louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03120104: Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision
Official title: Physical Exercise for Colorectal Cancer Patients After Transanal Total Mesorectal Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fecal incontinence is common in patients with rectal cancer after surgery. Previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. We are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. This article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.


Eligibility criteria: Inclusion Criteria:

* rectal cancer patients who have received transanal total mesorectal excision(TaTME) surgery; 20\~75 years old

Exclusion Criteria:

* terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions

Primary outcomes:
measure: Change of The Wexner Score
timeFrame: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Secondary outcomes:
measure: Change of St. Mark's Hospital Incontinence Score
timeFrame: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
measure: Change of Functional assessment of Cancer Therapy - Colorectal (FACT-C)
timeFrame: measurement point 1: 2 weeks after the stoma closure; measurement point 2: 1 month after the intervention start
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University)
Study officials:
affiliation: Rehabilitation Department of Taipei Municipal WanFang Hospitial (Managed by Taipei Medical University)
name: Pin Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02657304: Effect of Early Education on the Observance of CPAP Treatment
Official title: Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Keywords: Sleep Apnea
CPAP
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

Detailed description: Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

The investigators hypothesize that an early education and information of SA (in the first 2 weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of CPAP (\> 5 h/night).

Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).

Eligibility criteria: Inclusion Criteria:

* Patients affiliated or entitled to a French medical insurance
* Patients of both gender, aged from 18 to 80 years
* Patients with AHI \> 30/hour or between 15 \& 30/h with Sleep Fragmentation Index (SFI) of more than 10/h
* Signature of consent

Exclusion Criteria:

* Known diseases which contraindicated used of CPAP treatment

Primary outcomes:
measure: Observance
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: St Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Frédéric ROCHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214304: Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy
Official title: Aromatherapy With Lavender Oil to Reduce Pain and Anxiety During Cervical Colposcopy: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colposcopy
Keywords: Colposcopy
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
Collaborators: name: American Academy of Family Physicians
First posted: 2010-10-05
Enrollment: 262
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.

Detailed description: Aromatherapy is a modality that might reduce anxiety. Women experience high levels of anxiety and negative emotional responses at all stages of cervical cancer screening. High levels of anxiety before and during colposcopy can be bad. If lavender oil aromatherapy reduces anxiety, then simple use of this modality may improve experiences during colposcopy.

Eligibility criteria: Inclusion Criteria:

* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB
* All women at least 18 yrs of age undergoing colposcopy who have not previously participated in this protocol.

Exclusion Criteria:

* age \<18 years
* pregnancy
* breastfeeding
* asthma
* poor sense of smell
* allergy to one of the essential oils
* consumption of any analgesic
* short-term anxiolytic (i.e. benzodiazepines) or chronic anxiolytic medications (i.e. SSRI)

Primary outcomes:
measure: Pain Level
timeFrame: 8 months
Secondary outcomes:
measure: Anxiety Level
timeFrame: 8 months
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Federal Medical Center
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Federal Medical Center
name: Paul Crawford, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02182804: A Diagnostic Study of the Advanced Endoscopy to Detect Early Esophageal Cancer
Official title: Diagnostic Values of Probe-based Confocal Laser Endomicroscopy (pCLE) and Magnifying Narrow Band Imaging (M-NBI) for Early Neoplasms Detection in Esophageal Lugol'S-voiding Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Keywords: Confocal Laser Endomicroscopy
Narrow Band Imaging
Lugol Chromoendoscopy
Esophageal Neoplasm
Head and Neck Cancer
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chulalongkorn University
First posted: 2014-07-08
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pCLE) and the magnifying narrow band imaging (M-NBI) in the Lugol's voiding lesions.


Eligibility criteria: Inclusion Criteria:

* Age over 20 years
* Having histological-confirmed diagnosis of head and neck cancer
* Having no esophageal symptoms

Exclusion Criteria:

* Having index cancer of nasopharynx
* History of esophageal surgery
* Having esophageal stricture or obstruction
* Having esophageal varices
* Known case of esophageal cancer
* Uncorrectable coagulopathy and thrombocytopenia
* Pregnancy
* Thyrotoxicosis
* Creatinine clearance less than 30 ml/min
* Allergy to iodine or fluorescein.

Primary outcomes:
measure: Accuracy
timeFrame: an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Chulalongkorn Memorial Hospital
name: Rapat Pittayanon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06485804: AI Mobile App vs Self Exercises in Workers With Neck Pain
Official title: Comparing Efficacy and Adherence of Smartphone-guided Exercises to Conventional Self-directed Exercises for Neck Pain in Office Workers: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Work-Related Condition
Keywords: Office Workers
Clinical trial Protocol
Exercise Therapy
Mobile Application
Neck Pain
Patient compliance
Self-management
Workplace
Lead sponsor: University of Monastir
Sponsor class: OTHER
Collaborators: name: Sana Salah
name: Amr Chaabeni
First posted: 2024-07-03
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an Artificial Intelligence embedded mobile application and written sheet.


Eligibility criteria: Inclusion Criteria:

* The presence of a chronic NP lasting for more than three months, and a pain level at baseline assessment ≥ 30 (VAS)

Exclusion Criteria:

* Acute neck pain, neck pain from specific causes (eg; Chronic inflammatory diseases), spine trauma or surgery, cervical radiculopathy or myelopathy, and physical therapy treatments in the last six months before baseline assessment.

Primary outcomes:
measure: Pain intensity
timeFrame: Pain intensity will be assessed at baseline, and at 4, and 8 weeks of follow-up.
Secondary outcomes:
measure: Function
timeFrame: Function will be assessed at baseline, and at 4, and 8 weeks of follow-up.
measure: Quality of life measure
timeFrame: Quality of life will be assessed at baseline, and at 4, and 8 weeks of follow-up.
measure: Patient adherence
timeFrame: Patient adherence will be assessed at 4, and 8 weeks of follow-up.
Other outcomes:
measure: Gender
timeFrame: Assessed at baseline
measure: Age
timeFrame: Assessed at baseline
measure: Body mass index (BMI)
timeFrame: Assessed at baseline
measure: Comorbidities
timeFrame: Assessed at baseline
measure: Musculoskeletal disorders
timeFrame: Assessed at baseline
measure: Work seniority
timeFrame: Assessed at baseline
measure: Time spent in front of computer
timeFrame: Assessed at baseline
Locations:
Study officials:
affiliation: University of Monastir
name: Sana Salah, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06071104: Next Generation Cataract Surgery Study
Official title: Next Generation Cataract Surgery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Anterior segment ophthalmic surgery
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 121
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect user preference data.

Detailed description: Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated. This study will be conducted in the United States.

Eligibility criteria: Key Inclusion Criteria:

* Able to understand and sign an IRB/IEC approved Informed Consent form.
* Willing and able to attend all scheduled visits as required by the protocol.
* Clinically documented diagnosis of age-related noncomplicated cataract.
* Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential as defined in the protocol.
* Planned postoperative procedures during the course of the study in the operative eye.
* Previous intraocular or corneal surgery in the operative eye.
* Diagnosis of glaucoma or ocular hypertension (IOP \> 21 mmHg) in the operative eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"
timeFrame: Day 0
Secondary outcomes:
measure: Time From Incision Entry to Incision Closure
timeFrame: Day 0 surgery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Gordon Schanzlin New Vision Institute, A TLC Laser Eye Center
state: California
city: Ventura
country: United States
facility: Miramar Eye Specialists Medical Group
state: California
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Surgical
role: STUDY_CHAIR
References:
Clinical trial NCT05404204: The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy
Official title: Strategy to ROTAblate and PACE (ROTA-PACE) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Coronary Artery Calcification
Bradycardia
Keywords: Coronary Artery Calcification
Rotational Atherectomy
Temporary Pacemaker
Lead sponsor: Vancouver Island Health Authority
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing rotational atherectomy for calcific coronary disease without any exclusion criteria

Brief summary: Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.


Eligibility criteria: Inclusion Criteria:

* Age 18-90 years
* Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.
* Calcific coronary disease requiring rotational atherectomy

Exclusion Criteria:

* Pre-existing pacemaker or implantable cardioverter defibrillator.
* Mobitz II heart block or complete heart block.

Primary outcomes:
measure: Successful ventricular pacing
timeFrame: At the start of the PCI procedure immediately prior to rotational atherectomy
measure: Ventricular pacing threshold
timeFrame: At the start of the PCI procedure immediately prior to rotational atherectomy
Secondary outcomes:
measure: Complications
timeFrame: At the end of the PCI procedure
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
Study officials:
affiliation: Royal Jubilee Hospital, Victoria
name: Bilal Iqbal, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220504: 3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Official title: Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizophrenia Relapse
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Treatment
Maintenance
Lead sponsor: Fundación Marques de Valdecilla
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Biomédica en Red de Salud Mental
name: Instituto de Investigación Marqués de Valdecilla
First posted: 2014-08-20
Enrollment: 68
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the three years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.


Eligibility criteria: Inclusion Criteria:

* Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
* A minimum of 18 months on antipsychotic treatment.
* Meeting clinical remission criteria for at least the 12 months prior to inclusion.
* Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
* Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.

Exclusion Criteria:

* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
* Meeting DSM-IV criteria for mental retardation.
* Having a history of neurological disease or head injury.

Primary outcomes:
measure: Relapse rate.
timeFrame: At 3 years.
Secondary outcomes:
measure: Clinical psychopathology.
timeFrame: At 3 years.
measure: Time to relapse.
timeFrame: At 3 years.
measure: Clinical functionality.
timeFrame: At 3 years.
Other outcomes:
Locations:
city: Santander
country: Spain
facility: University Hospital Marques de Valdecilla
state: Cantabria
Study officials:
affiliation: University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain
name: Benedicto Crespo-Facorro, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayoral-van Son J, de la Foz VO, Martinez-Garcia O, Moreno T, Parrilla-Escobar M, Valdizan EM, Crespo-Facorro B. Clinical outcome after antipsychotic treatment discontinuation in functionally recovered first-episode nonaffective psychosis individuals: a 3-year naturalistic follow-up study. J Clin Psychiatry. 2016 Apr;77(4):492-500. doi: 10.4088/JCP.14m09540.
Clinical trial NCT05941104: The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
Official title: The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostatic Neoplasms
Frailty
Blood Biological Indicators
Quality of Life
Survival
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-12
Enrollment: 100
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients with Radical Prostatectomy.

Brief summary: The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.

The main questions it aims to answer are:

1. Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
2. Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.

Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
2. Radical prostatectomy is planned;
3. Voluntarily sign the informed consent form.

Exclusion Criteria:

1. Diagnosed with other malignant tumors at the same time;
2. Patients with acute infection.

Primary outcomes:
measure: Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)
timeFrame: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Secondary outcomes:
measure: Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)
timeFrame: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Other outcomes:
measure: Number of Participants Surviving up to 2 years
timeFrame: From date of hospitalization until the date of death from any cause, assessed up to 2 years.
Locations:
Study officials:
References: