louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00762450: Effect on Bacterial Glycolytic Acid Formation on Plaque
Official title: Effect on Bacterial Glycolytic Acid Formation on Plaque
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 6
Sex: ALL
Minimum age (years): 72
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.


Eligibility criteria: Inclusion Criteria:

* Maxillary dentition is preferentially natural.
* Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
* Natural mandibular front teeth and first premolars (4-4) are retained.
* Second mandibular molars are ideally present to serve as abutment teeth.
* Mandibular restorations and/or reconstructions must be in clinically good condition.
* Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
* Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
* Willingness to give their informed consent and comply with the protocol.
* No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Current participation in other dental clinical trials.
* Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
* Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
* Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
* Subjects taking drugs known to currently affect salivary flow.
* Subjects with un-stimulated salivary flow \<0.3 ml/min and/or stimulated flow \<0.9 ml/min.
* Women who are pregnant or breastfeeding
* History of allergy to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
* Medical condition which requires premedication prior to dental procedures/visits
* History of allergy to amino acids

Primary outcomes:
measure: ph of Dental Plaque After Sucrose Challenge
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich, Dental Institute Dept. of Preventive
Study officials:
name: Thomas Imfeld, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577850: Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose
Official title: Study to Determine the Pharmacokinetics of a Single 14C-labeled Intravenous Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose to Postmenopausal Women With Osteopenia or Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteopenia
Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2007-12-20
Enrollment: 32
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.


Eligibility criteria: Inclusion Criteria:

* have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol \< 20 pg/mL and follicle stimulating hormone (FSH) \> 40 IU/mL;
* have osteopenia or osteoporosis (\< 1.002 g/cm2 Lunar or \< 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately \< -1.5.

Exclusion Criteria:

* any clinically significant out-of-range laboratory values and vital signs,
* a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator
* a known hypersensitivity to bisphosphonates

Primary outcomes:
measure: compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.
timeFrame: 28 days
Secondary outcomes:
measure: to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Research Facility
state: Florida
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
Study officials:
affiliation: Procter and Gamble
name: Amy Sun, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05901350: The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation
Official title: The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Visual Impairment
Keywords: Deep Brain Stimulation
Levodopa
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with parkinson disease (PD) usually reduced the dose the levodopa after received deep brain stimulation (DBS). However, studies seldomly mentioned about the influences on non-motors systems after the reduction. Our study focused on the changes after DBS and attribute them to the levodopa variety.

Detailed description: We calculated that group sample sizes of 126 patients (63 in group 1; 63 in group 2) would provide 80% power to reject the null hypothesis of equal means when the mean difference is -5(10-15) with standard deviations of 10 for test group and 10 for control group at a two-sided alpha of 0.05. Given an anticipated dropout rate of 20%, total sample size required is 158 (79 in reduction; 79 in non-reduction group).

Written informed consent was obtained from all participants. After the baseline measurement, we informed the eligible patients the assigned randomization group with sealed opaque envelopes marked with the inpatient numbers .

Within 12 months after STN-DBS, the LEDD of the intervention group was consistent with that before operation, and gradually decreased under the guidance of physician according to the expert consensus of DBS after 12 months. The compliance problem was solved by determining the actual number of antiparkinsonian medications returned by participants.

Eligibility criteria: Inclusion Criteria:

* Participants underwent neuro-ophthalmologic examinations, including ocular fundus photography, automated perimetry, and OCT. Patients undergoing deep brain stimulation (DBS) took an extra VIPD-Q after the operation.

Exclusion Criteria:

* secondary causes of parkinsonism, prior brain surgery (except DBS), glaucoma, intraocular surgery, diabetes and other diseases affecting the visual field or neurologic systems, and the current use of medications affecting visual function.

Primary outcomes:
measure: VIPD-Q scores after STN-DBS
timeFrame: 12 months after STN-DBS
Secondary outcomes:
measure: RNFL thickness
timeFrame: 12 months after STN-DBS
measure: Vessel density in ocular fundus
timeFrame: 12 months after STN-DBS
measure: Saccades with DBS on status
timeFrame: 1 months after STN-DBS
Other outcomes:
Locations:
city: Jinan
country: China
facility: Chao Zhang
state: Sichuan
Study officials:
affiliation: Qilu Hospital of Shandong University
name: chao zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT00598650: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Official title: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Lewy Body Disease
Dementia
Clinical Trial
Phase II
E2020
donepezil hydrochloride
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-22
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).


Eligibility criteria: Inclusion criteria:

1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
2. Patients who have completed Phase II double-blind study (E2020-J081-431).
3. Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Exclusion criteria:

1. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or who underwent brain surgery causing unsolved deficiency.
2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Primary outcomes:
measure: Change From Baseline in Mini-mental State Examination (MMSE) Total
timeFrame: Baseline, Week 52, and Week 52 LOCF
measure: Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
timeFrame: Baseline, Week 52, and Week 52 LOCF
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New Product Development, Clinical Research Center, Eisai Co., Ltd.
name: Itaru Arimoto
role: STUDY_DIRECTOR
References:
Clinical trial NCT06765850: The Study Aims to Measure the Metabolome in Melanoma Patients Using NMR Spectroscopy and Gas Chromatography and to Analyse Differences Depending on the Course of the Disease.
Official title: Measurement of the Metabolome in Melanoma Patients Using NMR Spectroscopy and Gas Chromatography.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma of Skin
Keywords: Melanoma
Metabolomics
NMR
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: University Hospital Carl Gustav Carus
First posted: 2025-01-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving ongoing tumour therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital

Brief summary: Prospective, single-centre study with the central question of how the metabolome from blood samples, different body fluids and tissues between patients patients with malignant melanoma in different tumour tumour stages and healthy patients and whether this is suitable for early detection of initial diagnosis, recurrence or stage shift at an early stage.

The biosamples are collected in the BioBank Dresden and used for the NMR and LC-MS analyses described here. It is planned to use the biosamples for further analyses.


Eligibility criteria: Inclusion Criteria:

* Current or past history of melanoma
* Ongoing therapy or tumour aftercare at the Skin Cancer Centre at Dresden University Hospital

Exclusion Criteria:

* Refusal to participate in the study
* Lack of capacity to consent

Primary outcomes:
measure: Differences in metabolite concentrations
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus
state: Saxony
Study officials:
References:
Clinical trial NCT00204750: Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
Official title: A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lower Esophageal Ring
Dysphagia
Keywords: lower esophageal ring
dysphagia
electrosurgical incision
bougie dilation
GERD
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: PriCara, Unit of Ortho-McNeil, Inc.
First posted: 2005-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.

Detailed description: Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-80 with symptomatic Schatzki's ring
* No history of bleeding diathesis or other contraindication to bougie dilation or electrosurgical incision

Exclusion Criteria:

* Contraindication to proton pump inhibitors
* Pregnancy
* Inability to provide informed consent
* History of previous esophagogastric surgery
* Presence of esophageal peptic stricture, esophageal motility disorder or esophageal cancer that could otherwise account for dysphagia
* Nasopharyngeal lesion or nasal intubation intolerance causing inability to undergo esophageal motility testing and ambulatory pH monitoring

Primary outcomes:
measure: Recurrence at one year of Schatzki's ring
timeFrame: One year
Secondary outcomes:
measure: GERD score at 1,3,6,9,12 month time intervals
timeFrame: one year
measure: Dysphagia score at 1,3,6,9,12 month time intervals
timeFrame: one year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah HSC
state: Utah
Study officials:
affiliation: University of Utah HSC
name: John Fang, M.D.
role: STUDY_DIRECTOR
affiliation: University of Utah HSC
name: James A DiSario, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02800850: Bright Light Therapy for Individuals With Dementia
Official title: Bright Light Therapy for Individuals With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia
Depression
Agitation
Bright Light
Lead sponsor: Radford University
Sponsor class: OTHER
Collaborators: name: Commonwealth Care of Roanoke, Inc.
name: Virginia Center on Aging (ARDRAF)
First posted: 2016-06-15
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many older adults with dementia living in long-term care facilities experience depression and agitation, which cause angst and personal suffering. Prior to this research, evidence was inconclusive but indicated that bright light exposure may reduce depression and agitation in long-term care residents with dementia. The purpose of this study was to determine if the degree of improvement in depression and agitation scores over the course of eight weeks was significantly greater in persons with dementia receiving bright light exposure than in persons with dementia receiving placebo light exposure. Sixty individuals participated in the study, with 30 in the bright light group and 30 in the low level light group.


Eligibility criteria: Inclusion criteria were age 60 or older; diagnosis of dementia; ophthalmology screening indicating that the individual was able to perceive light and did not have cataracts, glaucoma, macular degeneration, or retinal problems; able to sit up and keep eyes open; and not too restless to sit for 30 minutes.

Exclusion criteria were age 59 or younger; no diagnosis of dementia; presence of cataracts, glaucoma, macular degeneration, or retinal problems; unable to sit up and keep eyes open; and too restless to sit for 30 minutes.

Primary outcomes:
measure: Depressive Symptom Assessment for Older Adults
timeFrame: After the eight-week experiment
measure: Cohen-Mansfield Agitation Inventory (Frequency)
timeFrame: After the eight-week experiment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Radford University
name: Lisa L Onega, PhD, RN, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Onega LL, Pierce TW, Epperly L. Effect of Bright Light Exposure on Depression and Agitation in Older Adults with Dementia. Issues Ment Health Nurs. 2016 Sep;37(9):660-667. doi: 10.1080/01612840.2016.1183736. Epub 2016 Jun 2.
Clinical trial NCT00226850: Using Hypnosis to Help Children Undergoing a Difficult Medical Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Voiding Cystourethrogram (VCUG)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study examined whether a hypnosis intervention, compared to standard care, could help reduce distress and pain for children undergoing an invasive medical procedure.


Eligibility criteria: Inclusion Criteria:

* The child: (1) was scheduled for an upcoming VCUG ; (2) must have undergone at least one previous VCUG; (3) was at least 4 years of age at the time of the previous VCUG; (4) experienced distress during the previous VCUG; and (5) both child and participating parent were English speaking.

Exclusion Criteria:

* Not meeting any of the above criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine
state: California
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Lisa D. Butler, Ph.D.
role: STUDY_DIRECTOR
affiliation: Stanford University
name: David Spiegel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Linda D Shortliffe, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butler LD, Symons BK, Henderson SL, Shortliffe LD, Spiegel D. Hypnosis reduces distress and duration of an invasive medical procedure for children. Pediatrics. 2005 Jan;115(1):e77-85. doi: 10.1542/peds.2004-0818.
Clinical trial NCT05484050: VEGF in Iris Tissue in Primary Congenital Glaucoma
Official title: Estimation of Vascular Endothelial Growth Factor (VEGF) in Iris Tissue in Primary Congenital Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iris
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen in primary congenital glaucoma through Immunohistochemistry.

Detailed description: Combined trabeculotomy with mitomycin C will done in infants with primary congenital glaucoma with histopathological examination of the the peripheral iris tissue specimen and vascular endothelial growth factor (VEGF) estimation in iris tissue specimen through Immunohistochemistry.

Estimation of vascular endothelial growth factor (VEGF) in iris tissue specimen taking from ocular trauma or congenital cataract used as control.

Eligibility criteria: Inclusion Criteria:

* primary congenital glaucoma

Exclusion Criteria:

* Infants with history of previous surgery.
* Secondary glaucoma.
* Glaucoma associated with other congenital anomalies.

Primary outcomes:
measure: VEGF
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hassan Lotfy
Study officials:
References:
Clinical trial NCT00905450: Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Inflammation
Keywords: Surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 415
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: This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
* Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
* Subjects who are candidates for cataract surgery.
* Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
* Subjects must be able and willing to comply with all treatment and follow- up procedures.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
timeFrame: 8 days
Secondary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
timeFrame: 8 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Laura Trusso, MS
role: STUDY_DIRECTOR
References: