louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02817243: The DDI Study of SP2086 and Simvastatin
Official title: The Drug Interaction Study of SP2086 and Simvastatin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-29
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the potential interaction between multiple oral doses of SP2086 and a single oral dose of Simvastatin in healthy adult volunteers.

Detailed description: This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of SP2086 and Simvastatin in healthy adult volunteers. SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2

Exclusion Criteria:

* History of diabetes
* History of heart failure or renal insufficiency
* Urinary tract infections, or vulvovaginal mycotic infections
* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or Simvastatin

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SP2086
timeFrame: up to Day 9
measure: The maximum plasma concentration (Cmax) of SP2086 acid
timeFrame: up to Day 9
measure: The maximum plasma concentration (Cmax) of Simvastatin
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of SP2086
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of SP2086 acid
timeFrame: up to Day 9
measure: The area under the plasma concentration-time curve (AUC) of Simvastatin
timeFrame: up to Day 9
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability
timeFrame: up to Day 9
Other outcomes:
Locations:
city: Changchun
country: China
facility: the First Hosital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT00357643: Effect of Calcium and Vitamin D on Bone Loss From the Hip
Official title: Effect of Calcium and Vitamin D on Bone Loss From the Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: calcium
vitamin D
bone loss
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-07-27
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.

Detailed description: In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.

Eligibility criteria: Inclusion Criteria:

\>65 years calcium intake \< 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment

Exclusion Criteria:

Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine \> 300 mg/d women or \>350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.

Primary outcomes:
measure: Bone Density of the hip
Secondary outcomes:
measure: Annual and Seasonal patterns of change in bone mineral density of the hip
measure: Associations between biochemical, physical and life-style factors
measure: Examine influence of clinical status, lifestyle, medication use and season on the occurrence of falls
Other outcomes:
Locations:
city: Boston
country: United States
facility: Human Nutrition Research Center on Aging at Tufts U
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Bess Dawson-Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson-Hughes B, Harris SS, Krall EA, Dallal GE. Effect of calcium and vitamin D supplementation on bone density in men and women 65 years of age or older. N Engl J Med. 1997 Sep 4;337(10):670-6. doi: 10.1056/NEJM199709043371003.
citation: Dawson-Hughes B, Harris SS, Ceglia L, Palermo NJ. Serum sclerostin levels vary with season. J Clin Endocrinol Metab. 2014 Jan;99(1):E149-52. doi: 10.1210/jc.2013-3148. Epub 2013 Dec 20.
citation: Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
Clinical trial NCT01040143: A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
Official title: A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Keywords: Pneumococci
Streptococcus pneumoniae
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2009-12-29
Enrollment: 450
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community samples taken within the home of eligible subjects.

Brief summary: A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.


Eligibility criteria: Inclusion Criteria:

* Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled
* Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or
* Written informed consent given by the subject after the nature of the study has been explained to them

Exclusion Criteria:

* Moderate to severe disability.
* Cerebral palsy, syndromes and neurological disorders affecting swallowing.
* Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears.
* Confirmed or suspected immunodeficiency (congenital or acquired).
* On immunosuppressive therapy.

Primary outcomes:
measure: Presence of pneumococci in nasopharyngeal swabs
Secondary outcomes:
Other outcomes:
Locations:
city: Stevenage
country: United Kingdom
facility: Health Protection Agency
state: Hertfordshire
city: Gloucester
country: United Kingdom
facility: Health Protection Agency
city: London
country: United Kingdom
facility: Health Protection Agency
Study officials:
References:
citation: van Hoek AJ, Sheppard CL, Andrews NJ, Waight PA, Slack MP, Harrison TG, Ladhani SN, Miller E. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine. 2014 Jul 23;32(34):4349-55. doi: 10.1016/j.vaccine.2014.03.017. Epub 2014 Mar 21.
Clinical trial NCT00000543: Oral Calcium in Pregnant Women With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Diseases
Heart Diseases
Hypertension
Pre-Eclampsia
Pregnancy Toxemias
Vascular Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.

Detailed description: BACKGROUND:

Maternal and fetal complications are more likely to occur in pregnant women with preexisting hypertension. Alterations in calcium metabolism, the renin angiotensin system, and intracellular free calcium concentration have been identified in this high risk population. The beneficial effects of calcium supplementation on blood pressure and the incidence of superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for vasoconstriction. The trial sought to prove that oral calcium lowered parathyroid hormone, reduced intracellular free calcium, and decreased vascular endothelin production, resulting in vasodilation and compensatory stimulation of the renin-angiotensin system.

DESIGN NARRATIVE:

Randomized. Double blind. In this observational study, subjects were assigned to two grams of supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. The trial determined the effect of oral calcium supplementation on: the level of blood pressure; the need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin D3, ionized calcium, parathyroid, renin activity, angiotensin II, endothelin, nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and platelets. These variables were measured prior to randomization and every two months throughout pregnancy and the postpartum. Support ended in July 1999.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: Pregnant women with chronic hypertension.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hojo M, August P. Calcium metabolism in normal and hypertensive pregnancy. Semin Nephrol. 1995 Nov;15(6):504-11.
citation: Hojo M, Suthanthiran M, Helseth G, August P. Lymphocyte intracellular free calcium concentration is increased in preeclampsia. Am J Obstet Gynecol. 1999 May;180(5):1209-14. doi: 10.1016/s0002-9378(99)70618-6.
citation: Curnow KM, Pham T, August P. The L10F mutation of angiotensinogen is rare in pre-eclampsia. J Hypertens. 2000 Feb;18(2):173-8. doi: 10.1097/00004872-200018020-00007.
Clinical trial NCT00771043: A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a
Official title: Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ®) or Interferon beta-1a (AVONEXÂ®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of RRMS.
* Patients with unilateral AON consistent with Multiple Sclerosis (MS).
* Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.
* Age 18-55 years.
* Expanded Disability Status Scale (EDSS) 0 to 5.0.
* Understand and sign informed consent.

Exclusion Criteria:

* History or presence of progressive multifocal leukoencephalopathy (PML).
* Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
* Immune-compromised in the judgment of the Investigator.
* History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.
* Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
* Previous history of severe disc edema, hemorrhage, or \> 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago.
* Previous treatment with \> 1 Disease Modifying Therapy (DMT).
* Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy.
* Previous treatment with TYSABRI®
* Women who are not postmenopausal, surgically sterile, or willing to practice contraception.
* Women pregnant, breast feeding, or planning to become pregnant.
* Involved with other study protocol simultaneously without prior approval.
* Determined not suitable for study participation by Investigator and/or Sponsor.

Primary outcomes:
measure: Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.
timeFrame: Between week 4 and weeks 36
Secondary outcomes:
measure: Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.
timeFrame: Between week 4 and weeks 36
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03675243: Quality of Life After Transanal Endoscopic Microsurgery (TEM)
Official title: Quality of Life After Transanal Endoscopic Microsurgery (TEM) for Rectal Neoplasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transanal Endoscopic Microsurgery (TEM)
Keywords: Transanal endoscopic microsurgery
TEM
QoL
quality of life
rectal cancer
rectal surgery
rectal neoplasm
Lead sponsor: State Scientific Centre of Coloproctology, Russian Federation
Sponsor class: OTHER_GOV
First posted: 2018-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rectal neoplasms with planning transanal endoscopic microsurgery (TEM)

Brief summary: This is a observational cohort study to determine the influence of Transanal endoscopic microsurgery (TEM) on patients Quality of Life

Detailed description: Patients who planning Transanal Endoscopic Microsurgery (TEM) for rectal neoplasms should undergoing fecal incontinence quality of life scale and Wexner score before and after surgery for measurement their quality of life. For objectification data sphinctrometry will be perform.

Eligibility criteria: Inclusion Criteria:

* Have a planned of Transanal endoscopic microsurgery (TEM)
* Have signed approved informed consent form for the study

Exclusion Criteria:

* non epithelial malignancy
* recurrent neoplasm
* stoma formation

Primary outcomes:
measure: Fecal incontinence quality of life scale
timeFrame: 3 month
Secondary outcomes:
measure: Wexner score
timeFrame: 3 month
measure: Sphinctrometry
timeFrame: 3 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Scientific Centre of Coloproctology
Study officials:
References:
Clinical trial NCT02099643: Crucial Areas on AF Termination
Official title: Crucial Areas on Atrial Fibrillation Termination by Substrate Ablation: Relevance to Anatomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrilation Termination Endpoint
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 113
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 with symptomatic Atrial Fibrilation undergoing EGM-based substrate ablation were included.

Brief summary: Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation.

The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.


Eligibility criteria: Inclusion Criteria:

* Atrial Fibrilation
* Undergoing EGM-based substrate ablation

Exclusion Criteria:

* Age \< 18

Primary outcomes:
measure: Atria fibrillation termination during procedure
timeFrame: 240 min
Secondary outcomes:
measure: Crucial points
timeFrame: 240 min
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier;
city: Paris
country: France
facility: Institut Mutualiste Montsouris;
city: London;
country: United Kingdom
facility: Morphology Unit Royal Brompton Hospital
Study officials:
References:
Clinical trial NCT06172543: The Effects of Nutritional Supplementation on Occupational Performance in Firefighters
Official title: The Effects of Protein and Carbohydrate Supplementation, With and Without Creatine, on Occupational Performance in Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: Creatine
Lead sponsor: University of Wisconsin, La Crosse
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Des Moines University
name: Lindenwood University
First posted: 2023-12-15
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals with mixed finding.

Furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or without creatine, in firefighters is largely unknown. Therefore, the primary aim of the current study was to examine the effects of protein and carbohydrate supplementation, with or without creatine, on occupational performance in firefighters.


Eligibility criteria: Inclusion Criteria:

* Being a firefighter between the ages of 18-55 years of age, and medically cleared for field duty.

Exclusion Criteria:

* Any current musculoskeletal or neurological condition that would prohibit the completion of performance testing.

Primary outcomes:
measure: Time to completion
timeFrame: 24 Days
measure: Time Trial
timeFrame: 24 Days
Secondary outcomes:
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Fire Department
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Andrew Jagim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05127343: Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants
Official title: One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Keywords: Pit and fissure sealant
Retention rate
Caries formation
Hydrophilic sealant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.


Eligibility criteria: Inclusion Criteria:

* Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
* Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
* Cooperative patients who will allow the clinical applications

Exclusion Criteria:

* Uncooperative behaviour limiting the use of sealants throughout the procedure.
* Patients with history of medical diseases, drug therapies or any other serious relevant problem.
* Patients with well coalesced pits and fissures
* Patients allergic to sealant material
* Patients who underwent orthodontic treatment.

Primary outcomes:
measure: Retention rate
timeFrame: Change from baseline at 3, 6, 12 months
Secondary outcomes:
measure: Caries formation
timeFrame: Change from baseline at 3, 6, 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
Study officials:
affiliation: Cairo University
name: Iman I ElSayad, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Heba Helal
role: STUDY_DIRECTOR
References: