louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01649128: Screening for Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Official title: Screening Models for Early Detection of Late-onset Preeclampsia With Various Markers in Low-risk Pregnancy Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Keywords: preeclampsia
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 262
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: low risk women who had not a risk factor of preeclampsia.

Brief summary: For the prediction of late-onset preeclampsia (PE) in low risk women, the investigators established a cut-off value for sFlt-1/PlGF ratio and evaluated the combination models of Elecys, second trimester uterine artery (UtA) doppler, and fetoplacental proteins for Down syndrome screening.

Detailed description: A prospective study was carried on in Cha hospital. Serum samples for Down syndrome screening were assayed to estimate pregnancy-associated plasma protein-A (PAPP-A), alpha-fetoprotein , unconjugated estriol, human chorionic gonadotrophin , and inhibin-A. Women screened for Down syndrome were offered UtA Doppler at 20-24 weeks of gestation and then collected serial serum samples for sFlt-1/PlGF ratio at two time points (24-27 and 34-37 weeks' gestation).

Eligibility criteria: Inclusion Criteria:

* Women considered as a potential participant in this research were patients regularly visited at the prenatal care of Cha hospital in Seoul, Korea

Exclusion Criteria:

* early onset and cases not to measure the sFlt/PlGF ratio and other markers
* twin pregnancy
* Chronic hypertension
* prior history of preeclampsia
* pregestational diabetes mellitus
* gestational diabetes mellitus
* patients delivered before 35 weeks of gestation
* preeclamptic patients with onset before 35 weeks of gestation
* patients with body mass index 25kg/m2 or greater
* maternal age 40 years older

Primary outcomes:
measure: identification of patients at risk for late-onset preeclampsia with sFlt-1/PlGF ratio
timeFrame: at delivery
Secondary outcomes:
measure: identification of patients at risk for late-onset preeclampsia with combined biochemical markers
timeFrame: at delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01139528: Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal Bone
Official title: Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures of the Neck
Keywords: Fracture
5th metacarpal bone
Bouquet pinning
Fractures of the neck of the 5th metacarpal bone
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
name: Asker & Baerum Hospital
First posted: 2010-06-08
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone

Exclusion Criteria:

* Less than 30 degrees of volar angulation in the fracture
* rotational deformity
* pseudoclawing
* intra-articular involvement
* ad latus displacement more than one half of a bone width
* concomitant fractures or soft tissue damage
* admittance more than 14 days after injury
* non-compliant patient (language, drugs, tourist)
* patient who refuses to participate in the study

Primary outcomes:
measure: Quick-DASH
timeFrame: 6 weeks, 3 months, 1 year, 2 years
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks, 3 months, 1 year, 2 years
measure: Pain
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Eq-5d
timeFrame: 6 weeks, 3 months, 1 year, 2 years
measure: Complications
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Sick-leave
timeFrame: 1 week, 6 weeks, 3 months (1 year, 2 years)
measure: Range of motion in the joints in the 5th finger measured by hand therapist
timeFrame: 3 months, 1 year, 2 years
measure: Grip strength
timeFrame: 3 months, 1 year, 2 years
measure: Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand
timeFrame: 6 weeks, 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo
name: Lars Nordsletten, Prof. MD, PhD
role: STUDY_CHAIR
References:
citation: Sletten IN, Nordsletten L, Hjorthaug GA, Hellund JC, Holme I, Kvernmo HD. Assessment of volar angulation and shortening in 5th metacarpal neck fractures: an inter- and intra-observer validity and reliability study. J Hand Surg Eur Vol. 2013 Jul;38(6):658-66. doi: 10.1177/1753193412461582. Epub 2012 Oct 11.
Clinical trial NCT00693628: Effects of Shrinker Use on Healing and Volume
Official title: Effects of Shrinker Use on Healing and Volume for Transtibial Amputees
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transtibial Amputation
Keywords: volume
healing
shrinker
transtibial amputation
individuals who have undergone transtibial amputation
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2008-06-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".

Detailed description: Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.

Eligibility criteria: Inclusion Criteria:

* Recently undergone primary transtibial amputation
* Patients between ages of 18 and 100 years of age

Exclusion Criteria:

* Undergone previous amputations above the Symes level

Primary outcomes:
measure: Reduction in Time to Healing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center, O'Donoghue Orthotics & Prosthetics Clinic
state: Oklahoma
Study officials:
affiliation: University of Oklahoma Health Sciences Center Department of Orthopedic Surgery & Rehabilitation, Division of Orthotics & Prosthetics
name: Jonathan Day, BSPO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693328: Patient Satisfaction and Quality of Life Impact - PecFent®
Official title: A French, Multicentre, Open-label, Observational Study to Assess Quality of Life and Satisfaction in Subjects Taking PecFent® for the Treatment of Breakthrough Cancer Pain (BTPc)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breakthrough Cancer Pain
Keywords: quality of life
PecFent
Lazanda
fentanyl
intranasal
breakthrough cancer pain
Lead sponsor: Archimedes Development Ltd
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with breakthrough pain

Brief summary: National multicenter, prospective, observational study in cancer patients with chronic background pain and breakthrough pain to whom PecFent® has been prescribed under pragmatic condition by a specialist in the treatment of cancer pain conditions.

• Study objectives include assessment of early treatment satisfaction.


Eligibility criteria: Inclusion Criteria:

* Adult (aged ≥18 years) with cancer
* Taking at least 60 mg of oral morphine sulfate or equivalent per day for chronic background pain

Primary outcomes:
measure: Satisfaction
timeFrame: Satisfaction will be assessed approximately 1 hour after each BTPc episode treated with PecFent® from completion of titration through Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon-Bérard
Study officials:
affiliation: Head of Pain Federation - Palliative Medicine Lariboisiere Hospital, Paris France
name: Alain Serrie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05038228: High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
Official title: Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Eliquis
Anti-Coagulation
Bleed
Stroke
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 1
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: Adult patients with a diagnosis of non-valvular atrial fibrillation being treated with anticoagulation.

Brief summary: This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF with high risk of gastrointestinal bleed who initiate anticoagulant treatment with a Vitamin-K Antagonists (VKAs) or direct-acting oral anticoagulants (DOACs).


Eligibility criteria: Inclusion Criteria:

Patients covered by the French national health insurance general scheme With at least one reimbursement of AC treatment (apixaban, rivaroxaban, dabigatran, or VKAs) Aged ≥18 years as of the index date With a diagnosis of atrial fibrillation (AF) prior to or on the index date With at least one risk factor for gastrointestinal bleeding

Exclusion Criteria:

Patients with different types of AC treatment at the index date Patients with a diagnosis or procedure code indicative of rheumatic mitral valvular heart disease or valve replacement procedure Individuals with a diagnosis of VTE during the 12 months prior to or on the index date

Primary outcomes:
measure: Bleeding leading to hospitalization
timeFrame: 2016-2019
measure: Stroke
timeFrame: 2016-2019
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Pfizer Investigator
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05655728: Treatment With Metformin in Chinese Children With Alport Syndrome
Official title: Efficacy and Safety of Metformin in Alport Syndrome: A Randomized, Double-blind, Placebo-controlled Study in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alport Syndrome
Metformin
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 78
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center, prospective, double-blind randomized placebo-controlled trial will evaluate the efficacy and safety of metformin in Chinese children with Alport syndrome who have received (and continue to receive)) ACEi/ARB.


Eligibility criteria: Inclusion Criteria:

* (1) The diagnostic of Alport syndrome-hematuria with or without proteinuria meets one or more of the following 4 items: i) Immunofluorescence staining of the α5 (IV) chain of the glomerular basement membrane was abnormal; ii) electron microscopy of renal biopsy showed diffuse changes in the glomerular basement membrane; iii) There was one pathogenic variant in the COL4A5 gene or two pathogenic variants in the COL4A3/COL4A4 gene; iv) Family history of Alport syndrome.

  (2) Age is older than or equal to 10 years old. (3) The 24-hour urine protein quantification was greater than 150mg and the urine microalbumin-creatinine ratio was greater than 30 mg/g.

  (4) The estimated glomerular filtration rate (24-hour creatinine clearance) was greater than 45 mL/min/1.73m2.

  (5) Accept the maximum tolerated dose of renin-angiotensin-aldosterone system blockers (Blood pressure in the clinic was in the 50th percentile of the same age, same sex and same height but greater than 90/60mmHg, blood potassium was normal, and the increase of blood creatinine did not exceed 30%) for at least 3 months.

Exclusion Criteria:

* (1) Vitamin B12 deficiency was uncorrected. (2) Treated with Furosemide, amiloride, and nifedipine. (3) Hypertension, chronic liver disease, chronic heart disease, and chronic kidney disease resulting from causes except Alport syndrome.

  (4) History of hyperlactatemia. (5) Allergy to metformin. (6) kidney transplant. (7) Poor compliance. (8) Type 1 diabetes.

Primary outcomes:
measure: Efficacy of metformin for Alport syndrome
timeFrame: 24 months
measure: Safety of metformin for Alport syndrome
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05566028: The Efficacy and Safety of D745 Added to D150 Plus D759 Therapy in Patients with Type 2 Diabetes
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of D150, D745 and D759 Combination Therapy in Pateints with Type 2 Diabetes Inadequately Controlled with D150 Plus D759
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 172
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove that the group treated with D745 in combination added that the reduction of HbA1c superior to placebo treated group added in combination.

Detailed description: The aim of this phase 3 study is to evaluate the efficacy and safety of additional combined D745 administration for 24 weeks in patient with type 2 diabetes who are no adequately controlled for blood glucose by the combination of D150 and D759

Eligibility criteria: Inclusion Criteria:

* between 19 years and 85 years old(male or female)
* Type 2 diabetes mellitus
* BMI between 18.5kg/m2 and 40kg/m2
* Agreement with written informed consent

Exclusion Criteria:

* Type 1 diabetes mellitus or secondary diabetes mellitus
* Patients with complications of severe diabetes such as proliferative diabetic retinopathy
* Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Patients with abnormal laboratory test results according to the protocol
* Continuous or non continuous treatment insulin within 12 weeks prior to screening
* Chronic oral or non oral corticosteroids treatment within 4 weeks prior to screening

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline, 24 week
Secondary outcomes:
measure: Change from baseline in HbA1c
timeFrame: Baseline, 12 week
measure: Change from baseline in Fasting plasma glucose
timeFrame: Baseline, 12 week, 24 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University Hospital
name: Youngmin Cho, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01485328: Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics
Official title: Phase III - Efficacy Study of AMARGOL - Phytomedicine on Therapeutics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Digestive System Disorders
Keywords: Dyspepsia
Flatulence
Aerophagia
Constipation
Lead sponsor: Laboratorio Saude Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Phytopharm Consulting Brazil
First posted: 2011-12-05
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic digestive complaints.

Detailed description: This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product, under the Brazilian law for registration and revalidation RDC 14/2010.

AMARGOL® indications are for non specific digestive complaints as laxative and anti-dyspeptic.

Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum, Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.

Placebo controlled test

Eligibility criteria: Inclusion Criteria:

* 18-45 years old
* 65-85 Kg
* healthy volunteers

Exclusion Criteria:

* chronic dyspeptics illness chronic congestive cardiac problems
* pulmonary problems
* diabetes, thyroid problems
* pregnancy
* bowel syndrome
* hemorrhoids
* colitis
* allergies for any formula components.

Primary outcomes:
measure: VAS - visual analogue scale
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Phytopharm Consulting
state: RS
Study officials:
name: Angelo G Chaves, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809128: Multidisciplinary Approach to Breast Cancer Through the Study of Altered Transcriptomic and Immune Accompanied by the Identification of Extractable Markers From the Radiodiagnostic Bioimaging
Official title: Multidisciplinary Approach to Breast Cancer Through the Study of Altered Transcriptomic and Immune Accompanied by the Identification of Extractable Markers From the Radiodiagnostic Bioimaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Patients
Lead sponsor: IRCCS SYNLAB SDN
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients

Brief summary: Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of breast cancer.
* patients 25 to 80 years of age

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients who do not fall within the age range mentioned above

Primary outcomes:
measure: Multiparametric flow cytometry analyses of Custer of Differentiation (CD) proteins expression on tumor infiltrating lymphocytes
timeFrame: 1-24 months
measure: Analysis of gene expression profiles of cancer cells
timeFrame: 1-24 months
measure: Extraction of features from radiological images to be used as biomarkers.
timeFrame: 1-36 months
measure: Bioinformatics analysis
timeFrame: 37-48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: IRCCS Synlab SDN
Study officials:
References:
Clinical trial NCT05738928: Microbiological Profile of VAP Patients in Respiratory ICU
Official title: Microbiological Profile of Ventilator Associated Pneumonia in Respiratory Intensive Care Unit of Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: VAP - Ventilator Associated Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age more than 18 years.

Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.

Brief summary: Identification of the microbial profile of Ventilator associated pneumonia causing microorganisms among Respiratory ICU patients .

Detailed description: Ventilator-associated pneumonia (VAP) is one of the common serious infectious diseases encountered in the intensive care unit (ICU), which highly affects the healthcare cost and patient prognosis.

All-cause of mortality associated with VAP has been reported to range from 20% to 50%.

The etiology of VAP and their antimicrobial susceptibility pattern varies with different patient populations and types of ICUs.

VAP may be caused by a wide spectrum of bacterial pathogens, which may be polymicrobial and are rarely due to viral or fungal pathogens in immune-competent hosts.

Common etiologic agents are Gram-negative bacilli such as Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, and Acinetobacter spp. and Staphylococcus aureus among Gram-positive cocci.

Due to the increased incidence of MDR organisms in Intensive Care Units (ICUs), early and correct diagnosis of VAP is mandatory for optimal antibiotic therapy. The frequency of specific MDR pathogens causing VAP varies in hospitals, patient populations. Also varies according underlying disease.

this study will be conducted in respiratory intensive care unit, chest disease and tuberculosis department at Assiut university hospitals.

Eligibility criteria: Inclusion Criteria:

1. Mechanically ventilated patient who developed pneumonia after48 hours after endotracheal intubation.
2. Age \> 18 years.

Exclusion Criteria:

1. Patients with clinical and radiological signs suggestive of pneumonia before intubation (community acquired pneumonia or hospital acquired pneumonia)
2. Patients age ≤18 years old

Primary outcomes:
measure: Microbiological profile of ventilator associated pneumonia in Respiratory ICU in Assiut University Hospital.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: mohammed M Abdelhadi, PhD
role: STUDY_DIRECTOR
References: