louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00396656: Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients
Official title: A Randomized, Open-label, Multicenter, Cross-over Trial to Evaluate the Efficacy of a 20 Week Treatment of Valsartan 320 mg Versus Atenolol 100 mg in Combination With Hydrochlorothiazide on Microcirculation in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
valsartan
atenolol
hydrochlorothiazide
microcirculation
arterial compliance
pulse wave analysis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluated the effect of valsartan on small vessel blood flow in patients with mild-to-moderate hypertension in direct comparison to atenolol and hydrochlorothiazide.


Eligibility criteria: Inclusion Criteria:

* Caucasian; male or female outpatients and age between 40-65 years of age, inclusive.
* At Visit 2 all patients must have a mean sitting diastolic blood pressure (msSBP) of ≥ 90 mmHg and \< 110 mmHg.

Exclusion Criteria:

* If a single reading for arterial hypertension in msSBP \> 180 mmHg or msDBP \> 110 mmHg at any visit after randomization.
* Inability to discontinue all prior antihypertensive medications safely for a period of 2 weeks prior to randomization.
* Known history of hypotensive symptoms or orthostatic hypotension.
* Concomitant use of statins or statin intake during the four weeks prior to Visit 1.
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* A history of heart failure (NYHA II-IV).

Primary outcomes:
measure: Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Injected Sites Compared to NaCl Injected Sites
timeFrame: At end of each treatment period (Week 21 and Week 43)
Secondary outcomes:
measure: Difference in Mean Post-treatment Microcirculation at Acetylcholine (ACH) Plus L-NMMA Injected Sites Compared to NaCl Injected Sites
timeFrame: At end of each treatment period (Week 21 and Week 43)
measure: Difference in Mean Post-treatment Microcirculation at a Sodium Nitroprusside Injected Site Compared to NaCl Injected Sites
timeFrame: At end of each treatment period (Week 21 and Week 43)
measure: Mean Post-treatment Microcirculation at NaCl Injected Sites
timeFrame: At end of each treatment period (Week 21 and Week 43)
measure: Arterial Pressure Waveform Augmentation Index at the End of Treatment
timeFrame: At end of each treatment period (Week 21 and Week 43)
measure: Arterial Pressure Waveform Pulse Wave Velocity at the End of Treatment
timeFrame: At end of each treatment period (Week 21 and Week 43)
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharma Ag
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma Ag
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05717556: Success of Internal Jugular Vein Catheterization
Official title: Factors Affecting Success of First Attempt in Ultrasonography-Guided Internal Jugular Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound
Catheterization
Volume Status
Keywords: juguler vein catheterization
ultrasound guidance
pleth variability index
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Internal jugular vein cannulation can be performed with the blind technique under ultrasound (USG) guidance or using classical marker points. It has been shown that USG-guided interventions reduce the complication rate compared to the method performed with the blind technique (4%/13.5%). In addition, the initial entry success rate in the USG supported group is 65%. , this rate remained at 45% with the blind technique.

Although Pleth variability index monitoring is a noninvasive method, it is a technique that consistently predicts fluid sensitivity in patients under mechanical ventilation.

The aim of study is before applying USG guided catheterization; We think that by revealing the factors of the patient that are effective on the number of interventions, necessary measures can be taken for the success of catheterization as a result.


Eligibility criteria: Inclusion Criteria:

* aged 18-75
* underwent coronary artery bypass surgery

Exclusion Criteria:

* \<18 years old
* Hemodynamic instability
* Use of inotropic agents

Primary outcomes:
measure: factors of internal vein jugular catheterization success
timeFrame: Baseline (Before catheterization)
measure: factors of internal vein jugular catheterization success
timeFrame: Baseline (Before catheterization)
measure: factors of internal vein jugular catheterization success
timeFrame: Baseline (Before catheterization)
measure: factors of internal vein jugular catheterization success
timeFrame: Baseline (Before catheterization)
Secondary outcomes:
Other outcomes:
Locations:
city: Kozlu
country: Turkey
facility: Zonguldak Bülent Ecevit University Faculty of Medicine
state: Esenköy
city: Zonguldak
country: Turkey
facility: Zongulak Bülent Ecevit University
state: Kozlu
Study officials:
References:
Clinical trial NCT00507156: Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction
Official title: Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-segment Myocardial Infarction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 200
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: Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.

The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

Detailed description: Please see above

Eligibility criteria: Inclusion Criteria:

* Patients more than 18 years
* STEMI \< 12 hours
* TIMI 0-1 in infarct related artery

Exclusion Criteria:

* Multivessel disease (stenoses in non-infarct related arteries \>70%)
* Cardiogenic shock
* Left main occlusions
* Lesions that cannot be treated with stents
* Previous CABG
* Pregnancy
* Severe renal insufficiency
* Previous extensive Q-wave infarction
* LBBB

Primary outcomes:
measure: Final infarct size evaluated by MR
timeFrame: 3 month
Secondary outcomes:
measure: MACE (death, re-infarction, TLR)
timeFrame: 1, 15 month
measure: Stent thrombosis
timeFrame: 15 month
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Cardiac Catherization Lab., Heart Center, Rigshospitalet, University of Copenhagen
Study officials:
affiliation: Cheif Consultant
name: Thomas Engstrom, D.Sci., PhD
role: STUDY_CHAIR
References:
citation: Lonborg J, Holmvang L, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Treiman M, Jensen JS, Engstrom T. ST-Segment resolution and clinical outcome with ischemic postconditioning and comparison to magnetic resonance. Am Heart J. 2010 Dec;160(6):1085-91. doi: 10.1016/j.ahj.2010.09.026.
citation: Lonborg J, Kelbaek H, Vejlstrup N, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Treiman M, Jensen JS, Engstrom T. Cardioprotective effects of ischemic postconditioning in patients treated with primary percutaneous coronary intervention, evaluated by magnetic resonance. Circ Cardiovasc Interv. 2010 Feb 1;3(1):34-41. doi: 10.1161/CIRCINTERVENTIONS.109.905521. Epub 2010 Jan 26.
Clinical trial NCT03329456: MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus
Official title: Minimum Effective Volume (MEV95%) of Ropivacaine 7.5 mg/ml to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Disease
Anesthesia
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators have recently shown that LSIB in combination with a suprascapular and a cervical plexus block is a very good alternative for arthroscopic shoulder surgery. However, the investigators believe the total volume of local anesthetic for LSIB may be reduced. For shoulder surgery there is no need to block the medial cord and the investigators therefore hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord block

Detailed description: The MEV for a successful block in 50% of the participants will be determined by using the staircase up-and-down method introduced by Dixon and Massey. Logistic regression and probit transformation will be applied to estimate the MEV for a successful block in 95% of the participants.

Eligibility criteria: Inclusion Criteria:

* . Inclusion criteria are American Society of Anesthesiologists (ASA) physical status I-III, age between 18 and 70 years and body mass index (BMI) between 20 and 35 kg/m2.

Exclusion Criteria:

* Exclusion criteria are pregnancy, patients with contraindications to regional anesthesia, allergy to LAs, patients taking opioids regularly due to chronic pain, use of anticoagulation drugs other than acetylsalicylic acid or dipyridamole, atrioventricular block, diabetes.

Primary outcomes:
measure: Minimum effective volume (95%)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Lars M Ytrebø, M.D Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4.
citation: Musso D, Klaastad O, Wilsgaard T, Ytrebo LM. Brachial plexus block of the posterior and the lateral cord using ropivacaine 7.5 mg/mL. Acta Anaesthesiol Scand. 2019 Mar;63(3):389-395. doi: 10.1111/aas.13277. Epub 2018 Oct 18.
Clinical trial NCT06492356: Impact of Tripolar Radiofrequency on Acne Scar
Official title: Impact of Tripolar Radiofrequency on Acne Scar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scars - Mixed Atrophic and Hypertrophic
Scar
Radiofrequency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar

Detailed description: Acne scarring is a very troublesome complication associated with acne and is reported in as high as 95% of the patients, sometimes even with proper and prompt treatment. The visible depressed scars have been known to have a negative impact on patient's psychological well-being and quality of life. Post acne scarring can pose as a risk factor for depression, anxiety, and even suicide (Villani, 2020).

There are a multitude of treatment options that are traditionally used for the treatment of acne scars including many ablative and non-ablative methods (Dogra, 2014).

Furth more, the need of this study is developed from the lack in quantitative knowledge and information in the published studies which investigate the effect of tripollar RF This study will be designed to provide guidelines about the effect tripollar Radiofrequency on acne scars.

Eligibility criteria: Inclusion Criteria:

* Forty patients having acne scar, from both genders their ages will be ranged from 20 to 40 years old
* Both genders will participate in this study as the following distribution 17 male and 23 female.
* They diagnosed as acne scar by their physicians and referred for physical therapy management.
* Medically and psychologically stable patients.
* All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients

Exclusion Criteria:

* Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of acne scars that would interfere with study procedures (e.g., plaque psoriasis, tattoo, birthmark, facial hair).
* Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
* Medically unstable and uncooperative patients.
* Untreated and active/ongoing acne vulgaris.
* Immunocompromised status.
* History of skin cancer.
* Recurrent herpes viral infection.
* Pregnancy or breastfeeding status.
* Females take contraceptive pills
* Hormonal disturbance

Primary outcomes:
measure: Assessing the change in severity of acne scars
timeFrame: at base line and following 12 weeks
Secondary outcomes:
measure: Assessing the quantitative measurement of the acne scars
timeFrame: at base line and following 12 weeks
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Malawy Specialized Hospital
Study officials:
References:
Clinical trial NCT06234709: Long-term Mortality After Intensive Care Considering Comorbidity and Admission Diagnoses
Official title: Comorbidity With Greatest Impact on Mortality Considering Different Admission Diagnosis and After Landmark Time in an Intensive Care Population Compared to the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Keywords: Comorbidity
Intensive care
SAPS3
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2024-01-31
Enrollment: 200000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included all patients \> 16 years old admitted to an ICU during the years 2006 to 2012 and registered in the Swedish Intensive Care Registry (SIR)

Brief summary: This is a register-based study

The aim of this study is to investigate how common comorbidity is in different age groups and which comorbidity that has the greatest impact on mortality considering different admission diagnosis and after the acute phase compared to the general population. Also, how different degrees of comorbidity affect mortality, adjusted for other comorbidities and SAPS 3?

Detailed description: The study population included all patients \> 16 years old admitted to an ICU during the years 2006 to 2012 and registered in the Swedish Intensive Care Registry (SIR).

Hospital discharge diagnoses from in-patient care five years preceding the index time for the ICU admission were extracted from the National Patient Register (NPR) and linked to ICU admissions using unique person identity numbers. Follow-up for all-cause mortality were extracted from the cause of death register at NPR.

Eligibility criteria: Inclusion Criteria:

The study population included all patients \> 16 years old admitted to an ICU during the years 2006 to 2012 and registered in the Swedish Intensive Care Registry (SIR)

Exclusion Criteria:

-

Primary outcomes:
measure: All-cause mortality
timeFrame: january 1, 2005 til december 31, 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university department of surgical sciences
Study officials:
affiliation: Uppsala university department of surgical sciense
name: Anna Aronsson Dannewitz, med mag
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04106609: Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Official title: Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Kettering Health Network
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 251
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.


Eligibility criteria: Inclusion Criteria:

* Female; determined from electronic medical record
* Initial stage 0, 1 or 2 breast cancer diagnosis within the past 12 weeks determined from electronic medical record
* Age 30-80; determined from electronic medical record
* Physician clearance to participate in exercise

Exclusion Criteria:

* Participation in supervised physical exercise within 6 months prior to study enrollment
* Currently pregnant or planning to become pregnant
* Non-English speaking
* Unable to make own medical decisions and/or to follow verbal instructions

Primary outcomes:
measure: Missed Fractions
timeFrame: 12 weeks
measure: Numbers of Breaks in Cancer Treatment
timeFrame: 12 weeks
measure: Cost of Emergency Room Visits
timeFrame: 12 weeks
measure: Encounters
timeFrame: 12 weeks
measure: Cost of Total Unplanned Expenditures
timeFrame: 12 weeks
measure: Cost of Hospital Inpatient Care
timeFrame: 12 weeks
measure: Cancer Treatment Adherence
timeFrame: 12 weeks
measure: Cancer Treatment Symptom Management Medications
timeFrame: 12 weeks
measure: Cancer Treatment Related Side Effects
timeFrame: 12 weeks
measure: Patient Rated Pain Score
timeFrame: 12 weeks, measured at the start of their exercise program during their initial assessment and at the 12-week follow-up re-assessment.
measure: Cancer TreatmentTtolerance
timeFrame: 12 weeks - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment.
measure: Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire
timeFrame: Baseline was at the time of enrollment and follow up was after 12-weeks.
Secondary outcomes:
measure: Adherence Rate
timeFrame: 12 weeks
measure: Percentage of Participants Who Completed the Study (Attrition Rate)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Maple Tree Cancer Alliance
state: Ohio
Study officials:
affiliation: Maple Tree Cancer Alliance
name: Karen Wonders, PhD, FACSM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836909: Regulation of Lipid Metabolism in Guangzhou Individuals With Dyslipidemia by Red Yeast Rice, Phytosterol Esters and Lycopene
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Using Red Yeast Rice, Phytosterol Esters and Lycopene in Combination for Regulating Lipid Metabolism of Guangzhou Individuals With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2023-05-01
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effect of using red yeast rice, phytosterol esters and lycopene in combination for 12 weeks on improving the glycolipid metabolism of Guangzhou individuals with dyslipidemia. Our hypothesis is that when compared with placebo, red yeast rice, phytosterol esters and lycopene together as supplements would lead to greater improvements in lipid metabolism (including lipid profiles and parameters ) in participants after 12 weeks.


Eligibility criteria: Inclusion Criteria:

1. Age: 30-50 years old.
2. Non-obese individuals: 18.5 ≤ BMI \< 28.
3. Total cholesterol levels ranging from marginal increase to increase: 6.2\> TC ≥ 5.2 mmol/L (200 mg/dL).

Exclusion Criteria:

1. Currently being pregnant or breast-feeding or planning to become pregnant.
2. Having severe complications of diabetes mellitus as well as any forms of cardiovascular diseases, tumor, liver diseases and kidney diseases.
3. History (past 3 months) of intake of lipid-lowering or anti-diabetic health care products.
4. Having hemorrhagic diathesis (high bleeding tendencies) or currently taking aspirin.
5. Unwilling/unable to draw blood due to physical/personal reasons.
6. History (past 1 month) of surgery.
7. History (past 1 month) of large amounts of oral or intravenous treatment of glucocorticoids (such as prednisone, methylprednisone, betamethasone, beclomethasone propionate, Dubossone, prednisone, hydrocodesone, dexamethasone).
8. History (past 2 weeks) of taking supplements containing red yeast rice, phytosterol ester or lycopene.
9. Unqualified outcomes of safety measures at baseline.

Primary outcomes:
measure: Change in levels of total cholesterol
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: SunYat-senU
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Lili Yang, Professor
role: STUDY_CHAIR
References: