louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01274494: COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication
Official title: COMPLIANCE An Observational Study of Treatment Compliance and Quality of Life in Patients on Antihypertensive Medication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Blood Pressure
Keywords: Hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 1501
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multi-centre survey of patients

Brief summary: The aim of this multi-centre survey is to assess treatment adherence and quality of life in a Jordanian and Lebanese population newly diagnosed with hypertension or with uncontrolled essential hypertension being on antihypertensive treatment for at least 6 months.


Eligibility criteria: Inclusion Criteria:

* Patients older than 21 years of age
* Patients newly diagnosis with essential hypertension or with hypertension that is uncontrolled after being under the same antihypertensive treatment for at least 6 months (based on the criteria established by the Joint National Committee VII)
* Patients capable of providing an informed consent

Exclusion Criteria:

* Patients with secondary hypertension
* Pregnant women or nursing mothers
* Patients with acute illnesses or psychiatric diagnosis

Primary outcomes:
measure: Compliance rate
timeFrame: 6 months
Secondary outcomes:
measure: Health Related Quality of Life (MINICHAL Score)
timeFrame: 6 months
measure: Type of pharmacological treatments
timeFrame: 6 months
measure: Factors affecting adherence to treatment
timeFrame: 6 months
measure: Compliance rate by antihypertensive regimen used
timeFrame: 6 months
measure: Percentage of controlled patients
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01326494: Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
Official title: Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Respiratory Tract Infection
Asthma
Keywords: Upper Respiratory Tract Infection
Asthma
URTI induced exacerbation of Asthma
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-03-31
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment.

Detailed description: In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80% of asthma exacerbation.

Experts in asthma care acknowledge this critical problem and have developed guidelines to reduce asthma exacerbation.

The criteria for participation in this study to have 2 or more presentations to a Health Service centre in the past 12 months for URTI induced asthma. These patients will be followed and interviewed monthly over a 12 month period to investigate whether the use of Oral cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation to hospital

Eligibility criteria: Inclusion Criteria:

* 2 or more presentations to Emergency department in a 12 month period

Exclusion Criteria:

* less then 2 presentations to Emergency department in a 12 month period

Primary outcomes:
measure: Reduction of representation to Health Services for Exacerbation of URTI induced asthma
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Bruce Carleton, B.Pharm, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02597894: Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
Official title: Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stage III Prostate Adenocarcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.

Detailed description: PRIMARY OBJECTIVES:

I. Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of high-dose-rate (HDR) brachytherapy.

SECONDARY OBJECTIVES:

I. Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of non-homologous end joining and DNA double strand breaks using the following markers: Ku70, Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X (H2AX).

OUTLINE:

Patients undergo biopsy at baseline before start of ADT and during brachytherapy.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed primary adenocarcinoma of the prostate
* National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen \[PSA\] \> 20)
* Not currently on ADT
* Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion
* Karnofsky performance status (KPS) \>= 70 or Eastern Cooperative Oncology Group (ECOG) = 2
* Understands the trial and procedure and is willing and able to sign the informed consent form

Exclusion Criteria:

* Patient is unable to receive high dose rate prostate brachytherapy
* Patient is unable to have a MRI or transrectal ultrasound
* Refusal to sign the informed consent
* Patients who are participating in a concurrent treatment protocol

Primary outcomes:
measure: Changes in DNA damage repair pathways
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Mitchell Kamrava
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06252194: Comparative Study of Metformin Versus Doxycycline in Moderate to Severe Adult Acne Vulgaris Patients.
Official title: Comparative Study of Metformin Versus Doxycycline in Treatment of Moderate to Severe Adult Acne Vulgaris Patients: Multicentre, Randomized, Double-blind Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 120
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 goal of this clinical trial is to compare the effect of doxycycline and metformin in treatment of acne vulgaris patients. The main question is aimed to answer is whether metformin is more effective than doxycycline in treatment of acne vulgaris patient or not.

Patients will be asked to take doxycycline along with tropical treatment in one group and metformin along with tropical treatment in another group.

Researcher will compare the clinical improvement in two groups.


Eligibility criteria: Inclusion Criteria:

Newly diagnosed moderate and severe AV patients diagnosed by a dermatologist

-

Exclusion Criteria:

* Patients receiving topical retinoids within last two months
* Pregnancy and lactation
* History of corticosteroids intake
* Suffering from malignancy or any cosmetic induced acne

Primary outcomes:
measure: Global Acne Grading System (GAGS) Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BSMMU
Study officials:
References:
Clinical trial NCT04139694: Improving Insulin Resistance in Gynecological Cancer Patients
Official title: Improving Insulin Resistance in Gynecological Cancer Patients Post Treatment Using Integrative and Functional Food Plan With or Without Cinnamon Supplementation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: Woman's
Sponsor class: OTHER
Collaborators: name: Woman's Hospital, Louisiana
name: Dietitians in Integrative and Functional Medicine DPG
First posted: 2019-10-25
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.


Eligibility criteria: Inclusion Criteria:

* previously diagnosed with gynecological cancer and has completed all surgical intervention, chemotherapy, and/or radiation at least 3 months prior to enrollment but not greater than 24 months
* post-menopausal
* BMI \> 25 but \< 40

Exclusion Criteria:

* no previous diagnosis of diabetes
* no other cancer diagnosis (excluding skin)
* no chronic use of medication(s) interfering with glucose metabolism

Primary outcomes:
measure: Improvement in mean glucose concentration
timeFrame: 24 weeks
Secondary outcomes:
measure: body mass index (BMI)
timeFrame: 24 weeks
measure: body composition
timeFrame: 24 weeks
measure: glucose tolerance
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Woman's Hospital
state: Louisiana
Study officials:
References:
Clinical trial NCT06626594: Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool
Official title: Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep
Newborn Health
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates admitted to the department of Neonatology and neonatal intensive care unit who met the definition of newborn.

Brief summary: Sleep assessment of newborns in China is often neglected by medical staff, but sleep is related to the stability of vital signs and future neurobehavioral development. In order to understand the sleep quality of Chinese newborns and to protect their sleep during work, the neonatal sleep-wake assessment tool was translated into Chinese, revised, and tested for reliability and validity, in order to provide a reference for clinical staff to choose the timing of care.


Eligibility criteria: Inclusion Criteria:

* The clinical definition of a newborn was met.

Exclusion Criteria:

* A state of persistent convulsions

Primary outcomes:
measure: Neonatal sleep-wake state scores（composite outcome measure）
timeFrame: Results observed within 2 minutes.
Secondary outcomes:
measure: Sleep state as shown by Amplitude-integrated EEG
timeFrame: Measurements were performed simultaneously with the Chinese version of the Neonatal Sleep-Wake Assessment Tool for 2minutes.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: CHZhejiang
state: Zhejiang
Study officials:
References:
Clinical trial NCT04419194: Effect of Climatic Factors on the Seasonal Fluctuation of Pulmonary Embolism
Official title: Association Between Climatic Factors and Hospital Admissions for Pulmonary Embolism: Time Series Study in China Between Years 2014 to 2019.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Climate
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as pulmonary embolism who meet the inclusion criteria above.

Brief summary: To estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter \[aerodynamic diameter ≤2.5 μm; PM2.5\]) in China.

Detailed description: Hospital admissions for pulmonary embolism were identified based on the primary diagnosis. The central adjudication committee at Peking Union Medical College Hospital (Beijing, China) reviewed all medical and death records and determined the final diagnosis. Two adjudication committee members verified events independently, and discrepancies were resolved by discussion involving additional committee members.For each admission, we extracted data on the date of admission, sex, age, and location of the patient from hospital information system.

All the data of daily meteorological variables for the same period, including temperature variables (°C) (the min, max and mean temperature), relative humidity (%), air pressure (hPa), precipitation (mm), wind speed (m/s) and sunshine duration (h), were collected from the China Meteorological Data Sharing Service System (http://www.escience.gov.cn/metdata/page/index.html). The data on PM2.5 levels in each city was collected from the National Air Pollution Monitoring System.

An overdispersed generalised additive model was used to estimate associations between climatic factors and pulmonary embolism admissions. A distributed lag non-linear model (DLNM) was employed to examine their lagged effects.

Eligibility criteria: Inclusion Criteria:

* Males and females.
* With a primary diagnosis of pulmonary embolism based on clinical symptoms, with or without radiologic features.

Exclusion Criteria:

* Lack of important data.

Primary outcomes:
measure: Incidence of pulmonary embolism
timeFrame: From July 31, 2014 to July 31, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Shi Juhong, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT03641794: Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
Official title: A Phase I Study of DN1406131 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai De Novo Pharmatech Co., Ltd.
First posted: 2018-08-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.


Eligibility criteria: Inclusion Criteria:

* Age greater of 18 years and less than 45
* Weight ≥50 kg,body mass index of 19\~26 kg/m2
* Signed ICF

Exclusion Criteria:

* active autoimmune disease
* uncontrolled concurrent illness
* Smoking
* Drugs
* positive serology for HIV, Hepatitis B or C,Syphilis
* Pregnancy or breastfeeding

Primary outcomes:
measure: adverse events - type, incidence, severity
timeFrame: 28 day
measure: Maximum Tolerated Dose
timeFrame: 14 day
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 48 hours
measure: Serum for biomarkers of IDO activity (kynurenine and tryptophan)
timeFrame: 48 hours
measure: Elimination half-life
timeFrame: 48 hours
measure: peak time
timeFrame: 48 hours
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shandong
Study officials:
affiliation: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
name: Qinghong Zhou
role: STUDY_DIRECTOR
References:
Clinical trial NCT00852891: Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation
Official title: Cardiorespiratory Changes in Patients Being Weaned Off Mechanical Ventilation: a Randomized Crossover Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Weaning
Keywords: weaning
echocardiogram
diastolic dysfunction
Mechanical ventilation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving MV for more than 48 hours, who had been admitted to the Intensive Care Unit (ICU), and who met the criteria for weaning from MV according to the parameters previously defined were selected to participate in this study.

Brief summary: The objective of this study was to analyze changes in cardiac function using Doppler echocardiogram in critical patients during weaning from mechanical ventilation using two different weaning methods (pressure support and T-tube) and to compare a subgroup of patients: success vs. failure in weaning and patients with vs. without heart disease.

Detailed description: Weaning from mechanical ventilation (MV) involves physiological changes that can overload the cardiorespiratory system due to changes in the interaction between patient and ventilator.

This was a randomized crossover clinical trial that included patients in an intensive care unit (ICU) who had been on MV for more than 48 hours and who were considered ready for weaning. Cardiorespiratory variables, oxygenation, electrocardiogram (ECG) and Doppler echocardiogram findings were analyzed at baseline and after 30 minutes in each trial weaning method (PSV and T-tube). Comparisons were made between PSV and T-tube, weaning success and failure and patients with and without heart disease, using ANOVA and Student's t test. The level of significance was set at p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* patients hemodynamically stable
* conscious (Glasgow scale ≥ 13)
* with adequate gaseous exchange (O2 saturation ≥ 95%, fraction of inspired oxygen (FiO2) ≤ 40% and positive end-expiratory pressure (PEEP) = 5
* with no acidosis or alkalosis)
* normal electrolyte levels
* presence of respiratory drive
* informed consent was signed by the patients and/or family members

Exclusion Criteria:

* hemodynamic instability
* severe intracranial disease
* barotrauma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Silvia RR Vieira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764591: Tissue Perfusion for Different Approaches of Brachial Plexus Block
Official title: Effect of Different Approaches of Infraclavicular Brachial Plexus Block on Tissue Perfusion: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Fracture
Regional Anesthesia
Brachial Plexus Blocks
Perfusion Index
Tissue Perfusion
Keywords: lateral sagittal approach
costoclavicular approach
block success
perfusion index
brachial plexus
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application.


Eligibility criteria: Inclusion Criteria:

* patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
* American Society of Anesthesiologists class 1 to 3
* Ability to consent

Exclusion Criteria:

* History of allergic reaction to local anaesthetics
* Peripheral neuropathy
* Renal or hepatic insufficiency
* Coagulation disorders

Primary outcomes:
measure: perfusion index
timeFrame: up to motor block scale ≥3
measure: tissue oxygenation
timeFrame: up to motor block scale ≥3
Secondary outcomes:
measure: motor block onset time
timeFrame: Assessed 40 minutes after block completion
measure: sensorial block onset time
timeFrame: up to 24 hours
measure: complications
timeFrame: up to 24 hours
measure: duration of block application
timeFrame: during the intervention
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References: