louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06263062: Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study
Official title: Impact of the Awareness-Based Initiation Program on Cancer Fear and Awareness Level in Women Undergoing Colposcopy: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Fear
Cervical Cancer
Keywords: fear of cancer
MBSR
nursing
awareness
cervical cancer
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Colposcopy procedure due to HSIL, LSIL, ASC-H or HPV on cervical cytology
* Volunteering to participate in the 6-session Mindfulness-Based Coping Programme Knowing what a colposcopy procedure means,

Exclusion Criteria:

* interference with verbal communication,
* being diagnosed with major depressive disorder or psychiatric disorder,
* having participated in MBSR training or meditating before
* Lack of skills to use smart phones and computers
* learning biopsy results during the programme

Primary outcomes:
measure: The Cancer Worry Scale
timeFrame: This scale will be administered twice: pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Philadelphia Mindfulness Scale
timeFrame: This scale will be administered twice: pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Alanya
country: Turkey
facility: Alanya Alaaddin Keykubat University
Study officials:
affiliation: Alanya Alaaddin Keykubat University
name: fatma ozlem uner, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04979962: AI Colorectal Polyp Detection
Official title: Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp Colorectal
Adenoma Colon
Lead sponsor: Fujifilm Medical Systems USA, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 1162
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
* Patients aged 45 or older
* Patients who can provide an informed consent

Exclusion Criteria:

* Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
* Patients who are pregnant or are planning pregnancy during study period
* Patients who are not able to or refuse to give informed consent

Primary outcomes:
measure: Adenoma per colonoscopy (APC)
timeFrame: 1 day/procedure
Secondary outcomes:
measure: Positive predictive value (PPV)
timeFrame: 1 day/procedure
measure: Adenoma detection rate (ADR)
timeFrame: 1 day/procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medicine University of Southern California
state: California
city: Largo
country: United States
facility: Largo Medical Center (HCA)
state: Florida
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Flowood
country: United States
facility: GI Associates
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: New York
country: United States
facility: New York University/Manhattan Endoscopy
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Kansas City VA Medical Center
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01918462: Protective Immune Mechanisms in Alcoholic Hepatitis
Official title: Protective Immune Mechanisms in Alcoholic Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Hepatitis
Keywords: Alcoholic hepatitis
IL-22
Kupffer cells
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital

Brief summary: The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.

Detailed description: The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of alcoholic hepatitis:
* relevant history of alcohol consumption (\>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission)
* bilirubin \> 80 mol/l
* neutrophil granulocytes \> 10x10\^9/L
* exclusion of other liver pathology including biliary disease
* histological verification on liver biopsy
* Written, informed consent

Exclusion Criteria:

* Other chronic inflammatory or autoimmune diseases
* Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.)
* Cancer
* Prednisolon or pentoxifylline treatment within the past 8 weeks
* Pregnancy

Primary outcomes:
measure: Frequency of IL-22-producing cells
timeFrame: at day 1 ( the day of diagnosis/arrival to the department)
Secondary outcomes:
measure: IL-22 binding protein
timeFrame: at day 1 ( the day of diagnosis/arrival to the department)
measure: IL-22 receptor
timeFrame: at day 1 ( the day of diagnosis/arrival to the department)
measure: Signalling molecules and markers of hepatocyte destruction
timeFrame: at day 1, at day 7 and at day 90 after diagnosis.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Hepatology and gastroenterology V, Aarhus university hospital
Study officials:
affiliation: Department of hepatology and gastroenterology, Aarhus University Hospital
name: Sidsel Støy, Phd student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06946862: Factors Affecting Treatment Expectations in Chronic Neck Pain
Official title: Investigation of Factors Influencing Treatment Expectations in Individuals With Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neck Pain Chronic
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: neck pain chronic

Brief summary: The aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-80 years of both sexes diagnosed with chronic neck pain by a physical medicine and rehabilitation specialist will be included in the study. Volunteers who sign the consent form following verbal information will be included in the study.

Exclusion Criteria:

* The presence of instability in the neck joints, trauma within the last year, severe osteoporosis, previous neck surgery, physical therapy within the last 6 months, neurological findings or radiculopathy.

Primary outcomes:
measure: Treatment Expectation Questionnaire
timeFrame: Baseline
Secondary outcomes:
measure: Pain Beliefs Scale
timeFrame: Baseline
measure: Pain Self-Efficacy Questionnaire
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05532462: Trans-nasal Complete Nasolabial Cyst Excision
Official title: Trans-nasal Complete Nasolabial Cyst Excision
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasolabial Cyst
Keywords: Nasoalveolar - Nasolabial - Klestadt's - Cyst
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In upper Egypt In sohag universiy hospital terriary center

Brief summary: Background: Nasolabial cysts are rare benign epithelial nonodontogenic soft tissue cysts arising in the nasal alar region. Sublabial excision or transnasal endoscopic marsupialization is the standard treatment.

Patients and methods: Between 2019 and 2022, a descriptive retrospective study, including 20 patients who presented with Nasolabial cysts, was conducted.

Detailed description: A retrospective study of patients who were presented in the period from 2019 to 2022, with nasolabial cysts. Patients' files were checked for demographic data, clinical presentation, preoperative radiological investigations, histopathology, surgical approach, complications, and outcome.

Technique:

The surgery is carried out mainly using x5 magnification loupe and 0° degree sinoscope. Submucosal infiltration (lidocaine 2% and 1:100,000 adrenaline). An incision was made at the mucosal covering of the cyst wall and nasal floor in a transverse and anteroposterior direction. The mucosal flap is elevated and separated from the cyst wall and reflected toward the septum side. During dissection, cyst content is usually drained. The whole cyst wall was carefully dissected with sharp and blunt dissection from the mucous membrane, and laterally from the premaxillary area. Finally, endoscopic examination to check the operative bed and refashioning mucosal flap coverage. If mucosal flap is lacerated, then excised and operative bed left for healing by creeping from surrounding edges. Endoscopic trans-nasal complete excision has a shorter operative time, minimal intraoperative bleeding, and no postoperative pain or edema reported.

Eligibility criteria: Inclusion Criteria:

•Nasolabial cyst

Exclusion Criteria:

* Recurrent cases
* Previous operated

Primary outcomes:
measure: Symptoms and clinical sign
timeFrame: 2 years
measure: Preoperative Computer tomography or soft tissue ultrasound
timeFrame: 2 years
measure: lining epithelium and inflammatory cell in wall of histopathology
timeFrame: 2 years
measure: complications and outcome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mohammed Elrabie Ahmed
Study officials:
References:
Clinical trial NCT05397262: Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
Official title: Register-Trial Based on an Agreement of Health Insurances With the Department of Radiation Therapy of the University Hospital Erlangen for the Application of Regional Hyperthermia in Bladder Cancer: Organ-preservative Therapy of Bladder Cancer With Radiotherapy or Radiochemotherapy Combined With Hyperthermia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
Hyperthermia
Radiotherapy
Chemotherapy
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Analysis of the efficacy and the compatibility of deep regional hyperthermia in combination with radiotherapy and chemoradiotherapy in bladder cancer


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Histologically confirmed bladder cancer
* M0
* ECOG-performance status ≤ 2
* Informed consent

Exclusion Criteria:

* Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
* Cardiac Pacemaker
* Myocardial infarction within the past 12 months
* Congestive heart failure
* Complete bundle branch block
* New York Heart Association (NYHA) class III or IV heart disease
* Disease that would preclude TUR, chemoradiation or deep regional hyperthermia
* Metal implants (lenght \> 2cm or dense clusters of marker clips in the pelvis)
* Active or therapy-resistent bladder infections
* Pre-existing or concommitant immunodeficiency Syndrom
* Pregnant or lactating women
* Patients not willing to use effective contraception during and up to 6 months after therapy

Primary outcomes:
measure: Overall survival
timeFrame: Participants will be followed for up to 5 years after the end of therapy
Secondary outcomes:
measure: Bladder preservation rate
timeFrame: Participants will be followed for up to 5 years after the end of therapy
measure: Disease free survival
timeFrame: Participants will be followed for up to 5 years after the end of therapy
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Dept. of Radiation Therapy, University Hospital Erlangen
Study officials:
affiliation: Dept. of Radiation Therapy, University Hospital Erlangen
name: Oliver Ott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04985162: Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Official title: Comparison of the Effects of Ordinary and Differential Learning Based Physiotherapy on Subjects With Ischemic Stroke Torso Control, Balance and Gait in the Second Phase of Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the effect or ordinary and differential learning based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the second phase of rehabilitation

Detailed description: Ischemic stroke is still the second most common cause of death and one of the leading causes of disability worldwide. Half of all individuals with ischemic stroke do not regain lost body functions until the end of life. Individuals with ischemic stroke are most likely to have impaired cognitive, sensory, and motor functions, but the greatest challenge for health care professionals is impaired motor skills caused by motor nerve cell damage. In order to minimize the degree of disability, it is important to respond quickly to a person's condition. Because it has been shown that lost functions can be taken over by adjacent, non-stroke-affected areas of the cerebral cortex, early rehabilitation is a key factor that can help prevent function limitation by acting in conjunction with spontaneous recovery of body function.

The aim of the study is to assess the effect or ordinary and differential learning based physiotherapy for torso control, balance and gait on subjects with ischemic stroke in the second phase of rehabilitation.

The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2020-06-30 No.BEC-KN(B)-263).

Eligibility criteria: Inclusion Criteria:

* Patients rehabilitated in Neurorabilitation Departmen of Lithuanian University of Health sciences hospital Kauno Kliniko in the second stage of rehabilitation;
* Stroke for the first time;
* 45-74 m. age;
* Able to go with aids;
* Voluntary consent to participate in the study.

Primary outcomes:
measure: Torso control assessment scale
timeFrame: Baseline to 3 weeks
measure: Berg balance test
timeFrame: Baseline to 3 weeks
measure: Dynamic gait index is used to assess the likelihood of falling. A four-point ordinal scale, ranging from 0-3 points. Total maximum score is 24 points. 0 points indicates the lowest level of function and 3 points - the highest level of function.
timeFrame: Baseline to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences, Department of Rehabilitation
Study officials:
References:
Clinical trial NCT04128462: MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of MNK6105 (an Intravenous Formulation of L-Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Hyperammonemia Associated With an Episode of Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hepatic Encephalopathy
Keywords: Overt HE diagnosis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 0
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: This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.

All patients will receive the standard of (regular) care. Each will have an equal chance (like flipping a coin) of receiving the experimental drug or placebo along with the standard care.

Each patient will have tests during the first 24 hours, receive treatment for up to 5 days, and have 30 days of follow-up.


Eligibility criteria: Inclusion Criteria:

To be included, a patient must:

* Be the age of majority in their country (considered an adult)
* Be male or non-pregnant, non-lactating female
* Have OHE (Stage 2, 3, or 4) as a complication of cirrhosis
* Have been hospitalized within 24 hours before start of infusion (SOI)
* Receive at least 6 hours of SoC treatment

Exclusion Criteria:

Patients will be excluded if they have inadequate renal function or any other disease, laboratory value, or condition (including allergy, drug use or treatments) that per protocol or in the opinion of the investigator, might increase the risk of compromising:

1. health or well-being of the patient
2. safety of study staff
3. analysis of results

Primary outcomes:
measure: Number of patients with a clinical response at Day 5
timeFrame: at Day 5 (within 36 months)
Secondary outcomes:
measure: Number of patients discharged 30 days after end of treatment.
timeFrame: at Day 35 (within 36 months)
measure: Number of patients readmitted to the hospital due to overt hepatic encephalopathy (OHE) 30 days after discharge.
timeFrame: 30 days after discharge (within 36 months)
measure: Number of patients with adverse events or deaths during the study
timeFrame: within 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT02617862: PCI Imaging System in Pediatric Ophthalmology
Official title: The Use of the PCI Wide Field Imaging System for Pediatric Ophthalmic Photography of the Posterior and Peripheral Retina
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinoblastoma
Keywords: Diagnostic imaging
Retina
Pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Phoenix Clinical Inc.
First posted: 2015-12-01
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the RetCam (Clarity Medical Systems, Pleasanton, CA) to a new prototype pediatric imaging system, COSMOS, produced by Phoenix Clinical Incorporated (PCI) (Pleasanton, CA).


Eligibility criteria: * Exclusion Criteria:

  * Any patient who has a cloudy cornea.
  * Any patient whose RetCam imaging exam easily produces blanching of the optic nerve in the normal course of imaging.
  * Any patient who has consented to the procedure, but whose course of examination has filled the time allotted, leaving no time to evaluate the COSMOS.
* Inclusion Criteria:

  * Current patients undergoing clinically indicated EUA and RetCam imaging for surveillance and treatment of ophthalmic conditions at The Hospital for Sick Children.

Primary outcomes:
measure: Comparison of the field of view in RetCam and COSMOS images
timeFrame: 1 day
measure: Comparison of the color in RetCam and COSMOS images
timeFrame: 1 day
measure: Comparison of the dynamic range in RetCam and COSMOS images
timeFrame: 1 day
measure: Comparison of the sharpness in RetCam and COSMOS images
timeFrame: 1 day
measure: Comparison of the detail in RetCam and COSMOS images
timeFrame: 1 day
measure: Comparison of the resolution in RetCam and COSMOS images
timeFrame: 1 day
measure: Comparison of the evenness of illumination in RetCam and COSMOS images
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Brenda L Gallie, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: