louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00829088: Investigation of Rate + Extent of Excretion of Radioactivity in Urine +Faeces After Oral Administration of [14C]AZD2066
Official title: An Open Label, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD2066 to Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Mass balance
AZD2066
Pain
Pain conditions
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-26
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD2066 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent
* Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives of the study.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examinations).

Primary outcomes:
measure: Excretion (rate and extent) of radioactivity in urine and faeces following oral administration of [14C]AZD2066
timeFrame: Until >90% of predicted total radioactivity has been recovered
measure: Pharmacokinetics of total radioactivity in plasma and unchanged AZD2066 in plasma
timeFrame: Sampling at defined timepoints during residential period from pre-dose until 168h post-dose.
measure: Metabolite profile in plasma and excreta
timeFrame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.
Secondary outcomes:
measure: AZD2066 metabolites in plasma+excreta if feasable
timeFrame: Sampling at defined timepoints during residential period from pre-dose until 48h post-dose.
measure: Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables, ECG and adverse events
timeFrame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period) and follow up visit 3.
Other outcomes:
Locations:
city: Cheshire
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, CPU Alderley Park, UK
name: Emeline Ramos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Lars Ståhle, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01917188: Promoting Patient-Centered Care Through a Heart Failure Simulation Study
Official title: Promoting Patient-Centered Care Through a Heart Failure Simulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Intermountain Research and Medical Foundation
First posted: 2013-08-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The initial aim of this study will be to assess current methods of heart failure (HF) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. The second aim will be to design and create a "living with HF at home" simulation session. The third aim will test the hypothesis that hospitalized HF patients who receive education in a simulation room in addition to usual HF education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.


Eligibility criteria: Inclusion Criteria:

1. Male or female \> 18 years of age.
2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
3. Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis.
4. Heart failure of either preserved or reduced ventricular function.

Exclusion Criteria:

1. Patients requiring ICU monitoring
2. LVAD candidate/recipient
3. Cardiac transplant candidate/recipient
4. Confusion
5. Sepsis
6. Terminal illness (other than HF) with expected survival of less than 1 year
7. Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
8. Inability to comply with planned study procedures
9. Active illicit drug use
10. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
11. Other conditions that in the opinion of the Primary Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Primary outcomes:
measure: Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: Kismet D Rasmusson, FNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174588: Moderate Sedation for Elective Upper Endoscopy With Balanced Propofol Versus Propofol Alone: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EGD Procedure
Keywords: sedation, propofol, midazolam
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Since introduction in 1989, propofol has gained wide acceptance for sedation during endoscopic procedures. The optimal sedation drug during esophagogastroendoscopy (EGD) is not established. Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol. In this study, the investigators want to compare the patient satisfaction with EGD following balanced propofol sedation (BPS) versus propofol sedation alone.


Eligibility criteria: Inclusion Criteria:

1. over 19 years old, male and female
2. patients who have plan to get esophagogastroduodenoscopy (EGD)

Exclusion Criteria:

1. ASA class III or IV
2. Allergies to propofol, sulfites or eggs
3. patients who had surgery for esophagus, stomach or duodenum
4. inpatients
5. patients who had sleep apnea, gastroparesis or achalasia
6. patients who are taking sedative drugs more than 6 months
7. pregnancy
8. hypotension (systolic pressure less than 90mmHg), bradycardia (pulse rates less than 50 times per minute) or hypoxia (SpO2 less than 90%)
9. psychiatric or neurologic problems (ex. epilepsy or dementia)

Primary outcomes:
measure: visual analog scale
timeFrame: Within the 24 hours after EGD
Secondary outcomes:
measure: complications rates
timeFrame: Within the 1 hour after EGD
Other outcomes:
measure: complications rates
timeFrame: Within the 1 hour after EGD
measure: total dose of the sedation drugs
timeFrame: Within the 1 hour after EGD
measure: visual analog scale
timeFrame: Within the 1 hour after EGD
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei university College of Medicine
Study officials:
References:
Clinical trial NCT03543488: Neuromusuclar Adaptations in the Rheumatoid Arthritis Disease
Official title: Neuromusuclar Responses and Functional Outcomes in Middle-aged Women With Rheumatoid Arthritis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Muscular Weakness
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
First posted: 2018-06-01
Enrollment: 70
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 35 RA patients (class I and II according American Rheumatism Association) and 35 healthy women, age- and body size-matched to the RA patients, were recruited as controls (CG).

Brief summary: Rheumatoid arthritis (RA) is a chronic autoimmune disease that causes joint inflammation and progressive joint destruction. Rheumatoid cachexia is one of the structural manifestations of RA, and consists of a reduction in muscle mass, due to an increased muscle protein catabolism induced by inflammatory cytokines. This muscle mass loss generates an impairment in physical function and functional capacity in RA patients. The aim of study was to verify neuromuscular and functional responses in middle-aged women with RA compared to paired healthy women.


Eligibility criteria: Inclusion Criteria:

* RA patients with a class I and II RA diagnosis according to the American Rheumatism Association's 1987 revised criteria, were recruited from a university hospital's rheumatology clinic.

Exclusion Criteria:

* presence of any cardiovascular, neuromuscular and metabolic diseases or severe limitations in mobility

Primary outcomes:
measure: Knee-Extensor Muscular Strength
timeFrame: Only one day.
measure: Muscle architecture and tendon parameters
timeFrame: Only one day.
measure: Functional Capacity
timeFrame: Only one day.
measure: Quadriceps muscle activation
timeFrame: Only one day.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03054688: Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
Official title: Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 83
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.


Eligibility criteria: Inclusion Criteria:

* Able to give informed consent

Exclusion Criteria:

* Atrial fibrillation
* Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

Primary outcomes:
measure: Difference in mean 24h systolic blood pressure
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel City
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Thilo Burkard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Philipp Krisai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krisai P, Vischer AS, Kilian L, Meienberg A, Mayr M, Burkard T. Accuracy of 24-hour ambulatory blood pressure monitoring by a novel cuffless device in clinical practice. Heart. 2019 Mar;105(5):399-405. doi: 10.1136/heartjnl-2018-313592. Epub 2018 Sep 18.
Clinical trial NCT04643288: Nanocrystalline Hydroxyapatite Bone Substitute for Treating Periodontal Intrabony Defects
Official title: Clinical and Radiographic Evaluation of Open Flap Debridement With or Without Nanocrystalline Hydroxyapatite Bone Graft in Management of Periodontal Intrabony Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: periodontal intrabony defects
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present clinical trial included 20 patients (11 females and 9 males, aged 36 to 56 years) suffering from moderate or advanced chronic periodontitis. Subjects were recruited from the outpatient clinic, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. This clinical trial was meant to assess clinically and radiographically the possible predictable results regarding the use of nanocrystalline hydroxyapatite bone graft substitute together with open flap debridement versus open flap debridement alone in the treatment of periodontal intrabony defects.

Detailed description: periodontal intrabony defects in patients with moderate or advanced chronic periodontitis were treated with open flap debridement only in the control group while open flap debridement and Nanocrystalline Hydroxyapatite bone graft substitute was performed for the intervention group. probing pocket depth, clinical attachment level, gingival index, plaque index, gingival recession and bone defect area were assessed at baseline and six months post surgically to evaluate the possible improvement in the clinical and radiographic outcomes.

Eligibility criteria: Inclusion Criteria:

* systemically healthy patients
* diagnosed with moderate to advanced chronic periodontitis
* periodontal defects with at least one site with probing pocket depth (PPD) ≥ 5mm, clinical attachment loss (CAL) ≥ 4mm and two or three-walled intra-bony defects ≥ 3mm
* evidence of intrabony defects using periapical radiographs

Exclusion Criteria:

* teeth with suprabony defects or 1-wall intrabony defects
* pregnant or lactating women
* patients taking any medication 3 months prior to the study
* patients receiving any periodontal treatment 6 months prior to study initiation
* former or current smokers.

Primary outcomes:
measure: change in probing pocket depth
timeFrame: baseline and after six months
Secondary outcomes:
measure: change in clinical attachment level
timeFrame: baseline and after six months
measure: change in the bone defect area
timeFrame: baseline and after six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT01631188: Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Official title: Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: Minimally Invasive Surgery
Port Access Surgery
Heart
Pacing
Wire
MICS
Cardiac Bypass
Epicardial pacing
pacing catheter
pacing wire
pacing swan
pacing pulmonary catheter
Pulmonary Endovent
Catheter
Aortic Valve Surgery
Edwards Lifesciences
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that the Endovent kit can be used effectively as a passageway for a pacing wire system.

Detailed description: Many times cardiac surgery requires the use of epicardial pacing in order to wean the patient from bypass. During minimally invasive port access valve surgery, it may not be possible to place the leads on the surface of the heart because of the limited surgical exposure. In this case, transvenous pacing is used. Minimally invasive port access surgery uses specially designed, FDA approved catheters for the procedure. We wish to review the effectiveness of being able to place the wires through the catheters and pace the patient.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years of age patients having aortic valve port access surgery

Scheduled for Minimally Invasive Port Access Aortic Valve Study

Patient must agree to study participation; understand and sign the written informed consent

Exclusion Criteria:

* \< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery

Primary outcomes:
measure: Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
timeFrame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
measure: Number of Participants That Required Pacing Who Were Able to be Paced
timeFrame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Secondary outcomes:
measure: Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
timeFrame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Enrique L Pantin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers, The State University of New Jersey
name: Jonathan Kraidin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02125188: Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
Official title: Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing Endoscopic Sinus Surgery
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons and anesthesiologists despite several measures available for improving the surgical field. This study was conducted to evaluate the effect of desmopressin on blood loss and the quality of the surgical field in FESS.

Detailed description: Desmopressin, a synthetic analogue of vasopressin, has been employed as a non-transfusional treatment for hemophilia and von Willebrand's disease. Hemostatic effects of desmopressin include: 1) an increase in plasma factors through endogenous release of coagulation factor VIII, von Willebrand factor and tissue plasminogen activator; 2) an increase in platelet adhesiveness; and 3) a reduction in bleeding time. Randomized, double-blind studies have been performed on patients undergoing various types of surgical procedures. A study in patients undergoing orthognathic surgery showed a significant reduction in intraoperative blood loss and a study in patients undergoing lumbar fusion concluded that desmopressin was effective in reducing intraoperative blood loss. The purpose of this study was to investigate the effect of administration of desmopressin on intraoperative blood loss in patients undergoing FESS.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I-II
* aged 18-60 years

Exclusion Criteria:

* Patients receiving anticoagulants
* medically important liver or kidney dysfunction
* significant heart disease
* allergy to Desmopressin

Primary outcomes:
measure: Blood loss
timeFrame: During Functional Endoscopic Sinus Surgery of each patient
Secondary outcomes:
measure: Quality of the surgical field using a scoring scale
timeFrame: During Functional Endoscopic Sinus Surgery of each patient
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03024788: Determination of the Optimum Cut-off Value of Type 2 Diabetes Diagnosis Among Chinese Population(SENSIBLE STUDY II)
Official title: Determination of Cut-off Value of Advanced Glycation End-product and Glycosylated Haemoglobin in Type 2 Diabetes Diagnosis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type II Diabetes
Keywords: Glycosylated haemoglobin
advanced glycation end products
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 6000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese natural population

Brief summary: Study of the correlation between AGEsP and HbA1c and diabetic retinopathy prevalence: determination of cut-off value of AGEsP and HbA1c in type 2 diabetes diagnosis in China

Detailed description: To find the cut-off point of AGEsP and HbA1c for diagnosis of diabetes by drawing the logistic regression model between prevalence of retinopathy and AGEsP level and HbA1c level,and find the point where the prevalence of retinopathy changes most rapidly.

Eligibility criteria: Inclusion Criteria:

* 20\~70 years old;
* Volunteer to participate in this study and signed informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: prevalence of retinopathy
timeFrame: 3 years
Secondary outcomes:
measure: incidence of retinopathy
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00910078: Serum Free Light Change in Multiple Myeloma
Official title: Serum Free Light Chain Ratio, Total Kappa/Lambda Ratio, and Immunofixation as Prognostic Factors in Multiple Myeloma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Total kappa and lambda ratio
Stem cell transplantation
Serum immunofixation
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2009-05-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of patients undergoing autolog transplantatio

Brief summary: The purpose of this study is to evaluate the predictive role of free Kappa/Lambda ration in Multiple Myeloma post-transplant.


Eligibility criteria: Inclusion Criteria:

* Patients affected with Multiple Myeloma who underwent autologous or auto/allogenic stem cell transplantation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Azienda Ospedaliera S. Giovanni Battista
Study officials:
References: