louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01171248: Study of 24 Hour Blood Pressure and the Association to Complications to Type 1 Diabetes
Official title: Central and Peripheral 24h BP and the Association to Autonomic Neuropathy and Diabetic Nephropathy in Type 1 Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Hypertension
Keywords: nocturnal blood pressure dip
complications
ambulatory blood pressure
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2010-07-28
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 1 diabetic patients (600 patients) non-diabetic controls (50)

Brief summary: The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* more than 18 years of age

Exclusion Criteria:

* End Stage Renal Disease (ESRD)
* dialysis
* other kidney disease than diabetic nephropathy

Primary outcomes:
measure: Ambulatory blood pressure (AMBP)
timeFrame: 2 years
Secondary outcomes:
measure: Diabetic late complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Peter Rossing, MD, DmSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Theilade S, Lajer M, Hansen TW, Rossing P. Pulse wave reflection is associated with diabetes duration, albuminuria and cardiovascular disease in type 1 diabetes. Acta Diabetol. 2014 Dec;51(6):973-80. doi: 10.1007/s00592-014-0651-6. Epub 2014 Oct 2.
citation: Theilade S, Lajer M, Hansen TW, Joergensen C, Persson F, Andresdottir G, Reinhard H, Nielsen SE, Lacy P, Williams B, Rossing P. 24-hour central aortic systolic pressure and 24-hour central pulse pressure are related to diabetic complications in type 1 diabetes - a cross-sectional study. Cardiovasc Diabetol. 2013 Aug 27;12:122. doi: 10.1186/1475-2840-12-122.
Clinical trial NCT06233448: Thorathic Fluid Content as an Early Predictor of Weaning From Mechanical Ventilation in Acute Respiratory Distress Syndrome
Official title: Thorathic Fluid Content as an Early Predictor of Weaning From Mechanical Ventilation in Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult Patient with ARDS on ventilator in our ICU prepared for weaning

Brief summary: Thorathic fluid content measurement using indirect cardiometry is required for prediction of Weaning from mechanical ventilation in cases of acute respiratory distress syndrome and its value in sucsess Weaning


Eligibility criteria: Inclusion Criteria:

* patients with ARDS on ventilator for more than 48 hr. proceed for extubation

Exclusion Criteria:

* heart, renal, hepatic failure Obesity , pregnancy Pneumothorax, pneumonia, hemorrhage

Primary outcomes:
measure: Success of weaning from mechanical ventilation
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University hospitals
Study officials:
References:
Clinical trial NCT01003548: Embryo Development in Microfluidics System of Culture
Official title: Comparison of the in Vitro Development of Human Embryos in Static and and Microfluidics Systems of Culture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility
Keywords: Embryo culture
IVF
Microfluidics
infertility
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Incept Biosystems
First posted: 2009-10-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.

Detailed description: Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.

Eligibility criteria: Inclusion Criteria:

* Age between 21 and 35 years old
* No more than 1 previous IVF failure
* Absence of physical conditions that can interfere in oocyte quality
* At least 8 zigotes 24 hours after fertilization

Exclusion Criteria:

* Use of epididimary or testicular sperm
* Sperm or egg donation
* Untreated systemic diseases

Primary outcomes:
measure: Embryo morphology on days 2 and 3 of embryo culture according to the criteria described by Lucinda Veeck
timeFrame: Embryo culture for 3 days before transference to the uterus
Secondary outcomes:
measure: Implantation rate and pregnancy rate
timeFrame: 24 month
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Departamento de Ginecologia
Study officials:
affiliation: Department of Gynecology - Universidade Federal de Sao Paulo
name: Eduardo LA Motta, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00558948: Musculoskeletal Outcomes After Bone Marrow Transplant
Official title: Musculoskeletal Outcomes After Bone Marrow Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survivors of Bone Marrow Transplant
Autologous and Allogeneic
Keywords: Bone Marrow Transplant
Bone Mineral Density
Survivors
Muscle Strength
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 48
Sex: ALL
Minimum age (years): 8
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of bone marrow transplant (autologous and allogeneic) who are at least 1 year from transplant.

Brief summary: The purpose of the study is to evaluate bone mineral density and muscle strength in survivors of bone marrow transplant. Association with age, type of transplant, steroids, years since transplant, body composition, endocrinopathies, radiation, quality of life and physical activity will be explored.

Detailed description: Bone marrow transplant survivors are at risk of diminished bone mineral density. Mechanisms and risks are not well understood. This study will help identify risks factors for developing this complication.

Eligibility criteria: Inclusion Criteria:

* Ages 8-30 years
* One year from transplant

Exclusion Criteria:

* No current steroid use
* Medical conditions that would prohibit testing
* Neuropsychological conditions that prohibit completing questionnaires

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University, Bayview Campus
state: Maryland
Study officials:
affiliation: Johns Hopkins University, School of Nursing
name: Kathy Ruble, PhDc, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT06531148: A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
Official title: A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemo-Mechanical Caries Removal
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a randomized controlled clinical trial with split-mouth technique
Primary purpose: TREATMENT

Brief summary: This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.

The assessed parameters will be:

* Efficacy of caries removal.
* Pain reaction and mean time required for the treatment.
* Total bacterial count before and after treatment.

Detailed description: Subjects:

A total of 30 children 7-9 years old with no history of systematic disease will be recruited from the out-patient pediatric dental clinic, Faculty of Dentistry, Mansoura University.

Each child with the following criteria will be eligible for the present study (22).

Inclusion criteria:

1. Cooperative child
2. Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
3. The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
4. The selected molars should have normal structure and morphology.

Exclusion criteria:

1. Un-cooperative child
2. Molars with clinical and radiographic signs of pulp involvement.
3. Children with special health care needs.
4. Molars which have already been restored or have developmental anomaly.

Eligibility criteria: Inclusion Criteria:

1. Cooperative child
2. Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
3. The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
4. The selected molars should have normal structure and morphology.

Exclusion Criteria:

* 1- Un-cooperative child 2- Molars with clinical and radiographic signs of pulp involvement. 3- Children with special health care needs. 4- Molars which have already been restored or have developmental anomaly.

Primary outcomes:
measure: Clinical evaluation
timeFrame: 11.2 ± 3.3 min
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Dentistry
state: El-dahlewa
city: Mansoura
country: Egypt
facility: Dentistry
Study officials:
References:
Clinical trial NCT00903448: Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
Official title: Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Normal Healthy Subject Population
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2009-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.


Eligibility criteria: Inclusion Criteria:

* normal subjects who are age 18-65
* generally healthy
* non-childbearing potential females or those using birth control

Exclusion Criteria:

* history of significant GI disease
* any significant medical illness
* history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or other proton pump inhibitors
* currently using GI medications
* GI disorder or surgery leading to impaired drug absorption

Primary outcomes:
measure: Mean Percent Time That Gastric pH > 4.0 on Day 5
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
Study officials:
affiliation: Procter and Gamble
name: Simon H Magowan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01411748: Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight infants \< 1500 gr

Exclusion Criteria:

* Genetic anomalies
* Not willing to participate
* Allergy to S. boulardii components

Primary outcomes:
measure: Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
timeFrame: 6 months
Secondary outcomes:
measure: Effect of S. boulardii on sepsis
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Study officials:
References:
citation: Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. doi: 10.1053/j.semperi.2007.01.006.
citation: Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Lukaszewicz M. Capric acid secreted by S. boulardii inhibits C. albicans filamentous growth, adhesion and biofilm formation. PLoS One. 2010 Aug 10;5(8):e12050. doi: 10.1371/journal.pone.0012050.
Clinical trial NCT01566526: Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Macular Oedema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) who received OZURDEX® as part of the Belgium Medical Needs Program.

Brief summary: The purpose of this study is to use retrospective data to evaluate the efficacy, safety and re-injection interval of OZURDEX® in the treatment of macular oedema due to retinal vein occlusion (RVO) in patients who received OZURDEX® as part of the Belgium Medical Needs Program.


Eligibility criteria: Inclusion Criteria:

* Macular oedema in at least one eye due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
* Received at least two OZURDEX® injections in the study eye as part of the Belgium Medical Needs Program

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to OZURDEX® Re-Injection in the Study Eye
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye
timeFrame: Baseline, 7 to 12 weeks following the last injection
measure: Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye
timeFrame: Baseline, Up to 12 Months
measure: Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye
timeFrame: Baseline, Up to 12 Months
measure: Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection
timeFrame: Baseline, 7 to 12 weeks following the last injection
measure: Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Up to 12 Months
measure: Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Up to 12 Months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01813526: Infants With Protein Sensitive Colitis
Official title: Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Sensitive Colitis
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 53
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.


Eligibility criteria: Inclusion Criteria:

* Less than or equal to 6 months of age
* 36-42 weeks gestational age at birth
* Singleton or Twin birth
* Diagnosed with protein sensitive colitis
* Negative stool culture at time of study entry
* No previous history of consuming free amino acid-based medical food
* Not receiving cisapride or steroids
* No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
* No milk or soy products for the duration of the study

Primary outcomes:
measure: Physician Rated Symptom Score
timeFrame: Study Day (SD) 1 and 43
Secondary outcomes:
measure: Mean Rank Stool Consistency
timeFrame: Study Day (SD) 2-4 and 40-42
measure: Weight
timeFrame: Study Day (SD) 1 and 43 Visits
measure: Formula Intake
timeFrame: Study Day (SD) 2-4 and 40-42
measure: Daily Stool Number
timeFrame: Study Day (SD) 2-4 and 40-42
measure: Stool Occult Blood
timeFrame: Study Day (SD) 2-4 and 40-42
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Omaha
country: United States
facility: Children's Hospital
state: Nebraska
Study officials:
name: Marlene Borschel, PhD, RD
role: STUDY_CHAIR
References:
citation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
Clinical trial NCT00860626: Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B
Official title: Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B, Chronic
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 50
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: For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA is undetectable (\<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.


Eligibility criteria: Inclusion Criteria:

* HBsAg posive for 6 months
* HBeAg positive, and HBeAb negative
* HBV DNA\>1.0×E5 copies/ml
* ALT\>80 u/L within 3 months

Exclusion Criteria:

* pregnant women
* conbination infection of HCV, HAV, or HEV
* conbination infection of HIV
* any contraindication of interferon α

Primary outcomes:
measure: HBeAg seroconversion rate
timeFrame: 3-6 months
Secondary outcomes:
measure: HBV DNA loss rate
timeFrame: 3-6 months
measure: HBsAg loss rate
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Guang zhou
country: China
facility: The Third Affliated Hospital of Sun Yat-sen University
state: Guang dong
Study officials:
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Gao zhiliang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT04455126: Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma
Official title: Preservative-free Tafluprost Eye Drops in Newly Diagnosed Patients With Glaucoma: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glaucoma
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops.
Primary purpose: TREATMENT

Brief summary: Glaucoma encompasses a collective group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells and their axons, resulting in cupping, a distinctive appearance of the optic disc, and a pattern of visual loss

Detailed description: Saflutan® is the first preservative-free prostaglandin analog introduced to the Egyptian market. It contains the PG analog tafluprost. Better tolerability, higher adherence to treatment and improvement of patients' quality of life are associated with using preservative-free eye drops.

Eligibility criteria: Inclusion Criteria:

* Adult males and females, newly diagnosed with glaucoma, naïve to glaucoma medications and surgery, able to read, comprehend, and complete the Ocular Surface Disease Index (OSDI) questionnaire, and able to provide informed consent form.

Exclusion Criteria:

* Unable to provide informed consent form

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Medicine
Study officials:
affiliation: Alexandria Faculty of Medicine
name: Mohamed Doheim
role: PRINCIPAL_INVESTIGATOR
References: