louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01910350: Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
Official title: Kin KeeperSM: Reducing Disparities Through Cancer Literacy and Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Cervical Cancer
Keywords: Breast & cervical cancer prevention & screening
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-07-29
Enrollment: 516
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1) To determine if the Kin KeeperSM Cancer Prevention Intervention increases first time and appropriately timed breast cancer screening rates among Black, Latina and Arab women; 2) To determine if the Kin KeeperSM Cancer Prevention Intervention increase first time and appropriately time cervical cancer screening rates among Black, Latina and Arab women; 3) To measure functional cancer literacy over time at the individual and familial level and 4) Assess rates of healthcare utilization cost among women in the Kin KeeperSM intervention and control-comparison groups.


Eligibility criteria: Inclusion Criteria:

* Participants:self-identified as Black Latina and Arab women ho can recruit at least two bloodline female family members (mother daughter sister, etc.; can accommodate two in-home visits by a community health worker; and 21-70 years of age.

Exclusion Criteria:

* are not self-identified as Black, Latina, or Arab; do not have direct bloodline relatives; and are younger than 21 or older than 70 years of age.

Primary outcomes:
measure: First time AND appropriately timed, clinical breast exam, mammogram, pap test
timeFrame: Baseline through 36 months.
Secondary outcomes:
measure: Increased Breast and Cervical Cancer Literacy rates.
timeFrame: Baseline-36 months.
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References:
citation: Williams KP, Roman L, Meghea CI, Penner L, Hammad A, Gardiner J. Kin KeeperSM: design and baseline characteristics of a community-based randomized controlled trial promoting cancer screening in Black, Latina, and Arab women. Contemp Clin Trials. 2013 Mar;34(2):312-9. doi: 10.1016/j.cct.2012.12.005. Epub 2012 Dec 28.
Clinical trial NCT06524050: Puppet Show and Storytelling Effect Among Children With Cancer
Official title: Puppet Show and Storytelling Effect on Oral Medication Adherence and Negative Emotions Among Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Cancer
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective The objective of this study was to evaluate the effectiveness of puppet show and storytelling effect on oral medication adherence and negative emotions among children with cancer.

Methods A non-equivalent control group pre-test and post-test, between subjects design was conducted in the Maternity \& Children Hospital Bisha, Al-Namas General Hospital, Kingdom of Saudi Arabia and Suez Canal University Hospital at Egypt. A total of 100 children (ages 3-12) admitted for treatments in this hospital were invited to participate in the study. Of the 100 paediatric patients; 50 received puppet show and storytelling interventions and 50 received usual care.

Detailed description: Hospitalization is a stressful and threatening experience, which can be emotionally devastating to children with cancer. Pediatric nurses play interventions such as puppet show and storytelling have been used to promote oral medication adherence for children with cancer also to help them to overcome their negative emotions during hospitalization

.

Eligibility criteria: Inclusion Criteria:

* children with cancer who were diagnosed with the disease
* stay in the hospital for a minimum of three days in a row.
* The children were aged between three and twelve.

Exclusion Criteria:

* Children who were getting palliative care
* weren't enrolled in a comparable program
* those with recognized cognitive
* learning disabilities were not included in our sample

Primary outcomes:
measure: Measurment tool: Questionnaire Evaluate the effectiveness of puppet shows and storytelling effect on oral medication adherence and negative emotions among children with cancer
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abeer
Study officials:
affiliation: Al-Azhar University
name: Abeer Almowafy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03562650: Text Message Treatment for Social Anxiety
Official title: Computerized Treatment for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Active treatment and active treatment control conditions.
Primary purpose: TREATMENT

Brief summary: This is an intervention study designed to evaluate a text message based safety behavior fading treatment for people with social anxiety disorder.

Detailed description: This study hopes to assess whether a month long text message based safety behavior fading protocol is effective in reducing safety behaviors and social anxiety symptoms. Over the course of four consecutive weeks, text messages will be sent to participants the first day of the study and every other day for four weeks (14 texts in total). These text messages will remind participants to either avoid using their three most engaged in safety behaviors (assessed at pre-treatment) or to stay present-focused. The past week frequency of the participants' safety behaviors will be assessed at the beginning of pre-treatment, post-treatment, and four week follow up assessments Participants will be asked to complete an additional online questionnaire for both a post-treatment and a 4-week post-treatment follow up assessment. We hypothesize that: 1) the safety behavior group will show a greater overall reduction in social anxiety symptoms, 2) that the safety behavior group will show a reduction in the frequency of safety behavior use, and 3) that the present-focused group will show an increase in mindfulness.

Eligibility criteria: Inclusion Criteria:

* Social Phobia Inventory score \> 29

Exclusion Criteria:

* receiving therapy
* changes in the past 4 weeks with medication for emotional difficulties
* psychotic symptoms

Primary outcomes:
measure: Social Phobia Inventory (SPIN)
timeFrame: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary outcomes:
measure: Subtle Avoidance Frequency Examination(SAFE)
timeFrame: Change in safety behavior use from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Change in mindfulness from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Department of Psychology
state: Florida
Study officials:
References:
citation: Cougle JR, Mueller NE, McDermott KA, Wilver NL, Carlton CN, Okey SA. Text message safety behavior reduction for social anxiety: A randomized controlled trial. J Consult Clin Psychol. 2020 May;88(5):445-454. doi: 10.1037/ccp0000494. Epub 2020 Feb 27.
Clinical trial NCT01915550: Metformin as Adjuvant to Insulin Therapy in Insulin-resistant Diabetes Mellitus With Pregnancy
Official title: The Role of Adding Metformin in Insulin-Resistant Diabetic Pregnant Women - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Pregnancy
Insulin
Metformin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show insulin resistance may be equivalently effective to further raising the insulin dose


Eligibility criteria: Inclusion Criteria:

* pregnant women with insulin-resistant diabetes mellitus

Exclusion Criteria:

* type-1 diabetes mellitus
* secondary diabetes mellitus

Primary outcomes:
measure: Proper Glycemic Control
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
Clinical trial NCT01053650: Placebo Effect of Paracetamol in Healthy Volunteers
Official title: Placebo Effect of Paracetamol in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Open / hidden
Placebo effect
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Paracetamol is one of the most commonly used drugs in the world, indicated for the symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug used to relieve pain and reduce fever. The objective of this study is to analyze whether a placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of paracetamol is partly due to the simple fact of taking a drug.

Moreover, during the study you propose to do a saliva sample, optional, for biological research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your body..

Detailed description: Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.

Eligibility criteria: Inclusion Criteria:

- Healthy volunteers,

* Aged over 18 years and more than 50 years
* Males,
* Values of vital signs before administration of the test products:
* Systolic between 100-140 mm Hg
* diastolic between 50-90 mm Hg
* cardiac pulse between 45-90 beats per minute
* Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory)

Exclusion Criteria:

* Contraindications to the administration of paracetamol : Hypersensitivity to paracetamol, History of hepatitis B or C, Severe renal impairment
* Hepatic insufficiency
* Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain,
* Pathology evolutionary time of the review of inclusion
* Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse,

Primary outcomes:
measure: The main objective of this protocol is to assess the placebo effect in healthy volunteers by comparing pain thresholds and tolerance between two passages, when taking paracetamol.
Secondary outcomes:
measure: The secondary objectives of this study are 1 - explore, through testing Cantab ®, if the administration of paracetamol alter performance on cognitive tests. 2 - to analyze the determination of paracetamol and its metabolites in urine and blood samples,
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Gisèle Pickering, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05287750: Brain Diseases on 7.0T Magnetic Resonance Imaging
Official title: Brain Diseases on 7.0T Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
MRI
Cerebrovascular Disease
Keywords: Brain tumor
Cerebrovascular disease
MRI
Ultra high field
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting brain diseases. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

Detailed description: 7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of brain diseases on 7T MRI.

Eligibility criteria: Inclusion Criteria:

* Age≥18 and ≤80
* Having brain diseases (eg: brain tumor, cerebrovascular diseases)
* Having no contraindications against MRI or intravenous contrast agent administration
* Clinically stable

Exclusion Criteria:

* Age\<18 or \>80
* Pregnancy and other contraindication to MRI scan
* Informed consent not obtained

Primary outcomes:
measure: the correspondence between brain tumor cells found in the biopsies and region of interest(ROI) signal intension on the 7T MRI scan and 3T MRI scan
timeFrame: within a month after biopsy
measure: The visibility of white matter tracts on 7T MRI
timeFrame: within a month after biopsy
Secondary outcomes:
measure: The correlation between the ROI's signal intension on 7T MRI scan and the KPS in 1 month after operation
timeFrame: within a month after biopsy
measure: The visibility of white matter tracts on 7T MRI and 3T MRI
timeFrame: Six months after the biopsy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT03443050: Training on Unstable Surfaces and Effects on the Balance of Healthy Young People
Official title: Training on Unstable Surfaces and Effects on the Balance of Healthy Young People, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to determine the effects on balance and postural control produced by the implementation of a training program that includes work with unstable surfaces in its methods. It also seeks to quantify to what extent the benefits exceed those achieved with a training of similar characteristics, but implemented on a stable surface. An intensive program is proposed, whose target population is young adults.


Eligibility criteria: Inclusion Criteria:

* Healthy young adults aged between 18 and 30

Exclusion Criteria:

* Professional athlete
* Musculoskeletal injury in the last 12 months (i.e. sprain, bone fracture)
* Known balance disorders including vertigo, central or vestibular limitations

Primary outcomes:
measure: Y-balance test
timeFrame: change from baseline to end of intervention (4weeks)
Secondary outcomes:
measure: Posturography (1)
timeFrame: change from baseline to end of intervention (4weeks)
measure: Posturography (2)
timeFrame: change from baseline to end of intervention (4weeks)
measure: Emery test
timeFrame: change from baseline to end of intervention (4weeks)
measure: Functional reach
timeFrame: change from baseline to end of intervention (4weeks)
Other outcomes:
measure: Jumping sideways test
timeFrame: change from baseline to end of intervention (4weeks)
measure: T-agility test
timeFrame: change from baseline to end of intervention (4weeks)
Locations:
city: Valencia
country: Spain
facility: University of Valencia. Facultat de Fisioterapia
Study officials:
affiliation: University of Valencia
name: Jose M Blasco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02544750: An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Official title: A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberous Sclerosis Complex
Seizures
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: GW Pharmaceuticals Ltd
First posted: 2015-09-09
Enrollment: 199
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.


Eligibility criteria: Key Inclusion Criteria:

* Completion of the GWEP1521 Blinded Phase

Primary outcomes:
measure: Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
timeFrame: OLE Day 1 up to 4 years
measure: Number of Participants With Any TEAE, by Severity
timeFrame: OLE Day 1 up to 4 years
Secondary outcomes:
measure: Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period
timeFrame: OLE Day 1 up to 4 years
measure: Number of Participants Considered Treatment Responders During the OLE Treatment Period
timeFrame: OLE Day 1 up to 4 years
measure: Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period
timeFrame: OLE Day 1 and up to 4 years
measure: Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period
timeFrame: OLE Day 1 up to 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Thiele EA, Bebin EM, Bhathal H, Jansen FE, Kotulska K, Lawson JA, O'Callaghan FJ, Wong M, Sahebkar F, Checketts D, Knappertz V; GWPCARE6 Study Group. Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex: A Placebo-Controlled Randomized Clinical Trial. JAMA Neurol. 2021 Mar 1;78(3):285-292. doi: 10.1001/jamaneurol.2020.4607.
citation: Thiele EA, Bebin EM, Filloux F, Kwan P, Loftus R, Sahebkar F, Sparagana S, Wheless J. Long-term cannabidiol treatment for seizures in patients with tuberous sclerosis complex: An open-label extension trial. Epilepsia. 2022 Feb;63(2):426-439. doi: 10.1111/epi.17150. Epub 2021 Dec 27.
Clinical trial NCT03040050: Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
Official title: Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Therapy
Prostate Biopsy
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 38
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or standard of care (control) prostate biopsy. The subjects will have a rectal culture swab performed prior to the prostate biopsy. One rectal culture swab will be used for rapid multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The subjects randomized to the intervention group will have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. The subjects randomized to the control group will not have the qPCR results shared with the physician to determine if additional standard of care antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days after the prostate biopsy, the research staff will conduct a chart review and/or telephone call to ask about any prostate biopsy infections and complications.


Eligibility criteria: Inclusion Criteria:

* Be able to give informed consent
* Be age 50 or older
* Recommended to undergo a prostate biopsy
* No allergy or side effect to fluoroquinolone antibiotics
* No history of prostate biopsy infection
* No hepatic or renal insufficiency in which fluoroquinolone antibiotics are contraindicated.

Exclusion Criteria:

* Unable to give informed consent
* Age \< 50
* Not recommended to have prostate biopsy
* Allergic to or have side effects to fluoroquinolone antibiotics
* History of prostate biopsy infection
* Hepatic or renal insufficiency in which fluoroquinolones antibiotics are contraindicated.

Primary outcomes:
measure: Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.
timeFrame: Day of prostate biopsy
Secondary outcomes:
measure: Determine if rapid qPCR test results in longer patient wait times.
timeFrame: Day of prostate biopsy
measure: Determine if rPCR results and standard rectal culture results are the same.
timeFrame: 1 week
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Veterans Health Care
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Michael Liss, MD
role: PRINCIPAL_INVESTIGATOR
References: