louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01812681: Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities
Official title: Is Higher Cord Blood 25(Oh)-Vitamin D Level Preventive For Any Morbidity Including Rds, Pda, Nec, Bpd And Rop In Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Keywords: vitamin D, Respiratory distress syndrome, sepsis, preterm
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 81
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants

Brief summary: Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

Detailed description: It was shown that vitamin D play important role in the pathogenesis of long term morbidities of newborn. Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

Eligibility criteria: Inclusion Criteria:

* infants \<32 weeks of gestational age

Exclusion Criteria:

* infants with major congenital abnormality
* infants \>32 weeks of gestational age

Primary outcomes:
measure: Respiratory Distress Syndrome
timeFrame: three days
Secondary outcomes:
measure: Sepsis
timeFrame: four weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sami Ulus CH
Study officials:
affiliation: Sami Ulus CH
name: Dilek Dilli, Assoc Prof
role: STUDY_DIRECTOR
References:
citation: Grant WB. Vitamin D supplementation of mother and infant could reduce risk of sepsis in premature infants. Early Hum Dev. 2010 Feb;86(2):133. doi: 10.1016/j.earlhumdev.2010.02.003. Epub 2010 Feb 25. No abstract available.
citation: Fettah ND, Zenciroglu A, Dilli D, Beken S, Okumus N. Is higher 25-hydroxyvitamin D level preventive for respiratory distress syndrome in preterm infants? Am J Perinatol. 2015 Feb;32(3):247-50. doi: 10.1055/s-0034-1383849. Epub 2014 Sep 13.
Clinical trial NCT04482881: Isosorbide Mononitrate in Induction of Labour
Official title: Isosorbide Mononitrate and Misoprostol in Induction of Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Labor Fast
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Suez Canal University
First posted: 2020-07-23
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

Detailed description: There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.

Eligibility criteria: Inclusion Criteria:

* Single vertex presentation. 2. Gestational age \> 37weeks calculated from last menstrual period or U/S scanning.

Exclusion Criteria:

1. Patients with rupture of membranes.
2. Previous uterine scar.
3. Fetal malpresentation.
4. Multiple pregnancies.

Primary outcomes:
measure: the number of women who will be reach active phase within 24 hours
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01356381: Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin in Patients With Type 2 Diabetes
Official title: A Single-center,Double-blind,Randomised,Placebo-controlled,Parallel-group Study to Assess the Effect of 24 Weeks of Treatment With Vildagliptin on Insulin Sensitivity and Its Underlying Mechanism in Patients With T2DM Treated With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will demonstrate the effect of 24 weeks of treatment with vildagliptin compared to placebo on insulin sensitivity in patients with type 2 diabetes mellitus (T2DM) treated with metformin, assessed as glucose Rd (rate of glucose disposal) during a hyperinsulinemic euglycemic clamp.


Eligibility criteria: Inclusion Criteria:

1. Age in the range of 18-70 years.
2. Patients with T2DM, diagnosed at least 6 months prior to Visit 1, who have received metformin for at least 3 months and have been on a stable dose of at least 1000mg daily for a minimum of 4 weeks prior to Visit 1.
3. HbA1c ≤ 7.6% at Visit 1.
4. Body mass index (BMI) in the range of 22-38kg/m2 inclusive at Visit 1.

Exclusion Criteria:

1. Pregnant or nursing (lactating) women.
2. Patients with cardiac pacemakers or with metallic implants incompatible with magnetic resonance methodology.
3. Congestive heart failure requiring pharmacologic treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Measure: effect of treatment on insulin sensitivity, assessed as glucose Rd (rate of glucose disposal).
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Macauley M, Hollingsworth KG, Smith FE, Thelwall PE, Al-Mrabeh A, Schweizer A, Foley JE, Taylor R. Effect of vildagliptin on hepatic steatosis. J Clin Endocrinol Metab. 2015 Apr;100(4):1578-85. doi: 10.1210/jc.2014-3794. Epub 2015 Feb 9.
citation: Macauley M, Smith FE, Thelwall PE, Hollingsworth KG, Taylor R. Diurnal variation in skeletal muscle and liver glycogen in humans with normal health and Type 2 diabetes. Clin Sci (Lond). 2015 May 1;128(10):707-13. doi: 10.1042/CS20140681.
Clinical trial NCT03082781: Dietary Choice in Active Older Adult Women
Official title: A Comparative Assessment of Weight Loss and Anti-lipid Effects of Negative Calorie Diet and Low-calorie Diet in Overweight/Obese Middle-aged and Older Women Under Exercise Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Addiction
Diet Habit
Obesity
Overweight
Weight Loss
Keywords: Diet
Exercise
Obesity
Overweight
Weight loss
Lead sponsor: P.L.Shupik National Medical Academy of Post-Graduate Education
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 66
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

Detailed description: Background: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.

Objectives: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

Material and Methods: Participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). They were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility criteria: Inclusion Criteria:

Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.

Exclusion Criteria:

History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.

Primary outcomes:
measure: Weight
timeFrame: Baseline
measure: Total cholesterol (Total-C)
timeFrame: Baseline
measure: High-density lipoprotein -cholesterol (HDL-C)
timeFrame: Baseline
measure: Low-density lipoprotein -cholesterol (LDL-C)
timeFrame: Baseline
measure: Triglycerides (TG)
timeFrame: Baseline
Secondary outcomes:
measure: Weight
timeFrame: 3-month
measure: Total cholesterol (Total-C)
timeFrame: 3-month
measure: High-density lipoprotein -cholesterol (HDL-C)
timeFrame: 3-month
measure: Low-density lipoprotein -cholesterol (LDL-C)
timeFrame: 3-month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02237781: Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins
Official title: Prospective Randomized Trial on the Level of Anti-Mullerian Hormone (AMH) in Women Undergoing Controlled Ovarian Stimulation for IVFwith Gonadotropins.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Female Infertility
Keywords: AMH
IVF
ovarian stimulation
Lead sponsor: University of Athens
Sponsor class: OTHER
Collaborators: name: Lito Maternity Hospital
First posted: 2014-09-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anti-Mullerian Hormone (AMH) is produced only in small ovarian follicles with quite stable levels during the cycle. There is not yet sufficient data to inform couples undergoing IVF about the effect of ovarian stimulation on the levels of AMH due to the increasing size of follicles and chances of success of the method.

Detailed description: Patients undergoing IVF will be included in the study. All patients will be counseled regarding their prognosis. Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of IVF and during ovarian stimulation. Patients will be stimulated with a short GnRH-antagonist protocol. All women will have measurements of serum FSH and estradiol (E2) and a pelvic sonogram on the second day of their cycle. Ovarian stimulation will be initiated with of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. The dose of gonadotropins will depend on the levels of estradiol and FSH prior stimulation. All patients will be re-evaluated on day 3 and 5 of the stimulation (measurment of AMH, E2 and pelvic sonogram), and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated on day 5. Measurment of AMH, E2 and pelvic sonogram to conferm the size of follicles will be continue every second day untill the oocyte retrieval. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval.

Eligibility criteria: Inclusion Criteria:

* All infertile women undergoing ovarian stimulation for IVF.

Exclusion Criteria:

* Women who can not undergo IVF

Primary outcomes:
measure: Level of AMH
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Athens, 2nd Department of Obstetrics and Gynecology
name: Nikos Vlahos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04062981: Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Official title: Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lennox Gastaut Syndrome
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-20
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-Label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through early termination (ET)/end of study (EOS) visit
Primary purpose: BASIC_SCIENCE

Brief summary: Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).

Detailed description: Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate.

This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed the YKP509C001 study
* Investigator believes subject could benefit from continued exposure to study drug
* Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study

Exclusion Criteria:

* Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
* There are no additional exclusion criteria in this study

Primary outcomes:
measure: Concomitant medication
timeFrame: Up to 20 months
measure: 12-lead electrocardiograms (ECGs)
timeFrame: Up to 20 months
measure: Physical examinations
timeFrame: Up to 20 months
measure: Seizure Frequency
timeFrame: Up to 20 months
Secondary outcomes:
measure: Safety- adverse events
timeFrame: The duration of this OL study will be until carisbamate bas been approved for treatment of LGS and is available by prescription, or development of carisbamate for LGS has stopped, whichever is first. This could occur up to 36 months.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Salt Lake City
country: United States
facility: The University of Utah School of Medicine - Primary Children's Hospital (Primary Children's Medical Center)
state: Utah
city: Renton
country: United States
facility: UW Valley Medical Center
state: Washington
Study officials:
affiliation: SK Life Science, Inc.
name: Marc Kamin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01370681: A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics After Administration of CJ30001 and Co-administration of HKB0701/SLM0807 in Korean Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
* Subjects with no history of any significant chronic disease
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
* Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
* Subjects with a history of clinically significant allergies including drug allergies
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.25 times to normal range or total bilirubin \> 1.5times to normal range)
* Subjects with a history of drug, caffeine abuse(caffeine drink \>5cups/day)
* Subjects with a history of alcohol abuse(alcohol\>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration
* Heavy smoker ( \>10cigarettes/day)
* Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
* Subjects who have donated plasma within 60days prior to drug administration
* Subjects who have participated in a clinical study within 90days prior to drug administration
* Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
* Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control

Primary outcomes:
measure: Geometric mean Cmax
timeFrame: up to 24hrs
measure: Geometric mean AUCt
timeFrame: up to 24hrs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae Gook Shin, MD, ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05278481: Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers
Official title: Latinos Kick Buts: Mobile Engagement and Cessation Support for Latino Smokers Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-03-14
Enrollment: 408
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3 x 2 factorial design
Primary purpose: OTHER

Brief summary: Latino Kick Buts (LKB) is a smoking cessation treatment program available to patients identified as smokers at the University of Rochester Medical Center. Latino Kick Buts smoking cessation mobile program encompasses two integrated components: (1) a 12-week text messaging counseling program with interactive capabilities; and (2) pharmacotherapy support (provision of nicotine replacement therapy at no cost). LKB utilization among Latino smokers remains minimal. The aim of this pilot study is to identify types of text message that are more effective to enrolling Latino smokers in the LKB.


Eligibility criteria: Inclusion Criteria:

* self-identify as Hispanic/Latinos
* be 21 years old or older
* have smoking status recorded in the EMR
* patient of URMedicine

Exclusion Criteria:

* Not Hispanic/Latino
* under 21 years of age
* not a smoker

Primary outcomes:
measure: Number of participants who enroll in smoking cessation treatment
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00688181: The Prefyx PPS™ System eRegistry
Official title: The Prefyx PPS™ System eRegistry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Urinary Incontinence
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) should be eligible for enrollment in the PPS eRegistry. However, any patient meeting any of the contraindications should NOT be included as noted in the Directions For Use. Minors are excluded from the registry per contraindications in which mesh implants are contraindicated in 'patients with the potential for future growth'.

Brief summary: Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).

Detailed description: Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SUI. No additional procedures are required beyond the physician's standard of care.

Eligibility criteria: Inclusion Criteria:

* Patients presenting for treatment of female Urinary Stress Incontinence (SUI)

Exclusion Criteria:

* Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
* Any patients with soft tissue pathology into which the implant is to be placed.
* Patients with any pathology which would compromise implant placement.
* Patients with any pathology, such as blood supply limitations or infections that would compromise healing.

Primary outcomes:
measure: Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up
timeFrame: 3 months
measure: Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up
timeFrame: 12 months
measure: Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression
timeFrame: 12 months
measure: Number of Participants With Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pembroke Pines
country: United States
facility: South Florida Urology Center
state: Florida
city: West Palm Beach
country: United States
facility: OB/GYN Specialists of the Palm Beaches
state: Florida
city: Atlanta
country: United States
facility: Urology Specialists of Atlanta, LLC /Northside Hospital
state: Georgia
city: Westland
country: United States
facility: Affiliates in Urology
state: Michigan
city: Tulsa
country: United States
facility: HillCrest Medical Center
state: Oklahoma
Study officials:
affiliation: Boston Scientific Corporation
name: Robert Walsh, M.D.
role: STUDY_DIRECTOR
References: