louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02010723: Surgery Versus Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Official title: Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicose Veins
Keywords: varicosis
foam sclerotherapy
surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.


Eligibility criteria: Inclusion Criteria:

* reflux in anterior accessory great saphenous vein (AAGSV) \> 0,5 sek

Exclusion Criteria:

* concomitant reflux in great saphenous vein (GSV)
* reflux in the deep venous system (postthrombotic syndrome)
* acute thrombosis
* hypercoagulability
* allergy to aethoxysclerol or local anesthetics
* immobility
* open foramen ovale
* bacterial infection of the skin
* pregnancy and breast feeding
* peripheral arterial occlusive disease III, IV (PAOD)

Primary outcomes:
measure: duplex-sonographic recurrence after 3 years
timeFrame: 3 years
Secondary outcomes:
measure: duplex-sonographic recurrence after 1 year
timeFrame: 1 year
measure: clinical recurrence
timeFrame: 1 year and 3 years
measure: neovascularisation in the saphenofemoral junction
timeFrame: 1 year and 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of General Dermatology
Study officials:
affiliation: Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology
name: Kornelia Boehler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prinz N, Selzle K, Kamionek I, Sagoo KS, Leberig A, Kaiser R, Schonath M. [Surgery of the lateral accessory saphenous vein]. Zentralbl Chir. 2001 Jul;126(7):526-7. doi: 10.1055/s-2001-16280. German.
citation: Breu FX, Guggenbichler S, Wollmann JC; Second European Consensus Meeting on Foam Sclerotherapy. Duplex ultrasound and efficacy criteria in foam sclerotherapy from the 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37(1):90-5. doi: 10.1024/0301-1526.37.1.90.
citation: Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg. 2009 Apr;37(4):477-81. doi: 10.1016/j.ejvs.2008.11.035. Epub 2009 Feb 7.
Clinical trial NCT01690923: Nasal Pillows vs. Nasal Masks at High CPAP Pressure
Official title: Nasal Pillows at High CPAP Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2012-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this evaluation is to test:

1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks
2. Patient mask type preferences at high pressures


Eligibility criteria: Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients being treated for OSA for \>6 months
* Patients ≥ 18 years of age
* Patients using nasal mask systems with fixed pressure ≥ 12 cm H2O
* Patients who can trial the trial masks up to 14 nights
* Patients naive to pillows mask systems

Exclusion Criteria:

* Patients using an inappropriate mask system
* Patients using Bilevel flow generators
* Patients who are pregnant
* Patients who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)

Primary outcomes:
measure: AHI on Nasal Mask and Pillows Mask
timeFrame: 7 days
Secondary outcomes:
measure: Usability
timeFrame: After 7 days of use
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: ResMed
state: New South Wales
Study officials:
affiliation: ResMed
name: Klaus Schindhelm, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu X, Wimms AJ, Benjafield AV. Assessment of the performance of nasal pillows at high CPAP pressures. J Clin Sleep Med. 2013 Sep 15;9(9):873-7. doi: 10.5664/jcsm.2984.
Clinical trial NCT00310323: Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
Official title: Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: sleep apnea
phenotyping
cytochrome P450
drug metabolism
child
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: University of Louisville
First posted: 2006-04-03
Enrollment: 69
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (OSAS).

Detailed description: The purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The specific aims are to evaluate the activities of cytochrome P450 (CYP)1A2, N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to determine the effect of OSAS treatment on the activities of these enzyme systems.

Eligibility criteria: Inclusion Criteria:

* Children ages 4 to 16 years with suspected uncomplicated OSAS

Exclusion Criteria:

* Children with complicated OSAS (craniofacial abnormalities, neuromuscular disorders)
* Children who are receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity
* Children who are exposed to second hand smoke for greater than 8 hours per day.
* Children with hypersensitivity to caffeine or dextromethorphan
* Children who are receiving corticosteroids or thyroid hormone

Primary outcomes:
measure: Caffeine urinary molar ratio
timeFrame: Pre and post T&A
measure: Dextromethorphan urinary molar ratio
timeFrame: Pre and post T&A
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Mary Jayne Kennedy, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03665623: Prediction of Preeclampsia by Comprehensive Markers.
Official title: A Prospective Multi-center Study on the Prediction of Preeclampsia by Comprehensive Markers in Early Pregnancy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Keywords: preeclampsia prediction
competing risk model
11~13+6 gestational weeks
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 11741
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: we aimed to recruit as many as possible the women without discrimination during the study periods.

Brief summary: Preeclampsia is one of the most serious complications in pregnancy that causes maternal death and preterm delivery. Series studies has show that the competing risk model developed by the Fetal Maternal FouNdation in early pregnancy has the potential to predict preeclampsia effectively but has show crowd difference. We aim to evaluate the performance of various screening model based on FMF model in Chinese population.

Detailed description: The prospective multi-center observational study aimed to recruit at least 10,000 pregnant woman during the first trimester conducted among 12 medical centers in China. The medical history of each candidate was recorded , blood pressure was measured , blood sample was taken between 11 gestational weeks and 13+6 gestational weeks, to get the PlGF and PAPPA tested. Routine ultrasound was taken with measurement of the uterine artery pulsatility index. The results of the recruited patients were not released to the patients or the doctor. Pregnancy outcome was recorded as to whether the women develop preeclampsia , the SGA babies, or low birth Apgar score and other preeclampsia related adverse maternal and neonatal outcomes. The basic medical information, the mean artery pressure, the PlGF and PAPPA MOM, the UtA PI were used in combination to do the risk stratification, and to develop prediction model for Chinese people.

Eligibility criteria: Inclusion Criteria:

1. gestational weeks between 11\~13+6
2. agreed to participate the study
3. live fetus at recruitment.

Exclusion Criteria:

1. first obstetric visit beyond 14 gestational weeks
2. artificial abortion or spontaneous abortion before 20 weeks or lost to follow-up.
3. refused to participate the study.
4. fetus with major chromosome or structural abnormality

Primary outcomes:
measure: detection rate of preterm preeclampsia at fixed false positive rate 5%,10%,15%,20%
timeFrame: at delivery and reviewed 60 days postpartum
Secondary outcomes:
measure: detection rate of small for gestational neonates at fixed risk cut of defined in primary outcome
timeFrame: at delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00005423: Dietary Quality and Subsequent Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine dietary quality and subsequent cardiovascular disease (CVD).

Detailed description: BACKGROUND:

Although considerable evidence exists for associations between diet and subsequent cardiovascular disease (CVD) among younger and middle-aged adults, no comprehensive studies of these relationships have been conducted using a national sample of older Americans. National guidelines have recommended reductions of dietary fat, saturated fat, cholesterol and sodium as dietary practice to reduce CVD. However, it is possible that the focus on eliminating dietary components may obscure the advantages of consuming diets that are nutritionally adequate.

Findings from this study could have important implications for setting research priorities to further study the effects of specific dietary variables on CVD, and for implementing national nutrition policies to assist Americans in selecting healthy diets.

DESIGN NARRATIVE:

Data from NHANES I and the three cycles of NHANES I Epidemiologic Followup Study (NHEFS) were used to 1) to examine the associations between several measures of dietary quality at baseline and subsequent 14-year morbidity and mortality from CVD for a national sample of 6109 United States adults aged 45 to 74 years at baseline; 2) to assess the relative importance of the associations of dietary quality and CVD for older adults compared to middle-aged adults. Dietary variables were based on responses to the 24-hour dietary recall and the food frequency questionnaire administered at baseline and included a composite measure of dietary quality, intakes of specific nutrients, and usual consumption of foods from 19 food groups. Baseline measures used as covariates included body mass index, blood pressure, serum cholesterol, sociodemographic variables (e.g., age, race, income, occupation), behavioral variables (e.g., smoking, alcohol consumption, activity level), and chronic health conditions. CVD outcomes were determined from medical history questionnaires, hospital records and death certificates. Change in blood pressure between baseline and 10-year followup were examined as an outcome variable as well as a covariate in the association between diet and CVD.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03435523: The Open Lung Approach During One Lung Ventilation in Thoracic Surgery
Official title: Optimal PEEP Based on the Open Lung Approach During One Lung Ventilation in Thoracic Surgery: a Physiological Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: * Question: Ventilatory strategy to counterbalance the effect of one lung ventilation during thoracic surgery.
* Findings: the open lung approach improved oxygenation and lung compliance, reducing respiratory system driving pressure and transpulmonary driving pressure.
* Meaning: patients undergoing thoracic surgery during one lung ventilation may benefit of an open lung approach strategy to avoid ventilator lung injury.

Detailed description: Background: During thoracic surgery in lateral decubitus, one lung ventilation (OLV) may impair respiratory mechanics and gas exchange. The investigators tested a strategy based on an open lung approach (OLA) consisting in lung recruitment immediately followed by a decremental positive-end expiratory pressure (PEEP) titration to the best respiratory system compliance (CRS) and separately quantified the elastic properties of the lung and the chest wall. The investigators hypothesis was that this approach would improve gas exchange and increase lung compliance (CL).

Methods: In thirteen patients undergoing upper left lobectomy the investigators studied lung and chest wall mechanics, transpulmonary pressure (PL), respiratory system and transpulmonary driving pressure (ΔPRS and ΔPL), gas exchange and hemodynamics at two time-points (a) during OLV at zero end-expiratory pressure (OLVpre-OLA) and (b) after the application of the open-lung strategy (OLVpost-OLA).

Eligibility criteria: Inclusion Criteria:

* age \> 18 years,
* surgery and OLV lasting ≥ 60 min

Exclusion Criteria:

* lung reduction surgery, pneumonectomy, patients with severe COPD with preoperative forced expiratory volume in 1 s (FEV1) to forced vital capacity (FVC) ratio, expressed as a percentage (FEV1/FVC%) \<60%, presence of large bullae, pleural diseases and/or acute or chronic uncompensated cardiac disease

Primary outcomes:
measure: Change in respiratory mechanics before and after the open lung approach
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rauseo M, Mirabella L, Grasso S, Cotoia A, Spadaro S, D'Antini D, Valentino F, Tullo L, Loizzi D, Sollitto F, Cinnella G. Peep titration based on the open lung approach during one lung ventilation in thoracic surgery: a physiological study. BMC Anesthesiol. 2018 Oct 31;18(1):156. doi: 10.1186/s12871-018-0624-3.
Clinical trial NCT01586923: RBC Transfusion in Severe Anemia With Lactic Acidosis
Official title: A Prospective Study of RBC Transfusion in Children With Severe Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
Transfusion
RBC storage age
Tissue oxygenation
Malaria
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 290
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.

Detailed description: This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

Eligibility criteria: Inclusion Criteria:

* Age 6 mos to 5 years
* Hg \< 5 g/dL and Lactate \> 5 mM

Exclusion Criteria:

* Receiving transfusion other than RBCs
* Children with known or suspected cardiac disease

Primary outcomes:
measure: Reduction of elevated levels of blood lactate during 24 following RBC transfusion
timeFrame: 24 hours
Secondary outcomes:
measure: Normalization of vital signs
timeFrame: 24 hours
measure: Correction of acidosis
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Walter H Dzik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhabangi A, Ainomugisha B, Cserti-Gazdewich C, Ddungu H, Kyeyune D, Musisi E, Opoka R, Stowell CP, Dzik WH. Effect of Transfusion of Red Blood Cells With Longer vs Shorter Storage Duration on Elevated Blood Lactate Levels in Children With Severe Anemia: The TOTAL Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2514-23. doi: 10.1001/jama.2015.13977.
Clinical trial NCT02147223: Sex-dependent Effects of Flavanols on Vascular Status
Official title: Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: flavanols
sex-related cardiovascular effects
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* healthy post-menopausal femal subjects (\>50 years)
* healthy male subjects (\>50 years)

Exclusion Criteria:

* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* CRP \> 1 mg/dl
* malignant disease

Primary outcomes:
measure: Absolute change of Flow-mediated Vasodilation (FMD)
timeFrame: 2 hours
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: 2 hours
measure: Augmentation index
timeFrame: 2 hours
measure: Ambulatory blood pressure
timeFrame: 2 hours
measure: Plasma flavanol metabolites
timeFrame: 2 hours
measure: laboratory safety parameters
timeFrame: 2 hours
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonology and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Ana Rodriguez Mateos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02156323: A Phase 1 Clinical Study in Healthy Volunteers to Investigate the Drug-drug Interaction Between Multiple Doses of RO7033877 and Multiple Doses of Colistin Methanesulfonate Sodium (CMS)
Official title: A SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, TWO SEQUENCE, 3-WAY CROSSOVER STUDY TO INVESTIGATE THE INTERACTION BETWEEN MULTIPLE DOSES OF COLISTIN METHANESULFONATE SODIUM (CMS) AND MULTIPLE DOSES OF RO7033877 IN HEALTHY SUBJECTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This single center, open-label, randomized study will investigate the drug-drug interaction potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate sodium (CMS).


Eligibility criteria: Inclusion Criteria:

* Adult male or female (of non childbearing potential) healthy volunteers between 18 to 55 years
* Body mass index (BMI) between 18 and 30 kg/m2
* Non smokers
* Use adequate contraception methods

Exclusion Criteria:

* Evidence of active of chronic disease
* Regular consumption of drugs of abuse
* Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
* History of significant allergic reactions
* Abnormal blood pressure
* Clinically significant abnormalities (e.g. cardiovascular, laboratory values)

Primary outcomes:
measure: Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)
timeFrame: up to 4 days (for each period)
Secondary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 9 weeks
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: