louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06427928: Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled Trial
Official title: The Effect of Explaining the Perioperative Process with Our Drawings on Anxiety in Pediatric Patients; Prosperative Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: perioperative anxiety
pediatric
general anhesthesia
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Preoperative anxiety is characterized by subjective emotions such as irritability, irritability, sadness, and unhappiness. Studies have shown that preoperative anxiety negatively affects children both psychologically and physiologically. Preoperative anxiety occurs in 60-80% of children undergoing anesthesia and surgery and is associated with undesirable consequences such as nightmares, separation anxiety, eating disorders, negative behavioral changes such as increased fear of doctors, increased need for analgesics. The aim of this study is to evaluate the preoperative and pre-sedation anxiety levels in pediatric patients by explaining the peroperative process to the patients with drawings.


Eligibility criteria: Inclusion Criteria:

* ASA I patients without any comorbidities who were operated on by the ENT,
* Patients between the ages of 5-12,
* And patients who could be contacted and did not have any anxiety problems were included.

Exclusion Criteria:

* Patients with liver and/or kidney failure, trauma patients, ASAII-III-IV patients, patients with bleeding disorders,
* those using medications that would affect the coagulation system, patients with local anesthetic allergy, patients with immobility and malnutrition, .And patients who did not want to participate in the study were excluded from the study.

Primary outcomes:
measure: Modified Yale Preoperative Anxiety Scale
timeFrame: surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from the parent to the operating room (T2), upon entry to the operating room (T3), and at the time of starting intravenous induction (T4).
Secondary outcomes:
measure: Riker agitation scala
timeFrame: after extubation
measure: Visual analog scala
timeFrame: surgical ward (T0), in the preoperative waiting area (T1), at the time of separation from their child
measure: mean arterial pressure
timeFrame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after
measure: heart rate
timeFrame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Health Sciences University Gazi Yaşargil Training and Research Hospital
state: Kayapınar
Study officials:
References:
Clinical trial NCT02072928: Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-02-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with incontinence from NDO due to spinal injury or MS treated as per standard of care in clinical practice.

Brief summary: This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium
* Previous treatment with anticholinergic drugs ineffective
* Last BOTOX® treatment ≥18 months.

Exclusion Criteria:

* Diagnosis of urinary incontinence less than 9 months.
* No anticholinergic drug use in the last 9 months.

Primary outcomes:
measure: Change From Baseline in Anticholinergic Drug Use
timeFrame: Baseline, 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
city: Esneux
country: Belgium
facility: CHU de Liège
city: Ghent
country: Belgium
facility: UZ Gent
city: HUY
country: Belgium
facility: Centre Hospitalier Regional de Huy
city: Leuven
country: Belgium
facility: UZ Leuven
city: Overpelt
country: Belgium
facility: Maria Ziekenhuis Noord-Limburg
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03015428: "Living Together With Dementia"_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Family caregivers
training programme
dementia
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study aims to experimentally evaluate the training program for family caregivers of people with dementia_"Living together with Dementia."

Detailed description: This study will begin in March 2016, with the initial assessment of family caregivers of people with dementia.

These were recruited through hospital neurology clinic and must comply with a set of pre-established criteria.

It is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group).

Interventions will take place over the months of March and April. The final evaluation is scheduled for late April and the follow up to July 2016.

an evaluation document itself for this study was built.

Eligibility criteria: Inclusion Criteria:

* Be primary caregiver of the person with dementia
* Be able to read and write
* Carers of peolpe with dementia in initial or moderate stage

Exclusion Criteria:

* The person with dementia have severe mental pathologies associated

Primary outcomes:
measure: Caregiver Overload Scale
timeFrame: 7 weeks
measure: Carers Assessment Satisfaction Index
timeFrame: 7 weeks
measure: Carers Assessment Difficulties Index
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oporto
country: Portugal
facility: CHSaoJoao
Study officials:
affiliation: Centro Hospitalar De São João, E.P.E.
name: Lia Sousa, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03515928: The Effects of Ultrasonic Noise Exposure on Human Hearing
Official title: An Investigation of the Effects of Ultrasonic Noise Exposure on the Human Auditory System Via Pure Tone Audiometry (PTA) on Audiometrically Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Ultrasound, Hearing
Lead sponsor: Ultrahaptics Ltd
Sponsor class: INDUSTRY
Collaborators: name: Avon Partnership NHS
First posted: 2018-05-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. A cohort of 20 audiometrically healthy volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity, at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A subgroup of 10 subjects will be used as a control group. The resulting audiograms will establish the extent of any recoverable loss in hearing sensitivity known as temporary threshold shifts (TTS).


Eligibility criteria: Inclusion Criteria:

* Adult, audiometrically healthy

Exclusion Criteria:

* Underlying/pre-existing hearing impairment

Primary outcomes:
measure: Temporary Threshold Shifts (TTS)
timeFrame: Audiometry will be conducted immediately (with 2 hours) from noise exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Ultrahaptics
Study officials:
References:
Clinical trial NCT02160028: Pain and Placebo Analgesia. Does Extended Information About Dental Procedures Reduce Pain Induced by Dental Treatment?
Official title: Pain and Placebo Analgesia. A Double Blinded, Randomized, Clinical Study About the Impact of Information About Anesthesia, and the Experience of Pain and Stress During Dental Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Odontophobia
Keywords: Information
Pain
Stress
Fear
Placebo analgesia
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University of Bergen
name: Tannhelsetjenestens Kompetansesenter Vest, TK Vest
name: Tannlegesenteret Madlagården, TSMG
First posted: 2014-06-10
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. In this study it will be investigated whether this finding translates to the dental clinic. It will be investigated whether information that suggested that minimal pain will be experienced during filling therapy, can reduce the pain associated with that procedure compared to a group that receives standard information. All patients will receive the same amount of anesthesia and similar procedures during filling therapy. It is predicted that extended information should reduce pain, and that the reduction in pain should be associated with a reduction in stress.


Eligibility criteria: Inclusion Criteria:

* Patients to be treated for dental caries
* Patients should be able to read and communicate in Norwegian

Exclusion Criteria:

* Patients with life threatening diseases
* Patients taking pain killers for other reasons on the day of treatment

Primary outcomes:
measure: Reduction of pain
timeFrame: 1 hour
Secondary outcomes:
measure: Reduction of stress
timeFrame: One hour
Other outcomes:
Locations:
city: Hafrsfjord
country: Norway
facility: Tannlegesenteret Madlagården, TSMG
Study officials:
affiliation: Norwegian University of Science and Technology
name: Magne A Flaten, phd prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01346228: Using Smart Phone Technology To Rural Veterans
Official title: USING SMART PHONE TECHNOLOGY AS A PLATFORM FOR DELIVERING MENTAL HEALTH CARE TO RURAL VETERANS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Panic Disorders
Anxiety Disorders
Keywords: Panic
Panic Disorder
Anxiety
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
Collaborators: name: South Central VA Mental Illness Research, Education & Clinical Center
First posted: 2011-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if a new Smart Phone application can help Veterans manage their panic symptoms after completing a two-day treatment for panic attacks.

Detailed description: The first goal is to see how helpful the Smart Phone application is in helping veterans with panic symptoms continue to improve after you complete treatment.

The second goal of this study is to find out how much veterans like the Smart Phone application.

The third goal is to see how practical it is to use the Smart Phone application as a form of follow-up care. We want to see how much time is needed to provide technical support in using the application.

Eligibility criteria: Inclusion Criteria:

Participants must

1. be an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veteran
2. currently meet criteria for PD with or without Agoraphobia
3. complete the weekend PD treatment at the Lufkin, Conroe or Texas City CBOC.

Exclusion Criteria:

1. current substance dependence
2. organic psychosis
3. symptomatic bipolar disorder
4. severe depression with suicidal intent or plan
5. cognitive impairment (indicated by scores \<20 on SLUMS)

Primary outcomes:
measure: Panic Control Treatment (PCT)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Ellen Teng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05023928: Tumor Antigen-sensitized DC Vaccine As an Adjuvant Therapy for Esophagus Cancer
Official title: Research on the Transformation of Postoperative Adjuvant Therapy of Tumor Antigen-sensitized DC Vaccine Applied to Esophagus Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Esophagus Cancer
Keywords: esophagus cancer
tumor neo-antigen DC vaccine
safety
clinical efficacy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of esophageal cancer.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed diagnosis of esophageal squamous cell carcinoma；
* Immunotherapy for preoperative；
* Karnofsky performance status 0-1;
* The postoperative pathological stage is (y) Pt + and / or N + M0 according to AJCC 8th
* Function of the main organs is normal;
* Edition Patient's written informed consent

Exclusion Criteria:

* Tumor emergencies;
* Abnormal coagulation function;
* Contagious diseases, such as HIV, HBV, HCV infection;
* Mental disorders;
* Concomitant tumors;
* Immunological co-morbidities

Primary outcomes:
measure: Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
timeFrame: 3 months after the last administration of cells
Secondary outcomes:
measure: Disease-free Survival
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Sichuan University
name: Zhen-Yu Ding, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03766828: Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion
Official title: Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Central Venous Catheter Thrombosis
Keywords: thoracic central venous occlusion
Dialysis access
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients with thoracic central venous occlusion requiring vascular access

Brief summary: A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.


Eligibility criteria: Inclusion Criteria:

* Patients with thoracic central venous occlusion

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Achievement of dialysis access
timeFrame: 1 day
Secondary outcomes:
measure: procedure related complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
Study officials:
affiliation: Department of Medicine III, Division of Nephrology
name: Gürkan Sengölge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320628: Randomized Double-Blind Controlled Clinical Trial
Official title: Randomized Double-Blind Controlled Clinical Trial Comparing Sodium Hypochlorite Antiseptic to Normal Saline in Reducing Bioburden in Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wounds
Acute Wounds
Lead sponsor: SerenaGroup, Inc.
Sponsor class: NETWORK
Collaborators: name: Anacapa Technologies Inc
First posted: 2020-03-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline.
Primary purpose: TREATMENT

Brief summary: The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds.

Detailed description: The study is a randomized double-blind controlled clinical trial designed to compare the ability of NaOCl to NSS in the reduction of bacterial burden in nonhealing acute and chronic wounds. Using the generally accepted surrogate endpoint of surface area reduction at 4 weeks, the study will also compare the healing of subjects utilizing NaOCl vs. NSS.

After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed with NaOCl or NSS. After cleansing the wound a second MiX is performed. The subject is given a four-week supply of either NaOCl or NSS.

Eligibility criteria: Inclusion Criteria:

1. Adult patients with acute or chronic wounds that have been present for a minimum of 4 weeks.
2. A signed and dated informed consent form.
3. Subject is willing and able to comply with instructions and scheduled visits.

Exclusion Criteria:

1. The Subject has other concurrent conditions that in the opinion of the Investigator may compromise subject safety.
2. The subject's wound has not been present for at least 4 weeks.

Primary outcomes:
measure: Reduction in bacterial bioburden
timeFrame: 4 weeks
Secondary outcomes:
measure: Healing rate
timeFrame: 4 weeks
measure: Pain Score (PEG)
timeFrame: 4 weeks
measure: Adverse Events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Serena Group Research Institute
state: Pennsylvania
Study officials:
affiliation: Serena Group
name: Thomas E Serena, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01859728: GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
Official title: GAMBIT Trial: A Randomized,Non-comparative, Open-label Clinical Trial Evaluating Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Biliary Cancer
Keywords: biliary cancer
irinotecan
cisplatin
gemcitabine
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.


Eligibility criteria: Inclusion Criteria:

* biopsy-proven gallbladder or biliary tract cancer;
* Recurrent, metastatic or unresectable disease;
* Chemo-naïve.
* Not candidates to curative-intent treatment, such as surgery or radiation-therapy;
* Measurable disease according to RECIST 1.1;
* ECOG 0-2;
* Adequate hematologic and biochemistry tests;
* Creatinine clearance \>= 60ml/min.

Exclusion Criteria:

* Known hypersensibility or previous therapy with cisplatin, gemcitabine or irinotecan;
* Chronic immunosuppressive therapy;
* Known CNS metastasis;
* Previous diagnosis of other cancer;
* Chronic or acute active infection, except asymptomatic HIV infection;
* Active bleeding;
* Any severe medical condition;
* Pregnant or lactating women, or with childbearing potential;

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to 24 weeks from randomization
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 6mo after the last enrolled patient
measure: Overall Survival (OS)
timeFrame: 6mo after the last enrolled patient
measure: Disease Control Rate
timeFrame: Up to 6 weeks from randomization
measure: Safety
timeFrame: 6 mo after the last enrolled patients
Other outcomes:
measure: Biomarker evaluation
timeFrame: Baseline
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
state: SP
Study officials:
affiliation: Barretos Cancer Hospital
name: Lucas V dos Santos, MD
role: STUDY_CHAIR
affiliation: Barretos Cancer Hospital
name: Kathia C Abdalla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos Cancer Hospital
name: Joao Paulo S N Lima, MD, PhD
role: STUDY_DIRECTOR
References: