louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05407454: Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability
Official title: Turkish Version of The Diabetes Quality of Life Brief Clinical Inventory Validity and Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetes
Keywords: Diabetes
Quality of Life
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Bitlis Eren University
First posted: 2022-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Aged between 18-65 years old with diabetes

Brief summary: This study aims to develop Turkish version of the Diabetes Quality of Life Brief Clinical Inventory (DQL-BCI) and to perform validity and reliability evaluations.

Detailed description: The study will be carried out in two phases: DQL-BCI will be translated into Turkish and adapted to the cultural context, and the reliability and validity of the Turkish version of DQL-BCI will be investigated. The translation process will be performed in accordance with generally accepted international principles of translation and cultural adaptation of measurement tools. At least 150 subjects with type 2 diabetes will complete the Turkish version of DQL-BCI, the EQ-5D-3L questionnaire and the SF-12 quality of life questionnaire. The examination will provide information about the reliability and the construct validity of the studied tool.

Eligibility criteria: Inclusion Criteria:

* Aged between 18-65 years old
* Diagnosed with diabetes for one year or more (Type 1 or Type 2)
* Literacy
* Being on at least one anti-diabetes medication

Exclusion Criteria:

* Not willing to participate in the study

Primary outcomes:
measure: The Diabetes Quality of Life - Brief Clinical Inventory
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
References:
Clinical trial NCT05861154: Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection
Official title: Effectiveness of Laser Photobiomodulation Therapy in Reducing Child Pain During Local Anesthesia Injection (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Local Anesthesia Injection Pain
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the impact of laser photobiomodulation therapy used as pre-anesthetic technique to reduce child pain during local anesthesia administration


Eligibility criteria: Inclusion Criteria:

* Completion of the written informed consent form by parents/guardian.
* Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
* Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
* Lack of history of allergy to the materials used for anesthesia and sulfite
* Children free of any systemic disease or special health care needs (ASA 1)

Exclusion Criteria:

* Children who receive any analgesic drugs at least 24 hours before treatment.
* Any inflammation or lesion in the injection site
* Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
* Child coming for emergency treatment of pain

Primary outcomes:
measure: Heart Rate
timeFrame: during local anesthesia administration
measure: Pain Reaction
timeFrame: during local anesthesia administration
measure: Perceived Pain
timeFrame: immediately after local anesthesia administration
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Aliaa Hamouda, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Amani Khalil, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Laila El-Habashy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01958554: Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence
Official title: Randomised Controlled Trial of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Domestic Violence
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: NMP Medical Research Institute
First posted: 2013-10-09
Enrollment: 120
Sex: FEMALE
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: Intimate partner violence (IPV) against women have negative mental health consequences for survivors; interventions designed to improve survivors' depressive symptoms and health status are limited.Present study evaluate the effectiveness of an integrated intervention in reducing intimate partner violence (IPV) improving health status.


Eligibility criteria: Inclusion Criteria:

* Women over 18
* For those who agreed to participate
* Given written consent
* Screening for abuse was positive

Exclusion Criteria:

* Screened Negative
* serious mental condition including suicide, hallucination, Dementia
* Drug or substance abuse, alcoholism
* Pregnant

Primary outcomes:
measure: Depression
timeFrame: Change from Baseline in Beck Depression Inventory at 12 weeks
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: Change from baseline in SF-36 at 12 weeks
Other outcomes:
Locations:
city: Mahesana
country: India
facility: Sonal Foundation
state: Gujarat
Study officials:
affiliation: Sonal Foundation, India
name: Bharat Chaudhari, MA
role: STUDY_DIRECTOR
affiliation: Macmillan Research Group
name: Neha sharma, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05707754: Sphenopalatine Ganglion Block Study
Official title: A Randomized Trial of a Sphenopalatine Ganglion Block With Bupivacaine for Acute Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sphenopalatine Ganglion Nerve Block
Keywords: Sphenopalatine ganglion nerve
Peripheral nerve block
Headache
Migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question\[s\] it aims to answer are:

* Does a high dose (3ml) give more relief than a low dose (1ml)?
* Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.

Researchers will compare dosage and administration to see how symptoms are reduced.


Eligibility criteria: Inclusion Criteria:

* Present to ED for management of headache
* Headache is moderate or severe in intensity

Exclusion Criteria:

* Allergy to bupivacaine
* Nasal or sinus surgery

Primary outcomes:
measure: Number of participants demonstrating sustained headache relief
timeFrame: 48 hours
Secondary outcomes:
measure: Number of participants demonstrating satisfaction with the procedure/medication
timeFrame: 48 hours
Other outcomes:
measure: Number of participants demonstrating improvement in 0-10 pain scale
timeFrame: 60 minutes
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02855554: Quantitative Cardiac Parametric Mapping
Official title: Novel Magnetic Resonance Imaging Techniques for Quantitative Cardiac Parametric Mapping
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiomyopathy, Myocarditis, Ischemic Heart Disease
Keywords: myocardial tissue characterization
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall goal of this project is to evaluate the clinical potential of fast quantitative myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.


Eligibility criteria: Inclusion Criteria:

* Subject must be 18-90 years of age.
* Subject must be previously diagnosed with or suspected to have one of the following conditions.
* Myocardial ischemia or infarction (group 1)
* Hypertrophic cardiomyopathy (group 2)
* Infiltrative cardiomyopathy (group 3)
* Myocarditis (group 4)
* Subject must have been referred for a clinically indicated CMR.

Exclusion Criteria:

* Subject has any implanted device or condition in which an MR scan would be contraindicated.
* Subject has an acute psychiatric disorder or is cognitively impaired.
* Subject is using or is dependent on substances of abuse.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject has previously entered this study.
* Subject has an allergy against MRI contrast agents.
* Subject is in acute unstable condition.

Primary outcomes:
measure: Clinical value of fast T1, T2, and T2* mapping of the left ventricle for the assessment of necrosis/scar, edema, and possible intramyocardial hemorrhage in patients with heart disease.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Joseph U. Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02784054: Reduced Dose Radiotherapy Following High Dose Chemotherapy in Intracranial Non-germinomatous Germ Cell Tumor
Official title: Reduced-dose Radiotherapy Following High-dose Chemotherapy and Autologous Stem Cell Transplantation in Patients With Central Nervous System Non-germinomatous Germ Cell Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intracranial Non-germinomatous Germ Cell Tumor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the outcome of intracranial non-germinomatous germ cell tumor (NGGCT) treated with reduced radiotherapy following high dose chemotherapy and autologous stem cell transplantation (HDCT/auto-SCT).

Detailed description: Treatment outcome of intracranial NGGCT is around 50% with conventional chemo- and radiotherapy. Also, late sequelae such as endocrinopathy or cognitive problem are unavoidable especially with craniospinal irradiation. In this study, high dose chemotherapy and reduced dose of radiotherapy will be used to improve survival and minimize the late sequelae in the patients with intracranial NGGCT.

Eligibility criteria: Inclusion Criteria:

* Patients with pathologically proven intracranial non-germinomatous germ cell tumor or
* Patients who have brain mass which are suspected as intracranial germ cell tumor and elevated serum or cerebrospinal fluid alpha-feto protein.

Exclusion Criteria:

* Patients with organ dysfunction (ejection fraction \<40%, creatinine \> 3 x upper limit of normal (ULN), aspartate aminotransferase/alanine aminotransaminase \> 5 x ULN).
* Pregnant or nursing women

Primary outcomes:
measure: Rate of event free survival
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of late adverse events
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05192954: Comparing Postoperative Pain After Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery
Official title: Comparing Postoperative Pain After LigaSureTM Vessel Sealing Device Versus Conventional Suturing Methods for Vaginal Hysterectomy and Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic Organ Prolapse
Vaginal Hysterectomy
Vaginal Vault Suspension
Prolapse Repair
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
Collaborators: name: TriHealth Hatton Research Institute
First posted: 2022-01-14
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study will investigate pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using the LigasureTM vessel sealing device as compared to conventional clamping and suturing methods.


Eligibility criteria: Inclusion Criteria:

* English speaking, able to understand informed consent
* Vaginal hysterectomy with vaginal vault suspension
* with or without anterior and posterior repairs
* with or without removal of fallopian tubes or ovaries
* with or without procedures for stress urinary incontinence

Exclusion Criteria:

* Use of mesh for prolapse repair
* Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
* Concomitant procedure done by an additional surgeon
* Concomitant anal sphincteroplasty or rectovaginal fistula repair
* History of chronic pelvic pain receiving medical care
* Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
* Pregnancy

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3-6 hours postoperative
Secondary outcomes:
measure: Vaginal Pain
timeFrame: 3-6 hours postoperative
measure: Abdominal Pain
timeFrame: 3-6 hours postoperative
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Jennifer Yeung, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06187454: Transcranial Direct Current Stimulation for Depression
Official title: Transcranial Direct Current Stimulation for Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2024-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have shown that tDCS is valuable and safe options to improve depressive symptoms in adult patients . However, regarding the tDCS to treat depression in elderly population, only few studies have been reported, and there is no consensus among them. To our knowledge, prefrontal cortex tDCS could be reasonably safe and efficient options for the treatment of several psychiatric illnesses in a population presenting resistance to and/or intolerance of pharmacotherapy . Moreover, the safety tolerability profile of tDCS is a strong argument in favour of exploring their use in the depressed population. Therefore, current study will investigate the efficacy and safety of prefrontal tDCS used as additive treatment in patients with LLD.


Eligibility criteria: Inclusion Criteria:

1. Participants who meet the criteria of major depression defined by DSM-5 criteria
2. Participants will be non-responders and taking an antidepressant of adequate dose and for ≥4 weeks in the current episode which has not led to sufficient clinical improvement (defined as a minimum level of 2 on the ATHF); or can't tolerate the adverse effects of antidepressant in the current episode
3. Ambulatory participants with or without any aiding device

Exclusion Criteria:

1. An urgent risk of suicide or severe depression
2. A history of ineffectiveness with tDCS
3. People who are clinically contraindicated to receive tDCS intervention or MRI assessment, such as having any brain lesion, intracranial implants (clips, cochlear implants), a tattoo or metal embedded in their scalp or brain
4. Any instable medical condition
5. A history of epilepsy,
6. A history of substance use (within one year)
7. People with dementia or psychotic disorder.
8. Any condition which would make the subject unsuitable for the study under the physician's assessment.

Primary outcomes:
measure: Efficacy and safety of tDCS
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TaipeiVGH
Study officials:
References:
Clinical trial NCT04152954: Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain
Official title: Comparison of a Multi-tined Cannula Versus a Conventional Cannula for Cervical Medial Branch Radiofrequency Ablation in Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Radiofrequency Ablation
Facet Joint Pain
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Chronic neck pain is a common disorder for spine specialists. Radiofrequency ablation of medial branches has been proven effective in selected patients for relieving pain. A newer radiofrequency ablation cannula has been developed (multi-tined), allowing perpendicular access. It is proposed as an alternative to the more technically challenging traditional approach. This study aims to compared the technical and clinical aspects of both techniques.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Cervical neck pain at least 4/10 at rest or with activity
* Neck pain lasting at least 6 months and refractory to conservative treatments
* Neck pain is primarily axial (more than upper extremity)
* Success to medial branch block protocol

Exclusion Criteria:

* failure to medial branch block protocol (pain relief less than 75% on 2 occasions)
* Cervical neck pain less than 4/10
* Neurological deficits of upper extremity
* neuropathic pain of upper extremity
* pregnancy or breastfeeding
* inflammatory or neoplastic lesion on x-ray
* neck cortisone injection in last 3 months
* any medical or psychiatric condition contra-indicated for radiofrequency ablation

Primary outcomes:
measure: Numerical Pain Rating scale for patient's pain during the procedure
timeFrame: 1 day of the intervention
Secondary outcomes:
measure: Fluoroscopy time
timeFrame: 1 day of the intervention
measure: Radiation dosage
timeFrame: 1 day of the intervention
measure: time of procedure
timeFrame: 1 day of the intervention
measure: Patient pain (Numerical Rating Scale - NRS score)
timeFrame: 0, 3, 6 12 months
measure: Patient function (Neck disability Index - NDI)
timeFrame: 0, 3, 6, 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT04353154: The RAPID COVID-19 TRIAGE Algorithm
Official title: Development and Evaluation of Applying a Point-of-Care COVID-19 Test Strategy to Triage Patients Presenting with Acute Coronary Syndromes, Respiratory or Hemodynamic Instability and Out of Hospital Cardiac Arrests
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 66
Sex: ALL
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: Study population is admitted patients who have had a positive core-lab virology test for COVID-19.

Brief summary: This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada. Phase I of this study will determine the best route for the swabs (nasal, throat, or both), and to determine if this POC test results are comparable to the standard core-lab test results.

Detailed description: Currently, testing for COVID-19 is carried out with swabs and blood tests that are sent to hospital laboratories for analysis. With the current technology, the turnaround time for test results may take any where from 8 hours up to several days for confirmation of whether you have COVID-19. This delay in diagnosis may delay care, prevent other testing modalities, consume isolation beds and deplete the valuable personal protective equipment (PPE) needed while providing treatment for patients with COVID-19.

Using a new, Health Canada approved technology, we can conduct the virus genetic testing at the bedside with a nostril and throat swab, with results in under 45 minutes. This new "point-of-care (POC)" technology, if proven accurate, may help future patients receive faster and more definitive treatment. At the same time, it might help health care teams to preserve resources and optimize care for patients (example: triage use of intensive care or isolation unit beds, determine need for PPE, get quarantined staff back to front line to help with care if they are non-carriers).

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 yo referred to the cardiology, internal medicine, ICU, CICU, CSICU or RACE teams who have tested positive for COVID-19.

Exclusion Criteria:

* Patients in whom conventional COVID-19 testing would not have otherwise been instituted or in whom immediate test results would not alter short-term treatment, Patients with pre-existing wishes for DNR.

Primary outcomes:
measure: Sensitivity
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
References: