone irradiation

Primary outcomes:
measure: The goal of this clinical research study is to find out if the expression of certain genes is linked with the response of cervical cancer to radiation.
timeFrame: 8 Years
Secondary outcomes:
measure: Researchers will study a large number of genes located in tumor material to learn this information.
timeFrame: 8 Years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anuja Jhingran, MD
role: PRINCIPAL_INVESTIGATOR
References: