louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04296409: The Turkish Deglutition Handicap Index
Official title: The Turkish Version of the Deglutition Handicap Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing Disorder
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with swallowing difficulties

Brief summary: The purpose of this study is to test the reliability and validity of the The Turkish Deglutition Handicap Index among adult patients with swallowing disorders.

Detailed description: The purpose of this study is to test the reliability and validity of the The Turkish Deglutition Handicap Index among adult patients with swallowing disorders.The internal consistency, test-retest reliability, and criterion validity of the instrument will be investigated. The internal consistency will be assessed using Cronbach's alpha. Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability. The criterion validity of the scale will be determined by assessing the correlation between The Turkish Deglutition Handicap Index and Turkish Eating Assessment Tool.

Eligibility criteria: Inclusion Criteria:

* Willing to participate
* Having swallowing problems

Exclusion Criteria:

* Being under the age of 20 years, and above the age of 60 years
* Not willing to participate
* Having no swallowing problems

Primary outcomes:
measure: Turkish Deglutition Handicap Index
timeFrame: 3 months
Secondary outcomes:
measure: The Turkish version of the Eating Assessment Tool-10
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02030509: Quick Diagnostic Program for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Head and Neck
Keywords: cancer diagnosis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with symptoms of head and neck cancer

Brief summary: Head and neck cancer would be suitable for quick diagnostic programs because their initial symptoms are easy detectable and the curation rates in the initial stages are very high.

Actually the stages at diagnosis are about 30% in initial stages and 70% in advanced stages.

The hypothesis of this study is that a program for quick referral of patients with symptoms of head and neck cancer would help early diagnosis.


Eligibility criteria: Inclusion Criteria:

* patients with symptoms of head and neck cancer in the Hospital reference area

Exclusion Criteria:

* Patients already diagnosed when refered to Hospital

Primary outcomes:
measure: Time from symptom onset to diagnosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT06414109: Mindfulness-Based Intervention for Adolescents With Chronic Migraine
Official title: Mindfulness-Based Intervention for Adolescents With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Migraine in Adolescence
Keywords: Adolescent
Mindfulness
Mindfulness Intervention
Migraine
Headache
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2024-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.

Detailed description: Mindfulness-based intervention (MBI) shows promise in adults with migraine, but research is limited in adolescents. The current study aims to advance behavioral treatments for adolescents with frequent migraine by adapting an existing empirically-supported MBI for adolescents (Learning to BREATHE) to meet the unique needs of adolescents with chronic migraine. In Phase I of the study, we will use feedback solicited from interviews with teens with chronic migraine, their parents, and healthcare providers documenting the experience of living with chronic migraine and on the content and delivery of the MBI to create an adapted telehealth group intervention specifically tailored for adolescents with frequent migraine. In Phase II of the study, the adapted MBI will be piloted in a single-arm trial with adolescents with frequent migraine to assess feasibility, acceptability, and preliminary clinical signals.

Eligibility criteria: Inclusion Criteria:

* Age 13 to 18 years
* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition
* Patient report of \>= 8 headache days per month
* PedMIDAS Score of \> 10 (at least mild headache-related disability)

Exclusion Criteria:

* Weekly or bi-weekly therapy with a licensed behavioral health provider
* Major comorbid medical condition (e.g., cancer, epilepsy)
* Active psychosis or suicidal ideation
* Inability to provide consent/assent

Primary outcomes:
measure: Intervention feasibility
timeFrame: Up to 6 weeks
measure: Intervention acceptability
timeFrame: 7 weeks
Secondary outcomes:
measure: Change in headache-related disability
timeFrame: Baseline, 6 weeks
measure: Change in emotion regulation
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michelle A Clementi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854009: Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated.


Eligibility criteria: Inclusion Criteria:

1. Men, aged 20 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. History of drug abuse within 1 year.

Primary outcomes:
measure: Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.
timeFrame: 15 days
Secondary outcomes:
measure: Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
timeFrame: 4 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05378009: Functional Dyspepsia Response to Relaxation Therapy and Physical Activity
Official title: Functional Dyspepsia Response to Relaxation Therapy Alone or Combined With Physical Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyspepsia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional dyspepsia (FD) is a common gastrointestinal disease with high morbidity. Due to the drop in estrogen level, perimenopausal women with FD (PMFD) have an increase in emotional disorders such as depression, anxiety and sleep disorder.

Detailed description: the research will include 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation), physical exercise (on treadmill), and proton pump inhibitors. Also, the research will include another 30 FD women during their perimenopause to receive for 8 weeks the following: relaxation therapy (Benson relaxation) and proton pump inhibitors

Eligibility criteria: Inclusion Criteria:

* perimenopausal women With FD symptoms

Exclusion Criteria:

* other gastrointestinal disease
* Cardiovascular, metabolic, respiratory, renal complaints
* Pregnancy
* Women in Lactation
* neurological / Psychic Women

Primary outcomes:
measure: cortisol
timeFrame: It will be measured after 8 weeks
Secondary outcomes:
measure: Glasgow dyspepsia severity score
timeFrame: It will be measured after 8 weeks
measure: Visual analogue scale
timeFrame: It will be measured after 8 weeks
measure: depression anxiety stress scales-42
timeFrame: It will be measured after 8 weeks
measure: Pittsburgh sleep quality index
timeFrame: It will be measured after 8 weeks
measure: Estradiol
timeFrame: It will be measured after 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04773509: Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
Official title: Effect of Intraoperative Paravertebral Block on Postoperative Pain and Recovery in Patients Undergoing Mechanical Correction for Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 32
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides. In contrast, PVB are not performed in the control group.
Primary purpose: TREATMENT

Brief summary: Pain management after scoliosis surgery is challenging for the anesthesiologists. This surgery causes severe postoperative pain and patients undergoing these operations are children or adolescents who are increased pain sensation compared with adults. Therefore, we aim to evaluate whether intraoperative paravertebral block (PVB) decreases postoperative pain in these patients. Thirty-two patients scheduled for mechanical correction due to scoliosis will be divided into PVB (n=16) and control (n=16) groups. Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides. In contrast, PVB are not performed in the control group.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing mechanical correction

Exclusion Criteria:

* The subjects who cannot communicate
* The subject is a foreigner or illiterate

Primary outcomes:
measure: Pain score
timeFrame: 6 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Bora Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742609: A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit
Official title: A Randomised Controlled Trial of a Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Written Information
Written Info and Hearing Aid Reminder
Written Info and Planning on Hearing Aid Use
All Materials
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.

Detailed description: The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years old or above
2. Have never used a hearing aid before
3. Have good understanding of English
4. have sufficient mental capacity to provide informal consent based on audiologist's opinion

Exclusion Criteria:

1. Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
2. presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)

Primary outcomes:
measure: Hearing aid use
timeFrame: 6-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Audiology Clinic
Study officials:
affiliation: Manchester Centre for Audiology and Deafness,University of Manchester
name: Piers Dawes, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ismail AH, Armitage CJ, Munro KJ, Marsden A, Dawes PD. Evaluation of the I-PLAN Intervention to Promote Hearing Aid Use in New Adult Users: a Randomized Controlled Trial. Ear Hear. 2022 Jul-Aug 01;43(4):1103-1113. doi: 10.1097/AUD.0000000000001195. Epub 2022 Jan 6.
Clinical trial NCT05513209: Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia for Tonsillectomy Operations
Official title: Comparative Study Between Opioid Free Pterygopalatine Ganglion Block Based Multimodal Anesthesia Versus Conventional Opioid Based Multimodal Anesthesia for Tonsillectomy Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PREVENTION OF POSTTONSILLECTOMY PAIN
DECREASE POSTTONSILLECTOMY NAUSEA AND VOMITTING
DECREASE POSTOPERATIVE HOSPITAL STAY
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: intraoperative opioid administration versus intraoperative pterygopalatine ganglion block based opioid free anesthesia to compare outcomes such as postoperative administration of opioid rates of nausea and vomiting, Post Anesthesia Care Unit (PACU) length of stay

Detailed description: Group A ;( opioid based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid based multimodal anesthesia.

Group B ;( opioid free pterygopalatine ganglion block based multimodal anesthesia) One hundred and twenty pediatric patients will do elective tonsillectomy or adenotonsillectomy surgery using opioid free pterygopalatine ganglion block based multimodal anesthesia.

For each patient, intraoperative hemodynamics, additional intraoperative analgesia required, the length of PACU stay, administration of postoperative opioids, administration of postoperative non-opioid analgesics, postoperative (visual analogue score) VAS score, will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age 4 to 13 years old.
* Elective tonsillectomy or adenotonsillectomy surgery

Exclusion Criteria:

* Allergies to xylocaine.
* Developmental delays.
* Significant cognitive impairment.
* American Society of Anesthesiologists (ASA) Class 3 and 4.
* Patients who underwent any additional concurrent procedures such as lingual tonsillectomy.

Primary outcomes:
measure: postoperative VAS score
timeFrame: EVERY HOUR AFTER SURGERY FOR 24 HOURS
Secondary outcomes:
measure: TOTAL AMOUNT OF OPIOD REQUIRED POSTOPERATIVELY
timeFrame: 24 HOURS AFTER SURGERY
measure: INTRAOPERATIVE BLOOD PRESSURE
timeFrame: EVERY 10 MINUTES up to 1 hour
measure: INTRAOPERATIVE HEART RATE
timeFrame: EVERY 10 MINUTES up to 1 hour
measure: TOTAL AMOUNT OF GIVEN INTRAOPERATIVE OPIODS
timeFrame: DURING SURGERY
measure: length of PACU stay
timeFrame: one day after operation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ramymahrose
Study officials:
References:
Clinical trial NCT01839409: Biological Rhythms and Vestibular System
Official title: Biological Rhythms and Vestibular System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unspecified Disorder of Vestibular Function, Bilateral
Keywords: Circadian Rhythm
Exercise
Reflex, Vestibular Ocular
Postural Balance
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to study the relationship between the vestibular system and chronobiology

Detailed description: The purpose of this study is to study the relationship between the vestibular system and chronobiology.

Two parts will be performed. In the first one patients with bilateral vestibular areflexia will be compared to control subjects.

In the second the effect of vestibular stimulation on circadian rhythms will be evaluated

Eligibility criteria: Inclusion Criteria:

* No treatment changing vigilance/wakefulness
* Moderate caffein uptake (2 to 3 cups a day)
* Moderate smoker (5 cigarettes a day)
* Regular sleeping habits

Exclusion Criteria:

* Sleeping duration \<6 hours or \>9 hours
* Night workers
* Pregnancy
* Sleep or wakefulness disorders
* Progressive neurodegenerative disorders
* Progressive psychiatric disorders
* Thyroid disease
* Type 1 diabetes
* Not able to practice physical activity
* Drug or alcohol addiction during the last 6 months

Primary outcomes:
measure: Measurements of vestibular reflexes (ocular and spinal) and circadian rhythms of biological functions.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
affiliation: University Hospital of Caen
name: Pierre Denise, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041509: ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)
Official title: ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthroplasty
Keywords: venous thromboembolism
thromboembolism
pulmonary embolism
deep vein thrombosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-07-12
Enrollment: 343
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
* Patients who have given written informed consent to participate in this study.

Exclusion Criteria:

* Patients with a contraindication to contrast venography
* Patients with an increased risk of bleeding.
* Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
* Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Primary outcomes:
measure: VTE
timeFrame: 28 day treatment period
Secondary outcomes:
measure: types of VTE
timeFrame: 28 day treatment period
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: