louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00299754: Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
Official title: The Randomised-Controlled Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Induction of Labour
Keywords: Low dose misoprostol
dinoprostone
cervical priming
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: National Healthcare Group, Singapore
First posted: 2006-03-07
Enrollment: 171
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.

Detailed description: 171 women with singleton term pregnancies and modified Bishop score (mBS) ≤ 5 were recruited and randomized into 3 arms: current dinoprostone regime, double dose misoprostol or single dose misoprostol. The primary outcome was the number of women who achieved favourable mBS\>6 or active labour by Day 2. Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy, cephalic presentation, gestation greater than 37 completed weeks, no known contraindication to vaginal delivery, and Bishop score≤5.

Exclusion Criteria:

* previous caesarean section or other uterine surgery, significant maternal medical/obstetric complication in pregnancy (such as severe pre-eclampsia, significant antepartum haemorrhage), antepartum evidence of fetal compromise (such as fetal growth restriction), previous attempt at cervical priming, contraindication to receiving prostaglandins, including asthma and glaucoma.

Primary outcomes:
measure: The primary outcome was the number of women who achieved favourable mBS>6 or active labour by Day 2.
Secondary outcomes:
measure: Secondary outcomes were time interval from insert to active labour or delivery, abnormal uterine activity, delivery method and adverse neonatal outcome.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Thiam-Chye Tan
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Tseng-Meng Chua
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rath W. A clinical evaluation of controlled-release dinoprostone for cervical ripening--a review of current evidence in hospital and outpatient settings. J Perinat Med. 2005;33(6):491-9. doi: 10.1515/JPM.2005.087.
Clinical trial NCT01851954: Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)
Official title: Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Very Low Birth Weight Infant
Ureaplasma/Mycoplasma Positive
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 6
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.


Eligibility criteria: Inclusion Criteria:

* birthweight \< 1500gm or GA \< 32 weeks
* transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)

Exclusion Criteria:

* sepsis, hypotension, shock
* major congenital anomaly

Primary outcomes:
measure: pharmacokinetics
timeFrame: 72 hours after first infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05592353: Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS
Official title: Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS: A Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Arthroscopy
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The routine application of hip brace following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) has no proven clinical benefits. This study will investigate whether the application of hip brace affects the post-operative course and patient reported outcomes in patients undergoing hip arthroscopy for FAIS.


Eligibility criteria: Inclusion Criteria:

* Patient age of 18 years or older
* Patients with femoroacetabular impingement syndrome (FAIS) and who are candidates for surgical treatment with hip arthroscopy

Exclusion Criteria:

* Patient age \< 18 years
* Patients with FAIS who are not surgical candidates (surgical therapy is not indicated)
* Patients with previous, ipsilateral hip procedures

Primary outcomes:
measure: Hip Outcome Score
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of the University of Southern California
state: California
Study officials:
References:
Clinical trial NCT00133653: The Double Exposure Study: The Impact of Job Strain and Marital Cohesion on Blood Pressure
Official title: The Impact of Job Strain and Marital Cohesion on Ambulatory Blood Pressure Over One Year: The Double Exposure Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension; Job Strain; Marital Strain; Blood Pressure
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2005-08-23
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).

In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.

Detailed description: Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).

In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.

Eligibility criteria: Inclusion Criteria:

* Age 40-65
* Unmedicated for at least 6 months
* Living with spouse for at least 6 months
* Working for at least 6 months

Exclusion Criteria:

* Working rotating or evening shifts

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook & Women's College Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook & Women's College Health Sciences Centre
name: Sheldon W Tobe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baker B, Paquette M, Szalai JP, Driver H, Perger T, Helmers K, O'Kelly B, Tobe S. The influence of marital adjustment on 3-year left ventricular mass and ambulatory blood pressure in mild hypertension. Arch Intern Med. 2000 Dec 11-25;160(22):3453-8. doi: 10.1001/archinte.160.22.3453.
Clinical trial NCT06371053: The Effect of Community Intervention on Different Degrees of Dementia
Official title: The Effect of Community Intervention on Different Degrees of Dementia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Buraidah Central Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Detailed description: Regular exercise can increase brain function, improve memory, speed up cognitive processes, and fight off diseases like Alzheimer ' s and dementia.

The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility criteria: Inclusion Criteria:

* Age over 60 years old.
* No hospitalization within the past six months.
* Alzheimer's disease
* The elderly people who voluntarily participate and agree to adhere until the end of the study.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Difficulty in mobility.
* Simultaneously receiving other therapies that might influence this study.

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: day 1 and day 14
Secondary outcomes:
measure: Barthel Index
timeFrame: day 1 and day 14
measure: Functional near-infrared spectroscopy
timeFrame: day 1 and day 14
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Louis Wi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04915053: Black Garlic Nutraceuticals and Blood Pressure Control
Official title: Black Garlic Nutraceuticals Supplementation for the Control of Blood Pressure in Hypertension. A Triple-blind Randomized Placebo Control Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Garlic
Nitric oxide
Angiotensin-converting enzyme
Antioxidant capacity
Endothelial function
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
Collaborators: name: Pharmactive, S.L.
First posted: 2021-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three measurements, initial, middle, and final.
Primary purpose: TREATMENT

Brief summary: Black garlic contains a series of allyl-sulfur compounds with the ability to modulate nitric oxide synthetase, angiotensin-converting enzyme system, and endothelial activation, which together could help better control blood pressure. The main objective of this study is to evaluate the effect on blood pressure and endothelial health of a daily intake of a black garlic supplement named ABG (registered mark), which has a higher concentration of black garlic bioactive compounds, in people with moderate hypertension.


Eligibility criteria: Inclusion Criteria:

- Clinical hypertension, medically treated with no more than 2 drugs

Exclusion Criteria:

* Body mass index above 35 kg/m2
* Fasting blood cholesterol levels below 115 mg/dL
* Fasting blood glucose levels above 126 mg/dL
* Taking anyone of the Angiotensin-converting enzyme inhibitors
* Anemia (hemoglobin below 13 g/dL in men and below 12 g/dL in women)
* Vitamin or nutraceutical intake in the last 30 days before the study enrollment
* Chronic gastrointestinal diseases
* Pregnancy and breastfeeding
* Garlic allergy
* Participation in another study 30 days before the study enrollment

Primary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in Blood nitric oxide content
timeFrame: Baseline and 12 weeks
measure: Change in Angiotensin-converting enzyme activity
timeFrame: Baseline and 12 weeks
measure: Change in Endothelial function
timeFrame: Baseline and 12 weeks
measure: Change in Blood lipid profile
timeFrame: Baseline and 12 weeks
measure: Change in Blood cytokine profile
timeFrame: Baseline and 12 weeks
measure: Change in Blood antioxidant capacity
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Universitat de Lleida
name: Manuel S Portero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792553: Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite
Official title: Effects of Tongue Tamers and Customized Bonded Spurs as an Early Treatment of Anterior Open Bite: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tongue Habits
Open Bite
Keywords: open bite
tongue thrust
habit breaking appliance
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 75
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and psychological concerns, emphasizing the significance of beginning treatment as soon as possible to correct the disorder. The main etiological determinants of AOB include finger-sucking, pacifiers, and oral habits; hence, it is vital to use interceptive treatments focused on correcting and increasing bite stability during childhood to avoid the need for advanced therapy


Eligibility criteria: Inclusion Criteria:

* male or female patients in early mixed dentition period with age range 7-9 years
* dental anterior open bite equal to or greater than 1 mm,
* class I malocclusion
* clinical signs of anterior tongue thrusting.

Exclusion Criteria:

* Patients with skeletal open bite
* posterior crossbite
* tooth agenesis or loss of permanent teeth
* crowding,
* systemic diseases

Primary outcomes:
measure: Change of the anterior open bite
timeFrame: 3 months
Secondary outcomes:
measure: cephalometric variables
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT06172153: Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study
Official title: Diagnostic Efficacy of Metagenomic Next-generation Sequencing in Patients With Spinal Infections: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Infection
Diagnositic Efficacy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: "The patients suspected of spinal infections were admitted to the Orthopedic Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University."

Brief summary: Comparing the diagnostic efficacy between traditional laboratory methods and second-generation high-throughput sequencing in patients suspected of spinal infections.


Eligibility criteria: Inclusion Criteria:

"Patients suspected of spinal infections, as per the American Infectious Diseases Society's 2015 criteria for primary vertebral osteomyelitis, were identified based on their clinical symptoms, laboratory tests, and imaging examinations. All cases included in the study underwent laboratory examinations, histopathological examinations, and second-generation high-throughput sequencing (metagenomic sequencing)."

Exclusion Criteria:

"The absence of laboratory examinations, histopathological examinations, and results from second-generation high-throughput sequencing (metagenomic sequencing)."

Primary outcomes:
measure: The diagnositic efficacy
timeFrame: 1 year
measure: The diagnositic efficacy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen memorial hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Chunhai Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997953: Screening of Postpartum Depression in Egyptian Women
Official title: Assessment of the Edinburgh Postnatal Depression Scale as Screening Tool for Postpartum Depression Among Women Delivering at Egyptian Tertiary Care System University Hospital: Prevalence and Risk Factors Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Depression
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2000 patients who underwent either vaginal birth or cesarean section at El-Hussien University Hospital and agreed for followup and participation in this study.

Brief summary: The goal of this cross-sectional study is to assess the Edinburgh Postnatal Depression Scale as screening tool for Postpartum Depression among women delivering at Egyptian tertiary health care system, University Hospital, regarding Prevalence and risk factors.

participants of this study with fill the Edinburgh Postnatal Depression Scale and their socio-demographic, obstetric and psychological data will be collected and analysed.

prevalence of postpartum depression in Egyptian women will be assessed as well as the associated risk factors


Eligibility criteria: Inclusion Criteria:

All patients who underwent vaginal/cesarean delivery and reported for follow and willing to participate in the study.

Exclusion Criteria:

* Patients who were unwilling to participate in the study.
* Patients who are having difficulties comprehending the questionnaire of the study.
* Women who were on psychiatric medication during pregnancy.

Primary outcomes:
measure: Number screening positive for possible postpartum depression by Arabic EPDS
timeFrame: 2 weeks postpartum
Secondary outcomes:
measure: Sociodemographic, clinical, and psychosocial predictors of postpartum depression risk
timeFrame: At 2 weeks postpartum
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty od Medicine, Department of Obstetrics and Gynecology.
state: Cairo.
Study officials:
References:
Clinical trial NCT00860353: Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551
Official title: A Double Blind, Randomised, Placebo-controlled, Phase I Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single, Ascending, Oral Doses of AZD2551 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteer
Single Ascending Dose
Safety
Tolerability
AZD2551
Healthy Volunteer Study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
* Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg

Exclusion Criteria:

* Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
* History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
* Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
* Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome

Primary outcomes:
measure: Safety and tolerability of AZD2551 by assessment of vital signs, ECG, laboratory variables and adverse events
timeFrame: Baseline assessments at Visit 1 (enrolment). Assessments pre-dose and at defined timepoints post-dose at Visit 2. Follow up assessment at Visit 3
measure: Pharmacokinetic profile: concentration of AZD2551 in blood
timeFrame: Samples taken at Visit 2. Up to 15 samples to be taken at defined timepoints post-dose, plus one sample pre-dose
Secondary outcomes:
measure: Pharmacokinetic profile: concentration of AZD2551 in urine
timeFrame: Samples collected at Visit 2 from pre-dose up to 48 hours post-dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, E Floor, Queens Medical Centre, Nottingham NG7 2UH
name: William Fahy, MA, MBBS (Hons)
role: PRINCIPAL_INVESTIGATOR
References: