louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05954637: Correlation of Structure and Function in Glaucoma
Official title: Correlation of Structure and Function in Glaucoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glaucoma
Lead sponsor: Vienna Hospital Association
Sponsor class: OTHER_GOV
First posted: 2023-07-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group, who have been diagnosed with "glaucomatous optic neuropathy" are eligible for inclusion in the study.

Brief summary: The aim of the study is to correlate structure and function in patients with glaucoma. To this end, a cross-sectional study unsing perimetry and optical coherence tomography is performed.


Eligibility criteria: Inclusion Criteria:

- Diagnosis of glaucomatous optic neuropathy

Exclusion Criteria:

* Age \< 18 years
* Diabetes
* Pregnancy
* Hypertensive retinopathy
* Smoking
* Intraocular surgery 1 month prior to study entry
* Systemic or ocular disease, excluding glaucoma, which the investigator believes could affect the test results
* Insufficient quality of the optical coherence tomography imaging
* Insufficient cooperation during examinations or measurements

Primary outcomes:
measure: Association of retinal sensitivity with peripapillary retinal nerve fiber layer thickness
timeFrame: 1 day
measure: Association of retinal sensitivity with peripapillary vessel density
timeFrame: 1 day
Secondary outcomes:
measure: Glaucoma Activity Limitation score
timeFrame: 1 day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group
Study officials:
affiliation: Department of Ophthalmology, Clinic Hietzing, Vienna Healthcare Group
name: Pia V Vécsei-Marlovits, MD, MSc, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04843137: Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord
Official title: Investigating the Acute Effects of Transcutaneous Electrical Stimulation Parameters on Neural Circuits, Motoneuron Behavior and Motor Performance in Individuals With Cervical Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Spinal Cord Injuries
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with chronic, cervical spinal cord injury.

Brief summary: The purpose of this study is to examine how delivery of subthreshold electrical stimulation of the spinal cord alters the excitability of neural pathways and consequently movement performance in healthy and spinal cord injured individuals. Specifically, we assess how stimulation parameters such as electrode configurations and stimulation frequency affect spinal excitability, corticospinal excitability, intracortical excitability, motor unit properties and force production. This study is not an intervention study, but a mechanistic study trying to shed light on how this novel neuromodulatory technique acutely affects the central nervous system.


Eligibility criteria: Inclusion Criteria:

* cervical level injury (C5 to C7)
* at least 1 year post-injury

Exclusion Criteria:

* individuals with damage to the nervous system other than to the spinal cord
* pregnant women (effects of stimulation on the fetus are unknown).

Transcranial magnetic stimulation-specific exclusion criteria:

* participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
* participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
* participants with a history of seizures or epilepsy
* participants taking any medication which may reduce seizure threshold

Primary outcomes:
measure: Motor evoked potentials recruitment curves
timeFrame: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)
measure: Intracortical excitability
timeFrame: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)
measure: Intramuscular coherence
timeFrame: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)
measure: Force control
timeFrame: Assessment up to 4 hours each visit; up to 4 visits per individual (32 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville, Kentucky Spinal Cord Injury Research Centre
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Jessica D'Amico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467737: Assessment of Starch Digestibility and Amylase Sufficiency in Children
Official title: Assessing Malian and U.S. Children for Starch Digestion and Amylase Sufficiency and Identifying Better Energy Providing Foods for Growth and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2018-03-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Research has demonstrated that there is a relationship between malnourishment and insufficient production of pancreatic enzymes, such as α-amylase which digests starch into glucose. Starchy foods that can be easily digested into glucose are critical to the development child for energy and proper growth. This study investigated the use of a noninvasive breath test for the assessment of amylase sufficiency, digestibility of normal and modified sorghum porridges and gastric emptying rate of a sorghum porridge in Malian and U.S. children.

Detailed description: The purpose of this research is to test the hypotheses that: 1.) Moderately malnourished stunted children have low pancreatic α-amylase activity; and 2.) Modified starchy food preparations will have better (higher) digestibility than the commonly given foods for both moderately malnourished stunted and healthy non-stunted children. A noninvasive breath test was used to assess amylase insufficiency in moderately malnourished and stunted children in Mali, as well as in healthy children in Mali and the United States. Moderately malnourished and healthy children in Mali were fed sorghum porridges, which are commonly consumed in Mali. Porridges contained a 13C-labeled substrate (algal starch or octanoic acid) for assessment of amylase insufficiency and gastric emptying rate. In a follow-up study, healthy children in the United States were also assessed for amylase sufficiency.

Eligibility criteria: Inclusion Criteria:

* Stunted weaned children in the age range 18 - 30 months with height-for-age Z-score (HAZ) below -2 (HAZ\<-2)
* Healthy, weaned children 18-30 months of age for study 1
* Healthy, weaned children up to 5 years old

Exclusion Criteria:

* Acutely ill and wasted child with weight for height lower than -2 z-score
* No medical problems other than their malnutrition status
* No medications

Primary outcomes:
measure: Alpha-amylase sufficiency in children
timeFrame: 3 hours after being fed test meal
measure: Starch digestibility
timeFrame: 3 hours after being fed test meal
measure: Gastric emptying
timeFrame: 3 hours after being fed test meal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01318837: A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment
Official title: Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Over Active Bladder
Keywords: OABSS
IPSS
PPBC
Solifenacin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2011-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.


Eligibility criteria: Inclusion Criteria:

* Symptoms of OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  * a. Number of micturition ≥8 times/day
  * b. Number of urgency episodes in 3 days ≥3

Exclusion Criteria:

* Significant stress incontinence or mixed stress/urge incontinence
* Subject with indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
* Subjects who are prohibited from taking solifenacin as contraindications
* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
* Participation in any clinical trial in 30 days except for Part-1 of RESORT
* Diabetic neuropathy

Primary outcomes:
measure: Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)
timeFrame: week 0 (baseline) and week 4
measure: Changes from baseline to week 12 in OABSS
timeFrame: week 0 (baseline) and week 12
Secondary outcomes:
measure: Changes from baseline in International Prostate Symptom Score (IPSS) at week 4
timeFrame: week 0 (baseline) and week 4
measure: Changes from baseline in IPSS at week 12
timeFrame: week 0 (baseline) and week 12
measure: Changes from baseline in Quality of Life (QoL) Score at week 4
timeFrame: week 0 (baseline) and week 4
measure: Changes from baseline in QoL Score at week 12
timeFrame: week 0 (baseline) and week 12
measure: Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4
timeFrame: week 0 (baseline) and week 4
measure: Changes from baseline in PPBC at week 12
timeFrame: week 0 (baseline) and week 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
city: Sungnam
country: Korea, Republic of
Study officials:
affiliation: Bundang Seoul National University Hospital, Seong Jin Jeong, MD.
name: Use Central Contact
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29.
Clinical trial NCT04627337: Efficacy and Safety of Saccharomyces Boulardii in the Treatment of Small Intestinal Bacterial Overgrowth
Official title: Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in the Treatment of Small Intestinal Bacterial Overgrowth in Patients Suffering From Irritable Bowel Syndrome With Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Lead sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 71
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: Non-constipated irritable bowel syndrome is a common disorder that may be related to small intestinal bacterial overgrowth. Saccharomyces boulardii CNCM I-745 is a probiotic yeast that has proven efficacy for the treatment of acute gastroenteritis and antibiotic-associated diarrhea. However, its efficacy for the treatment of diarrhea-predominant irritable bowel syndrome with small intestinal bacterial overgrowth has not been assessed. Hence, an exploratory randomized, open label trial comparing the efficacy and safety of Saccharomyes boulardii CNCM I-745 plus diet administration versus diet administration only for 15 days among adult patients with the aforementioned condition was conducted.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Diagnosis of Irritable Bowel syndrome according to Rome III criteria
* Diagnosis of concomitant small intestinal bacterial overgorwth (SIBO) by breath test

Exclusion Criteria:

* Pregnancy
* Diagnosis of Celiac disease
* Diagnosis of Inflammatory Bowel Disease or other immune-mediated gastrointestinal conditions
* Immunosuppression
* Diagnosis of active cancer

Primary outcomes:
measure: Change in symptom severity measured by the Irritable Bowel Syndrome Symptom Severity Scale
timeFrame: 15 days
Secondary outcomes:
measure: Change in hydrogen excretion measured by lactulose breath test
timeFrame: 15 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: CEMIC
Study officials:
References:
Clinical trial NCT01712737: The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children
Official title: The Effects of Ad Libitum Pre-Meal Raisin Snack on Satiety and Food Intake in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Intake Regulation
Keywords: raisins, grapes, snacks, appetite, food intake
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Mount Saint Vincent University
name: Toronto Metropolitan University
name: California Raisin Marketing Board
First posted: 2012-10-23
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: No studies have reported the effect of pre-meal snacking on raisins compared to other commonly consumed snacks on energy intake in children. Therefore, the objective of the current study was to examine appetite and energy intake following consumption of ad libitum snack of raisins, grapes or mix of almonds and raisins, compared with a water control, on appetite and food intake 30 min later in 8 - 11 y old normal weight children. The investigators hypothesized that raisins would lower subsequent energy intake in children and reduce hunger.


Eligibility criteria: Inclusion Criteria: healthy boys and girls between 8-11 y Exclusion criteria: learning and behavioral problems

Primary outcomes:
measure: ad libitum snack intake (kcal)
timeFrame: 15 min
measure: ad libitum pizza intake (kcal)
timeFrame: at 30 min after treatment
Secondary outcomes:
measure: subjective appetite
timeFrame: 0-105 min
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Harvey Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00476437: Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.
Official title: Safety and Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Human Insulin 50 in Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-05-22
Enrollment: 81
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: This trial is conducted in Japan. The purpose of this trial is to investigate the safety and the effect of biphasic insulin aspart 50 compared to biphasic human insulin 50 in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Current treatment with pre-mixed human insulin preparation or biphasic/pre-mixed insulin analogue in twice daily treatment for at least 8 weeks.
* HbA1C: less than 11.0%
* BMI: less than 30.0 kg/m2

Exclusion Criteria:

* Total daily insulin dose: 100 IU/U and more
* Treatment with oral hypoglycaemic agents within the last 4 weeks.
* Treatment with insulin sensitizer within the last 12 weeks
* A lifestyle that is considered unsuitable for this trial (frequent or routine night shift workers etc.)

Primary outcomes:
measure: Incidence of hypoglycaemic episodes
timeFrame: During 16 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04611737: Self-Determination Theory and Motivational Interviewing
Official title: Developing and Testing of Integrating Self-Determination Theory and Motivational Interviewing Based Diabetic Self-management Program Among Schizophrenic Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Diabetes
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.

Detailed description: Participants would be randomly allocated into either the intervention group or the usual care group from baseline to 3 months follow-up. The intervention is based on integrated self-determination theory and motivational interviewing.

Eligibility criteria: Inclusion Criteria:

* patients with schizophrenia and Type 2 Diabetes
* between 20 years old to 80 years old
* can communicate in Chinese langue

Exclusion Criteria:

* can not communicate well
* have neurocognitive disorders

Primary outcomes:
measure: HbA1C
timeFrame: on interviewing day1, and 3 months
measure: Body weight
timeFrame: on interviewing day1, and 3 months
measure: height
timeFrame: on interviewing day1, and 3 months
Secondary outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: on interviewing day1, and 3 months
measure: Treatment Self-Regulation Questionnaire-Diabetes
timeFrame: on interviewing day1, and 3 months
measure: Perceived Diabetes Self-Management Scale
timeFrame: on interviewing day1, and 3 months
measure: Depression Anxiety Stress Scales
timeFrame: on interviewing day1, and 3 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Assistant professor, School of Nursing, Kaohsiung Medical University
name: Ching-Yun Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00960037: Trial to Assess Response to Oral Vitamin D3 Supplementation in Obese Individuals
Official title: The Vitamin D Dose Response Curve in Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Vitamin D3
obesity
cholecalciferol
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is an extension of an earlier study of vitamin D supplementation conducted on normal weight individuals by Dr. John Aloia of the Bone Mineral Research Division at Winthrop University Hospital. The investigators plan to compare the response to vitamin D supplementation in obese individuals with the response already measured in normal weight individuals. The same dosing schedule of vitamin supplementation will be used as in the past. The doses used in the past have demonstrated safety in a number of trials, here at Winthrop as well as outside of Winthrop Hospital. Sixty study volunteers are planned for enrollment in the study. The study participants will mainly be recruited from a group of patients who have in the past been enrolled in the weight loss program at Winthrop Hospital. Each participant will be on vitamin D supplementation for a total of 8 weeks. Vitamin D blood levels will be measured before and at the end of the supplementation period. They will then be compared to see the change over time as a result of supplementation.


Eligibility criteria: Inclusion Criteria:

* obese adults aged 18-65 years and BMI\>35

Exclusion Criteria:

* chronic medical illness (diabetes, malignancy, uncontrolled hypertension, kidney disease)
* subjects who have undergone bariatric surgery or currently enrolled in a medically supervised weight loss program
* BMI \< 35
* pregnancy
* use of medication that influences vitamin D metabolism
* history of of hypercalcemia, hypercalciuria, nephrolithiasis

Primary outcomes:
measure: Change in serum 25(OH)D level from baseline.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: John F Aloia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00437437: A Phase I Study to Determine the Effect of Food on Brivanib (BMS-582664)
Official title: Phase I Study to Determine the Effect of a High Fat Meal on the Pharmacokinetics of BMS-540215, the Active Metabolite of Brivanib Alaninate in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Advanced or metastatic solid tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-02-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the effect of food versus a fasted state on single-dose pharmacokinetics of BMS-540215, the active metabolite of Brivanib alaninate


Eligibility criteria: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Histologic/cytologic diagnosis of advanced or metastatic solid tumors
* ECOG 0-2
* 4/6 weeks since prior therapy

Exclusion Criteria:

* Brain metastases
* Second primary malignancy
* Thromboembolic disease requiring full anticoagulation within 6 months
* Inability to swallow or absorb oral therapy

Primary outcomes:
measure: To determine the effect on pharmacokinetics of BMS-540215, the active metabolite of brivanib alaninate, when administered following a high fat meal versus administration in a fasted state
timeFrame: throughout the study
Secondary outcomes:
measure: To assess safety and tolerability of Brivanib alaninate when administered in a fasted state, or following a high fat meal
timeFrame: throughout the study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Harvard Cancer Care
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Durham
country: United States
facility: Duke University Medical Center-Dept Of Medicine
state: North Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: