louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01394367: Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
Official title: Study of Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Ventricular Function in Severe Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: respiratory therapy
exercise therapy
oxygen uptake
quality of life
right ventricular function
severe pulmonary hypertension
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-07-14
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: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of this study is to investigate whether and to what extent a cautious respiratory and exercise therapy can complement medical treatment and change the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* Consent form
* men and women\> 18 years \<75 years
* invasively confirmed chronic PH who have received complete diagnostic evaluation by specialized doctors / physicians according to the WHO classification at a center for pulmonary hypertension and were adjusted for 2 months under intensive medical therapy and are stable.

Exclusion Criteria:

* Pregnancy or lactation
* Change in medication during the last 2 months
* Patients with signs of right heart decompensation
* severe walking disturbance
* uncertain diagnoses
* No previous invasively confirmation of PH
* acute diseases, infections, fever
* Serious lung disease with FEV1 \<50% or TLC \<70% of target
* Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function

Primary outcomes:
measure: Improvement of peak O2 uptake (VO2peak) under stress
timeFrame: up to 15 weeks
Secondary outcomes:
measure: Changes in hemodynamics at rest and during exercise
timeFrame: up to 15 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Study officials:
affiliation: Center for pulmonary hypertension, Thoraxclinic Heidelberg
name: Ekkehard Grünig, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05068167: Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery
Official title: Assessment of Acute Kidney Injury as a Risk Factor for Myocardial Injury After Non Cardiac Surgery in Critical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury (AKI)
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who were candidates for major surgery in the Cancer Institute of South Egypt, Assiut University, Egypt. Patients excluded from this study were patients with chronic cardiac diseases (myocardial ischemia, heart failure, Active severe infection, pregnancy, chronic kidney disease, DM, and advanced malignancy on chemotherapy or radiotherapy.

Brief summary: The incidence of acute kidney injury (AKI) postoperatively has been identified to be 21.6% in adults and 18.3% in hospitalized individuals. Surgery-related AKI is a severe complication that is related not only to short-term complications as increases in mortality rate and development of cardiac complications but also with complications on long term, such as development of chronic kidney disease. A better understanding of the mechanism of this hypthesis will lead to better management of this complication.

Detailed description: A randomized blinded prospective study included 206patients who the candidate for major surgery at South Egypt Cancer Institute, Assiut University, Assiut, Egypt. From April 2018 till April 2019, a detailed history and careful examination, routine laboratory investigations were done, Baseline ECG was recorded 24hours before surgery and 48hours postoperative at ICU.

Eligibility criteria: Inclusion Criteria:

* patients who were candidates for major non cardiac surgery

Exclusion Criteria:

* chronic cardiac diseases (myocardial ischemia, heart failure), Active severe infection, pregnancy, chronic kidney disease

Primary outcomes:
measure: Creatinine level
timeFrame: every 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Alaa Ali Elzohry
Study officials:
References:
Clinical trial NCT03066167: Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer
Official title: Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia, Esophageal
Esophageal Cancer
Keywords: Cancer of the gastro-esophageal junction
Watson score
Ogilvie score
Goldschmid score
Validation
Quality of Life
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Sahlgrenska University Hospital
name: The Göteborg Medical Society, Sweden
First posted: 2017-02-28
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer in the oesophagus and as Controls, healthy volunteers.

Brief summary: This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

Detailed description: In the present study, our aim was to firstly, validate 3 commonly used scales for use in patients with dysphagia due to malignancy, and secondly, to validate them in the Swedish language. The 3 scales were: The Watson dysphagia scale, which was developed in studies on surgical treatment of reflux disease. It consists of questions about food with 9 different viscosity and solidity and the patient answer if they have problems with a specific food: never, sometimes or always when ingesting this. The scores are added and provides a range of 0-45 where 45 is the worst possible dysphagia. The Ogilvie score is a 5-graded scale 0-4 where 4 is total inability to swallow. The Goldschmid score is graded from 0-5 where 0 is inability to swallow and 5 is normal function. QoL was measured with validated instruments originating from the European Organization for Research and Treatment of Cancer (EORTC), which has a generic instrument that measures global QoL in patients with cancer (QLQ-C30) and a more symptom-specific instrument that is developed for cancer in the oesophagus and stomach (QLQ-OG25). These are well known, validated instruments that also have normal reference values for the healthy population. The symptom specific instrument QLQ-OG25 includes a dysphagia module consisting of 3 questions which is validated to malignant disease and food intake with the help of expert groups and deep interviews with patients.

Eligibility criteria: Inclusion Criteria:

* Cancer in the gastro-esophageal junction or in the esophagus
* Dysphagia
* Ability to fill in the questionnaires
* Written acceptance of the informed consent

Exclusion Criteria:

* Not for-filling inclusion criteria
* No consent

Primary outcomes:
measure: Validation of dysphagia scores
timeFrame: 10-14 days
measure: Translation of scores to the Swedish language
timeFrame: 10-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Surgical Department, Sahlgrenska University Hospital
state: Västra Götalandsregionen
Study officials:
References:
Clinical trial NCT01363167: Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
Official title: Identifying Vit D Deficiency in VLBW Infants Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Very Low Birth Weight
Calcium Deficiency
Vitamin D Deficiency
Keywords: vitamin D
preterm infants
calcium
bone
parathyroid hormone
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2011-06-01
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.


Eligibility criteria: Inclusion Criteria:

* Any infant born at the Medical University of South Carolina \<34 weeks gestation
* Less that 1500g at birth
* AGA
* Must be African American or Caucasian
* Each infant born of twin and triplet pregnancies will be eligible

Exclusion Criteria:

* Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
* Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
* Maternal uncontrolled thyroid disease
* Maternal Parathyroid disease
* Infants of races other than African American or Caucasian

Primary outcomes:
measure: Intestinal Calcium Absorption
timeFrame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth
measure: Parathyroid hormone concentration
timeFrame: At term age (expected 2-4 months)
measure: Serum 25 hydroxyvitamin D status
timeFrame: At term age (expected 2-4 months)
measure: Bone Health
timeFrame: At term age (expected 2-4 months)
measure: Serum inflammatory cytokine concentrations
timeFrame: At birth (day 1)
Secondary outcomes:
measure: Phosphorus Homeostasis
timeFrame: At term age (expected 2-4 months)
measure: Growth parameters
timeFrame: At term age (expected 2-4 months)
measure: Vitamin D Dose Safety as Measured by Urinary Calcium Excretion
timeFrame: At term age (expected 2-4 months)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sarah N. Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522067: Support Annual Strain Update, Safety and Immunogenicity of an Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects 18-64 Years Affected by Chronic Diseases.
Official title: A Phase II, Open Label, Uncontrolled, Multi-Center Study to Support Annual Strain Update and to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Subjects Aged 18-64 Years Affected by Chronic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Disease
Keywords: influenza
influenza vaccine
adjuvanted influenza vaccine
subunit influenza vaccine
surface antigen
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase II, open label, is designed as a seasonal study to support annual strain update evaluating the safety, clinical tolerability and immunogenicity of the 2007-2008 formulation of Novartis Vaccines' adjuvanted, subunit influenza vaccine in adults with underlying chronic diseases


Eligibility criteria: Inclusion Criteria:

* 18 to 64 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry, suffering from at least one of these chronic diseases: hypertension, heart disease, chronic obstructive pulmonary disease (COPD) or asthma, hepatic or renal insufficiency, arteriosclerotic disease or insulin dependent diabetes mellitus

Exclusion Criteria:

* Hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
* Known or suspected impairment/ alteration of immune function;
* Having received within the past 12 months more than one injection of influenza vaccine
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Primary outcomes:
measure: Evaluate the antibody response to each flu vacc. antigen, measured by SRH at 21-day post-vacc. in at risk adults in compliance with the requirements of the EU recommendations for the evaluation of the immunog. for a new formulation of a licensed flu vacc
measure: To evaluate the safety of the administration of a single intramuscular(IM) injection of an inactivated, adjuvanted influenza vaccine, in at risk adult subjects.
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Azienda Sanitaria USL 7 di Siena
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT03118167: Intervention Effect of TP and AOB-w on Acrylamide Exposure in Chinese Adolescents
Official title: Intervention Effect of Tea Polyphenols (TP) and Water-Soluble Antioxidant Of Bamboo Leaves (AOB-w) on Short- and Long-term Internal Exposure of Acrylamide in Chinese Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Keywords: Acrylamide
Tea polyphenols
Water-soluble antioxidant of bamboo leaves
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 110
Sex: ALL
Minimum age (years): 17
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A double-blind randomized controlled trial (RCT) was conducted in current human study. This study aims to investigate the intervention effect of AOB-w on the short-term exposure and toxicokinetics of acrylamide, a dietary hazardous substance generated during heat processing, in Chinese adolescents.

Detailed description: In the morning of test day, participants were served with a meal of potato chips, corresponding to a single oral dose of 12.6 μg/kg b.w. exposure to acrylamide, and an edible capsule, which contains 350 mg AOB-w or the placebo with the same dose. Urine were collected within 48 hours thereafter. The diet was rigorously controlled within 24 hours prior to study till entire study finished. Four mercapturic acid metabolites have been investigated as urinary biomarkers for short-term internal exposure of acrylamide in human

Eligibility criteria: Inclusion Criteria:

* Subject has no smoking or drinking hobby

Exclusion Criteria:

* Having any drugs within 7days
* Smoking or drinking
* Pregnant, trying to become pregnant or breast feeding
* Allergic frying foods

Primary outcomes:
measure: Change of four urinary biomarkers of acrylamide
timeFrame: up to 48 hours
measure: Change of two hemoglobin adducts of acrylamide
timeFrame: baseline, 3 and 10 days
Secondary outcomes:
measure: Area under the concentration versus time curve (AUC) Of acrylamide urinary biomarkers
timeFrame: baseline, 2, 4, 6, 8, 10, 14, 24, 36 and 48 hours
measure: Maximum Concentration (Cmax) of Acrylamide Urinary Biomarkers
timeFrame: 48 hours
measure: Time to Peak Concentration (tmax) of Acrylamide Urinary Biomarkers
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01517867: Early Parenting Intervention Comparison
Official title: Comparing Two Parenting Programs for At-Risk Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Problems, Child
Keywords: preschool children behavior problems
child between 2 and 5 years old
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: University of Iowa
name: National Institute of Nursing Research (NINR)
First posted: 2012-01-25
Enrollment: 161
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.


Eligibility criteria: Inclusion Criteria:

* child 2 to 5 years old
* parent reports reason for referral is child behavior problems
* parent is a biological or adoptive parent, or legal guardian of child

Exclusion Criteria:

* parent is psychotic or actively abusing substances
* child is autistic or severely developmentally delayed

Primary outcomes:
measure: Change in Child Behavior Problems
timeFrame: baseline, first follow-up (up to 2 years)
Secondary outcomes:
measure: Aggregate Cost
timeFrame: through end of study (up to 2 years)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Family Center at Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Johns Hopkins University, School of Nursing
name: Deborah Gross, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gross D, Belcher HME, Budhathoki C, Ofonedu ME, Dutrow D, Uveges MK, Slade E. Reducing Preschool Behavior Problems in an Urban Mental Health Clinic: A Pragmatic, Non-Inferiority Trial. J Am Acad Child Adolesc Psychiatry. 2019 Jun;58(6):572-581.e1. doi: 10.1016/j.jaac.2018.08.013. Epub 2018 Nov 12.
citation: Gross DA, Belcher HM, Ofonedu ME, Breitenstein S, Frick KD, Chakra B. Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families? Trials. 2014 Mar 1;15:70. doi: 10.1186/1745-6215-15-70.
Clinical trial NCT00549367: The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand
Official title: The Role of Diet Education and Nutritional Counselling in the Ongoing Care of People Living With HIV in Thailand (TACH001)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Nutritional status
Nutrition counselling
Nutrition assessment
HIV
Alternative Medicine
Complementary Medicine
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2007-10-25
Enrollment: 153
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: SUPPORTIVE_CARE

Brief summary: To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand.

Detailed description: To evaluate the effectiveness of nutrition education and dietary counselling to improve the nutritional status, well-being and quality of life of people living with HIV/AIDS (PLWHA) attending an HIV treatment facility in Bangkok Thailand. This will be achieved by determining if dietary counselling and nutrition education has an effect on nutritional status (weight, lean body mass and fat mass), dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction

Eligibility criteria: Inclusion Criteria:

* HIV positive
* 18 years of age or older
* Receiving ongoing care as part of the TRCARC Family Clinic (TRCARC Wellness Plus clinic)
* Either ART naive or have been on stable ART for more than 6 months

Exclusion Criteria:

* HIV negative
* Unintentional weight loss of more than 10% usual body weight, or BMI\<17
* BMI\>30
* Suspected or documented HIV related opportunistic infection
* Pregnant women
* Women less than 3 months post-partum

Primary outcomes:
measure: body composition measured by BIA and anthropometry
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in dietary intake, food security, quality of life, biochemical parameters (including total cholesterol, LDL/ HDL cholesterol and Triglyceride), experience of symptoms and patient satisfaction
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Thai Red Cross AIDS Research Centre
state: Pathumwan
Study officials:
affiliation: Albion Street Centre
name: Simon J Sadler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515267: Automated Left Ventricular Function Evaluation by LVivoEF
Official title: Automated Left Ventricular Function Evaluation by LVivoEF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EF Evaluation From 4 Chamber Plane
EF Evaluation From 2 Chamber Plane
Biplane EF Evaluation
Left Ventricular Function
Keywords: EF
EDV
ESV
Biplane
Echocardiography
Lead sponsor: DiA Imaging Analysis Ltd
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients referred to an echocardiographic examination

Brief summary: Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination either by visual estimation (eyeballing) requiring high level of training and expertise and/or by manual tracing of the endocard from which EF is calculated (manual biplane method (MBP)). This procedure is subjective and time consuming. The objective of this study is to compare the performance of LVivoEF software system to the measurements obtained by the routinely used methods.

Detailed description: LVivoEF is a decision support system (software) for automated global left ventricle (LV) systolic function evaluation from echocardiographic examinations. LVivoEF technology is based on a novel image processing algorithm for LV edge detection and ejection fraction (EF) evaluation. LVivoEF provides fully automated measurements of the left ventricle (LV) from two apical views the four chamber (4CH) and the two chamber (2CH).

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Patients referred to an echocardiographic examination. The patients will be consecutive until 30% of patients with normal LV function are enrolled. After that only consecutive patients with abnormal LV function will be included.

Exclusion Criteria:

* Examinations in which more than one third of the endocard is not visible in a plane (2CH/4CH)
* Patients with Left bundle branch block (LBBB)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka university medical center
Study officials:
affiliation: Soroka University Medical Center
name: Noah Liel-Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: