louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00787072: AZD8075 Single Ascending Dose Study
Official title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of AZD8075 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to assess the safety, tolerability and pharmacokinetics of single ascending oral doses of AZD8075 in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures.
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs (vital signs (ie, supine BP and pulse) or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk.
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Primary outcomes:
measure: Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
timeFrame: Frequent sampling occasions during study days
Secondary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva Pettersson
role: STUDY_DIRECTOR
affiliation: Quintiles, Uppsala, Sweden
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05758272: Evaluation of a Workplace Smoking Cessation Program in Hong Kong (Phase VI)
Official title: Evaluation of a Workplace Smoking Cessation Program in Hong Kong: a Pragmatic Cluster Randomized Controlled Trial of Mobile Supported Simple Physical Exercise for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smokers
Workplace
Exercise
Keywords: smokers
Workplace
Exercise
mhealth
intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test, by a 2-arm RCT, the effectiveness of an intervention that includes mobile phone-supported simple physical exercise for smoking cessation in workplaces in Hong Kong.


Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents aged 18 or above
2. Smoke at least 1 cigarette per day or use other tobacco products (EC, HTP and others) daily
3. Able to communicate in Cantonese/Mandarin and read Chinese
4. Able to use instant messaging tools (e.g. WhatsApp) for communication
5. Stay in Hong Kong during the intervention and follow-up periods (12 months)

Exclusion Criteria:

1. Smokers who are psychologically or physically unable to communicate
2. Currently joining other smoking cessation program(s)
3. Smokers who cannot tolerate the proposed exercise program
4. Smokers who have severe mental illnesses

Primary outcomes:
measure: Self-reported 7-day point-prevalence abstinence (PPA) at 6-months follow-up
timeFrame: at 6-month after treatment initiation (3 months after the end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
affiliation: School of Nursing, The University of Hong Kong Hong Kong, Hong Kong China
name: Man Ping WANG, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02900872: Systematic Chart Review of Carotidynia Patients
Official title: Systematic Chart Review of Carotidynia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotidynia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients suffering from acute cervical pain or tenderness, fulfilling the characteristics of an idiopathic neck pain syndrome, and presenting with abnormalities of carotid arteries on dedicated vessel imaging

Brief summary: Systematic retrospective study of medical charts and medical imaging files, of patients consulting for acute neck pain and presenting unclassified abnormalities on dedicated vessel imaging.


Eligibility criteria: Inclusion Criteria:

* acute cervical tenderness or neck pain fulfilling the characteristics of an idiopathic neck pain syndrome as defined by the International Headache Society in 1988
* the performing of a diagnostic imaging like MRI, CT or US of the cervical area with a dedicated vessel analysis
* unilateral or bilateral abnormalities of common carotid, carotid bifurcation or internal carotid arteries on dedicated vessel imaging.

Exclusion Criteria:

* patients without imaging, or without dedicated vessel analysis
* patients presenting with pain caused by a clearly identified vascular disease on dedicated vessel analysis imaging such as carotid occlusion, carotid dissection, vasculitis like giant cell arteritis.
* patients with no abnormality on cervical or vessel imaging

Primary outcomes:
measure: Presence or absence of perivascular carotid artery enlargement on dedicated vessel imaging
timeFrame: Within 1 week following admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00950872: Safety and Efficacy Study of Duet TRS
Official title: A Prospective, Single-Center Investigation of the Safety and Performance of the ENDO GIA Staplers With ENDO GIA Single Use Loading Units With DUET TRS TM in a Gastric Bypass Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Roux En Y Gastric Bypass
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-08-03
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.


Eligibility criteria: Inclusion Criteria:

* The patient must be 18-65 years of age.
* The patient has a BMI of 40-60 kg/m2 or 35-40 kg/m2 with comorbidities
* The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria:

* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
* The patient is pregnant.
* The patient has an active, or history of, infection at the operative site.
* The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Patient has an abdominal ventral hernia
* The patient has a history of liver disease
* The patient has a history of drug or alcohol abuse
* The patient has a history of venous thrombosis or pulmonary embolism
* The patient has a history of coagulopathy

Primary outcomes:
measure: Incidence of Adverse Events.
timeFrame: Day 30
Secondary outcomes:
measure: Operating Room (OR) Time
timeFrame: Day 0
measure: Length of Hospital Stay
timeFrame: Day 2 (Approximately 1.5 days post randomization)
measure: Incidence of Stapler 'Misfires'
timeFrame: Day 0
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Aurora Pryor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702272: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - CTS
Official title: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican and US Blood Donors - Creative Testing Solutions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 150000
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: volunteer blood donors from the US and Puerto Rico

Brief summary: The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.


Eligibility criteria: Inclusion Criteria:

* Donor must meet all the blood collection sites' standard eligibility requirements.
* Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.

Primary outcomes:
measure: Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.
timeFrame: Approximately three years
Secondary outcomes:
Other outcomes:
Locations:
city: St Petersburg
country: United States
facility: Creative Testing Solutions - Tampa
state: Florida
Study officials:
affiliation: Gen-Probe, Incorporated
name: Jennifer Reid, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02096172: Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA
Official title: Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urine Toxicology
Lead sponsor: Renaissance RX
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2014-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects who are considered candidates for UDT.

Brief summary: The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Pharmacogenomic testing within the last 60 days
* Planned UDT

Exclusion Criteria:

* Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
* Subject has a history of abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST or ALT \>1.5x normal, or suspected cirrhosis)
* Subject has a history of malabsorption (short gut syndrome);
* Subject has a history of any gastric or small bowel surgery;
* Subject is currently hospitalized;
* Subject is currently receiving intravenous medication.

Primary outcomes:
measure: Influence of CYP450 drug metabolism on quantitative UDT
timeFrame: 24 months
Secondary outcomes:
measure: Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications
timeFrame: 24 months
measure: Non-prescribed drugs detected on UDT and the GEM classification associated with these medications
timeFrame: 24 months
measure: False positive immunoassay results, defined as positive immunoassay concurrent with negative quantitative testing
timeFrame: 24 months
measure: Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results
timeFrame: 24 months
measure: Frequency of illicit drug changes by the subject due to UDT results, as observed at the time of repeat UDT
timeFrame: 24 months
measure: Frequency of non-prescribed drug changes by the subject due to UDT results, as detected at the time of repeat UDT
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02960672: Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
Official title: Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease, Desquamative
Keywords: KL-6
disease progression
predict
biomarkers
MMP-7
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2016-11-10
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects with a diagnosis of idiopathic interstitial pneumonias made in accordance with the American Thoracic Society (ATS)/European Respiratory Society (ERS) consensus classification

Brief summary: Interstitial lung disease is a chronic progressive fibrosis lung disease that with a highly variable clinical process.thence it is significant for the patient to search a convenient and accurate prediction method. The objective of this study was to determine whether peripheral blood biomarkers can predict disease .

Detailed description: The median follow-up period was 12 months, each patient received 4 or 5 follow-ups in our center, 336 person-times in study enrollment totally. The patients with interstitial lung disease had significantly higher serum baseline KL-6 and MMP-7 levels compared with healthy control.They divided into progressive group and non-progressive group according to disease change. Serum KL-6 and MMP-7 levels were elevated in patients if disease progression, but baseline level of biomarkers in progressive group were not significant higher compare with non-progressive group .Binary logistic regression showed △KL-6 and △MMP-7 were significant predictors for disease progression. Multivariate Cox analysis showed KL-6 and MMP-7 were significantly associated with survival along with other variables.

The serum levels of KL-6 and MMP-7 were elevated in the individuals with interstitial lung disease compared with healthy controls. The rate of poor prognosis and mortality more associated with the variability increased biomarker concentrations，rather than the baseline concentration.Therefore，Serial measurements of biomarkers contribute to the disease monitoring in clinical management.

Eligibility criteria: Inclusion Criteriar:

* Clinical diagnosis of interstitial lung disease

Exclusion Criteria:

* Diagnosise of interstitial lung disease acute excerbation
* Combined pulmonary embolism, pulmonary edema, pulmonary tuberculosis, and peumonias

Primary outcomes:
measure: Sequential Changes of Serum KL-6 Predict Progression in Interstitial Lung Disease
timeFrame: 3 years
Secondary outcomes:
measure: Sequential Changes of Serum MMP-7 Predict Progression in Interstitial Lung Disease
timeFrame: 3 years
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Ying Jiang
state: Guangdong
Study officials:
References:
Clinical trial NCT05808972: 0.9% Saline Versus Balanced Solutions in Severe Diabetic Ketoacidosis
Official title: 0.9% Sodium Chloride Versus Ringer's Lactate in the Treatment of Severe Diabetic Ketoacidosis: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Ketoacidosis
Ketoacidemia
Acetonemia
Acetonuria
Keywords: Severe diabetic ketoacidosis,
Sodium chloride 0.9%
Ringer lactate
Base excess
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 92
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Independant groups included by randomisation
Primary purpose: TREATMENT

Brief summary: Severe diabetic ketoacidosis (DKA) is a potentially serious complication of diabetes mellitus. The treatment regimen is based on insulin and rehydration. The choice of rehydration solution is a question that remains open. We sought to compare the effect of sodium chloride 0.9% (SC) versus ringer lactate (RL) in the resolution of severe DKA as well as on the variation of electrolytes.

Detailed description: We design an open randomized trial in adult patients admitted to our ICU for severe DKA. The insulin therapy protocol was identical and the randomization concerned the rehydration solution either by SC or RL. The primary endpoint was resolution of DKA at H48 defined by a composite endpoint (glycemia \<11 mmol/l, bicarbonates \> 15 mmol/l or pH\>7.30 and anion gap \<16). The secondary endpoints were resolution of DKA at H24, change in base excess to ≥ -3 meq/L at 48 h and H24 and change in electrolytes, insulin requirements, length of stay and mortality. Blood gases, ionogram with chloride and lactate were performed at baseline, H6, H12, H24 and H48.

Eligibility criteria: Inclusion Criteria:

- All patients aged 16 and over hospitalized in intensive care for severe ketoacidosis defined as arterial pH ≤ 7.25 (or serum bicarbonate ≤ 15 mmol/L) and blood glucose ≥ 14 mmol/L and need for ICU.

Exclusion Criteria:

* \< 16 Y

Primary outcomes:
measure: Number of participants with composite endpoint achievement
timeFrame: 48 hours from inclusion
Secondary outcomes:
measure: change in base excess to ≥ -3 meq/L
timeFrame: at 48 hours and at 24 hours from inclusion
measure: Number of participants with hyperchloremia
timeFrame: at 48 hours from inclusion
measure: Total insulin dose received
timeFrame: through study completion, an average of 9 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Ahlem Trifi
Study officials:
affiliation: Rabta
name: Ahlem Trifi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04277572: Outcomes of Surgery of Aortic Valve
Official title: Outcomes of Different Modalities for Surgery of Aortic Valve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients registered in cardiac surgery department database, and who meet the listed inclusion and exclusion criteria will be eligible for the study.

Brief summary: Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent results and complications.

* Objective 1: Identify predictors of complications following different types of aortic valve surgery accordingly.
* Objective 2: Determine the value of each type in terms of advantages and disadvantages.
* Objective3: Assess outcomes such as postoperative life expectancy, hospital stay, prognosis and quality of life.


Eligibility criteria: Inclusion Criteria:

1. Patients with severe symptomatic aortic valve lesion.
2. Asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (LV end diastolic diameter\>70 mm or LV end systolic diameter\>50 mm.
3. Patients with aortic regurgitation caused by:

   * a dilated aortic annulus
   * conjoined cusp prolapse in bicuspid aortic valves (BAV)
   * single cusp prolapse in tricuspid aortic valves
   * aortic valve cusp perforation from endocarditis

Exclusion Criteria:

* Patients with previous aortic root or valve surgery.

Primary outcomes:
measure: Outcomes of different techniques of aortic valve surgery in the indicated patients for each type of surgery such as :
timeFrame: Up to one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03696472: Robotic-assisted Left Hemicolectomy for Left Colon Cancer
Official title: Robotic-assisted Left Hemicolectomy for Left Colon Cancer With a Medial-to-lateral Approach Orientated by AMA or AMV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection.

Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated

Detailed description: Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.

Eligibility criteria: Inclusion Criteria:

Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2

Exclusion Criteria:

With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy

Primary outcomes:
measure: 5-years overall survival rate
timeFrame: 5 years
Secondary outcomes:
measure: Short-term morbidity rate
timeFrame: 30 days
measure: Anastomosis leakage rate
timeFrame: 6 months
measure: Operation Time
timeFrame: 1 day
measure: Blood loss during operation
timeFrame: 1 day
measure: Complication incident rate of surgery
timeFrame: 1 day
measure: C-reaction protein level
timeFrame: 7 days
measure: Recovery time after surgery
timeFrame: 60 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
Study officials:
References: