louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03233984: Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition
Official title: Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Endocrine System
Prevention Program
Keywords: bisphenol-A
prevention
endocrine disruptors
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 267
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth.

Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water.

Through a prevention program, the investigators tried to warned pregnant women on endocrine disruptors exposition risks. The goal here is to assess the effectiveness of this program on their fresh products consumption.


Eligibility criteria: Inclusion Criteria:

* Patients over 18
* Patients living in Poitiers or city around (near the immersive environment)
* Patients on pregnancy and who declared their pregnancy to the authority
* Patients who planned to give birth in Poitiers's hospital, Châtellerault's hospital or Clinique Fief de Grimoire, in Poitiers.
* Patients giving her agreement

Exclusion Criteria:

* Patients planning to move during the study
* Patients under legal protection
* Patients expecting twins
* Patients unable to speak french
* Patients willing to give birth in another hospital than those mentionned before

Primary outcomes:
measure: program effectivness
timeFrame: During the pregnancy (second and third trimester)
Secondary outcomes:
measure: psychosocial aspects
timeFrame: During the pregnancy (second and third trimester)
measure: Urine concentration
timeFrame: During the pregnancy (second and third trimester)
measure: Milk concentration
timeFrame: After the birth of the child (first year)
measure: foetal growth
timeFrame: After the birth of the child (first year)
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
Study officials:
References:
citation: Ouazzani HE, Rouillon S, Venisse N, Sifer-Riviere L, Dupuis A, Cambien G, Ayraud-Thevenot S, Gourgues AS, Pierre-Eugene P, Pierre F, Rabouan S; DisProSE Group; Migeot V, Albouy-Llaty M. Impact of perinatal environmental health education intervention on exposure to endocrine disruptors during pregnancy-PREVED study: study protocol for a randomized controlled trial. Trials. 2021 Dec 4;22(1):876. doi: 10.1186/s13063-021-05813-5.
Clinical trial NCT05506384: Treatment Study for Problematic Gaming and Gambling
Official title: Treatment Study for Problematic Gaming and Gambling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Gambling
Internet Gaming Disorder
Keywords: Gaming
Gambling
Adolescent
Children
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2022-08-18
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is twofold: 1) to evaluate an Relaps Prevention(RP) treatment for Problematic Gaming (PG) and Internet Gaming Disorder (IGD) patients recruited from child and youth psychiatry (CAP) clinics and 2) to test whether the quality of parent-child relationships plays role in the effect of RP treatment and vice versa - whether the RP treatment has a spillover effect on the quality of parent-child relationships.

Detailed description: This study is a two-arm, parallel-group, single-blind, early-stage Randomized Clinical Trial (RCT) with embedded qualitative components. Participants will be randomized in a 1:1 ratio to either intervention or control, with a total of 162 participants (81+81) in the trial. The primary outcomes are measures of gaming and gambling behavior pre- and post-intervention, and the secondary outcomes include child ratings of parent-child communication, including parental knowledge, control and solicitousness about child gaming, as well as child disclosure and secrecy related to gaming.

Preliminary analyses will be conducted with regression analyses, paired sample t-tests and ANOVAs and performed in Mplus. In addition to the RCT, the study will be supplemented with a qualitative component with semi-structured individual interviews to capture participants' and clinicians' experiences of the treatment, as well as attitudes about parent-child relationships and parenting needs in carers whose children completed the RP treatment. The qualitative data will be analyzed with thematic analysis.

Eligibility criteria: Inclusion criteria

* age 12-18
* over cut-off on GASA
* over cut-off on CLiP

Exclusion criteria

* not being able to speak Swedish

Primary outcomes:
measure: Gaming changes
timeFrame: treatment and 3 months
measure: Gambling changes
timeFrame: treatment and 3 months
Secondary outcomes:
measure: Family climate/communication
timeFrame: treatment and 3 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Child and adolescent Clinic Rehion Skane
Study officials:
affiliation: emma.claesdotter-knutsson@skane.se
name: Emma Claesdotter-Knutsson, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01905384: Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Official title: Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Bile Duct Obstruction
Keywords: pancreatic cancer
cholangiocarcinoma
metastatic malignancy
jaundice
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.


Eligibility criteria: Inclusion Criteria:

* distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
* 18 years of age or older
* serum bilirubin \> 2mg/dL

Exclusion Criteria:

* prior endoscopic or percutaneous biliary drainage
* post-surgical anatomy
* primary site of biliary obstruction involving the common hepatic duct or hilum
* tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation

Primary outcomes:
measure: Rate of Long-term Stent Failure
timeFrame: One year
Secondary outcomes:
measure: Rates of Adverse Stent-related or Intervention-related Outcomes
timeFrame: One Year
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Patrick Yachimski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06781684: Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children
Official title: Ulnar Shaft Fracture Fixation by Antegrade Versus Retrograde Intramedullary k Wires in Children;A Comparative Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fracture of Ulna Shaft
Keywords: Fixation of pediatric ulna shaft fracture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is made to see and evaluate the outcomes of treating and fixing ulnar shaft fracture in children by antegrade versus retrograde intramedullary k wires

Detailed description: This study is made on children with ulnar shaft fracture and treating their fracture by intramedullary k wires ,dividing them into two groups ,one of them the child ulnar fracture is reduced and fixed by intramedullary antegrade k wire and the other group the fracture is reduced and fixed by retrograde k wire ,and compare the functional, clinical and radiological outcomes between the two groups

Eligibility criteria: Inclusion Criteria:

* Pediatric patient
* aging from 4 to 15 years old
* diaphyseal ulnar fracture
* either isolated or combined with radius fracture (both bone).

Exclusion Criteria:

* Segmental fractures
* Montaggia variants
* Gelliazzi fracture
* Fractures associated with radial head fracture - Compound fractures
* Fractures with neurovascular affection

Primary outcomes:
measure: The duration of complete union of the bone in every group
timeFrame: The evaluation is done at 2,4,6 and 12 weeks and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
References:
Clinical trial NCT06062784: Bedside Tests of Cardiorespiratory Fitness
Official title: Exploring the Utility of Bedside Tests for Predicting Cardiorespiratory Fitness in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 64
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling adults over the age of 65y who were able to provide written, informed consent and had no contraindications to exercise testing.

Brief summary: A study of 64 older adults over the age of 65y to assess the utility of patient characteristics and bedside measures of physical function and muscle size to predict cardiorespiratory fitness.

Detailed description: A study of 64 older adults over the age of 65y to assess the utility of patient characteristics (age, gender and BMI) and bedside measures of physical function (handgrip strength and step box test) and muscle size (muscle thickness via B-mode ultrasonography (US)) to predict cardiorespiratory fitness (VO2peak and anaerobic threshold) as measured by the gold-standard assessment method, cardiopulmonary exercise testing (CPET).

Each participant will take part in a single assessment day (after health screening against CPET safety criteria) whereby they will have US measures of the vastus lateralis before completing HGS and step box test assessments, and finally a CPET.

Eligibility criteria: Inclusion Criteria:

* Over 65y
* Independent, community-dwelling

Exclusion Criteria:

* Contraindications to CPET safety criteria

Primary outcomes:
measure: Cardiorespiratory fitness (CRF) - VO2 max
timeFrame: Single time-point - 8 to 12 minutes
measure: Cardiorespiratory fitness (CRF) - Anaerobic threshold
timeFrame: Single time-point - 8 to 12 minutes
Secondary outcomes:
measure: Muscle architecture - muscle thickness
timeFrame: Single time-point: 10 minutes
measure: Muscle architecture - pennation angle
timeFrame: Single time-point: 10 minutes
measure: Muscle architecture - fascicle length
timeFrame: Single time-point: 10 minutes
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Centre of Metabolism, Ageing and Physiology (COMAP), University of Nottingham
state: Derbyshire
Study officials:
References:
Clinical trial NCT01632384: The Effects of Smoking Withdrawal On Resting State Functional Connectivity
Official title: The Effects of Smoking Withdrawal on Resting State Functional Connectivity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Smoking
Keywords: Smoker
Non-Smoker
Healthy
Drug free
MRI
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to see how the brain differs between smoking regularly and after not smoking for 24 hours. The investigators will be using an MRI machine to get the information from adult smokers and non-smokers while they lie in the scanner with their eyes closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after smoking. It is our hypothesis that brain activity will be altered after not smoking for 24 hours.

Detailed description: The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in brain functional connectivity during smoking abstinence. The investigators will measure changes in regional blood oxygenation levels using fMRI while adult smokers and non-smokers lie in the scanner with their eyes closed. Smokers will be scanned when they are abstinent from smoking for 24 hrs and shortly after smoking. Our primary hypothesis is that smoking abstinence will alter resting state brain activity (or resting state functional connectivity; RSFC) across widely distributed neural networks and that high-resolution fMRI will help in resolving the exact nature of such changes. Data will be analyzed using methods developed in our laboratory and applied to other resting state datasets. All of the procedures used in the study are well validated and introduce only minor risk to participants (e.g. blood draw; MRI).

Eligibility criteria: Inclusion Criteria:

* Right handed
* Drug free
* No known health problems
* Currently not taking any medication
* Uninterested in quitting smoking long term

Exclusion Criteria:

* Left handed/ambidextrous
* Currently taking medication
* Interested in quitting long term

Primary outcomes:
measure: Blood-oxygen-level-dependent (BOLD) signal
timeFrame: following smoking cigarette 30 minutes prior to scan
Secondary outcomes:
measure: Blood-oxygen-level-dependent (BOLD) signal
timeFrame: 24 hours abstinence
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health Behavior Neuroscience Research Program
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis J McClernon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03701984: The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy
Official title: The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy in Postmenopausal Women: Randomized Double-Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 156
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women.

Detailed description: The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women. Postmenopausal Women undergoing outpatient hysteroscopy in Cairo university will be divided into three groups, the first group will receive Tramadol 5mg 1 hour before the procedure, the second group will receive 20 ml lidocaine in 1000 ml normal saline infusion during the procedure, and the third will receive a placebo. A visual analog scale will assess pain.

Eligibility criteria: Inclusion Criteria:

* Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
* Consent to the procedure

Exclusion Criteria:

* Positive Chlamydia culture.
* patients who have an Allergy to local anesthesia or tramadol.
* A previous adverse reaction to any of the drugs used in the study.
* Patients were receiving any form of analgesia or current use of monoamine oxidase inhibitors.
* Nulliparous patients and patients with cervical pathology, retroverted uterus (detected by transvaginal ultrasound), and previous cervical surgery.
* Patients who have severe vaginal bleeding.

Primary outcomes:
measure: Pain perception during the procedure
timeFrame: 10 minutes after starting the procedure.
Secondary outcomes:
measure: Pain perception after the procedure
timeFrame: 10 minutes after the procedure.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of medicine Cairo university
Study officials:
affiliation: Cairo University
name: AHMED S ASHOUR, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.
Clinical trial NCT01697384: Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer
Official title: Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Adenocarcinoma of the Prostate
Keywords: prostate cancer, PSA
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 138
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study.

Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (\<=50 ng/dL) through 52 weeks of treatment with an implant.

Detailed description: Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.

An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.

Eligibility criteria: Key Inclusion Criteria:

* Male Age 45 or older
* Histologically confirmed adenocarcinoma of the prostate
* Disease Staging III or IV
* Clinical indication for androgen suppression therapy
* Serum testosterone at least 150 ng/dL at screening
* WHO Performance Scale 0 to 3
* Life expectancy of at least one year

Key Exclusion Criteria:

* Bilateral orchiectomy
* Prior androgen-ablative therapy within past year
* Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
* Spinal cord compression

Primary outcomes:
measure: Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
timeFrame: 52 weeks
Secondary outcomes:
measure: PSA measurements
timeFrame: 52 weeks
measure: Pain measurements
timeFrame: 52 weeks
measure: QoL outcomes
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Endo Pharmaceuticals (formerly Valera/Indevus Pharmaceuticals)
name: Regulatory Division
role: STUDY_DIRECTOR
References:
citation: Schlegel PN; Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006 Apr;175(4):1353-8. doi: 10.1016/S0022-5347(05)00649-X.
Clinical trial NCT06138184: Learning Theory Patient Education for Anticoagulants
Official title: Patient Education for Anticoagulants Using Learning Theories - a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: anticoagulant
direct oral anticoagulant
vitamin k antagonist
warfarin
patient education
learning theory
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-11-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to test the feasibility of a randomized control trial evaluating the educational tool for anticoagulated patients.

Participants will be randomized to use new educational materials or current existing educational materials and answer survey questions.

Detailed description: Eligible patients will be randomized using stratified block randomization to control for the type of anticoagulant (warfarin vs. DOAC) and status (naïve vs. experienced) to either the education intervention from Aim 2 or standard of care Data will be collected via online surveys before the intervention, immediately after, and then 3 months after the intervention.

Patients at the University of Utah Thrombosis Clinic will be recruited.

Eligibility criteria: Inclusion Criteria:

* initiating (naïve) or currently taking (experienced) oral anticoagulants with an anticipated treatment duration of at least three months
* Experienced patients will be eligible if they score less than 75% on the Anticoagulation Knowledge Test

Exclusion Criteria:

* Deficits in cognitive abilities, sensory input, or language significant enough to impede their use of the education tool and/or provision of written informed consent

Primary outcomes:
measure: Feasibility of implementing a randomized control trial
timeFrame: 18 months
Secondary outcomes:
measure: Acceptability
timeFrame: 3 months
measure: Acceptability - Educational Tool
timeFrame: At time of intervention
measure: Acceptability - Workflow Disruption
timeFrame: 18 months
measure: Acceptability - Satisfaction
timeFrame: 3 months
measure: Acceptability - Intervention/Survey Fatigue
timeFrame: 3 months
Other outcomes:
measure: Patient knowledge
timeFrame: 3 months
measure: Information overload
timeFrame: 3 months
measure: Adherence
timeFrame: 3 months
measure: Clinical outcomes
timeFrame: 3 months
Locations:
Study officials:
affiliation: University of Utah
name: Aubrey E Jones, PharmD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: