louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05373680: Efficacy and Safety of Metformin Versus Empagliflozin on Chronic Kidney Disease Progression
Official title: Clinical Study Evaluating the Efficacy and Safety of Metformin Versus Empagliflozin for Halting Chronic Kidney Disease Progression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Renal Insufficiency, Chronic
Keywords: Metformin
Empagliflozin
Chronic kidney disease
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Mansoura University
First posted: 2022-05-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims at evaluating the efficacy and safety of the antidiabetics metformin versus empagliflozin on chronic kidney disease (CKD) progression in patients with CKD stages 2 or/and 3.


Eligibility criteria: Inclusion Criteria:

* Patients with mild or/and moderate chronic kidney disease (stages 2 or/and 3, estimated glomerular filtration rate (eGFR) between 30-89 ml/min/1.73 m2) at the time of the baseline visit.
* Patients with and without type 2 diabetes.
* Patients with or without proteinuria.
* Age: ≥ 18 years.

Exclusion Criteria:

* Type 1 diabetes.
* Patients with eGFR ˂30 ml/min/1.73 m2.
* Patients with known hepatic cell failure.
* Decompensated heart requiring acute management.
* Active malignancy.
* Planned coronary or surgical interventions.
* Known hypersensitivity to study medications.
* Chronic inflammation, trauma, or infection.
* Pregnant or lactating women.
* Patients already on metformin or a sodium-glucose cotransporter-2 (SGLT2) inhibitor.
* Any of the study treatments labeled contraindications.

Primary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR) values from baseline
timeFrame: Period of 12 months
measure: Change in albumin or protein excretion values from baseline
timeFrame: Period of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia Governorate
city: Tanta
country: Egypt
facility: Tanta University Teaching Hospitals
state: Gharbia Governorate
Study officials:
References:
Clinical trial NCT01451580: Lipo-dox and Cyclophosphamide /5-Fluorouracil in Patients With Metastatic Breast Cancer
Official title: A Phase II Study of Pegylated Liposomal Doxorubicin (Lipo-Dox) Combined With Cyclophosphamide /5-Fluorouracil as Second Line Chemotherapy in the Treatment of Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Phase II
Metastatic Breast Cancer
Lead sponsor: TTY Biopharm
Sponsor class: INDUSTRY
First posted: 2011-10-13
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine the overall objective response rate of pegylated liposomal doxorubicin （Lipo-Dox）combined with cyclophosphamide/5-FU as second-line treatment in patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* histologically proved breast cancer with metastatic disease

Exclusion Criteria:

* life expectancy less than 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Linko
country: Taiwan
facility: CGMH
Study officials:
affiliation: Chang Gung Memorial Hospital, Lin-Kou Medical Center
name: Hsien-Kun Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06522880: Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study
Official title: Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study: An Observational Study to Evaluate CMV Transmission and Immune Correlates of Viral Shedding Among Young Children in Early Education and Care Settings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus Infections
Keywords: cytomegalovirus
CMV
congenital cytomegalovirus
cCMV
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: ModernaTX, Inc.
First posted: 2024-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited from all children and all staff at each center.

Brief summary: The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.


Eligibility criteria: Inclusion Criteria

Children

1. All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled.
2. Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home

Center Staff

1. Individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.
2. Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home

Exclusion Criteria

Children

1. \>/= 37 months of age
2. State Department of Children and Families (DCF) custody

Center Staff

1. Do not regularly (average \< 5 days per year) work inside the center
2. Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Primary outcomes:
measure: Prevalence of CMV shedding
timeFrame: Stage I up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: Laura Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03689062: Premature Rupture of Membranes at 34 to 37 Weeks' Gestation
Official title: Premature Rupture of Membranes at 34 to 37 Weeks' Gestation :Active vs Conservative Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Rupture of Membrane
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prelabour rupture of membrane is deﬁned as rupture of membranes prior to the onset of labour. Approximately 8% of pregnant women at term experience PROM, but the decision as to how term PROM should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. Although for the majority of women labour will start spontaneously within 24 hours following term PROM, up to 4%of women will not experience spontaneous onset of labour within seven days.


Eligibility criteria: Inclusion Criteria:

* Preterm premature rupture of membranes.
* Singleton gestation.
* Pregnant between 34 weeks 0 days to 36 weeks 6 days.

Exclusion Criteria:

* Non cephalic presentation.
* fetal distress.
* Labour on admission.
* Medical or obstetric complications such as(suspected chorioamnionitis ,hypertensive disorders, diabetes mellitus , active genital herpes , placenta previa , infection, meconium stained amniotic fluid ,severe fetal anomalies).

Primary outcomes:
measure: the percentage of patients with chorioamnionitis
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00159562: Effects of Psycho-education of Patients With Bipolar Disorder
Official title: Effects of Psycho-education of Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Psycho-education
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Norwegian Council for Mental Health
name: Norwegian Foundation for Health and Rehabilitation
First posted: 2005-09-12
Enrollment: 85
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 purpose for this study is to determine whether psycho-education in groups is more effective than individual psycho-education for patients with bipolar disorder.

Detailed description: The main aim of the study is to compare the effects of psycho-education in groups with short individual psycho-education.

It is a randomized controlled trial including Bipolar 1 and 2 patients in a stable euthymic phase. 42 or 43 patients will receive group education in 10 weekly sessions and then a session every third month for two years. 42 or 43 patients will receive three individual sessions of education. Symptoms, admittances to hospital and function will be followed for two years.

Eligibility criteria: Inclusion Criteria:

* Bipolar Disorder 1 or 2 Euthymic

Exclusion Criteria:

* Active depression or mania/hypomania

Primary outcomes:
measure: Score on depression and mania rating scales
timeFrame: 12 months
measure: Admissions to hospital
timeFrame: 24 months
measure: Working activity
timeFrame: 24 months
Secondary outcomes:
measure: Symptoms, function, use and change in medication, need for
timeFrame: 24 months
measure: consultations
timeFrame: 24 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St Olavs Hospital, University Hospital of Trondheim
Study officials:
affiliation: Norwegian University of Science and Technology
name: Gunnar Morken, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kallestad H, Wullum E, Scott J, Stiles TC, Morken G. The long-term outcomes of an effectiveness trial of group versus individual psychoeducation for bipolar disorders. J Affect Disord. 2016 Sep 15;202:32-8. doi: 10.1016/j.jad.2016.05.043. Epub 2016 May 24.
Clinical trial NCT01793662: Norwegian Laparoscopic Aortic Surgery Trial
Official title: Norwegian Laparoscopic Aortic Surgery Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortobifemoral Bypass
Aortoiliac Occlusive Disease
TASC Type D Lesions
Laparoscopic Versus Open Bifurcation Graft
Keywords: Aortobifemoral bypass
Laparoscopic aortic surgery
Aortoiliac occlusive disease
TASC Type D Lesions
Open aortic surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. The cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence.

However, no randomized control trial has yet been published to compare the two procedures.

In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC type D atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.

Detailed description: The primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc.

Secondary endpoints are as follows,

* health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of SF36v2 questionnaire and EQ5D5L.
* perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes
* perioperative inflammatory response
* cost-utility analysis
* cost differences

Eligibility criteria: Inclusion Criteria:

* Aortoiliac occlusive disease (TASC Type D lesions)

Exclusion Criteria:

* Active cancer disease
* Acute critical limb ischemia
* Prior major abdominal surgery
* Heart failure (Ejection fraction \<40%

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: health related quality of life
timeFrame: 3 months postoperatively
Other outcomes:
measure: Operative stress response
timeFrame: During operation
measure: Cost utility examination
timeFrame: 30 days
measure: Inflammatory stress response
timeFrame: 30 days
Locations:
city: Oslo
country: Norway
facility: Department of vascular surgery, Oslo University Hospital
Study officials:
affiliation: Department of vascular surgery, Oslo University Hospital, Oslo, Norway
name: Syed Sajid Hussain Kazmi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780062: Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
Official title: Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Minor Traumatic Brain Injury
Treatment by Antiplatelet
Keywords: S100B protein
minor traumatic brain injuries
antiplatelet therapy
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.

No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 Years old
* Minor traumatic brain injury measured by a Glasgow score between 13 and 15
* Antiplatelet agent therapy
* Free subject without tutorship or curatorship

Exclusion Criteria:

* Age \< 18 years old
* Glasgow score \<13
* Traumatic brain injury older than 6 hours
* Patient without any social security system
* Patient with renforced protection (tutorship, curatorship, ...)

Primary outcomes:
measure: Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU of MONTPELLIER
city: Nice
country: France
facility: CHU of NICE
city: Paris
country: France
facility: La Pité Salpêtrière
city: Poitiers
country: France
facility: CHU of POITIERS
Study officials:
References:
Clinical trial NCT00835562: Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
Official title: Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Proximal Humeral Fractures
Keywords: Shoulder fractures
Proximal humeral fractures
Randomised clinical trial
elderly
Displaced four-part fractures of the proximal humerus
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Zealand University Hospital
name: Odense University Hospital
First posted: 2009-02-03
Enrollment: 162
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: Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.

The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.

The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.


Eligibility criteria: Inclusion Criteria:

* Displaced four-part fracture of the proximal humerus
* Mentally alert
* Physically fit for surgery and rehabilitation (ASA-group 1-3)
* Informed written consent
* Operation can be conducted within 2 weeks of injury

Exclusion Criteria:

* Fracture-dislocations
* Head-splitting fractures
* Previous shoulder surgery on injured side
* Chronic shoulder pain
* Abuse problems
* Patients unable to understand instructions in Danish

Primary outcomes:
measure: Constant Disability Scale
timeFrame: 3 years
Secondary outcomes:
measure: Oxford Shoulder Score, Short Form-36
timeFrame: 3 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital, Department Orthopaedic Surgery
Study officials:
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT03985462: Very Small Embryonic-like Stem Cells for Ovary
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Stem Cell Transplant Complications
Premature Ovarian Failure
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
First posted: 2019-06-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with confirmed premature ovarian failure were divided into three groups, each group was injected with different numbers of VSEL cells, and the control group was injected with platelet-rich serum which is the cell solvent
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.

Detailed description: Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, \> 40 IU/L)、luteinizing hormon (LH, \> 40 IU/L)、estradiol (E2, \> 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.

Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed as premature ovarian failure by professional doctor.
* Those have clear abnormal sex hormone levels

Exclusion Criteria:

* Unmarried woman
* Suffering from other serious gynecological diseases or gynecological tumors
* Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin

Primary outcomes:
measure: Concentration of Blood female hormones level
timeFrame: 1 month after injection
Secondary outcomes:
measure: Concentration of Blood female hormones level
timeFrame: 6 months after injection
measure: Incidence of amenorrhea
timeFrame: 6 months after injection
measure: Concentration of Blood female hormones level
timeFrame: 12 months after injection
measure: Incidence of amenorrhea
timeFrame: 12 months after injection
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT05081362: Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
Official title: Cardiovascular Assessment in Patient Recovered From COVID-19 and Recovery of Autonomic Nervous System in Association With the Severity of the Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of the study is to assess autonomic nervous system and cardiovascular controll during orthostatic challenge in 90 patients recovered from COVID-19 and devided into three groups depend on severity of the morbidity.


Eligibility criteria: Inclusion Criteria:

* age over 18
* spontaneous sinus rhythm
* signed informed consent

Exclusion Criteria:

* no spontaneous sinus rhythm
* pregnancy

Primary outcomes:
measure: Arterial pressure measured in mmHg
timeFrame: 6 months
measure: Heart rate measured in bpm
timeFrame: 6 months
measure: Respiratory frequency
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
Study officials:
References: