louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04248322: Qualitative Assessment of the Impact of TTNS on QOL and Participation
Official title: Qualitative Assessment of the Impact of Transcutaneous Tibial Nerve Stimulation (TTNS) on Quality of Life and Participation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurogenic Bladder
Urinary Retention
Urinary Tract Infections
Spinal Cord Injuries
Keywords: Quality of Life
Participation
Barrier
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will purposively recruit consumers Y1-Y4 to explore their experience with bladder function, as well as NLUTD-related barriers and impact on one's life. Recruitment will be guided by a random sampling of patient characteristics to promote comprehensive sampling as follows: usual bladder management, and etiology of NLUTD (n=20).

Brief summary: This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Detailed description: Identify NLUTD user-defined themes regarding bladder function and and the daily impacts on one's life Specific Aim: Using iterative, semi-structured interviews or focus groups to explore the lived experience using TTNS neuromodulation to generate user-defined themes regarding bladder function and the daily impacts on one's life.

Eligibility criteria: Inclusion:

Participated in TTNS Study for 1 year.

Primary outcomes:
measure: Consumer user-defined themes from qualitative interviews
timeFrame: Collected once at study completion at 1 year
Secondary outcomes:
measure: Follow-up calls regarding user-defined themes
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Emily Leonard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02069522: Healthy Term Infants Fed Milk-Based Formulas
Official title: Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infants
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2014-02-24
Enrollment: 91
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.


Eligibility criteria: Inclusion Criteria:

* Infant is in good health
* Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
* Infant's birth weight was \> 2490 g (\~5 lbs 8 oz)
* Infant is between 14 and 28 days of age
* Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
* Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
* Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance

Primary outcomes:
measure: Carotenoid Concentration
timeFrame: Change from Baseline to end of Study Period A (~21 Days)
Secondary outcomes:
measure: Carotenoid Concentration
timeFrame: Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days)
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: Tuscon Medical Center
state: Arizona
city: Indianapolis
country: United States
facility: Northpoint Pediatrics
state: Indiana
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: John B Lasekan, PhD, CCRP
role: STUDY_CHAIR
References:
Clinical trial NCT01812122: Effects of Vildagliptine and Glimepiride on Glucose Variability
Official title: Effects of Vildagliptine and Glimepiride on Glycemic Variability and Cardiovascular Parameters in Patients With Type 2 Diabetes by CGMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze the differences of blood sugar level and glycemic variability between sulfonylurea and DPP-4 inhibitor groups applying CGMS for a chosen number of type 2 DM patients. The investigators also reveal influences of each drugs on cardiovascular risk factors by measuring related biomarkers.

Detailed description: We enroll patients with type 2 DM with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%).

Before drug administration, we conduct basal lab study including CGMS. After 3 month of random administration of vildagliptin or glimepiride, we check CGMS, glucose levels, CV biomarkers, and estimate hypoglycemic index. We replace with the other drug for 3 months, and then conduct the same measurements. No wash-out period is necessary since result variables are measured after the 3 months of administration for a different drug.

Eligibility criteria: Inclusion Criteria:

* with type 2 DM
* with uncontrolled glucose level on Metformin monotherapy over 1000mg /day (HbA1C over 7%). Provided that the tolerance for metformin is poor, enrollment of patients with lower dose of metfomrin is open.
* who have never been prescribed with test drugs, sulfonylurea or DPP-4 inhibitor/GLP-1 analogue in 3 months
* who can be applied with CGMS

Exclusion Criteria:

* who has liver function abnormality or renal function abnormality
* who has any kind of diseases, operations, medical treatments that can affect glucose levels

Primary outcomes:
measure: Glycemic variability index
timeFrame: before and after 3 months of each drug administration
measure: Cardiovascular disease risk factor
timeFrame: before and after 3 months of each drug administration
Secondary outcomes:
measure: glucose profile and lipid profile
timeFrame: before and after 3 months of each drug administration
measure: hypoglycemic index
timeFrame: before and after 3 months of each drug administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hye Seung Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00052039: A Randomized, Double-Blind, Three-Arm, Phase 3b Study Comparing the Safety and Efficacy of Interferon Gamma-1b With Azathioprine, and Azathioprine Alone in Patients With IPF Receiving Prednisone
Official title: A Randomized, Double-Blind, Three-Arm, Phase IIIb Study Comparing the Safety and Efficacy of Interferon Gamma-1b Alone, IFN-Gamma 1b With Azathioprine, and Azathioprine Alone in Patients With Idiopathic Pulmonary Fibrosis Receiving Prednisone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lung Disease
Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2003-01-22
Enrollment: 0
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: Study GIPF-003 is a Phase 3b study designed to define better therapeutic use of IFN-gamma 1b in patients wtih IPF. The study will be conducted primarily in Europe and will enroll 210 patients.



Primary outcomes:
measure: This study was terminated prior to enrollment.
timeFrame: This study was terminated prior to enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale S. Luigi Gonzaga - Regione
state: Orbassano
Study officials:
affiliation: InterMune
name: Steven Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06591039: A Multicenter Prospective Observational Cohort Based on a Breast Cancer Medical Record Database in China
Official title: A Multicenter Prospective Observational Cohort Study of Breast Cancer Based on a Breast Cancer Medical Record Database in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with malignant breast tumors

Brief summary: 1. To construct a prospective, multi-center breast cancer treatment cohort in China, and analyze the factors affecting breast cancer diagnosis and treatment.
2. To evaluate the diagnosis and treatment and prognosis of breast cancer among patients in different regions and hospitals.

Detailed description: This research aims to:

A. Understand and analyze the current status of breast cancer diagnosis and treatment; B. Publish an annual report on diagnosis and treatment; C. Data sharing, dynamic evaluation; D. Evaluate consensus and guideline promotion and implementation effects; E. Propose and set clinical quality standards for industry associations, and propose improvement goals; F. Provide a basis for industry associations to formulate specialized training programs; G. To provide assistance in the formulation of health insurance policies; H. Provide a platform for clinical research on breast cancer; I. Provide evidence for the formulation of clinical guidelines and consensus

Eligibility criteria: Inclusion Criteria:

* Patients with malignant breast tumors must be diagnosed by cytology or histology, and their pathological types include but are not limited to breast carcinoma in situ, invasive carcinoma, and breast sarcoma.

Exclusion Criteria:

* None

Primary outcomes:
measure: The current status of patients diagnosed with breast cancer and their types of treatment
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Prognostic outcomes of patients
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: Prognosis-recurrence-free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
measure: Prognosis-overall survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital/ Institute, Fudan University
state: Shanghai
Study officials:
affiliation: Cancer Hospital/ Institute, Fudan University
name: Jiong Wu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00871039: Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam
Official title: Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Alcoholism
Respiration, Artificial
Keywords: Alcoholism
Mechanical ventilation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.

Detailed description: No detailed description

Eligibility criteria: Inclusion Criteria:

* Diagnosis of alcohol use disorders
* Need for invasive mechanical ventilation
* Need for continuous intravenous infusion of sedative(s)

Exclusion Criteria:

* Age \< 18 years
* Pregnant women
* Prisoners
* Receiving propofol prior to randomization
* Patient experiencing active alcohol withdrawal
* Immunosuppression
* Shock
* Attending physician does not feel patient is candidate to receive either propofol or midazolam
* Patient has contraindication(s) to receiving either propofol or midazolam
* Inability to enroll patient within 96 hours after initiation of mechanical ventilation
* Transfer from another intensive care unit

Primary outcomes:
measure: Stress response and immune function.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center (formerly known as Medical College of Virginia)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Marjolein de Wit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03708939: Microbiome and Non-caloric Sweeteners in Humans
Official title: The Role of the Microbiome in Personalized Human Response to Non-caloric Sweeteners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Intolerance
Glucose, Low Blood
Glucose, High Blood
Lead sponsor: Weizmann Institute of Science
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.


Eligibility criteria: Inclusion Criteria:

1. BMI\<28
2. Age - 18-70
3. Capable of working with smartphone application
4. Capable to work with a glucometer

Exclusion Criteria:

1. Consumption of antibitioics 3 months prior to the first day of the experiment.
2. Consumption of Non caloric sweetners 6 months prior to the first day of the experiment.
3. Diagnosis with type 1 or type 2 diabetes.
4. Pregnancy, fertility treatments
5. Breastfeeding (Including baby to breast and bottle feeding expressed breast milk)
6. Chronic disease (e.g. AIDS, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.)
7. Cancer and recent anticancer treatment
8. Psychiatric disorders
9. Coagulation disorders
10. IBD (inflammatory bowel diseases)
11. Bariatric surgery
12. Alcohol or substance abuse
13. BMI\>28
14. Aspartame group only: phenylketonuria.

Primary outcomes:
measure: Blood glucose level
timeFrame: 28 days
Secondary outcomes:
measure: Microbiome
timeFrame: 28 days
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Weizmann Institute of Science
Study officials:
affiliation: Weizmann Institute of Science
name: Eran Elinav
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01799239: Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura
Official title: Investigating the Safety and Performance of Newly Developed 1-piece Ostomy Product Concept Compared With SenSura 1-piece in Subjects With an Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: stoma ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the bags themselves
4. Have an ileostomy with a diameter between 15 and 55 mm
5. Have had their ileostomy for at least 3 months
6. Currently use a 1-piece flat ostomy appliance with open bag
7. Use minimum 1 product every second day, i.e. maximum 2 days wear time
8. Be suitable for participation in the study and for using a standard adhesive, flat base plate
9. Must be able and willing to use custom cut products
10. Accept to test two 1-piece products within the study period

Exclusion Criteria:

1. Use irrigation during the study period (flush the intestines with water)
2. Currently receiving or have within the past 2 months received chemotherapy or radiation therapy
3. Currently receiving or have within the past month received systematic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Currently using a ostomy belt
7. Currently using extended wear product
8. Have a loop ileostomy
9. Known hypersensitivity towards any of the test products
10. Suffering from severe peristomal skin problems prior to participation in the investigation (assessed by the study nurse)

Primary outcomes:
measure: Leakage (Percentage of All Baseplates With Leakage)
timeFrame: After each baseplate change over a period, of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Skövde Hospital
Study officials:
affiliation: Coloplast A/S
name: Daniel Carter, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT03182439: Accuracy of Commercially Available Heart Rate Monitors III
Official title: Accuracy of Commercially Available Heart Rate Monitors in Cardiac Rehabilitation Patients: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: WEARABLE HEART RATE MONITORS, ACCURACY
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the accuracy of four heart rate monitors in cardiac rehabilitation patients during typical, supervised cardiac rehabilitation involving exercise on a treadmill and/or stationary bicycle.

Detailed description: This study will assess the accuracy of four of the best-selling optical heart rate monitors when worn by cardiac rehabilitation patients.

During testing, each subject will wear:

1. Two different optical heart rate monitors (one on each wrist)
2. A Polar chest-strap based monitor
3. ECG leads

The types of wrist-worn heart rate monitors assigned to each subject will be randomly assigned.

The location (left or right wrist) will also be randomly assigned.

Heart rate will be assessed using each of the 4 monitors with the subject on the exercise machines under each of the following conditions:

1. Pre-exercise
2. Treadmill: at 3, 5 and 7 min.
3. Stationary Cycle: at 3, 5 and 7 min.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients enrolled in cardiac rehabilitation program at Cleveland Clinic Main Campus

Exclusion Criteria:

* Presence of a cardiac pacemaker
* Known chronic and persistent heart rhythm disorders
* Tattoos around the wrist or forearm area
* Use of a radial artery graft for coronary artery bypass grafting

Primary outcomes:
measure: Heart Rate Monitor Accuracy Compared to ECG
timeFrame: 16 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Marc Gillinov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang R, Blackburn G, Desai M, Phelan D, Gillinov L, Houghtaling P, Gillinov M. Accuracy of Wrist-Worn Heart Rate Monitors. JAMA Cardiol. 2017 Jan 1;2(1):104-106. doi: 10.1001/jamacardio.2016.3340. No abstract available.