louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01340066: Safety and Efficacy Study of a New Treatment for Symptoms of Urinary Incontinence
Official title: A Randomized, Double-blind, Parallel, Placebo-controlled Study for the Assessment of the Safety and Efficacy of UISH001 for the Symptomatic Improvement of Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence
Keywords: urinary incontinence
stress incontinence
urge incontinence
mixed incontinence
Lead sponsor: Beech Tree Labs, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Norwich Clinical Research Associates Ltd.
First posted: 2011-04-22
Enrollment: 94
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 if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Women who have moderate to severe urge, stress or mixed Urinary Incontinence

Exclusion Criteria:

* Medical history of migraines, neurologic problems, swallowing disorder, stroke or severe depression.
* Medical history of heart failure, peripheral edema or moderate to severe asthma or chronic obstructive pulmonary disease (COPD)
* Certain restricted medications
* Any other condition that would interfere with the safety of the subject

Primary outcomes:
measure: Percentage of Participants With a Decrease in Leakage Events of 30% or More.
timeFrame: Change from baseline after 4 weeks of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Upper St. Clair
country: United States
facility: PEAK Research, LLC
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00784966: Islet After Kidney Transplant for Type 1 Diabetes
Official title: Pancreatic Islet Transplantation in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Islet transplantation
Type 1 Diabetes Mellitus
Kidney Transplantation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of Miami
First posted: 2008-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.

Exclusion Criteria:

* Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
* Active infections (clinically or by laboratory testing)
* History of current malignancy or suspicion of malignancy until properly investigated and excluded
* Liver or biliary abnormalities
* Unstable cardiovascular disease
* Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception

Primary outcomes:
measure: The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy.
timeFrame: Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months.
Secondary outcomes:
measure: Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control.
timeFrame: Outcome measures will be assessed at protocol prescribed intervals.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Adrian H Cotterell, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University Health System
name: John N Clore, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056366: The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy
Official title: The Effect of α-lipoic Acid Treatment in Patient With Cardiac Autonomic Neuropathy by Comparing the Change of HRV Index & ANS Function:A 6month Multicenter, Randomized, Open Label Clinical Trial CANON Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Cardiac Autonomic Neuropathy
Keywords: Cardiac Autonomic Neuropathy
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 see if it is safe and effective to give alpha lipoic acid in people with cardiac autonomic neuropathy(CAN). Cardiac autonomic neuropathy(CAN) affects the nerves that control heart rate and blood flow to the heart in people with diabetes. CAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart.

Detailed description: Study type : Interventional Study Design : Allocation: Randomized Control: no treatment Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Primary Outcome Measures : Heart rate variability(HRV) Index

Secondary Outcome Measures : Autonomic Nerve System(ANS) function 5 test, EuroQoL 5-Dimension Questionnaire(EQ-5D)

Eligibility criteria: Inclusion Criteria :

* Established Cardiac Autonomic Neuropathy in type 2 diabetes.
* aged 20 years to 80 years
* Capable of giving informed consent

Exclusion Criteria :

* History of other significant disease such as the nerve system (Parkinson's disease, epilepsy, multiple sclerosis), hepatic disease, hypothyroid, etc Other medical condition or treatment likely to affect the autonomic nerve system
* HbA1C \> 11%
* Not controlled hypertension (SBP≥160mmHg, DBP≥100mmHg)
* Diagnosed ketoacidosis within 4 weeks
* Unstable cardiac disease (unstable angina or myocardial infarction )
* Pregnancy
* Involvement in other clinical trial in last 4 weeks
* Known or suspected sensitivity to trial products

Primary outcomes:
measure: Primary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
timeFrame: up to 24weeks
Secondary outcomes:
measure: Secondary Efficacy of α-lipoic Acid in patients with cardiac autonomic neuropathy
timeFrame: up to 24weeks
Other outcomes:
measure: Number of Patients with Adverse events as a Measure of Safety
timeFrame: up to 24weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
city: Seoul
country: Korea, Republic of
facility: Sejong General Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Bong Yun Cha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06863766: Effects of Milk Powder Intervention on Blood Glucose Control and Fluctuation in Middle-aged and Elderly People With Pre-diabetes
Official title: Effects of Daily Supplementation With Milk Powder on Blood Glucose Control and Fluctuation in Middle-aged and Older Adults: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-diabetes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to conduct a 8-week intervention involving one formula milk powder for middle-aged and elderly individuals with pre-diabetes, assessing its impact on blood glucose control and fluctuations in comparison to interventions using regular milk powder.


Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 75 years, regardless of gender.
2. Impaired fasting glucose (5.6 mmol/L ≤ FPG \< 6.9 mmol/L) or glycated hemoglobin (HbA1c) between 5.7-6.4% (39-47 mmol/mol).
3. Resided in Guangzhou for the past six months and no plans to relocate or travel outside the city in the next month.
4. Signed informed consent form and voluntarily agreed to participate in the project.

Exclusion Criteria:

1. Patients with a confirmed diagnosis of diabetes who are currently taking glucose-lowering medications (e.g., insulin, GLP-1 receptor agonists, or SGLT2 inhibitors).
2. Individuals with lactose intolerance or dairy product intolerance.
3. Pregnant, planning to become pregnant within the next three months, or currently breastfeeding.
4. Weight change \> 5% in the past three months or plans to lose weight or change dietary habits.
5. Alcohol consumption \> 40g/day.
6. Individuals with communication barriers, cognitive impairments, or other conditions that may prevent them from completing the study procedures.
7. Severe diseases that may affect participation in the study, including but not limited to endocrine disorders, severe cardiovascular or cerebrovascular diseases, cancer, metabolic diseases, etc.
8. Participation in or current involvement in other clinical trials within the past three months.
9. No use of antibiotic medications within the past three months.

Primary outcomes:
measure: fasting blood glucose
timeFrame: up to 8 weeks
measure: 2h-piAUC after standardized breakfast
timeFrame: up to 8 weeks
measure: TIR (time in range)
timeFrame: up to 8 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: up to 8 weeks
measure: weight
timeFrame: up to 8 weeks
measure: intestinal bacteria
timeFrame: up to 8 weeks
measure: lipid metabolism
timeFrame: up to 8 weeks
measure: sleep quality
timeFrame: up to 8 weeks
measure: blood pressure
timeFrame: up to 8 weeks
measure: Continuous Glucose Monitoring (CGM) Data
timeFrame: up to 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04055766: A Diagnostic Test on DeepDoc-an AI-based Decision Support System
Official title: DeepDoc - Clinical Validation of an AI-based Decision Support System in the Early Diagnostic Evaluation of Neurological Diseases: a Prospective Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Headache
Vertigo
Meningitis/Encephalitis
Keywords: Artificial Intelligence
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4000 consecutive patients suspected of stroke，meningitis/encephalitis, vertigo and headache（1000 cases of each disease) are admitted to the department of neurology that consented to involvement in the study.

Brief summary: DeepDoc is an AI-based decision support system for the early etiology diagnosis of neurological diseases using clinical data points from patients admitted to hospital within 24 hours.This study aims to evaluate whether the diagnosis of the DeepDoc AI-based decision support system is better than the doctor's initial diagnosis by a multi-center, superiority diagnostic study.

Detailed description: The doctor completes the admission note within 24 hours after the patient is admitted to the hospital. After informed consent is given to the patient who meet the inclusion criteria, open the DeepDoc to fill in the patient identification information. Then take the picture of the initial diagnosis of the admission note page and upload it to DeepDoc, fill the doctor's initial diagnosis into the DeppDoc. And put the patient's clinical data points into the DeepDoc to get a DeepdDoc diagnosis.

Eligibility criteria: Inclusion Criteria:

1. Patients with clinical symptoms or signs suspected of stroke，meningitis/encephalitis, vertigo and headache.
2. Neurological examination results and imaging changes within 24 hours of admission.

Exclusion Criteria:

Patients discharged, transferred to the hospital, or died within 24 hours after admission.

Primary outcomes:
measure: Accuracy of diagnosis by DeepDoc AI-based Decision Support System
timeFrame: 24 hours
Secondary outcomes:
measure: Sensitivity of diagnosis by DeepDoc AI-based Decision Support System
timeFrame: 24 hours
measure: Specificity of diagnosis by DeepDoc AI-based Decision Support System
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Zhao Gang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002266: An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Official title: An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
ammonium trichloro(dioxoethylene-O,O'-)tellurute
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Standard therapy for infections.
* Acyclovir.
* Ganciclovir.
* Allowed only with permission of Wyeth-Ayerst medical monitor:
* Zidovudine (AZT).
* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Evidence of severe liver dysfunction (serum albumin \< 3 g/dl, SGOT or SGPT \> 5 x upper limit of normal, prothrombin time \> 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
* Evidence of AIDS-related central nervous system involvement.
* Disseminated Kaposi's sarcoma.

Concurrent Medication:

Excluded without permission of Wyeth-Ayerst medical monitor:

* Zidovudine (AZT).
* Immunomodulators.
* Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

* Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
* Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
* Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 4 weeks of study entry:

* Systemic antiviral agents.
* Immunosuppressive agents.
* Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.

Patients must:

* Have a diagnosis of AIDS or AIDS related complex (ARC).
* Demonstrate intolerance or refusal to take zidovudine (AZT).
* Provide written informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Univ of Arizona / Health Science Ctr
state: Arizona
Study officials:
References:
Clinical trial NCT00176566: A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
Official title: A Phase II Trial to Assess the Effects of Green Tea in Oral Leukoplakia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Oral Leukoplakia
Keywords: oral leukoplakia
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: You have been asked to participate in this research study because you have or may have oral leukoplakia. Oral leukoplakia is described as a white patch or plaque on the oral mucosa (mouth) that will not rub off and cannot be removed by scraping, reversed by elimination of obvious irritants (things that cause redness and/or swelling) such as dentures (artificial replacment for missing teeth), or lesions as described that are diagnosed by your dentist.

Detailed description: Since oral leukoplakia may precede the development of cancer, using agents that may prevent cancer, called chemoprevention, may be useful. The purpose of this study is to determine whether taking a green tea preparation may have effects on your leukoplakia. It is hoped that these effects may reduce the subsequent risk of cancer in or around the area of leukoplakia. To assess for these effects, samples of the lining of your mouth will be obtained, and they will be analyzed looking for certain features (biomarkers).

Eligibility criteria: * Patients with oral leukoplakia without evidence of active infections in the mouth will be invited to participate in this study.
* Patients must currently consume no more than 3 cups of tea a day,
* not be taking large doses of vitamin A or its derivatives (more than 25,000 units), selenium, or beta-carotene.
* Additionally, patients must not participate in this study if they are allergic to caffeine, have GI ulcers, are pregnant, or have had previous invasive mouth cancer.

Primary outcomes:
measure: To assess the effect of green tea lozenge versus placebo on the prevalence, size, and histologic severity of oral leukoplakia.
timeFrame: 3 years
Secondary outcomes:
measure: Additionally, we will correlate the changes in oral leukoplakia with levels of tea polyphenols in saliva and in biopsied lesions; DNA content in leukoplakia cells obtained from buccal scrapings; and proliferation index, apoptotic index, and expression of
timeFrame: 3 years
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Susan Goodin, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00238966: Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
Official title: A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Keywords: Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.


Eligibility criteria: Inclusion/ Exclusion criteria

- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.
Secondary outcomes:
measure: Safety based on renal function within 6 months after medication switch.
measure: Pharmacokinetics (PK) in a randomized subpopulation.
measure: Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.
measure: Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.
measure: Graft survival and patient survival 6 months post medication switch.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT02832466: Quantifying the Deterioration of Physical Function in Renal Patients
Official title: Quantifying the Deterioration of Physical Function Along 6 Months in Patients in End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Chronic Kidney Diseases undergoing hemodialysis treatment

Brief summary: Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases.

The purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.


Eligibility criteria: Inclusion Criteria:

* people under hemodialysis treatment at least 3 months
* be medicable stable
* complete all the physical tests

Exclusion Criteria:

* heart stroke in the previous 6 weeks of the study
* inferior limb amputation without artificial aids
* cerebral vascular disease (ictus, ischemic)
* disability to complete functional tests

Primary outcomes:
measure: Change from Baseline Short Physical Performance Battery at 6 months
timeFrame: At the beginning of the study and after 6 months
measure: Change from Baseline One Leg Standing Test at 6 months
timeFrame: At the beginning of the study and after 6 months
measure: Change from Baseline Timed Up and Go at 6 months
timeFrame: At the beginning of the study and after 6 months
measure: Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months
timeFrame: At the beginning of the study and after 6 months
measure: Change from Baseline On leg heel rise at 6 months
timeFrame: At the beginning of the study and after 6 months
measure: Change from Baseline Handgrip strength at 6 months
timeFrame: At the beginning of the study and after 6 months
measure: Change from Baseline Six Minutes Walking Time at 6 months
timeFrame: At the beginning of the study and after 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Lecturer in the Cardenal Herrera University
name: Eva Segura Ortí
role: PRINCIPAL_INVESTIGATOR
References: