louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01047384: Management of Postoperative Pain Following Total Knee Arthroplasty by Using Acupuncture-moxibustion Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.

We design a prospective randomized study for postoperative pain control following total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* diagnosed for surgery of osteoarthritis of knee
* ability to tolerate surgery under general anesthesia.

Exclusion Criteria:

* refusal or the lack of mental ability to provide informed consent
* neuropathic pain or sensory disorders in the leg requiring surgery
* previous surgery of the knee joint
* coagulation abnormalities
* chronic opioid users
* known history of intolerance to acupuncture-moxibustion therapy

Primary outcomes:
measure: Pain VAS score
timeFrame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
Secondary outcomes:
measure: Functional score: SF-36
timeFrame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks
Other outcomes:
Locations:
city: Kweishian
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
References:
Clinical trial NCT00818584: An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Official title: A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Candida
Keywords: Micafungin
Candida
Neonates
Mycamine
FK463
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-01-07
Enrollment: 13
Sex: ALL
Minimum age (years): 48
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Detailed description: Subjects will be stratified by weight to receive one of two doses of study drug

Eligibility criteria: Inclusion Criteria:

* Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
* Infant has sufficient venous access to permit study drug dosing
* Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry

Exclusion Criteria:

* Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
* Infant has received an echinocandin within one month prior to study entry
* Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
* Infant has a life expectancy of less than 96 hours

Primary outcomes:
measure: Assessment of micafungin plasma pharmacokinetic parameters
timeFrame: Day 4
Secondary outcomes:
measure: Monitor adverse events
timeFrame: 11 or 12 Days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Orange
country: United States
state: California
city: Louisville
country: United States
state: Kentucky
city: Kansas City
country: United States
state: Missouri
city: Durham
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sanchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.
Clinical trial NCT01278784: Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Official title: Local Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Keywords: Dry eye syndromes
Chitosan-N-Acetylcysteine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.

Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES. We have recently shown in a phase I trial that single instillation of chitosan-N-acetylcysteine eye drops is well tolerated in young healthy subjects. However, due to the fact that intraocular pressure has been measured as one of the main safety variables, topical anesthesia was necessary. Thus, the data about local ocular discomfort after administration are limited. This trial seeks to investigate whether single instillation of chitosan-N-acetylcystein leads to ocular discomfort such as burning and stinging.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 45 years
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 dpt

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceding the study
* Abuse of alcoholic beverages
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Ametropia less than 6 dpt
* Pregnancy

Primary outcomes:
measure: Difference between 0.05% and 0.1% Chitosan-N-Acetylcysteine eye drops
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT00139984: Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance
Official title: Impact of Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance in Medical Outpatients: The Hyper-ABC Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Ambulatory blood pressure monitoring
Blood pressure
Risk assessment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2005-08-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
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 in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement.

Detailed description: Blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. Therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. Furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. However, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure.

Aim: To test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy.

Eligibility criteria: Inclusion Criteria:

* Uncontrolled hypertension (office BP \>139/89mmHg AND 24h BP \>129/79mmHg)

Exclusion Criteria:

* Severe concomitant illness including heart failure, significant valvular heart disease or malignancy

Primary outcomes:
measure: Change in 24-hour systolic blood pressure from baseline to 1 year
Secondary outcomes:
measure: Change in 24-hour diastolic blood pressure from baseline to 1 year
measure: Primary outcome measure in patients with treated hypertension at baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Medical Outpatient Clinic, University Hospital Basel
city: Basel
country: Switzerland
facility: Private Practice
Study officials:
affiliation: Cardiology, University Hospital Basel
name: David Conen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conen D, Tschudi P, Martina B. Twenty-four hour ambulatory blood pressure for the management of antihypertensive treatment: a randomized controlled trial. J Hum Hypertens. 2009 Feb;23(2):122-9. doi: 10.1038/jhh.2008.106. Epub 2008 Aug 28.
Clinical trial NCT06465784: Laser Lithotripsy for Ureteral Stones
Official title: Comparison Between Retrograde and Antegrade Ureteroscopic Laser Lithotripsy for Management of Medium Sized Proximal Ureteral Stones: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ureteric Stone
Keywords: laser treatment
ureteric stones
ureteroscope
retrograde
antegrade
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: laster lithotripsy for clearance of uretric stones
Primary purpose: TREATMENT

Brief summary: Objectives: To present the outcomes of retrograde and antegrade ureteroscopic laser lithotripsy in the treatment of proximal ureteral stones ranging in size from 10 to 20 millimeters in diameter.

Patients and methods: From March 2023 to December 2023, 70 patients were included in this prospective randomized double-arm interventional study. Patients were divided into two groups: Group 1: (35 patients) had semi-rigid retrograde ureteroscopic laser lithotripsy and group 2: (35 patients) had semi-rigid antegrade ureteroscopic laser lithotripsy.

Detailed description: The present study was conducted in Al-Azhar University Hospital (Damietta branch), urology department,at the period from March 2023 to December 2023. Seventy patients with symptomatic proximal medium sized ureteric stones were classified in two groups Retrograde Uretroscopic Laser Lithotripsy (group 1) and Antegrade Ureteroscopic Laser Lithotripsy (group 2) .

The preoperative-(patient- and stone-related), intraoperative- and postoperative- related parameters that might influence the perioperative course and short-term clinical outcomes were evaluated.

Eligibility criteria: Inclusion Criteria:

- Patients with medium-sized proximal ureteral stones (10-20 mm) situated between the ureteropelvic junction and the top edge of the L5 vertebral body; age 18-65 years

Exclusion Criteria:

* Pregnancy, bleeding disorders, morbid obesity (BMI \> 35), patients with stenosis of the ureter, history of previous surgery on the ipsilateral ureter, patients with a simultaneous kidney stone requiring surgery, and patients with an active urinary tract infection

Primary outcomes:
measure: Stone free rate
timeFrame: Direct after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Damietta Faculty of Medicine, Al-Azhar University, Damietta, Egypt.
Study officials:
References:
Clinical trial NCT02396784: Early Stockholm Obesity Prevention Program (EarlySTOPP-China)
Official title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity - China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overweight
Obesity
Keywords: child overweight
child obesity
prevention
targeted intervention
development of overweight
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2015-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 1-6 yrs

Brief summary: Early STOPP project promotes good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study.

Background: Several daily habits lead to less favorable health factors. For example, using the car instead of cycling or walking - leads to less activity in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children.

Good treatment for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is.

In Early STOPP project we study food, physical activity and sleep habits in the families with a child of one year of age. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured. Based on our observations we aim to develop the preventive strategies for the families with very young children.


Eligibility criteria: Inclusion Criteria:

* one obese or two overweight parents, 1 year old child

Exclusion Criteria:

* weight effecting diseases

Primary outcomes:
measure: Body Mass Index score(BMI sds) at the age 6 years
timeFrame: 5 years
Secondary outcomes:
measure: sleeping hehavior
timeFrame: 5 years
measure: biomarkers
timeFrame: 5 years
measure: physical activity and sedentary behavious
timeFrame: 5 years
measure: dietary intake
timeFrame: 5 years
measure: socioeconomic factors
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Medical College
state: Hubei
Study officials:
affiliation: Karolinska Institutet
name: Tanja Sobko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00541684: Health Assessment Study (0954-946)
Official title: A Randomized, Double-Blind, Two Arm, Parallel Group Health Assessment Study of Losartan or Atenolol in Patients With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 143
Sex: MALE
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will look at the effects of losartan or atenolol on frequency of sexual intercourse in subjects with newly diagnosed mild to moderate hypertension.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with mild to moderate hypertension\\
* Married male in stable heterosexual relationship
* No prior history of sexual dysfunction
* Satisfied with overall sex life
* Patient's spouse is in close proximity for the study
* Has had at least 2 but not more than 10 sexual intercourse events during the 2 week period prior to study start
* Patient able to visit doctor in the morning of each scheduled visit
* Able to complete the self administered health assessment questionnaire

Exclusion Criteria:

* Hypertension due to cancer, history of heart or circulatory problems
* History of mental disorder that might impair sexual function
* History or presence of drug or alcohol abuse
* Prior surgery for erectile dysfunction or other urological procedure
* No penile implant or assist devices
* History of chronic liver disease, history of diabetes
* History of severe life-threatening diseases such as, cancer, AIDS or positive HIV test
* Subjects with only 1 kidney
* Mental handicap or legal incapacity

Primary outcomes:
measure: number of sexual intercourse events in a 2-week period
timeFrame: 2 Weeks
Secondary outcomes:
measure: sexual functioning score and overall sexual satisfaction score after 16 weeks
timeFrame: 16 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04010084: Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease
Official title: Effectiveness of Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) is among the most common chronic respiratory diseases (CKD). Millions of people of all ages suffer from these diseases. COPD is between the fifth and sixth of the leading causes of death in Brazil. It generates an inflammatory pulmonary response that is softened by non-curative treatments and that present serious side effects. Low intensity laser (LBI) or laser therapy has been used for about 50 years to help the healing process, revealing efficient anti-inflammatory and analgesic responses, as well as experimental models of acute and chronic inflammation. However, little is known about its response in inflammatory lung diseases, especially COPD. Some reports indicate that laser therapy may interfere positively by relieving clinical signs, the onset, and the final symptoms of pulmonary inflammation. The present project aims to study the effects of LBI on Chronic Obstructive Pulmonary Disease in patients with pulmonary processes, determine their mechanisms of action and evaluate its effect on patients' functional capacity.


Eligibility criteria: Inclusion Criteria:

* Individuals of both sexes;
* Over 18 years of age;
* With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days;
* Performing routine outpatient treatment with a pulmonologist;
* Agreement to participate.

Exclusion Criteria:

* Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery.
* Patients with cystic fibrosis and Kartagner's syndrome.

Primary outcomes:
measure: Measure of functional capacity
timeFrame: 4 weeks
Secondary outcomes:
measure: TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α
timeFrame: 4 weeks
measure: Spirometry
timeFrame: 4 weeks
measure: Quality of life assessment questionnaire
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: