louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00508430: ASP 8825 - Study in Patients With Painful Diabetic Polyneuropathy
Official title: ASP 8825 Phase II Study-A Double- Blind, Placebo- Controlled Study in Patients With Painful Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Neuropathies
Keywords: ASP8825
Diabetic Neuropathies
Pain
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-07-30
Enrollment: 199
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the superiority of ASP8825 over placebo and dose response in patients with painful diabetic polyneuropathy.

Detailed description: Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with painful diabetic polyneuropathy.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 20 - 79 years
* Diabetes mellitus patients with diabetic polyneuropathy who have pain symptom for 26 weeks prior to the study
* Subjects who are compliant with diary completion

Exclusion Criteria:

* Subjects who have pain from other diseases at the evaluating site
* Subjects who have nerve diseases at the evaluating site
* Subjects with foot ulcer or gangrene

Primary outcomes:
measure: Pain severity rating
timeFrame: 8 week
Secondary outcomes:
measure: Severity of numbness, maximum pain, night pain and sleep disturbance.
timeFrame: 8 week
measure: Responder rate
timeFrame: 8 week
measure: Patient's global impression of change
timeFrame: 8 week
measure: Clinical's global impression of change
timeFrame: 8 week
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04966130: Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
Official title: Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle-Invasive Bladder Carcinoma
Keywords: muscle-invasive bladder cancer
robot-assisted radical cystectomy
urinary indwelling time
continence
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2021-07-19
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing robot- assisted radical cystectomy with orthotopic ileal neobladder will be enrolled.

Brief summary: The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Detailed description: Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.

Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically confirmed bladder cancer
2. Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder
3. Complete perioperative clinical data

Exclusion Criteria:

1. Patients diagnosed with distant metastasis
2. Patients who had urinary incontinence before surgery
3. Patients with unavailable follow-up data

Primary outcomes:
measure: Day-time continence rate
timeFrame: 1 year
measure: Night-time continence rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jian Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05214430: Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Official title: Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn Disease in Remission
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For patients with Crohn's diseases undergoing surgery，whether postoperative exclusive enteral nutrition(EEN) could delay the endoscopic relapse needs exploration.The trial will investigate the efficacy of postoperative EEN for maintaining disease remission.


Eligibility criteria: Inclusion Criteria:

- CD patients who undergoing bowel resection with anastomosis

Exclusion Criteria:

* patients who received stoma creation

Primary outcomes:
measure: postoperative endoscopic recurrence
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
state: Jiangsu
Study officials:
References:
Clinical trial NCT04066530: A Study to Evaluate the Efficacy and Safety of AD-203
Official title: A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AD-203 in Patients With Acute or Chronic Gastritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-26
Enrollment: 475
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: This is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the non-inferiority of AD-203 compared with Mucosta tab. in patients with acute or chronic gastritis


Eligibility criteria: Inclusion Criteria:

* Age is over 20 years old, under 75 years old, men or women
* Patients diagnosed with acute or chronic gastritis by gastroscopy

Exclusion Criteria:

* Patients who is impossible to receive gastroscopy
* Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit

Primary outcomes:
measure: A percentage of subjects showed improvement of stomach erosions by the endoscopy.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: JongJae Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787030: Application of Vitamin E on Anal Fissure
Official title: Application of Vitamin E Acetate Ointment vs Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 160
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: Patients were randomized into 2 groups:

* Vitamin E: Vitamin E ointment will be applied during 8 weeks
* Nitroglycerin: Nitroglycerin ointment will be applied during 8 weeks

Healing rate of chronic anal fissure in patients receiving Nitroglycerin ointment and subjects patients receiving Vitamin E ointment were evaluated .

Detailed description: Patients were randomly assigned to experimental and control groups: those patients receiving vitamin E ointment (Experimental Group - EG) and those receiving glyceryl trinitrate ointment (Control Group - CG).

Treatments:

Glyceryl trinitrate ointment (GTO): Commercially available aluminium tubes containing 0.4 glyceryl trinitrate ointment (Rectogesic, proStrakan Group, Galashiels, UK) were purchased from pharmacies. The dosage for all the patients was 375 mg of ointment (containing 1.5 mg of glyceryl trinitrate), applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Vitamin E acetate ointment (VEA): Commercially available plastic tubes containing VitaminE acetate ointment (Filme Olio, Hulka SRL, Italy) were purchased from pharmacies. The dosage for all the patients was 1ml, applied with a gloved finger to the distal anal canal, every 12 hours for an 8-week period.

Healing rate of chronic anal fissure was investigated.

Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of chronic anal fissure

Exclusion Criteria:

* patients with associated anal pathologies
* intestinal inflammation disorders
* immunosuppression
* fissures secondary to underlying diseases (eg, AIDS, tuberculosis, or sexually transmitted diseases)
* patients with a history of headaches, heart disease, or intolerance to nitrates
* pregnant or lactating women
* patients with closed angle glaucoma

Primary outcomes:
measure: Pain associated to anal fissure: Visual Analogic Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants achieving the healing of the fissure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Garcilaso Clinic
Study officials:
affiliation: Garcilaso Clinic
name: Carolina Llavero
role: STUDY_DIRECTOR
References:
citation: Ruiz-Tovar J, Llavero C. Perianal Application of Glyceryl Trinitrate Ointment Versus Tocopherol Acetate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial. Dis Colon Rectum. 2022 Mar 1;65(3):406-412. doi: 10.1097/DCR.0000000000002120.
Clinical trial NCT03914430: Breakfast Cereals Consumed in Dairy and Non-dairy Medium: the Effects on Blood Glucose, Satiety and Food Intake
Official title: The Effect of Dairy and Non-Dairy Cultured Products Added to Breakfast Cereals on Satiation, Satiety, Blood Glucose Control and Short-Term Food Intake in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Eating
Food
Keywords: Breakfast
Blood glucose
Food intake
Satiety
Lead sponsor: Mount Saint Vincent University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Dairy Farmers of Canada
First posted: 2019-04-16
Enrollment: 24
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The effects of dairy-free products consumed with a breakfast meal on food intake and glycaemic regulation remain unexplored. It is known that dairy products are an excellent source of protein, low glycaemic sugar lactose, calcium, and vitamin D. In our recent study the consumption of a dairy snack with high protein content resulted in reduced blood glucose response compared to non-dairy snack with the similar amount of available carbohydrate. The investigators hypothesize that the ad libitum intake of breakfast cereals served with a high-protein fermented dairy product will result in reduced and sustained blood glucose response compared to non-dairy control. The objective of this study is to investigate how dairy and non-dairy cultured products used as carriers for breakfast granola cereals and consumed ad libitum affect short-term food intake, satiety, and glycaemia within two hours.


Eligibility criteria: Inclusion Criteria:

* Healthy females

Exclusion Criteria:

* Overweight or obese
* Breakfast skippers
* Have any chronic metabolic diseases
* Smokers
* Taking medications

Primary outcomes:
measure: Postprandial blood glucose concentration
timeFrame: 0-120 minutes
measure: Subjective feeling of appetite
timeFrame: 0-120 minutes
measure: Ad libitum food intake
timeFrame: 0-120 minutes
Secondary outcomes:
measure: Circulatory insulin concentration
timeFrame: 0-120 minutes
measure: Subjective feeling of physical comfort
timeFrame: 0-120 minutes
measure: Subjective feeling of food palatability (pleasantness)
timeFrame: 0, 120 minutes
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Mount Saint Vincent University
state: Nova Scotia
Study officials:
affiliation: Mount Saint Vincent University
name: Bohdan Luhovyy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131530: Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using pCLE With Artificial Intelligence
Official title: Automatic Evaluation of Inflammation Activity in Ulcerative Colitis Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Artificial Intelligence
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who receive the endoscopy pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

Brief summary: Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables to evaluate the inflammation activity of ulcerative colitis with excellent correlation with histopathology. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80; diagnosed as UC

Exclusion Criteria:

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

Primary outcomes:
measure: The diagnosis efficiency of Artificial Intelligence
timeFrame: 3 months
Secondary outcomes:
measure: Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists
timeFrame: 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06584630: Molecular Classification of Endometrial Cancer: Impact on Adjuvant Treatment Planning.
Official title: Molecular Classification of Endometrial Cancer: Impact on Adjuvant Treatment Planning.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endometrial cancer patients that underwent surgery and were tested for molecular analysis (POLE, MSI, p53)

Brief summary: Molecular classification that has been recently incorporated in FIGO classification of endometrial cancer is a new triage tool for the better management of endometrial cancer patients.


Eligibility criteria: Inclusion Criteria:

* Histological confirmation of endometrial cancer.
* Surgical treatment at our Gynecological - Oncology Unit.

Exclusion Criteria:

* Refusal to be tested for the molecular classification
* Presence of a synchronous neoplasm.

Primary outcomes:
measure: Multidisciplinary Team Board decision change
timeFrame: 2 years (study completion)
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: 1st Department of Obstetrics & Gynecology, AUTh, "Papageorgiou" Hospital
Study officials:
References:
Clinical trial NCT04352530: Culturally Appropriate Nutrition Communication for Mexican American Women
Official title: Culturally Appropriate Nutrition Communication for Mexican American Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lifestyle Risk Reduction
Nutrition Poor
Chronic Disease
Obesity
Cancer, Breast
Keywords: sugar sweetened beverages
Health Communication
Values-based messages
Latinas
Latinx
Hispanic
Experiment
Message testing
tailoring
Lead sponsor: University of California, Merced
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-20
Enrollment: 881
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized controlled trial to test the effects of culturally appropriate nutrition communication for Mexican American women.

Detailed description: An unbalanced randomized controlled trial with pre-test and immediate post-test was employed to test the effects of different types of message features and appeals. The study was conducted online with Mexican American women aged 18-29 years old. Messages focused on sugary beverage consumption and the main outcomes were acceptance and receptivity to the message (i.e., perceived effectiveness), perceptions of social norms, and knowledge. The investigators also measured a number of hypothesized mediators and moderators of the effects.

Eligibility criteria: Inclusion Criteria:

* Self-identify as Latina/x or Hispanic
* Self-identify as a woman
* Self-reported as being of age between 18-29 years
* Undergraduate students enrolled in SONA at UC Merced

Exclusion Criteria:

- Not Mexican American

Primary outcomes:
measure: Perceived effectiveness
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Identification with the message
timeFrame: Immediately post-intervention
measure: Activation of social justice values
timeFrame: Immediately post-intervention
measure: Sugary beverage related media literacy
timeFrame: Pre-test and Immediately post-intervention
measure: Public health literacy
timeFrame: Pre-test and Immediately post-intervention
measure: Empowerment
timeFrame: Pre-test and Immediately post-intervention
measure: Beverage knowledge
timeFrame: Pre-test and Immediately post-intervention
measure: Engagement
timeFrame: Immediately post-intervention
measure: Similarity
timeFrame: Immediately post-intervention
measure: Elaboration
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Merced
country: United States
facility: University of California Merced SONA System (Online Platform)
state: California
Study officials:
References:
Clinical trial NCT03558230: Sensory Stimulation During CIMT
Official title: Sensory Stimulation During Constraint-Induced Movement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: pediatric
hemiplegic
hand function
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 13
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.

Detailed description: The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.

Eligibility criteria: * Between the ages of 3 and 9
* Have unilateral upper limb motor weakness.
* Use the affected extremity as a gross assist during play and self-care activities.
* No significant developmental delays that would limit spontaneous use of the more affected extremity.
* Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity.
* No other health impairment other than hemiparesis.

Primary outcomes:
measure: Feasibility (Total Number of Hours That Participants Wear the Device)
timeFrame: through 5-day study completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Na Jin Seo, PhD
role: PRINCIPAL_INVESTIGATOR
References: