louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04108351: Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone As a Positive Control
Official title: Development and Validation of a Driving Simulator for Evaluating the Residual Effects of Drugs on Driving Performance - Sensitivity Analysis Using Zopiclone As a Positive Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nagoya University
First posted: 2019-09-30
Enrollment: 28
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to confirm of assay sensitivity of Driving Simulator by positive control


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of drug and food allergy
* Hypersensitivity to zopiclone
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
* Other protocol defined inclusion criteria could apply

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP)
timeFrame: 60 min
Secondary outcomes:
measure: Distance Coefficient of Variation (DCV)
timeFrame: 5 min
measure: Brake Reaction Time (BRT)
timeFrame: 5 min
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
city: Fukuoka
country: Japan
facility: The medical facility selected by Taisho Pharmaceutical Co., Ltd
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
citation: Iwata M, Iwamoto K, Kambe D, Tachibana N, Ando M, Ozaki N. Development and validation of a driving simulator for evaluating the residual effects of drugs on driving performance - sensitivity analysis using zopiclone as a positive control: Study Protocol Clinical Trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Mar;99(12):e19395. doi: 10.1097/MD.0000000000019395.
Clinical trial NCT04082351: Using Nanotechnology Structured Water to Control Blood Glucose in Type 2 Diabetic Patients.
Official title: Evaluation of Using a Nanotechnology Structured Water Magnalife® to Achieve Controlled Blood Glucose Level in Type 2 Diabetic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Nanotechnology water
HbA1c
Type 2 Diabetes mellitus
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 387
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 DM is due to insulin resistance or low insulin secretion or sometimes a combination of both. Nanotechnology structured water is a type of water that is produced using energy field modulators to change the biological, chemical, and physical properties of water molecules and improve the bioavailability of this nano-water. Objective: To find out the effect of drinking nanotechnology structured water (Magnalife®) on the blood glucose levels in patients with type 2 diabetes mellitus.

Detailed description: This is a blind randomized control trial, according to CONSORT guidelines for randomization, "Participants were randomly assigned following simple randomization procedures (computerized random numbers) to 1 of 2 treatment groups.", that included 387 patients with Type 2 diabetes mellitus in Diabetes Care Center, Sulaymaniyah, Kurdistan region from July 2016 till February 2018. A total of 387 patients with type 2 diabetes who were patients in this center and agreed to participate in this clinical trial were included in this study.

In group A, patients were given nanotechnology structured water Magnalife® and in group B they were given ordinary bottled drinking water as a control . The bottles were unlabeled so that the patients did not know which water they were drinking. Then they were asked to eat their usual food and to drink their usual drinks, also they could drink water ad libitum after drinking the daily doses, and to have the same physical activities that they used to do in their usual daily life. They were instructed to take their medications as usual, and were told to come to test their blood sugar level at the end of the third month to get the HbA1c tested at the end of the three months of drinking the water.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients

Exclusion Criteria:

* Malignancy
* Steroids
* Immunotherapy
* Chemotherapy
* Radiotherapy
* Chronic infections
* Drugs that antagonize or synergies insulin effects

Primary outcomes:
measure: HbA1c
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: College of Medicine, University of Sulaimani
name: Ali K M.Sami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sami AKM, Amin KH, Kurmanji MT. The Novel Use of Nanotechnology Structured Water Magnalife to Control Blood Glucose Level in Type 2 Diabetic Patients. Diabetes. 2018;67(Supplement 1):1155.
Clinical trial NCT01341951: Granulocyte Colony Stimulating Factor (G-CSF) in Acute Liver Failure and Alcoholic Hepatitis
Official title: G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Failure, Acute
Keywords: liver failure, Acute
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2011-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis

Detailed description: In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.

Eligibility criteria: Inclusion Criteria:

* Patients with Acute Liver failure as defined by AASLD.65
* Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but \<300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.

Exclusion Criteria:

• Known hypersensitivity to filgrastim

* creatinine \> 150 µmol/L
* infection or hemorrhage within the last 10 days
* documented hepatocellular carcinoma
* hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy

Primary outcomes:
measure: • Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
timeFrame: 1 year
Secondary outcomes:
measure: clinical and biochemical improvement in liver functions
timeFrame: 1 year
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research Chandigarh India
Study officials:
affiliation: Postgraduate Institute of Medical Education and Research Chandigarh India
name: virendra singh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spahr L, Lambert JF, Rubbia-Brandt L, Chalandon Y, Frossard JL, Giostra E, Hadengue A. Granulocyte-colony stimulating factor induces proliferation of hepatic progenitors in alcoholic steatohepatitis: a randomized trial. Hepatology. 2008 Jul;48(1):221-9. doi: 10.1002/hep.22317.
Clinical trial NCT03814551: Young Adult Beverage and Health Study
Official title: Young Adult Beverage and Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of California, Berkeley
First posted: 2019-01-24
Enrollment: 911
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At specific university: Undergraduate college students on meal plan and university staff

Brief summary: This study examines the impact of health signage on beverage consumption in a cafeteria.


Eligibility criteria: Inclusion Criteria:

* Undergraduate student or staff member at specific university
* Age 18+
* On meal plan if a student
* Works in specific cafeterias if staff

Exclusion Criteria:

* Age \<18 years
* Adults unable to consent or complete the written or online survey

Primary outcomes:
measure: Change in self-reported sugar-sweetened beverage consumption
timeFrame: 5 months
Secondary outcomes:
measure: Change in cafeteria sugar-sweetened beverage usage
timeFrame: 5 months
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: UC Davis
name: Jennifer Falbe, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638351: Resistance Training in Diabetic Elder Patients
Official title: Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus
Resistance exercise
Elderly
Skeletal muscle dysfunction
Metabolomics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 49
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* 65 years old or older
* no clinical diagnosis of cardiovascular disease
* patients with or without type 2 diabetes mellitus

Exclusion Criteria:

* glycated hemoglobin \> 10%
* pulmonary disease
* cancer
* cognitive dysfunction
* any neurological or musculoskeletal disease that will affect exercise performance

Primary outcomes:
measure: Maximal muscle strength
timeFrame: Twelve weeks
Secondary outcomes:
measure: Physical body function
timeFrame: Twelve weeks
measure: Quality of life
timeFrame: Twelve weeks
measure: Waist circumference
timeFrame: Twelve weeks
measure: Body mass index
timeFrame: Twelve weeks
measure: Functional capacity
timeFrame: Twelve weeks
measure: Blood biochemical parameters
timeFrame: Twevle weeks
measure: Muscle oxygenation
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)
name: Ying-Tai Wu, Ph.D.
role: STUDY_CHAIR
References:
citation: Castaneda C, Layne JE, Munoz-Orians L, Gordon PL, Walsmith J, Foldvari M, Roubenoff R, Tucker KL, Nelson ME. A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2335-41. doi: 10.2337/diacare.25.12.2335.
citation: Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
citation: Brandon LJ, Gaasch DA, Boyette LW, Lloyd AM. Effects of long-term resistive training on mobility and strength in older adults with diabetes. J Gerontol A Biol Sci Med Sci. 2003 Aug;58(8):740-5. doi: 10.1093/gerona/58.8.m740.
citation: Cheung NW, Cinnadaio N, Russo M, Marek S. A pilot randomised controlled trial of resistance exercise bands in the management of sedentary subjects with type 2 diabetes. Diabetes Res Clin Pract. 2009 Mar;83(3):e68-71. doi: 10.1016/j.diabres.2008.12.009. Epub 2009 Jan 20.
Clinical trial NCT02466451: Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)
Official title: Observational Longitudinal Study in Children With the Diagnosis of Diaphragmatic Hernia and/or Oesophageal Atresia for Assessing Lung Function Parameters and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragmatic Hernia
Oesophageal Atresia
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 33
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 33 Children operated at birth on diaphragmatic hernia and/or oesophageal atresia (age range : 5 months - 12 years old)

Brief summary: Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or oesophageal atresia : assessment of lung function parameters; assessment of quality of life and cognitive development; assessment of stress parenting and strategies of adaptation.

Detailed description: Observational longitudinal study in children operated at birth on diaphragmatic hernia and/or oesophageal atresia : assessment of lung function parameters; assessment of quality of life and cognitive development; assessment of stress parenting and strategies of adaptation.

Tools: Anamnestic-clinical questionnaire, Spirometry, Plethysmography, Fractional exhaled nitric oxide (FeNO) assessment (oral and alveolar ), 6-minutes walk test (WT 6'), Prick tests, Quality of life in children questionnaire(KINDL, quality of life), Psychological test for cognitive development (Raven Matrices)

Eligibility criteria: Inclusion Criteria:

* Children operated at birth on diaphragmatic hernia and/or oesophageal atresia
* Written informed consent, signed by parents

Exclusion Criteria:

* Children that have had infections in the last 4 weeks
* Children with ongoing diseases
* Children that take drugs able to modify the lung function

Primary outcomes:
measure: Pulmonary Function Test
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01473251: Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Official title: Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exudative Macular Degeneration
Diabetic Macular Edema
Lead sponsor: Vitreo-Retinal Associates, Michigan
Sponsor class: OTHER
Collaborators: name: Van Andel Research Institute
First posted: 2011-11-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female age 18 to 85 with diabetes and hemoglobin A1C \</= 10, or exudative macular degeneration.
* Diabetic macular edema with average retinal thickness central subfield \>/= 290um.

Exclusion Criteria:

* Macular atrophy/fibrosis.
* Ocular anti-VEGF treatment within 3 months.
* Treatment with topical or oral carbonic-anhydrase inhibitor within one month
* Laser photocoagulation within 3 months (diabetic cohort)

Primary outcomes:
measure: Analysis of collected vitreous samples to identify biomarkers.
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
Study officials:
affiliation: Vitreo Retinal Associates
name: Louis C. Glazer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357351: Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment
Official title: Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification.


Eligibility criteria: Inclusion Criteria:

* (18-50) years old with at least 2 sites with gingival recession type (RT1) Cairo Classification (GR with no interdental attachment loss). The interdental CEJ is not detectable clinically on the labial surfaces of the teeth.
* Recession in the maxillary anterior region ≥1 mm of attached gingiva, pocket depth (PD) of \<3 mm, recession depth (RD) ≥2 mm, and gingival index (GI) score ≤1.
* Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions

Exclusion Criteria:

* the presence of severe systematic diseases or immunodeficiency and contraindicated with surgical interventions.
* Allergies to medicaments used in the treatment process.
* Patients with removable or fixed dentures.
* Patients with cervical abrasion, direct and indirect restorations involving the cervical areas of the maxillary anterior.
* Participants with smoking, tobacco chewing, and alcohol consumption.
* The presence of high frenal attachment and participants who had previously undergone any periodontal surgical procedure or regenerative therapy in the past 1 year at the same site of the planned treatment.

Primary outcomes:
measure: Measuring the recession width in millimeter
timeFrame: baseline, 3 months and 6 months
measure: Measuring the recession depth in millimeter
timeFrame: baseline, 3 months and 6 months
measure: Measuring the width of keratinized gingiva in millimeter
timeFrame: baseline, 3 months and 6 months
measure: Mean of root coverage
timeFrame: baseline, and 6 months
Secondary outcomes:
measure: Measuring the probing depth
timeFrame: baseline, 3 months and 6 months
measure: Measuring the plaque index
timeFrame: baseline, 3 months and 6 months
measure: Measuring the gingival index
timeFrame: baseline, 3 months and 6 months
measure: Clinical attachment level
timeFrame: baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
References:
Clinical trial NCT04723251: The Gratitude Gallery - A Positive Psychology Intervention
Official title: The Gratitude Gallery - A Positive Psychology Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Photos
Photography
Gratitude
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the feasibility and acceptability of a positive psychology intervention, The Gratitude Gallery, for increasing gratitude in adults.

The study hypothesizes that participants will find the activity feasible and acceptable and complete the intervention as directed. The project also hypothesizes that those that complete the intervention will show an increase in self-reported gratitude, as well as a decrease in symptoms of anxiety and depression.


Eligibility criteria: Inclusion Criteria:

* Able to read/understand English and give consent
* Owns a smart phone capable of taking pictures
* Willing and able to comply with all aspects of study procedures
* PHQ-9 score greater or equal to 5 but less or equal to 14 with no suicidal ideation
* Generalized anxiety disorder (GAD-7) score greater or equal to 0 but less or equal to 9
* No plan to initiate a new program that could increase positive affect during the study period (e.g., psychotherapy, new exercise regimen, meditation classes)
* If on medication then stable (at least 3 months) on dose or not on medication

Exclusion Criteria:

* Having a psychotic disorder active suicidality or severe depressive or anxiety symptoms
* Other factors that at the discretion of the investigators that would adversely affect study participation

Primary outcomes:
measure: Acceptability of the The Gratitude Gallery
timeFrame: 2 years
measure: Feasibility of the The Gratitude Gallery
timeFrame: up to 21 days (days of treatment)
measure: Changes in the level of reported gratitude as measured by the Gratitude Questionnaire - 6 (GQ-6).
timeFrame: Baseline, up to day 60
Secondary outcomes:
measure: Changes in positive and negative affect as measured by the Positive and Negative Affect Scale (PANAS) Scale
timeFrame: Baseline, up to day 60
measure: Changes in General Life Satisfaction - Fixed Form B from the NIH Toolbox
timeFrame: Baseline, up to day 60
measure: Changes in sleep quality using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance - Short Form 4a
timeFrame: Baseline, up to day 60
measure: Changes in depressive symptoms using the Patient Health Questionnaire 9-Item (PHQ-9)
timeFrame: Baseline, up to day 60
measure: Changes in anxiety symptoms using the Generalized Anxiety scale (GAD-7)
timeFrame: Baseline, up to day 60
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Erin Hendriks, MD
role: PRINCIPAL_INVESTIGATOR
References: