louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00545337: Glulisine + Lantus in Type I Patients
Official title: 26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* type I diabetes mellitus (onset of diabetes under the age of 40),
* an HbA1c range of \>6.5 - \<11%,
* and on multiple injection regimen (more than 1 year of continuous insulin treatment),
* body mass index \<35.

Exclusion Criteria:

* Active proliferative diabetic retinopathy,
* Diabetes other than type I diabetes mellitus,
* Pancreatectomised subjects,
* Subjects who have undergone pancreas and or islet cell transplants,
* Requiring treatment with not permited drugs during the study,
* Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
* Hypersensitivity to insulin,
* Major systemic diseases,
* Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change of HbA1c
timeFrame: from baseline to endpoint
Secondary outcomes:
measure: Change of HbA1c
timeFrame: from baseline to week 26
measure: Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins
timeFrame: from baseline to endpoint
Other outcomes:
Locations:
city: Kiev
country: Ukraine
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Volodymyr Moshchych
role: STUDY_DIRECTOR
References:
Clinical trial NCT02204137: Falls Risk Questionnaire in Older Adults With Cancer
Official title: Pilot Study of the Falls Risk Questionnaire in Older Adults With Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Geriatric Assessment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients aged 65 years of age or older

Brief summary: The purpose of this research study is to look at the use of a series of questionnaires evaluating risk for falls in order to collect information that might be used to develop a larger study aiming to recognize who is more at risk for falls and how to best intervene to prevent falls in older adults with cancer.


Eligibility criteria: Inclusion Criteria:

* Age 65 or older; 5 patients will be enrolled in each of the following age cohorts: 65-69, 70-74, 75-79, 80 and older
* Diagnosis of cancer, any type
* Currently receiving or anticipated to initiate systemic cancer therapy within 1 month, including endocrine therapy, chemotherapy or targeted therapies
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Unable to understand written English
* Psychiatric illness/social situation that would limit compliance with the study requirements
* Unable to walk.

Primary outcomes:
measure: Percent completion of the Fall Risk Questionnaire (FRQ) and the Cancer and Aging Research Group Geriatric Assessment (CARG GA) of enrolled patients
timeFrame: Day 1
Secondary outcomes:
measure: Time to completion of FRQ and CARG GA of enrolled patients
timeFrame: Day 1
measure: Satisfaction with the questionnaires
timeFrame: Day 1
measure: Psychological consequences of falling
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tanya Wildes, M.D., M.S.C.I.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06358937: Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis
Official title: Clinical and Microbiological Evaluation of Laser Assisted New Attachment Procedure (LANAP) Using Nd:Yag vs. Diode Laser in the Management Of Stage II Periodontitis (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the efficacy of LANAP to conventional scaling and root planing in the management of stage II periodontitis.


Eligibility criteria: Inclusion Criteria:

* Patients with stage II generalized periodontitis PPD ≥ 5 mm with attachment loss 3-4 mm with horizontal bone loss

Exclusion Criteria:

* Patients with vertical bone loss or furcation involvement.
* History of smoking more than (10 cigarettes / day).
* Patient with medical condition that contraindicate surgical procedures.
* Patients receiving antibiotics in the past three months prior to the procedure.
* Pregnant or lactating females.

Primary outcomes:
measure: Microbiological assessment of Fusobacterium nucleatum
timeFrame: up to 6 months
measure: Microbiological assessment of Porphyromonas gingivalis
timeFrame: up to 6 months
measure: Microbiological assessment of Tannerella forsythia
timeFrame: up to 6 months
Secondary outcomes:
measure: Gingival index
timeFrame: up to 6 months
measure: Plaque index
timeFrame: up to 6 months
measure: Clinical attachment loss
timeFrame: up to 6 months
measure: Probing depth
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT05100537: Effect of Mindfulness Based Stress Reduction (MBSR) Programme for Reducing the Stress Level of Nursing Student
Official title: The Effect of Mindfulness Based Stress Reduction Programme for Reducing the Stress Level and Emotion Regulation of Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Emotion Regulation
Keywords: Mindfulness
Nursing student
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This research was planned to determine the effect of mindfulness-based stress reduction program on reducing the stress level and emotion regulation of nursing students.

Design: The research was planned as a pretest, posttest, follow-up and randomized controlled study in order to determine the effect of the mindfulness-based stress reduction program on the stress level and emotion regulation of nursing students.

Hypotheses: H1: The perceived stress level scores of nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease compared to the nursing students in the control group.

H2: The perceived stress level of the nursing students in the intervention group participating in the mindfulness-based stress reduction program will decrease according to their pretest scores.

H3: Emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the nursing students in the control group.

H4: The posttest and follow-up emotion regulation strategies of nursing students in the intervention group participating in the mindfulness-based stress reduction program will differ from the pretest.


Eligibility criteria: Inclusion Criteria:

* Age range is 18-25 years old
* Being a student in the second or third year of the nursing department
* Regular attendance at school
* Not having a communication problem related to vision or hearing
* It was determined as having a score of 26 or more from the perceived stress scale.

Exclusion Criteria:

* Have a psychiatric illness

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: For 3 months
measure: Cognitive Emotion Regulation Scale
timeFrame: For 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pendik
country: Turkey
facility: Ece alagöz
state: İstanbul
Study officials:
References:
Clinical trial NCT00185237: Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch
Official title: A Multicenter, Double-blind, Randomized, Placebo Controlled Study on the Effect of Ultra-low Dose Transdermal Estradiol (Menostar®) on the Incidence and Severity of Hot Flushes, Other Menopausal Symptoms and on Well-being in Postmenopausal Asian Women Over 12 Weeks.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hot Flashes
Keywords: Menopause
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 165
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Evidence of postmenopausal status

Exclusion Criteria:

* Contraindication to estrogen therapy

Primary outcomes:
measure: Relative change in frequency of hot flushes
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in intensity of hot flushes
timeFrame: 12 weeks
measure: Changes in vaginal pH
timeFrame: 12 weeks
measure: Changes in vaginal maturation index
timeFrame: 12 weeks
measure: Occurrence of urogenital symptoms
timeFrame: 12 weeks
measure: Change in MENQOL (menopausal quality of life questionaire)
timeFrame: 12 weeks
measure: Bleeding profile
timeFrame: 12 weeks
measure: Safety
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03380637: Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants
Official title: Ultrasound for Comparison of Gastric Volume in Pregnant Females Posted for Elective Lower Segment Cesarean Section With Non-pregnant Females Undergoing Elective Surgeries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-12-21
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population are term pregnants posted for elective lower segment cesarean section and non-pregnant patients posted for elective surgeries in PGIMER.

Brief summary: This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.

Detailed description: There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.

The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.

Eligibility criteria: Inclusion Criteria:Study group- Term pregnant patients, aged between 18 to 45 years, ASA II \& III, having BMI between 18.5 to 30 kg/m2, scheduled for elective lower segment cesarean section.

Control group- Non-pregnant female patients, aged between 18 to 45 years, ASA I \& II, having BMI between 18.5 to 30 kg/m2, scheduled for elective surgery.

Exclusion Criteria:Subjects with-

* Gastrointestinal pathology
* On any medication delaying gastric motility
* Systemic lupus erythematosis
* Diabetes mellitus
* Gestational diabetes
* Hypothyroidism Those who were not willing to give consent

Primary outcomes:
measure: Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility
timeFrame: October 2016 to October 2017
Secondary outcomes:
measure: Qualitative assessment of Gastric antrum
timeFrame: October 2016 to October 2017
measure: Quantitative assessment of Gastric Antrum
timeFrame: October 2016 to October 2017
Other outcomes:
Locations:
Study officials:
affiliation: Post graduate institute of medical education and researchh
name: Snigdha Bellapukonda, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
Clinical trial NCT01910337: Evaluation of Heart Rate Variability in Third Lower Molars Surgeries
Official title: Evaluation of Heart Rate Variability in Third Lower Molars Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Patients
Keywords: ASA I patients
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2013-07-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients from the community sample in Dentistry School - University of Sao Paulo

Brief summary: The purpose of this study is to use heart rate variability as a monitor of cardiovascular safety during third molar surgeries, using the Polar heart rate-meter.


Eligibility criteria: Inclusion Criteria:

* Healthy Patients (ASA I)
* Need to remove one of Lower Third Molar.

Exclusion Criteria:

* smoking
* pregnant

Primary outcomes:
measure: Evaluation of cardiac safety during third molar surgeries
timeFrame: 3 weekes
Secondary outcomes:
measure: study of heart rate variability during third molars surgeries with the Polar Cardiac Rate-meter.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da Universidade de são Paulo
Study officials:
References:
Clinical trial NCT00562237: Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine
Official title: Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Surface Antigen Influenza Vaccine in Healthy Adults Aged ≥18 Years and ≤ 49 Years.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: immunogenicity
safety
adjuvanted pandemic vaccine
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-11-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several combinations of H5N1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.


Eligibility criteria: Inclusion Criteria:

* being healthy and ≥ 18 and ≤ 49 years of age
* willing and able to give informed consent

Exclusion Criteria:

* having participated in an influenza H5 vaccine trial in the past
* known to be allergic to any constituent of the vaccine
* serious adverse reactions to previous (influenza) vaccination
* currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study
* using medication that influences the immune system

Primary outcomes:
measure: Hemagglutination inhibition titers
timeFrame: one year
Secondary outcomes:
measure: CHMP criteria
timeFrame: one year
measure: Virus neutralization
timeFrame: one year
measure: Anti-HA antibody level kinetics
timeFrame: one year
measure: Safety
timeFrame: one year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Site 21
city: Tampere
country: Finland
facility: Site 22
city: Turku
country: Finland
facility: Site 23
city: Goch
country: Germany
facility: Site 12
city: Hamburg
country: Germany
facility: Site 10
city: Nürnberg
country: Germany
facility: Site 11
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT05087537: Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve
Official title: Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Disorder
Hydronephrosis in Children
Hydronephrosis, Secondary
Hydronephrosis Congenital
Bladder-Neck; Obstruction, Congenital
Urethral Valve
Renal Function Disorder
Keywords: PUV
BNI
Urethral valve
Valve ablation
Bladder dysfunction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 62
Sex: MALE
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.


Eligibility criteria: Inclusion Criteria:

* Patients who are less than 12 years of age with presenting to the Mansoura University Urology and Nephrology Center with the diagnosis of PUV will be s creended for eligibility

Exclusion Criteria:

* Patients with other conditions that can potentially affect lower and upper urinary tract functions
* Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
* Patients who had primary treatment of posterior urethral valve ablation at other hospitals.

Primary outcomes:
measure: compare numbers of reintervention between groups
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center, Mansoura university
state: Dakahlia
Study officials:
References:
Clinical trial NCT06318637: Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates
Official title: A Clinical Evaluation of the Acceptability and Feasibility to Caregivers of a Bedtime Routine for Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.


Eligibility criteria: Inclusion Criteria:

Infant:

* Full term at birth (gestational age greater than or equal to \[\>=\] 37 weeks)
* A singleton birth. (Having other infants/children in the household will be allowed but only 1 child per household may be enrolled)
* Breastfed, formula-fed, or combination

Caregiver:

* Able to read, write, speak, and understand English
* Must be the parent (biological or adoptive) and legal guardian of the infant participant who is willing and able to present proof of legal guardianship (example: birth certificate/hospital discharge paperwork along with valid ID of legal guardian, etc.)

Exclusion Criteria:

Caregiver and infant:

* Has known allergies or adverse reactions to common topical skincare products or the ingredients in the investigational study materials
* Has a history of or a concurrent health condition/situation which, in the opinion of the Principal Investigator (PI) or Study Physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Is simultaneously participating in any other clinical study or has participated in a clinical study since infant's birth
* Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
* Presents with a skin condition that may influence the outcome of the study (specifically psoriasis, eczema, atopic dermatitis, or erythema)

Primary outcomes:
measure: Bedtime Routine Acceptability and Feasibility to Caregivers
timeFrame: At Day 10
measure: Bedtime Routine Acceptability and Feasibility to Caregivers
timeFrame: At Day 17
measure: Bedtime Routine Acceptability and Feasibility to Caregivers
timeFrame: At 3 months
measure: Bedtime Routine Acceptability and Feasibility to Caregivers
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: SGS North America, Inc.
state: Texas
Study officials:
affiliation: SGS North America, Inc.
name: Nancy Rodgers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: