louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06226636: Immediate Pressor Response to Oral Salt
Official title: Diagnostic Accuracy of Using an Immediate Pressor Response to Oral Salt (IPROS) to Identify Salt Sensitivity of Blood Pressure (SSBP): a Time Series Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Blood Pressure
Lead sponsor: Mulungushi University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to establish a diagnostic accuracy of an immediate pressor response to oral salt (IPROS) to identify salt sensitivity of blood pressure (SSBP)

Detailed description: Participants are given dietary salt and their BP is measured every 10 minutes for 2 hours. IPROS is diagnosed with significant mean arterial pressure increase

For SSBP, participants are put on high salt diet for a week and monitored and low salt week. The Mean arterial pressure difference between high salt and low salt is used to diagnose SSBP

Eligibility criteria: Inclusion Criteria:

* Participants will be included if they are males or females, aged 18-65 years.

Exclusion Criteria:

* Kidney disease, Cardiovascular disease

Primary outcomes:
measure: SSBP
timeFrame: 2 weeks
Secondary outcomes:
measure: IPROS
timeFrame: 2 hours
Other outcomes:
Locations:
city: Livingstone
country: Zambia
facility: Livingstone University Teaching Hospital
state: Southern
city: Lusaka
country: Zambia
facility: Kanyama General Hospital
Study officials:
References:
Clinical trial NCT01373736: 123I-MIBG Scintigraphy in Patients Being Evaluated for Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pheochromocytoma
Neuroblastoma
Paraganglioma
Medullary Thyroid Carcinoma
Carcinoid Tumors
Lead sponsor: Vancouver Coastal Health
Sponsor class: OTHER_GOV
First posted: 2011-06-15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: The study is designed to study the safety and effectiveness of 123I-MIBG as a diagnostic imaging agent in evaluating patients with known or suspected neuroendocrine tumors.


Eligibility criteria: Inclusion Criteria:

* Subjects must have a clinical indication for 123I-MIBG imaging to evaluate for the presence, extent, or status of neuroendocrine tumors;
* subjects must be able and willing to comply with study procedures.

Exclusion Criteria:

* Subjects with history of renal insufficiency (serum creatinine level \> 3.0 mg/dL \[265 µmol/L\]) and inability to be withdrawn from medications known to interfere with 123I-MIBG uptake;
* Subjects unable to tolerate lying supine;
* Subjects pregnant or breastfeeding, unless the information to be gained outweighs the possible hazardous effects of 123I-MIBG administration. Where the assessment of the risk/benefit ration suggests the use of 123I-MIBG in nursing mothers, the breastfeeding should be discontinued for at least 48 hours post-injection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health
name: Daniel Worsley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04466436: Anaesthesia and Tryptophan Pathway
Official title: Effect of Anaesthesia on Tryptophan Pathway
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tryptophan Pathway
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults undergoing elective surgery

Brief summary: Surgery has many immunomodulatory properties of which the mechanism is not clearly understood.

Detailed description: surgery and anesthesia have a deleterious effect on immune system,studyingtryptophan pathway might give more information on their effect.

Eligibility criteria: Inclusion Criteria:

* elective surgery

Exclusion Criteria:

* emergency surgery

Primary outcomes:
measure: tryptophan metabolites in serum
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00821041: Internet-based Treatment for Chronic Insomnia
Official title: Evaluation of an Internet-based Treatment for Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Insomnia Disorder
Keywords: insomnia
online systems
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.

Design This is a randomized controlled trial with online treatment and waiting list control conditions.

Participants

Participants are adults in Manitoba Canada with chronic insomnia.

Setting

Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.


Eligibility criteria: Inclusion Criteria:

* Access to high speed internet, insomnia duration \> 6 months and occurring at least 4 nights per week, sleep-onset latency \> 30 minutes and/or time awake at night \> 30 minutes, and/or early morning awakening \> 30 minutes before desired time, at least one type of daytime impairment.

Exclusion Criteria:

* Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake \> 14 drinks/week for males, \> 12 drinks per week for females, current or past behavioral treatment for insomnia

Primary outcomes:
measure: Sleep Quality
timeFrame: 6 weeks
Secondary outcomes:
measure: Pre-Sleep Arousal
timeFrame: 6 weeks
measure: Beliefs and Attitudes About Sleep
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Norah Vincent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vincent N, Walsh K, Lewycky S. Determinants of success for computerized cognitive behavior therapy: examination of an insomnia program. Behav Sleep Med. 2013;11(5):328-42. doi: 10.1080/15402002.2012.700662. Epub 2013 Jan 3.
Clinical trial NCT06693713: Sanctuary Youth Series Randomized Control Trial
Official title: The Youth Series Sanctuary Mental Health Ministries Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health
Mental Health Help-Seeking
Mental Health Literacy
Keywords: Mental Health
Youth
Lead sponsor: Sanctuary Mental Health Ministries
Sponsor class: OTHER
Collaborators: name: Excellence in Giving Insights
First posted: 2024-11-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Sanctuary Mental Health Ministries designed an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide. The facilitator would lead groups of 11-15 year olds by leading games, showing the films, and facilitating discussion. The series is freely available on Sanctuary's website; individuals can access the material by creating an account, logging in, and downloading the course content. This RCT is to evaluate the effectiveness of the Youth Series course on improving youth's mental health literacy, knowledge, and attitudes towards help-seeking.

Detailed description: Churches will be recruited to the study based on social media sites and through Sanctuary's newsletter distribution lists. Churches who agree to participate in the study will be randomized to one of two groups, the Pilot Group that receives the 8-week series, and the Comparison Group, that does not receive the series. Both groups will be asked to complete a baseline survey and then a follow-up (end line) survey 8-weeks later. The results will be scored and compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Youth between the ages of 11-18 attending a youth group that has been recruited to the study.

Exclusion Criteria:

* Youth outside of the age range that are not attending a youth group recruited to the study.

Primary outcomes:
measure: Mental Health Knowledge
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Excellence in Giving Insights
state: Colorado
Study officials:
affiliation: Excellence in Giving Insights
name: Kate Williams, Masters
role: PRINCIPAL_INVESTIGATOR
affiliation: Excellence in Giving Insights
name: Ashley Williams, Masters
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Lincoln Lau, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04675736: Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.
Official title: Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface: An in Vitro Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective

1. To determine the optimum brushing force for dental plaque removal.
2. To investigate the effect of brushing force on enamel characteristic.

Hypothesis H0 : Structural tooth loss is not significantly different between before and after brushing with excessive force on enamel surface.

H1 : Structural tooth loss is significantly different between before and after brushing with excessive force on enamel surface.

Study design: Experimental study


Eligibility criteria: Inclusion Criteria:

* extracted bovine incisors

Exclusion Criteria:

* no

Primary outcomes:
measure: optimum force
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Dentistry
state: Bangkok
Study officials:
affiliation: Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University, Bangkok Thailand
name: Kanyawat rattanasuwan
role: STUDY_DIRECTOR
References:
Clinical trial NCT04713436: The Effects of Antibiotic Combinations on Stem Cells
Official title: The Effects of Antibiotic Combinations on Mesenchymal Stem Cells Derived From Apical Papilla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cells
Anti-Bacterial Agents
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: TC Erciyes University
First posted: 2021-01-19
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tissue samples were obtained from the apex of the extracted third molar teeth of young adult patients aged between 16-22 .

Brief summary: The purpose of this study was to evaluate the indirect effects of antibiotic combinations. SCAP viability, proliferation and apoptosis of the cells were evaluated. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.

Detailed description: The purpose of this study was to evaluate the indirect effects of triple (TAP- ciprofloxacin, metronidazole and minocycline), double (DAP- ciprofloxacin and metronidazole) and modified triple antibiotic pastes (mTAP- ciprofloxacin, metronidazole and cefaclor) on mesenchmal stem cells derived from apical papilla (SCAP). SCAP were isolated from the impacted third molar teeth of the young adults. TAP, DAP and mTAP treatment (14-day medication and 28-day medication) were applied on SCAP and viability, proliferation and apoptosis of the cells were evaluated after four weeks. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with open apex third molar teeth for extraction indication

Exclusion Criteria:

* Patients with mature apex third molar teeth for extraction indication

Primary outcomes:
measure: Measurment of Cell Viability and Apoptosis
timeFrame: 1 year
measure: Measurment of cell differantiation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
Study officials:
affiliation: Eskişehir Osmangazi University
name: Seçil Çalışkan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01312636: Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency
Official title: A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Congenital FVII Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects with a FVII deficiency to whom activated recombinant human factor VII (NovoSeven®) is administered

Brief summary: This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.


Eligibility criteria: Inclusion Criteria:

* Congenital FVII deficiency
* Never been treated with NovoSeven® before
* Patients already in treatment with NovoSeven®

Exclusion Criteria:

* History of hypersensitivity to any of the components in NovoSeven®

Primary outcomes:
measure: Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions
timeFrame: once a year in years 1-4
Secondary outcomes:
measure: To assess the treatment evaluation for bleeding episodes
timeFrame: year 1, year 4
measure: To assess the course and outcome of pregnancy in women treated with novoseven
timeFrame: until 1 month after giving birth
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01306136: Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
Official title: Pilot Study of Exposure Therapy for the Treatment of Puerto Ricans With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic stress disorder
Prolonged exposure
Cognitive behavior therapy
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to examine the feasibility of a culturally adapted, manual based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto Ricans with posttraumatic stress disorder

Detailed description: This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of treatments for PTSD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with PTSD and the long-term negative consequences of this condition. Participants in this study are recruited by referral from mental health providers in a general health setting. Patients meeting criteria for enrollment will be randomly assigned to receive either Prolonged Exposure therapy or treatment as usual. Assessments for all participants will be collected at baseline, week 8, and week 16 after randomization.

Eligibility criteria: Inclusion Criteria:

* diagnosis of PTSD
* CAPS score of at least 45
* 18 to 65 years old
* Spanish speaker
* competent to provide informed consent

Exclusion Criteria:

* history of bipolar disease, schizophrenia or psychotic disorder
* alcohol or drug abuse in the past three months
* moderate to severe traumatic brain injury
* applying for or receiving disability benefits
* clinically judged to have a high acute suicide risk
* life-threatening medical condition
* currently receiving psychotherapy for PTSD or changed psychotropic medication within 2 months of randomization

Primary outcomes:
measure: Clinician-Administered PTSD Scale
timeFrame: Baseline, week 8, week 16
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
References:
Clinical trial NCT02754336: Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study
Official title: Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2016-04-28
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study compares the effect of working memory training and neurofeedback in non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive working memory training, while the other half will receive neurofeedback.


Eligibility criteria: Inclusion Criteria:

* ADHD/ADD

Exclusion Criteria:

* Positive effect of metylphenidate

Primary outcomes:
measure: Neuropsychological tests
timeFrame: 3-4 weeks after last training session
Secondary outcomes:
measure: Quantum EEG
timeFrame: 3-4 weeks after last training session
measure: Questionaires
timeFrame: 3-4 weeks after last training session
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Harald Beneventi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786536: Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System
Official title: Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Haemofiltration
Lead sponsor: MediSieve Limited
Sponsor class: INDUSTRY
Collaborators: name: University College London Hospitals
First posted: 2018-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteer study
Primary purpose: TREATMENT

Brief summary: This is a single centre, prospective, non-randomised healthy volunteer study to be undertaken at University College Hospital London.

The study will be used to demonstrate the safe use of the MediSieve blood filtration system in healthy volunteers prior to undertaking clinical trials on patients with relevant pathologies.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers who meet the following criteria will be considered eligible for the study:

1. Male or female, at least 18 and ≤30 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

Volunteers who meet the following criteria will NOT be eligible for the study:

1. Aged \<18 years of age;
2. Aged \>30 years of age;
3. Pregnant or lactating females;
4. Individuals \< 50kg
5. Individuals with an Hb blood level below 115 g/L
6. Individuals with coagulopathies or under medication that affects normal blood coagulation profile, including COCP in females;
7. Individuals with a previous history of heparin-induced thrombocytopenia;
8. Individuals with known allergy to heparin;
9. Individuals with acute or chronic concomitant conditions; such as diabetes, hypertension, autoimmune disease requiring on going therapy
10. Individuals with history of cancer in the last 5 years;(excluding localised skin cancer or CIS)
11. Individuals with haemoglobinopathy disease;
12. Concurrent participation in another experimental intervention or drug study;
13. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Safety and tolerability, measured by incidence of Treatment-Emergent Adverse Events.
timeFrame: During the study duration of 2 months and within the 6 month time period following treatment with the study device. following treatment
Secondary outcomes:
measure: Performance of device during use. Time required for the user to set up and shut down the haemofiltration pump..
timeFrame: Through study completion, an average of 6 months...
measure: Performance of device during use will be assessed by the incidence of flow-rate alarms on the haemofiltration pump during use.
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: MediSieve Limited
name: Cristina Blanco Andujar, PhD
role: STUDY_DIRECTOR
References: