louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04710706: Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique
Official title: Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique (WAVE): a Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyp
Keywords: COLONOSCOPY
ENDOSCOPY
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The colonoscopy procedure involves insertion of a thin, flexible tube with a tiny camera inside (colonoscope) passed inside the bowel. To allow passage of the colonoscope and adequate visualisation of the lining of the bowel wall a range of techniques can be used. During colonoscopy, you can distend the colon with water, CO2 and air.

Air is no longer recommended for gas insufflation during colonoscopy as it causes pain and excess bowel distention. So the options are water and/or CO2 but it is not entirely clear which combination is the best and at what point during the colonoscopy.

In practice, a hybrid technique where both CO2 and water are used during the colonoscopy in used. Here, water is exclusively used to help navigate the sigmoid colon with air pockets suctioned and turbid water exchanged with clean water. From splenic flexure to caecum a mixture of water and CO2 is used.

The aim of this study is to assess procedure comfort and efficiency of two different colonoscopy insertion techniques: water-alone insertion of the colonoscope (gas insufflation not allowed on insertion; water exchange technique) versus water-CO2 hybrid insertion (water used predominately to splenic flexure with water/CO2 used to caecum; modified water immersion technique).


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Capacity to consent

Exclusion Criteria:

* Pregnancy
* Previous bowel surgery
* Unable to consent

Primary outcomes:
measure: Insertion time
timeFrame: During procedure
measure: Total procedure time
timeFrame: During procedure
Secondary outcomes:
measure: Caecal intubation rate
timeFrame: During procedure
measure: Patient discomfort scores
timeFrame: Immediately after procedure
measure: Loop formation
timeFrame: During procedure
measure: Adenoma detection rate
timeFrame: 1 week after procedure with results of histology
measure: Serrated polyp detection rate
timeFrame: 1 week after procedure with results of histology
measure: Number of ancilliary procedures
timeFrame: During procedure
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
Study officials:
References:
Clinical trial NCT04266106: Probiotics and Recovery From Gastrointestinal Surgery - 2
Official title: Effect of Perioperative Probiotics on Clinical Outcomes of Patients Undergoing Major Abdominal Operation in Community Settings - 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Surgical Recovery
Lead sponsor: MercyOne Des Moines Medical Center
Sponsor class: OTHER
Collaborators: name: SuperBio
First posted: 2020-02-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.


Eligibility criteria: Inclusion Criteria:

* Adults aged ≥18 years undergoing elective major abdominal operation
* Functional GI tract expected after operation

Exclusion Criteria:

* Current episode of acute necrotizing pancreatitis as defined by surgeon
* Palliative decompressive GI tube
* Life expectancy ≤ 6 months
* Systemic immune-mediated disease active requiring systemic therapy:
* Prednisone ≥20 mg QD
* IV immunoglobulins
* Anti-rejection medication
* Presence of functional transplanted organ
* Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.
* Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed
* Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle
* Need for full systemic anticoagulation postoperatively.

Primary outcomes:
measure: Quality of Life
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: MercyOne Des Moines Medical Center
state: Iowa
Study officials:
affiliation: MercyOne Des Moines Medical Center
name: Jan Franko
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franko J, Raman S, Krishnan N, Frankova D, Tee MC, Brahmbhatt R, Goldman CD, Weigel RJ. Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation. J Am Coll Surg. 2019 Dec;229(6):533-540.e1. doi: 10.1016/j.jamcollsurg.2019.09.002. Epub 2019 Sep 25.
Clinical trial NCT01428206: Liverpool Care Pathway for the Dying at Residential Care Homes
Official title: Liverpool Care Pathway for the Dying at Residential Care Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-of-life Care
Keywords: palliative care
nursing homes
Liverpool care pathway
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Liverpool Care Pathway for the dying patient (LCP) was developed to transfer the care practice from the hospice setting to the hospital setting in UK. LCP is a pathway with standardized registration method to monitor the care and its results. The primary aim is to study the effects of LCP on dying patients symptom burden and communication with close relatives and health care professionals.

Detailed description: All residential care homes in Skellefteå municipality are included in the study and randomized either to control or intervention group. During the baseline period the care is provided as usual. During the intervention period the LCP is used for patients for whom the dying phase is diagnosed in the intervention group. Usual care is performed for the control group. After death of a patient a close relative fill in a questionnaire.

Eligibility criteria: Inclusion Criteria:

* nursing homes in Skellefteå municipality, Sweden

Exclusion Criteria:

-

Primary outcomes:
measure: quality of care
timeFrame: one month to six months after the relatives death
Secondary outcomes:
measure: place of death
timeFrame: the time of death
measure: drug consumption
timeFrame: the last three days before death
Other outcomes:
Locations:
city: Skellefteå
country: Sweden
facility: Skellefteå municipality
state: Västerbotten
Study officials:
affiliation: Department of nursing, Umeå University
name: Margareta Brännström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913406: Effect of Lutein in S-26 Gold On Growth And Safety
Official title: Effect of Lutein in S-26 Gold on Growth and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Effect of lutein fortification growth healthy term infants
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 232
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.


Eligibility criteria: Inclusion Criteria:

* Healthy infants aged 0-14 days
* Full Term birth and AGA Parent(s) signed informed consent

Exclusion Criteria:

* Unhealthy infant
* Participation in other clinical trial
* Use of prohibited medications

Primary outcomes:
measure: Weight gain/day in grams/day
timeFrame: 4 months
Secondary outcomes:
measure: Collection of adverse experiences
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04296006: Neurobehavioral Mechanisms of Cocaine Choice
Official title: Neurobehavioral Mechanisms of Cocaine Choice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A placebo-controlled, randomized, within-subjects design will be used to assess cocaine-vs-money choice in cocaine use disordered subjects as a function of alternative reinforcer value.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making "profile" associated with the decision to take cocaine and the reduced cocaine choice that occurs during a behavioral intervention (alternative money reinforcer) that models contingency management.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use, otherwise healthy

Exclusion Criteria:

* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Primary outcomes:
measure: The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
timeFrame: Choices occur across a 40 minute session
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Joshua Lile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434506: Prevalence of the Wire Syndrome
Official title: Prevalence and Risk Factors Associated With Wire Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthodontic Wires
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University who have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine

Brief summary: The Wire Syndrome problem referred to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive on teeth still contained by an intact orthodontic wire, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence of mandibular wire syndrome and the associated risk factors.


Eligibility criteria: Inclusion Criteria:-students in their 4th, 5th, and 6th year of dental studies at the Côte d'Azur University

- have undergone orthodontic treatment and are wearing a fixed mandibular retainer from canine to canine.

Exclusion Criteria:'- orthodontic treatment in progress

* absence/fracture of orthodontic fixed mandibular retainer
* wearing a removable mandibular retainer.

Primary outcomes:
measure: Prevalence of the Wire Syndrome
timeFrame: End : July 2023
Secondary outcomes:
measure: Identify risk factors associated with wire syndrome - questionnaire
timeFrame: End : July 2023
measure: Identify risk factors associated with wire syndrome - clinical examination periodontium
timeFrame: End : July 2023
measure: Identify risk factors associated with wire syndrome - clinical examination - Angle
timeFrame: End : July 2023
measure: Identify risk factors associated with wire syndrome - clinical examination: overbite / overjet
timeFrame: End : July 2023
measure: Identify risk factors associated with wire syndrome - clinical examination / presence/absence clinical signs
timeFrame: End : July 2023
measure: Identify risk factors associated with wire syndrome - clinical examination / description clinical signs
timeFrame: End : July 2023
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Carole Charavet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516006: Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
Official title: Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary sclerosing cholangitis (PSC) is an idiopathic condition with intrahepatic cholangitis and fibrosis, leading to multifocal bile duct stricture. Its main clinical manifestations are chronic cholestatic lesions and is deemed as autoimmune liver disease. PSC are immune abnormalities that occurs in patients with genetic susceptibility. No other pathogenesis is revealed yet. Ursodeoxycholic acid is used as an empirical treatment, and there is no approved drug or a acceptable treatment regimen. The disease often progresses to liver decompensation and requires liver transplantation. In recent years, the clinical application of stem cell therapy has seen many important advances. Stem cells are characterized with properties of multiple differentiation, repair of damaged tissue and immuno-modulation. This study aims to employ UCMSCs to treat PSC patients and observe its efficacy and safety, and to explore the possible therapeutic mechanisms.


Eligibility criteria: Inclusion Criteria:

* progressive PSC
* willing to give consent

Exclusion Criteria:

* decompensated liver cirrhosis
* total serum bilirubin \>5ULN
* refractory ascites
* serum creatinine \>1.5mg/dL
* Cirrhotic nodules with malignant tendencies
* primary biliary cholangitis
* IgG4-associated sclerosing cholangitis
* non-PSC induced bile duct stones
* biliary tract trauma
* recurrent suppurative cholangitis
* neoplastic disease
* pancreatic disease

Primary outcomes:
measure: adverse effects regarding UCMSC infusion
timeFrame: 1 year
Secondary outcomes:
measure: Pathological score of liver inflammation
timeFrame: 1 year
measure: Changes of biliary lesions in magnetic resonance image
timeFrame: 1 year
measure: alanine aminotransferase
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00240006: A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone
Official title: An Open Label, Prospective Parallel Cohort Study Comparing A 90-day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Copaxone®
Shared Solutions®
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.


Eligibility criteria: Inclusion Criteria:

1. Males or females, 18 years of age or older.
2. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted).
3. Beginning or restarting therapy with Glatiramer Acetate (Copaxone®).
4. Willing and able to complete all procedures and evaluations related to the study.
5. Willing to provide informed consent.

Exclusion Criteria:

1. Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®.
2. Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study.
3. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study.
4. Pregnant or trying to become pregnant, or breast feeding during the study.
5. Previously participated in this study or another clinical research study in the past 30 days.

Primary outcomes:
measure: Adherence rate of Copaxone therapy by procedural intervention
timeFrame: 90 days
Secondary outcomes:
measure: Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: MerriKay Oleen-Burkey, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00472706: Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease
Official title: A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bowen's Disease
Keywords: Treatment
Excision
Photodynamic therapy
Recurrence rate
Cosmetic outcome
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2007-05-14
Enrollment: 65
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: The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

Detailed description: The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Histological proven Bowen's disease on scalp, face, trunk, arms and legs
* Informed Consent

Exclusion Criteria:

* Recurrent Bowen's disease
* Anogenital or subungual Bowe's disease
* Other skin malignancy in the same area
* Porphyria

Primary outcomes:
measure: recurrence rate
timeFrame: two years
Secondary outcomes:
measure: cosmetic outcome
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Catharina hospital/Erasmus MC
name: Annette Verzijl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02318706: DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain
Official title: An Asian, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled 14-Week Study of DS-5565 in Patients With Diabetic Peripheral Neuropathic Pain Followed by a 52-Week Open-label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathic Pain
Keywords: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: CMIC Co, Ltd. Japan
name: Quintiles, Inc.
name: Quintiles Malaysia Sdn Bhd
First posted: 2014-12-17
Enrollment: 854
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigate the efficacy and safety of DS-5565 in subjects with Diabetic Peripheral Neuropathic Pain (DPNP) in comparison to placebo

Detailed description: \[Double Blind Phase\] The primary objective is to compare change in the Average Daily Pain Score(ADPS) from baseline to Week 14 in Asian subjects with DPNP receiving DS-5565 versus placebo.

\[Open Extension Phase\] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with DPNP.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus at screening
* Painful distal symmetric polyneuropathy
* At screening, a pain scale of ≥ 40 mm

Exclusion Criteria:

* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0%

Primary outcomes:
measure: Change in the Average Daily Pain Score (ADPS) From Baseline to Week 14 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain
timeFrame: Baseline to Week 14 (post-dose 1 [15 mg QD] and post-dose 2 [20 mg and 30 mg])
Secondary outcomes:
measure: Change in Visual Analog Scale From Baseline (Week 14) to Week 66 Following Administration of DS-5565 in Participants With Diabetic Peripheral Neuropathic Pain
timeFrame: From baseline (Week 14) to Week 66
Other outcomes:
Locations:
city: Oita
country: Japan
facility: Saiki Central Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29.