louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01970319: Mechanisms and Reversibility of Heart Failure Associated With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2013-10-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care patients with type 2 diabetes

Brief summary: Patients with diabetes have a higher incidence of heart failure and worse outcomes than normoglycaemic subjects. Basic science research has suggested many mechanisms for this observation including endothelial dysfunction, abnormal calcium handling, fibrosis and activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking. In this study the investigators will investigate the relationship between diabetes and heart failure by exploring the correlation between microvascular dysfunction and cardiac magnetic resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and fibrosis. The investigators also propose to see if this relationship is independent of blood pressure and markers of RAAS activity. This could have important clinical ramifications in type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a case for lower blood pressure targets.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes

Exclusion Criteria:

* Known cardiac or renal disease
* Uncontrolled hypertension
* Treatment with ACEi/ARB
* Treatment with insulin
* Contraindication to CMR

Primary outcomes:
measure: Left ventricle mass
timeFrame: One year
Secondary outcomes:
measure: Left ventricle function
timeFrame: 1 year
measure: RAAS activity
timeFrame: 1 year
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
Study officials:
References:
citation: Swoboda PP, Erhayiem B, Kan R, McDiarmid AK, Garg P, Musa TA, Dobson LE, Witte KK, Kearney MT, Barth JH, Ajjan R, Greenwood JP, Plein S. Cardiovascular magnetic resonance measures of aortic stiffness in asymptomatic patients with type 2 diabetes: association with glycaemic control and clinical outcomes. Cardiovasc Diabetol. 2018 Mar 5;17(1):35. doi: 10.1186/s12933-018-0681-4.
citation: Swoboda PP, McDiarmid AK, Erhayiem B, Ripley DP, Dobson LE, Garg P, Musa TA, Witte KK, Kearney MT, Barth JH, Ajjan R, Greenwood JP, Plein S. Diabetes Mellitus, Microalbuminuria, and Subclinical Cardiac Disease: Identification and Monitoring of Individuals at Risk of Heart Failure. J Am Heart Assoc. 2017 Jul 17;6(7):e005539. doi: 10.1161/JAHA.117.005539.
Clinical trial NCT01335919: Neonatal Non-Invasive Hemoglobin Determination
Official title: Non-invasive Continuous Hemoglobin in Pediatric Medicine: a Comparison Between Standard of Care CBC Hemoglobin (ADVIA 2120®) and the New Masimo® SpHb® Neonatal Sensor
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Surgical Procedures
Infant, Newborn
Infant, Low Birth Weight
Keywords: Hemoglobin
Monitoring, Physiologic
Blood Gas Monitoring, Transcutaneous
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Masimo Corporation
First posted: 2011-04-15
Enrollment: 0
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neonates admitted for a surgical procedure or admitted to the PICU or NICU where hemoglobin determinations are expected.

Brief summary: The purpose of this study is to evaluate hemoglobin (Hgb) measurement by Masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).

Detailed description: This collaborative study with Masimo Corporation will involve 2 phases. In the first phase of this study, 25 subjects weighing 0.5 to 3.0 kg will be recruited and hemoglobin values will be obtained from the non-invasive probe at the same time as blood samples are routinely drawn for Hgb analysis using the cyanomethemoglobin method (ADVIA 2121). Masimo Corporation will use this data to calibrate or modify the hemoglobin reading (SpHb®) sensors and monitors. All results and conclusions from this phase will be discussed with the investigation team in order to determine if additional subjects are needed (at increments of 25 subjects at a time). Once the sensor designs have been optimized, another group of patients will be studied to document the accuracy and precision of the hemoglobin reading (SpHb®) measurements.

Eligibility criteria: Inclusion Criteria:

1. Males or females weighing 0.5 kg to 3 kg.
2. Neonates and infants and children admitted to the Children's Hospital of Philadelphia (CHOP)operating room (OR), PICU and NICU where hemoglobin measurements are anticipated.
3. Parental/guardian permission (informed consent)

Exclusion Criteria:

1. Subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous).
2. Subject weighing more than 3 kg.
3. Subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor.
4. Any skin rash on the intended site of measurement. Severe allergy to adhesive tapes.

Primary outcomes:
measure: Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®)
timeFrame: up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Denis Jablonka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06077019: Role of Lung Function for Exercise Capacity in Well-trained Individuals
Official title: Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Performance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate


Eligibility criteria: Inclusion Criteria:

* Age 18-39
* Physically active \> 5 h weekly
* Maximal oxygen consumption classified as high or very high

Exclusion Criteria:

* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
* ECG abnormality
* ACQ score \> 1.5
* Severe bronchial hyperreactivity as determined by mannitol test
* FEV1/FVC ratio \< 0.7 determined with spirometry
* Chronic illness determined to be a potential risk for participant during study
* In chronic treatment with medication that may interfere with study results
* Pregnancy
* Smoker
* Blood donation during the past 3 months

Primary outcomes:
measure: Exercise capacity during a time trial
timeFrame: Through study completion, an average of 8 weeks
Secondary outcomes:
measure: Lung function
timeFrame: Through study completion, an average of 8 weeks
Other outcomes:
measure: Airway inflammation
timeFrame: Through study completion, an average of 8 weeks
measure: Mannitol induced bronchial hyper reactivity
timeFrame: Through study completion, an average of 8 weeks
measure: Exercise induced bronchial hyper reactivity
timeFrame: Through study completion, an average of 8 weeks
measure: Quadriceps muscle strength
timeFrame: Through study completion, an average of 8 weeks
measure: Lean body mass
timeFrame: Through study completion, an average of 8 weeks
measure: Fat mass
timeFrame: Through study completion, an average of 8 weeks
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
affiliation: University of Copenhagen
name: Morten Hostrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01588119: Register for New Oral Anticoagulants
Official title: Prospective Register Study to Record Safety and Efficacy of New Oral Anticoagulants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulation Treatment
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in clinical routine

Brief summary: Patients, who are adjusted to a new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) in routine treatment will recorded in this register. Within this register a characterization of patients (with regard to demography and indication) and therapy (with regard to medication, dose and duration) will be done. On basis of defined clinical relevant end points the long-term efficacy and safety will be evaluated.


Eligibility criteria: Inclusion Criteria:

* indication for treatment with long term anticoagulation
* initial adjustment or change to nex oral anticoagulant within routine treatment
* indication for treatment with long term anticoagulation within the register:
* permanent anticoagulation in arterial fibrillation
* intended anticoagulation in acute venous thromboembolism for min. 3 months
* other anticoagulation for min. 3 months within the approved indication

Exclusion Criteria:

* missing Informed Consent Form
* missing phone number for telephone follow up
* contraindication for therapy with new oral anticoagulant (Dabigatran, Rivaroxaban, Apixaban, Edoxaban) according to Summary of Product Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
Study officials:
affiliation: study site at Universitätsklinikum Dresden on behalf of GWT-TUD GmbH
name: Jan Beyer-Westendorf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beyer-Westendorf J, Marten S, Naue C, Tittl L, Hansel U, Beyer-Westendorf I, Mizera H, Schreier T, Festerling E, Reitter A, Spindler M, Bornhauser M. Rates, management and outcome of bleeding complications during edoxaban therapy in daily care - results from the DRESDEN NOAC REGISTRY. Thromb Res. 2020 Jun;190:91-98. doi: 10.1016/j.thromres.2020.03.021. Epub 2020 Apr 19.
citation: Beyer-Westendorf J, Ebertz F, Forster K, Gelbricht V, Michalski F, Kohler C, Werth S, Endig H, Pannach S, Tittl L, Sahin K, Daschkow K, Weiss N. Effectiveness and safety of dabigatran therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry. Thromb Haemost. 2015 Jun;113(6):1247-57. doi: 10.1160/TH14-11-0954. Epub 2015 Mar 5.
citation: Beyer-Westendorf J, Forster K, Pannach S, Ebertz F, Gelbricht V, Thieme C, Michalski F, Kohler C, Werth S, Sahin K, Tittl L, Hansel U, Weiss N. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood. 2014 Aug 7;124(6):955-62. doi: 10.1182/blood-2014-03-563577. Epub 2014 May 23.
Clinical trial NCT04727619: Evaluation of SLEEP Program
Official title: Sleep Education for Elders Program Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 210
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.


Eligibility criteria: Inclusion Criteria:

* participants who choose to enroll in the SLEEP program

Exclusion Criteria:

* younger than 40 years of age

Primary outcomes:
measure: Sleep quality: Pittsburgh Sleep Quality Index
timeFrame: immediately after the program
measure: Sleep quality: Pittsburgh Sleep Quality Index
timeFrame: Six months after program completion
measure: Sleep duration
timeFrame: immediately after the program
measure: Sleep duration
timeFrame: Six months after program completion
measure: Daytime sleepiness
timeFrame: immediately after the program
measure: Daytime sleepiness
timeFrame: Six months after program completion
measure: Insomnia symptoms
timeFrame: immediately after the program and six months later
measure: Insomnia symptoms
timeFrame: Six months after program completion
measure: Sleep hygiene habits
timeFrame: immediately after the program
measure: Sleep hygiene habits
timeFrame: Six months after program completion
Secondary outcomes:
measure: Sleep-related knowledge
timeFrame: immediately after the program
measure: Sleep-related knowledge
timeFrame: six months later
measure: Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
timeFrame: immediately after the program
measure: Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration
timeFrame: six months later
measure: Program satisfaction: questions and comments related to program experiences
timeFrame: immediately after the program
measure: Program satisfaction: questions and comments related to program experiences
timeFrame: six months later
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References:
Clinical trial NCT01209819: Bone Mineral Density in Adults With Hyperphenylalaninemia
Official title: Bone Mineral Density in Adults With Hyperphenylalaninemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phenylketonurias
Keywords: Bone Mineral Density
Adults
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: BioMarin Pharmaceutical
First posted: 2010-09-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with PKU or benign HPA followed at The University of Texas Health Science Center at Houston will be invited to participate in the study. In addition, adults with PKU or benign HPA in the State of Texas will be invited to participate.

Brief summary: Hyperphenylalaninemia (HPA) is a rare metabolic disorder caused by a deficiency of the enzyme phenylalanine hydroxylase (PAH). Elevated plasma levels of phenylalanine (phe) cause mental retardation, microcephaly, delayed speech, seizures, eczema, and behavior problems. Adequate control of the plasma levels of phe by a phe-restricted diet can prevent the developmental and behavioral problems.

The foundation of this diet is a phe-free medical product/formula made from free amino acids. Based on longitudinal studies, it has been reported that the most benefit is attained by individuals who maintain a phe-restricted diet throughout life. Despite the obvious benefits of the diet, it has been suggested that the dietary restrictions may be associated with poor bone health in these patients. However, data supporting this has been reported in studies with small sample sizes and/or inadequate sample populations that include children. There is a paucity of data on bone health in adults with HPA.

The investigators propose an observational study to describe the bone health status among adults with a diagnosis of HPA and to compare them to established normative age and gender-specific values among healthy individuals. The investigators hypothesize that adults with HPA will have lower bone density as measured by a dual x-ray absorptiometry (DXA) scan compared to the established normative values.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HPA at birth
* Aged 18 or older

Exclusion Criteria:

* Peri-menopausal women
* Menopausal women
* Patients taking bisphosphonates
* Pregnant women
* Women who have been pregnant within one year of study enrollment
* Women who have breastfed within one year of study enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Heather W Saavedra, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03995719: Educational Program for Ostomy Patients (Ostomeducat)
Official title: Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Colostomy Complications
Surgery
Colorectal Disorders
Keywords: colostomy
education
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
Collaborators: name: Hospitales Universitarios Virgen del Rocío
First posted: 2019-06-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stoma surgery is a relatively common treatment for patients suffering from colorectal diseases.This study aimed to investigate the impact on hospital stay and short-term overall complications prior to and following the introduction of an outpatient preoperative stoma education program.

Detailed description: 38 patients undergoing stoma surgery were analyzed, 73 prior education program and 65 following it.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age undergoing elective colorectal resections that eventually would require formation of a stoma (colorectal cancer up to 20 cm from the anal verge, colonic poliposis and inflammatory bowel disease).

Exclusion Criteria:

* Patients already had a stoma before the operation or in case of emergent surgery.

Primary outcomes:
measure: Rate of.complications
timeFrame: First 30 days after surgery
measure: Rate of mortality (assessed by Clavien-Dindo Classification)
timeFrame: First 30 days after surgery
Secondary outcomes:
measure: Rate of readmissions
timeFrame: the first 30 days after surgery
measure: Reinterventions
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
state: Seville
Study officials:
affiliation: coloproctology unit
name: ANA Mª GARCIA CABRERA, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01390519: A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor
Official title: Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Keywords: mRCC,
observational,
Afinitor,
everolimus,
2.line
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced renal cell cancer whose disease has progressed on or after one VEGF-TKI therapy

Brief summary: This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Confirmed diagnosis of advanced renal cell cancer
* Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib)
* Written informed consent

Exclusion Criteria:

None

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: maximum of 12 months after inclusion of the last patient
Secondary outcomes:
measure: Treatment algorithm
timeFrame: at end of study
measure: Quality of life (QoL)(EORTC-QLQ C30)
timeFrame: maximum of 12 months after inclusion of the last patient
measure: Tolerability
timeFrame: maximum of 12 months after inclusion of the last patient
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Novartis Investigative Site
city: Tromsø
country: Norway
facility: Novartis Investigative Site
city: Trondheim
country: Norway
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02685319: Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
Official title: Mapping Human Muscle Satellite Cell Fate By Real-Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flaccid Muscle Tone
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 7
Sex: MALE
Minimum age (years): 20
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging

Detailed description: The aim of this study is to obtain human muscle samples for cell culturing to analyze muscle cell development in real-time to uncover factors that influence growth.

Eligibility criteria: -Inclusion Criteria:

* men 20-29 yrs
* BMI between 20 and 34.9
* Fasting Glucose \<110 mg/dL
* Blood Pressure \<160/100mm Hg
* Non-Diabetic
* LDL-Cholesterol \<160mg/dL
* Triacylglycerol \<400 mg/dL
* Makers of kidney, liver, and heart functions within 10% of clinical normalcy
* \<1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months

Exclusion Criteria:

* men \<20or\>29 yrs

  * BMI between \<20 and \>34.9
  * Fasting Glucose \>110 mg/dL
  * Blood Pressure \>160/100mm Hg
  * Non-Diabetic
  * LDL-Cholesterol \>160mg/dL
  * Triacylglycerol \>400 mg/dL
  * Pre-existing kidney or liver conditions

    --\>1.5hr /wk of habitual aerobic exercise training and no resistance exercise training in the past 6 months
  * Currently taking prescribed blood thinners

Primary outcomes:
measure: Mapping Human Muscle Satellite Cell Fate By Real-Time Imaging
timeFrame: <10 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University - Stone Hall 700 W State St
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: