louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04474899: Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Official title: Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Hypertension
Lead sponsor: Royal Perth Hospital
Sponsor class: OTHER
Collaborators: name: The University of Western Australia
First posted: 2020-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double blind cross over study
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.

Detailed description: This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.

Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.

Eligibility criteria: Inclusion Criteria:

* Age: 25 -70 years
* (Body Mass Index) BMI≥30kg/m2
* Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
* Elevated clinic systolic (Blood Pressure) BP ≥135 or diastolic BP ≥85mmHg,
* on ACE inhibitor for at least 6 weeks prior to baseline assessment

Exclusion Criteria:

* Grade 2-3 hypertension (systolic office BP \>160, diastolic office BP \>100 mmHg)
* Secondary causes of hypertension
* CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR\<30ml/min}
* Heart failure NYHA (New York Heart Association) class II-IV
* Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
* medication such as corticosteroids, several antidepressants and antipsychotics
* Female participants of childbearing potential must have a negative pregnancy test prior to treatment

Primary outcomes:
measure: Blood Pressure
timeFrame: 30 weeks
Secondary outcomes:
measure: blood glucose levels
timeFrame: 30 weeks
measure: Gut microbiota profile
timeFrame: 30 weeks
measure: Lipid levels in blood
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Dobney Hypertension Centre
state: Western Australia
Study officials:
affiliation: University of Western Australia and Royal Perth Hospital
name: Markus Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1.
Clinical trial NCT00879099: Interaction Study of Timolol Eye Drops and Paroxetine Capsules
Official title: The Effect of Paroxetine on the Plasma Levels of Timolol Using Ophthalmic 0.5% Timolol Eye Drops and 0.1% Timolol Eye Gel in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Interaction
healthy volunteers
Interaction study for healthy volunteers
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma levels of timolol and its main metabolites after topical application of ophthalmic timolol products.

This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy male volunteers aged 18 - 40 years will be enrolled.

Placebo or paroxetine will be given for three days after which 1 drop of timolol product will be administered once in both eyes.

The duration of the paroxetine or placebo treatment period will be 3 days. There will be four different treatment periods. A washout between the study periods will be at least 4 weeks.


Eligibility criteria: Inclusion Criteria:

* male
* 18 - 40 years of age
* be in good general health
* be willing to follow instructions
* provide a written informed consent
* have a BMI of 18.5 - 26
* have systolic blood pressure at least 105 mmHg
* have haemoglobin at least 135 g/l.

Exclusion Criteria:

* known hypersensitivity to timolol, paroxetine or any component of the study medications
* any contraindications to timolol treatment including asthma and obstructive lung disease
* any contraindications to paroxetine treatment
* have heart rate 50/min or less in rest
* any regular medication
* allergy requiring antihistamine or ocular or nasal treatment
* clinically significant abnormalities (from normal limits) in laboratory values: basic blood count, creatinine, ALAT, AFOS, gamma-GT, K, Na
* clinically significant EKG abnormalities assessed by the investigator
* blood donation within the last 60 days (the required time period between two donations for men given by RedCross Finland).
* participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 60 days

Primary outcomes:
measure: The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki, Department of Clinical Pharmacology
state: Biomedicum
Study officials:
affiliation: Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki
name: Janne Backman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00569842: Investigation of the Cylex® ImmuKnow® Assay
Official title: Investigation of the Cylex® ImmuKnow® Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Hodgkin's Disease
Multiple Myeloma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Aplastic Anemia
Chronic Myelogenous Leukemia
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

1. Acute leukemia
2. Non-Hodgkin's Lymphoma
3. Chronic lymphocytic leukemia
4. Hodgkin's disease
5. Multiple myeloma
6. Myelodysplastic Syndromes
7. Myeloproliferative Disorders
8. Aplastic Anemia
9. Chronic myelogenous leukemia

Brief summary: Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur.


Eligibility criteria: Inclusion Criteria:

Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

1. Acute leukemia
2. Non-Hodgkin's Lymphoma
3. Chronic lymphocytic leukemia
4. Hodgkin's disease
5. Multiple myeloma
6. Myelodysplastic Syndromes
7. Myeloproliferative Disorders
8. Aplastic Anemia
9. Chronic myelogenous leukemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Universtiy Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Sherif Farag, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01639742: European New Texture Implant Clinical Experience With Round Breast Implants
Official title: European New Texture Implant Clinical Experience With Round Breast Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to obtain clinical experience with the use of new texture, round breast implants in bilateral primary breast augmentation.


Eligibility criteria: Inclusion Criteria:

* Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
* Be a candidate for the device styles and sizes available in the study

Exclusion Criteria:

* Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
* Have undergone any previous breast surgery
* Have tissue covering determined inadequate or unsuitable by the surgeon

Primary outcomes:
measure: Investigator Overall Satisfaction With the Device Using a 5-Point Scale
timeFrame: 3 months
Secondary outcomes:
measure: Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire
timeFrame: 6 months
measure: Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue
timeFrame: 6 months
measure: Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale
timeFrame: Interim analysis: 12 months
measure: Percentage of Participants With Local Complications
timeFrame: Interim analysis: 12 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Praxisklinik Siepe Friedrichstraße 57
city: Bonn
country: Germany
facility: Malteser Krankenhaus
city: Stockholm
country: Sweden
facility: Akademikliniken 10
city: Birmingham
country: United Kingdom
facility: Dolan Park Hospital
Study officials:
affiliation: Allergan
name: Per Heden
role: STUDY_DIRECTOR
References:
Clinical trial NCT04027842: Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
Official title: Effect of 10 Minute-prewarming on Core Body Temperature During Gynecologic Laparoscopic Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia; Anesthesia
Keywords: Perioperative hypothermia
Core body temperature
Prewarming
Gynecologic laparoscopic surgery
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 54
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (IPH). Warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. It has been proved that initiation of warming before surgery can be more useful for preventing IPH than warming only during surgery. Nevertheless, there are not many researches on effects of short period (\<30 min) prewarming, especially in gynecologic laparoscopic surgery. Accordingly, the investigators designed this study to test if IPH can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* ASA physical status 1 or 2 patients
* patients who underwent gynecologic laparoscopic surgery under general anesthesia

Exclusion Criteria:

* preexisting hypothermia (\<36℃) or hyperthermia (\>37.5℃)
* anesthesia last for \<1 hour or \>2 hours
* conversion from laparoscopic surgery to laparotomy
* patients with a body mass index (BMI) ≥ 31kg/m2
* patients with known thyroid disease

Primary outcomes:
measure: the incidence of intraoperative hypothermia
timeFrame: on arrival at operating theater, before anesthesia induced, every 15 minutes after anesthetic induction until admission to the post anesthetic care unit (PACU)
Secondary outcomes:
measure: the incidence of postoperative shivering
timeFrame: on the admission to PACU, 30 minutes after the admission to PACU
measure: Time-temperature interaction during the first 1 hour of anesthesia
timeFrame: Core body temperature was recorded at 15-min intervals from initiation of anesthesia for 1 hour.
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: DaeguCUMC
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jin Yong Jung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00918242: Prevalence of Coronary Artery Disease in the Siblings of Premature Coronary Heart Disease
Official title: Assessment of Occult CAD: Premature CAD Sibling Study (PreCASS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
computed tomography
prevalence of coronary artery disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Korean Society of Lipidology and Atherosclerosis
First posted: 2009-06-11
Enrollment: 87
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: the siblings of premature coronary heart disease (male\<55years old, female\<65yeasrs old: Framingham Heart Study) patients admitted relevant hospital within 1 year

Brief summary: The aim of this prospective study is to investigate the prevalence of coronary artery disease using computed tomography with family history of premature coronary heart disease


Eligibility criteria: Inclusion Criteria:

* within 1 year
* the siblings of premature coronary heart disease (male\<55years old, female\<65yeasrs old: Framingham Heart Study) patients admitted relevant hospital

Exclusion Criteria:

* Documented coronary heart disease
* experienced adverse events with relevant treatment
* contraindicated with beta-blockers
* Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects

Primary outcomes:
measure: evaluation of prevalence to coronary artery disease using CT
timeFrame: within 2 weeks from CT scanning
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
name: Hyuk-Jae Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arad Y, Spadaro LA, Goodman K, Newstein D, Guerci AD. Prediction of coronary events with electron beam computed tomography. J Am Coll Cardiol. 2000 Oct;36(4):1253-60. doi: 10.1016/s0735-1097(00)00872-x.
Clinical trial NCT03054142: China Collaborative Study on Epidemiology of Acute Kidney Injury
Official title: China Collaborative Study on Epidemiology of Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All inpatients (if outpatient identification is achieved, outpatient and inpatient patients can be judged to be the same individual, the outpatient electronic data is extracted at the same time)

Brief summary: Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital. AKI has become a huge medical burden in China. Little information is available about this disease burden in our country. The investigators aimed to evaluate the burden of AKI and to analyze the related risk factors.

Detailed description: The investigators launch a nationwide of all patients, who were admitted to hospital from 2011-2016. Patients were diagnosed on the basis of changes in serum creatinine by the laboratory information system. The investigators assessed rates of AKI according to the criteria of 2012 Kidney Disease Improving Global Outcomes (KDIGO).

Eligibility criteria: Inclusion Criteria:

* The patients diagnosed on the basis of changes in serum creatinine according to the criteria of 2012 Kidney Disease Improving Global Outcomes(KDIGO)

Exclusion Criteria:

* Serum creatinine record less than two times during hospitalization
* Patients being diagnosed with End-stage kidney disease (chronic kidney disease stage 5)
* Nephrectomy
* Kidney transplantation
* Peak serum creatinine of less than 53µ mol/L
* Serum creatinine decrease after amputation

Primary outcomes:
measure: Incidence of AKI
timeFrame: Jan. 2011 to Oct. 2016
Secondary outcomes:
measure: Recognition rate of AKI
timeFrame: Jan. 2011 to Oct. 2016
measure: Proportion of nephrology referral
timeFrame: Jan. 2011 to Oct. 2016
measure: In-hospital mortality
timeFrame: Jan. 2011 to Oct. 2016
measure: Longer ICU stay
timeFrame: Jan. 2011 to Oct. 2016
measure: Higher medical cost
timeFrame: Jan. 2011 to Oct. 2016
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nephrology Dept,Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Nephrology Dept,Guangdong General Hospital
name: Liang Xinling, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu L, Wu Y, Chen Y, Li R, Wang Z, Li Z, Liu G, Yu L, Shi W, Liang X; China collaborative study on AKI (CCS-AKI). Is acute kidney injury age-dependent in older adults: an observational study in two centers from North China. BMC Geriatr. 2021 Jan 6;21(1):7. doi: 10.1186/s12877-020-01906-z.
Clinical trial NCT00246142: A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
Official title: A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myofascial Pain Syndromes
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 76
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on myofascial pain syndrome.


Eligibility criteria: Inclusion Criteria:

* Chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments
* Presents at baseline with pain score greater than 50mm on 100mm length VAS. Pain score will be measured as overall pain over the 7 days preceding the visit during activities
* Active trigger point (TrP) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness AND referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation AND preferably local twitch response at palpation AND/OR jump sign at palpation

Exclusion Criteria:

* Disc/bone disease
* History of surgery on neck
* Neurological deficits, neuromuscular junction disorder, Motor Neuron disease
* Patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months
* Systemic inflammatory disease
* Hypersensitivity to Dysport®
* Diffuse tender points, or diagnosed with fibromyalgia
* Previous electrical stimulation
* Previous injection of Dysport® within 6 months of study enrolment

Primary outcomes:
measure: Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.
timeFrame: Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection
measure: Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
timeFrame: Before Dysport® injection and at 16 weeks after injection
Secondary outcomes:
measure: Pain threshold measured by pressure algometer.
timeFrame: At each visit
measure: Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
timeFrame: At each visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Seo HG, Bang MS, Chung SG, Jung SH, Lee SU. Effect of electrical stimulation on botulinum toxin a therapy in patients with chronic myofascial pain syndrome: a 16-week randomized double-blinded study. Arch Phys Med Rehabil. 2013 Mar;94(3):412-8. doi: 10.1016/j.apmr.2012.09.034. Epub 2012 Nov 1.