louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06184815: Effectiveness of a Multidisciplinary Treatment and Structured Education Programme
Official title: Effectiveness of a Multidisciplinary Treatment and Structured Education for Type 1 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
Autoimmune Diseases
Diabetes
Education Programme
DSMES
Diabetes self-management education and support
T1D
Insulin-dependent diabetes
Juvenile diabetes
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2023-12-28
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.
Primary purpose: TREATMENT

Brief summary: This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.

Detailed description: Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Diabetes duration \>1 year
* BMI 18.5-40kg/m2
* A1c 6.5-13%

Exclusion Criteria:

* Pregnancy
* Dementia or severe cognitive impairment
* Uncontrolled psychiatric disorder
* Absence of \>20% of the educational sessions

Primary outcomes:
measure: Changes in Glycemic Control Measured by A1c
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol
timeFrame: Baseline and 6 months
measure: Changes in insulin resistance control Measured by eGDR
timeFrame: Baseline and 6 months
measure: Changes in Mental health Measured by DDS, GAD7 and PHQ9
timeFrame: Baseline and 6 months
measure: Changes Anthropometry Measured by BMI and WC
timeFrame: Baseline and 6 months
measure: Changes in Glycemic Control Measured by severe hypoglycemia
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico
name: David Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00627315: Prospective Study of Hormone Levels After Bariatric Surgery
Official title: Prospective Study of Hormone Levels and Appetite After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Insulin Resistance
Bariatric Surgery
Gastric Banding
Gastric Bypass
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-03-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure.

Brief summary: This project will study the effects of surgery for obesity on bone metabolism and hormones that regulate appetite.

Detailed description: Subjects will be recruited from the outpatient obesity and surgical clinics at Columbia-Presbyterian Medical Center after they have chosen to undergo a surgical procedure. The groups will not be randomized. Rather, they will decide on their choice of surgery along with their physicians. The patients will be evaluated pre-operatively and followed post-operatively for 5 years.

Initial evaluation will include a complete history and physical examination, measurement of calcium, parathyroid hormone (PTH) and vitamin D, and assessment of skeletal health using markers of bone turnover and bone mineral density.

Eligibility criteria: Inclusion criteria:

1. Adult male or female \> 18 years of age
2. Scheduled to undergo bariatric surgery

Exclusion criteria:

1. Vitamin D deficiency
2. Primary hyperparathyroidism
3. Treatment with lithium or thiazide diuretics which may alter PTH levels
4. Osteomalacia
5. Untreated hyperthyroidism, liver disease, Cushing's syndrome, rheumatoid arthritis, myeloma or Paget's disease
6. Impaired renal function (serum creatinine \>2.0mg/dl) or history of renal osteodystrophy
7. Use of any anti-obesity medications for over 2 weeks 90 days prior to study
8. Participation in any research study 90 days prior to study
9. Any malabsorption syndromes such as celiac sprue
10. Previous bariatric surgery

Primary outcomes:
measure: Change in body weight
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Judith Korner, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000315: Human Dopamine Transported Imaging in Cocaine Abuse: 1 - 1
Official title: Human Dopamine Transported Imaging in Cocaine Abuse: 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Johns Hopkins University
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the density of DA transporters during prolonged cocaine abuse and during withdrawal from cocaine use. This aim will test the hypothesis that DA transporters are altered by cocaine abuse and reestablished during withdrawal.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Physiological changes in: heart rate and blood pressure
measure: Subjective effects of cocaine inducements and withdrawal
measure: Psychological effects
measure: Effects of investigational drug
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dean Wong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: JNM Suppl 38(5):35P May 97.
Clinical trial NCT04853615: SGLT2 Inhibitors Prophylaxis Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease?
Official title: Is SGLT2 Inhibitors a Better Prophylactic Agent Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease? A Multicenter Prospective Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SGLT2i Kideny Protection Against Contrast in Diabetic Kidney
Lead sponsor: Fayoum University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-04-21
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration

Brief summary: We will look for the possible effect of SGLT2i as a single agent to prevent post-contrast Acute Kidney Injury in diabetic kidney disease.

Detailed description: Population of Study o Group 1 :

1. st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast.

   o Group 2 :
2. nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily

   o Group 3 :
3. rd group will receive the SGLT2i empagliflosin 25 mg once daily

   o Group 4 :
4. thwill receive allopurinol and empagliflosin.

Inclusion Criteria :

o Age: more than30years, diabetes,diabetic kidney disease,GFR: more than30ml/min/1.73m2

Exclusion Criteria :

o Diabetics Patients with GFR less than 30 mL/min/1.73 m2.

Sample Size ( number of participants included ) :

800 patients Fayoum University Faculty of Medicine Scientific Research Ethics Committee

Methodology in details :

The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration. Baseline serum creatinine will be obtained 72 hours before the planned intervention and before administration of any protective protocol and follow-up serum creatinine will be obtained 72 hours and 1 week after contrast administration. The first control group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. Saline should be given by infusion pump to guarantee steady rate of infusion. 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily. 3rd group will receive the SGLT2i empagliflosin 25 mg once daily, and the 4th will receive allopurinol and empagliflosin.

Eligibility criteria: Inclusion Criteria:

* Age: more than30years, Diabetes, Diabetic kidney disease, GFR: more than30ml/min/1.73m2

Exclusion Criteria:

* Diabetics Patients with GFR less than 30 mL/min/1.73 m2.

Primary outcomes:
measure: SGLT2i proves protective effect
timeFrame: 72hours after contrast
Secondary outcomes:
measure: SGLT2i is non inferior to allopurinol
timeFrame: 72hours after contrast
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06140615: Lung Ultrasound - Prospective Study
Official title: The Utility of Lung Ultrasound Scores to Determine Extubation Readiness in Neonates With Respiratory Distress on Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Distress of Newborn
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Meriter Foundation
First posted: 2023-11-20
Enrollment: 180
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to determine whether lung ultrasound can predict extubation success in neonates with respiratory distress.

Participants will undergo a lung ultrasound pre- and post-extubation.


Eligibility criteria: Inclusion Criteria:

* Infants born at UnityPoint Health Meriter Hospital and University of Minnesota admitted to the Neonatal Intensive Care Unit (NICU) with respiratory distress requiring intubation
* Meeting the extubation readiness criteria per the attending neonatologist

Exclusion Criteria:

* Known major congenital disease (chromosomal abnormality, heart disease, respiratory malformation)
* Neonates with parents that are less than 18 years old

Primary outcomes:
measure: Ability of lung ultrasound score to predict extubation success
timeFrame: 12 hours pre-extubation to 24 hours post extubation
Secondary outcomes:
measure: Change in pre- and post-extubation lung ultrasound scores
timeFrame: 12 hours pre-extubation to 24 hours post extubation
measure: Time to re-intubation
timeFrame: Up to 72 hours post-intubation
measure: Change in heart rate
timeFrame: 5 minutes before to 5 minutes after lung ultrasound
measure: Change in respiratory rate
timeFrame: 5 minutes before to 5 minutes after lung ultrasound
measure: Change in oxygen saturation
timeFrame: 5 minutes before to 5 minutes after lung ultrasound
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Madison
country: United States
facility: Unity-Point Health Meriter
state: Wisconsin
Study officials:
affiliation: Meriter Foundation
name: Adam S Bauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294215: High Dose BAYA1040_Nifedipine: a Long Term Combination Study
Official title: A Multicenter, Open Label, Long Term Study of Oral BAYA1040_CR 80 mg (40 mg Bid) in Combination With Other Antihypertensives for 52 Weeks in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: BAYA1040
Nifedipine
Essential hypertension
Japanese Patients
Phase III
combination study
14024
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical study evaluating the safety and efficacy of long term administration of oral BAYA1040_Nifedipine 80 mg/day (40 mg twice daily) with other antihypertensives in patients with essential hypertension who are not at target blood pressure by the combination of BAYA1040_Nifedipine 40 mg once daily and other antihypertensives.


Eligibility criteria: Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Outpatient with essential hypertension
* Patients who are treated with Adalat CR 40 mg od and at least one antihypertensive drug (other than Ca antagonists) for 4 weeks or more before entry in this study

Exclusion Criteria:

* Patients whose sitting diastolic blood pressure (DBP) is 110 mm Hg or more
* Patients with secondary hypertension or hypertensive emergency

Primary outcomes:
measure: Efficacy changes measured by sitting diastolic blood pressure (DBP)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Efficacy changes measured by sitting systolic blood pressure (SBP)
timeFrame: Up to 52 weeks
measure: Proportion of subjects achieving a target BP based on the Japanese Society of Hypertension (JSH) 2009 guidelines
timeFrame: Up to 52 weeks
measure: Proportion of subjects achieving a target DBP and SBP based on JSH 2009 guidelines or a >10 mmHg reduction of DBP
timeFrame: Up to 52 weeks
measure: Safety variables
timeFrame: Up to 30 days after the last dose of study drug
Other outcomes:
Locations:
city: Ebina
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Kawaguchi
country: Japan
state: Saitama
city: Shinjuku
country: Japan
state: Tokyo
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06704815: Observational Cohort Study Evaluating the Effectiveness of an Educational Program (NGAYDAUTIEN) in Combination With Perindopril and Amlodipine Single-Pill Combination in Hypertensive Patients naïve of Antihypertensive Treatments.
Official title: Observational Cohort Study Evaluating the Effectiveness of an Educational Program (NGAYDAUTIEN) in Combination With Perindopril and Amlodipine Single-Pill Combination in Hypertensive Patients naïve of Antihypertensive Treatments.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: observational
blood pressure
SBP
DBP
hypertension
HBP
HTA
Viacoram®
Perindopril arginine and Amlodipine
patient educational program
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2024-11-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female who have a diagnosis of grade 1 or 2 hypertension and who initiate a new antihypertensive treatment

Brief summary: The primary objective is to assess the change of systolic blood pressure from baseline after a 6-month follow up for hypertensive patients initiating Viacoram® plus an educational program (NGAYDAUTIEN) in comparison to hypertensive patients initiating other antihypertensive drugs (except single pill combination).


Eligibility criteria: Inclusion Criteria:

1. Aged of at least 18 years (without upper limit of age)
2. Diagnosis of grade 1 or grade 2 hypertension
3. Naïve of treatment:

   * newly diagnosed hypertension and without treatment with antihypertensive effect for at least 3 months
   * previously diagnosed but without treatment with antihypertensive effect for at least 3 months
4. Patients follow-up within the scope of the current medical practice and in the same health centre during the 6-month period

Exclusion Criteria:

1. Previously attended to the Ngay Dau Tien educational program for HBP management
2. Plan to be hospitalized for other medical conditions during the next 6 months
3. Plan to move/relocate during 6-month follow-up
4. Have a severe disease (i.e. cirrhosis, end-stage renal disease ...)
5. Are unlikely to cooperate in the study
6. Arm 1: patient having contra-indication to take Viacoram® according to SmPC
7. Arm 2: patient showing interest in attending NDT educational program.

Primary outcomes:
measure: change of systolic blood pressure (measured in mmHg) from baseline after a 6-month follow up among the 2 arms
timeFrame: from baseline to 6-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Servier Affaires Médicales
Study officials:
References:
Clinical trial NCT02135315: Intensive Arterial Pressure Control in Acute Coronary Syndrome
Official title: One-year Outcome of Intensive Versus Standard Blood Pressure Treatment in Non-ST Elevation Acute Coronary Syndrome: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome, arterial pressure
Lead sponsor: University of Monastir
Sponsor class: OTHER
Collaborators: name: Emergency NGO Onlus
First posted: 2014-05-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intensive arterial pressure control in acute coronary syndrome (ACS) during the first 24 hours can improve the prognosis in the short and long term.

the study compare two treatment strategies (standard and intensive treatment) to assess their efficacy and safety in the treatment of acute coronary syndrome.

Detailed description: Acute coronary syndrome is often associated with arterial pressure elevation which are deleterious for the heart and needs urgent intervention to lower the blood pressure to the required values, however there is no clear recommendations concerning the treatment intensity in this situation.

The investigators know that high arterial pressure increases the oxygen myocardial consumption and it is deleterious in acute coronary syndrome, so , it is logical to reduce intensively this pressure.

Eligibility criteria: Inclusion Criteria:

* Non-ST segment elevation Acute Coronary Syndrome

Exclusion Criteria:

* SBP under 90 mmHg or hemodynamic instability
* Complicated ACS (arrythmias, atrio-ventricular block, shock, tamponade...) or ST elevation myocardial infarction (STEMI)
* Patients with contraindication to nitrates and/or beta blockers

Primary outcomes:
measure: mortality
timeFrame: 12 months
measure: major cardiovascular events (MACE)
timeFrame: 12months
measure: combined mortality and MACE rate
timeFrame: 1 year
Secondary outcomes:
measure: troponin change
timeFrame: 24 hours after baseline measurement
measure: Adverse events
timeFrame: 24 hours after start of protocol intervention
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: university of Monastir
Study officials:
affiliation: University of Monastir
name: Semir Nouira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01841515: Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug
Official title: Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bleeding
Tachycardia
Dyspnea
Lead sponsor: University of Ulsan
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in CKD patients taking antiplatelet agent. The synthetic vasopressin derivative, Desmopressin (DDAVP) shortens the prolonged bleeding time and improves platelet dysfunction measured by in vitro closure time: CEPI-CT in uremic patients. Desmopressin also antagonizes the in vitro platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin. The investigators designed a prospective study to evaluate the effect of desmopressin on platelet function, as measured by in vitro collagen/epinephrine - closure time, in uremic patients who were taking antiplatelet drugs.


Eligibility criteria: Inclusion Criteria:

* adult uremic patients with one or more antiplatelet medication,
* prolonged collagen/epinephrine (CEPI) closure time,
* need for emergent hemodialysis and
* subsequent catheter insertion

Exclusion Criteria:

* acute coronary syndrome,
* hemophilia, and nephrogenic diabetes insipidus,
* allergy against desmopressin

Primary outcomes:
measure: collagen-epinephrine closure time
timeFrame: 1 hour
Secondary outcomes:
measure: Bleeding after procedure
timeFrame: 1-4 hr after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References: