louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02390882: A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH
Official title: A Multicenter, Randomized, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostate Hyperplasia
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 494
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with Benign Prostatic Hyperplasia

Detailed description: A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of (Tamsulosin) HGP0412 and HIP1402 in patients with benign prostatic hyperplasia

Eligibility criteria: Inclusion Criteria:

* age\>=45, male, diagnosed on BPH, Total IPSS\>=13

Exclusion Criteria:

* Hypersensitivity to investigational products or components
* PSA\>=4ng/ml

Primary outcomes:
measure: Total International Prostate Symptom Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Total International Prostate Symptom Score
timeFrame: 4, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Guri Hospital
Study officials:
affiliation: Hanyang University
name: Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung JH, Oh CY, Kim JH, Ha US, Kim TH, Lee SH, Han JH, Bae JH, Chang IH, Han DH, Yoo TK, Chung JI, Kim SW, Jung J, Kim YI, Lee SW. Efficacy and safety of tamsulosin 0.4 mg single pills for treatment of Asian patients with symptomatic benign prostatic hyperplasia with lower urinary tract symptoms: a randomized, double-blind, phase 3 trial. Curr Med Res Opin. 2018 Oct;34(10):1793-1801. doi: 10.1080/03007995.2018.1447451. Epub 2018 Apr 12.
Clinical trial NCT00257582: Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics
Official title: Long-term Study of Cetirizine Dry Syrup in Children Suffering From Various Type of Cutaneous Disease Accompanied With Pruritus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pruritus
Keywords: cetirizine
various type of cutaneous disease accompanied with Pruritus
pediatrics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety of long-term use of cetirizine dry syrup in children with various type of cutaneous disease accompanied on pruritus.


Eligibility criteria: Inclusion Criteria:

* Chronic urticaria
* Eczema \& dermatitis group
* Atopic dermatitis
* Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
* Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
* Giving informed consent
* Children who have 2 grades or more pruritus score when assessed by the investigator or sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the patient diary.
* Children with a pruritus severity of "2.Mild" or severer on the first day of the treatment period.

Exclusion criteria:

* have a history of drug hypersensitivity
* are pregnant, lactating or possibly pregnant female children.
* have asthma that requires the treatment with corticosteroid.
* cannot avoid the use of external steroid classified into "strong", "strongest" or "very strong".
* have pruritus only on face and head.
* have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug.
* are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Primary outcomes:
measure: To assess the safety
Secondary outcomes:
measure: -severity of pruritus -total pruritus score -daily main prurutus score -Severity of eruption -Patient global Improvement rating -Body temperature -Adverse events -Cetirizine serum concentrations
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02178982: Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome
Official title: Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Acute Respiratory Distress Syndrome
Keywords: mechanical ventilation
ARDS
Ventilator strategy
outcome
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ARDS patients

Brief summary: The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases. In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of death in patients. There is no unified treatment process for ARDS currently and the treatment measures are not yet standardized, so the standardization of ARDS treatment processes is needed to reduce mortality in patients. Following the evidence-based medicine principles and six-step treatment standards of ARDS, this study uses the method of multi-center randomized controlled clinical trials to evaluate the standardized treatment process of ARDS, which provides the basis for the standardized treatment of ARDS.


Eligibility criteria: Inclusion Criteria:

* aged ≥ 18 years
* admitted to the ICU
* according to the diagnostic criteria of ARDS Berlin definition，admit patients with severe ARDS

Exclusion Criteria:

* age \<18 years old
* be expected to die within 24 hours
* end-stage malignancies
* be participating in other studies, which may affect the results of this study
* DNI (do not intubation) and DNR (do not recovery) patients
* family members do not agree to sign an informed consent

Primary outcomes:
measure: Number of medical staff who comply the protocol treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03212482: Patient-ventilator Asynchrony in Patients With Brain Injury
Official title: Patient-ventilator Asynchrony in Patients With Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injuries
Mechanical Ventilation
Keywords: brain-injured patients, patient-ventilator asychrony
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 100
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: Adult patients with brain injury and receiving MV for at least 72 hours in the intensive care unit, will be enrolled in the study.

Brief summary: Mechanical ventilation is an important support strategy for critically ill patients. It could improve gas exchange, reduce the work of breathing, and improve patient comfort. However, patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator may obfuscate these goals. Studies have shown that a high incidence of asynchrony (asynchrony index \> 10%) is associated with prolonged mechanical ventilation and ICU length of stay and high mortality. So far, there have been only a few studies on the epidemiology of asynchrony in brain-injured patients. Investigators conduct a prospective observational study among brain-injured patients to determine the prevalence, risk factors and outcomes of patient-ventilator asynchrony. Esophageal pressure monitoring, a surrogate for pleural pressure, combined with airway pressure and flow waveforms is used to detect patient-ventilator asynchrony.


Eligibility criteria: Inclusion Criteria:

* 1) \]older than 18 years 2) with brain injury in the ICU 3) mechanical ventilated for at least 72 hours

Exclusion Criteria:

* 1) ICU length of stay less than 24 hours 2) enrolled in another trial

Primary outcomes:
measure: The incidence of patient-ventilator asynchrony in brain-injured patients
timeFrame: Three days
Secondary outcomes:
measure: The risk factors of patient-ventilator asynchrony in brain-injured patients
timeFrame: Three days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jian-Xin Zhou
state: Beijing
Study officials:
affiliation: Acute Brain Injury and Critical Care Research Collaboration, ABC Research Collaboration
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
citation: Luo XY, He X, Zhou YM, Wang YM, Chen JR, Chen GQ, Li HL, Yang YL, Zhang L, Zhou JX. Patient-ventilator asynchrony in acute brain-injured patients: a prospective observational study. Ann Intensive Care. 2020 Oct 19;10(1):144. doi: 10.1186/s13613-020-00763-8.
Clinical trial NCT01649882: Ultrasound Evaluation of Endotracheal Tube Depth
Official title: Ultrasound Evaluation of Endotracheal Tube Depth for Proper Tube Placement in Different Patient Groups
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation, Intratracheal
Keywords: endotracheal tube position
intubation
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 100
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Correct positioning of the endotracheal tube (ETT) is crucial to ensure safe ventilation. To date, no test that can verify this right after intubation at the bedside exists. Indirect tests have false negative and positive results leading to complications or at least difficulties in performing effective ventilation of patients.

Bedside ultrasound could fill this need. Although bedside ultrasound may not be possible or useful in routine intubations, it may prove useful in difficult or questionable cases, where current clinical exams/techniques may not offer a reliable indication of endotracheal tube depth.

Detailed description: Ultrasound is able to visualize some parts of the trachea and the ETT therein and although the actual structures of interest (ETT tip and carina) are difficult or impossible to visualize reliably (due to their air contents reflecting ultrasound beams) one can use surrogates:

The cuff of the ETT can be visualized as it is in- or deflated or it can be filled with an air-fluid(saline) mixture to delineate it inside the trachea.

For the same reason (air reflecting ultrasound beams) the carina is difficult to visualize and one can use the aortic arch which is positioned just anterior to it instead.

This study apart from determining feasibility of the method may produce enough data from ultrasound exams to develop/derive a more pre-cise algorithm than available today aiding in positioning the endotracheal tube in regards to anatomic-al landmarks (teeth, gums, lips) even without the use of ultrasound.

Eligibility criteria: Inclusion Criteria:

* requiring anesthesia with an endotracheal tube placed for surgical or procedural purposes
* elective or stable and awake for urgent or emergent surgeries

Exclusion Criteria:

* known tracheal deformities
* thoracic aortic aneurysm
* neck/chest tissue thickness making U/S scanning difficult
* severe trauma, head injuries or any procedures that require immediate surgery

Primary outcomes:
measure: concomitant visualization of endotracheal tube cuff and aortic arch by ultrasound in situ
timeFrame: 15 minutes
Secondary outcomes:
measure: distance between endotracheal tube cuff and aortic arch by ultrasound in situ
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Kai Schoenhage, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279382: Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)
Official title: Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Symptoms
Psychological status
Hypnotherapy
Relaxation training
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 112
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: In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS.


Eligibility criteria: Inclusion Criteria:

* Irritable bowel syndrome (Rome II)
* Presence of complaints \< 12 months

Exclusion Criteria:

* Gastrointestinal disorders, other than IBS
* Previous psychotherapeutic treatment for IBS
* Severe psychological comorbidity

Primary outcomes:
measure: Mean symptom score (MSS)
Secondary outcomes:
measure: Psychological measures, i.e. anxiety and depression (HADS)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC - Leiden
Study officials:
affiliation: Head of dept
name: Ad Masclee, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591382: Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
Official title: Hydromorphone PCA or Hydromorphone PCA With Ketamine for Acute Postoperative Pain Relief in Opioid-Dependent Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Ketamine
Postoperative pain
Opioid dependent patients
Acute pain control
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.


Eligibility criteria: Inclusion Criteria:

* Chronic pain \> 6 months
* Long term use of opioids
* Major surgery

Exclusion Criteria:

* Use of regional anesthetic techniques
* No need for intravenous (IV) patient controlled analgesia (PCA) after surgery

Primary outcomes:
measure: Average Postoperative Pain Score
timeFrame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Secondary outcomes:
measure: Worst Postoperative Pain Score
timeFrame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
measure: Least Postoperative Pain Score
timeFrame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
measure: 24-Hour Postoperative Opioid Use
timeFrame: For 24 hours following surgery
measure: Number of Participants With Treatment Related Adverse Events (AEs)
timeFrame: Participants were followed for the duration of hospital stay, an average of approximately 3 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Srdjan S Nedeljkovic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223282: Effects of Exercise on Energy Intake-Prescription of Resistance Exercise
Official title: Effects of Acute Resistance Exercise With Varying Training Volume and Rest Intervals Under Equal Load on Appetite Control, Food Reward, and Energy Intake: a Five-arm Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Food Reward
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Healthy young males will complete five trials in a randomized crossover counter-balanced order, including three different inter-set rest of resistance exercise in equal training volume, one repeated until failure and sedentary control. During each trial, blood samples will be collected.

The investigators hypothesized that different inter-set rest and training volume would affect subjective appetite and energy intake.


Eligibility criteria: Inclusion Criteria:

* Age: 20-30
* Healthy male

Exclusion Criteria:

* No acute or chronic musculoskeletal symptoms
* Smoking
* Alcohol or drug abuse
* Failure to conduct resistance exercise

Primary outcomes:
measure: Subjective appetite
timeFrame: 4-hour during each study intervention
measure: Change in acyl-Ghrelin
timeFrame: 4-hour during each study intervention
measure: Change in total-Ghrelin
timeFrame: 4-hour during each study intervention
measure: Change in PYY
timeFrame: 4-hour during each study intervention
measure: Change in active-GLP-1
timeFrame: 4-hour during each study intervention
measure: Change in total-GLP-1
timeFrame: 4-hour during each study intervention
measure: Change in lactate
timeFrame: 4-hour during each study intervention
Secondary outcomes:
measure: Explicit liking
timeFrame: 4 hours during each study intervention
measure: Explicit wanting
timeFrame: 4 hours during each study intervention
measure: Implicit wanting
timeFrame: 4 hours during each study intervention
measure: Relative preference
timeFrame: 4 hours during each study intervention
measure: Fat appeal bias
timeFrame: 4 hours during each study intervention
measure: Taste appeal bias
timeFrame: 4 hours during each study intervention
measure: Change in glucose
timeFrame: 4 hours during each study intervention
measure: Change in TG
timeFrame: 4 hours during each study intervention
measure: Change in insulin
timeFrame: 4 hours during each study intervention
measure: Energy intake
timeFrame: 3 days during each study intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
affiliation: National Taiwan Normal University
name: Hung-Wen Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00526682: The Use of Irvingia Gabonensis (Bush Mango)and Cissus Quadrangularis to Reduce Weight and Blood Lipids
Official title: The Effect of Combining Cissus Quadrangularis and Irvingia Gabonensis on Obesity and Obesity Related Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Dyslipidemia
Keywords: Antiobesity
Weight loss
Lead sponsor: Gateway Health Alliance
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Cissus quadrangularis as well as Irvingia gabonensis are used in weight management and related conditions. This study set out to investigate if a combination of the two could have additional benefits to overweight and obese people.

Detailed description: To assess and compare the effects of administration of Cissus quadrangularis (Linn) and a Cissus quadrangularis /Irvingia gabonensis combination on body weight blood pressure, fasting blood glucose, plasma total and LDL cholesterol in 72 overweight and obese subjects.

The study was a 10 week randomized, double-blind, placebo-controlled design, involving 72 obese or overweight participants. Participants were randomly divided into three groups (24 participants/ group):

Group 1 - Placebo; Group 2 - Cissus quadrangularis (CQ); Group 3 - Cissus quadrangularis and Irvingia gabonensis (CQ-IG).

The placebo (250mg) or active formulations ((150 mg CQ and 250 mg CQ-IG) were administered twice daily before meals. Weight as well as fasting blood was taken at baseline, and at 4, 8 and 10 weeks.

No major dietary changes or exercises were suggested during the study.

Eligibility criteria: Inclusion Criteria:

* BMI\>26kg/m2

Exclusion Criteria:

* Diabetics
* Pregnant and lactating
* Subjects on any other weight loss program
* Following any specific low calorie diet

Primary outcomes:
measure: Weight change
timeFrame: 10 weeks
Secondary outcomes:
measure: Blood lipids Body fat Fasting blood glucose
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Yaounde 1
name: Julius E OBEN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03254082: Glycemic Response of Sorghum
Official title: Glycemic Response of Cooked Grains Including Sorghum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Keywords: sorghum health
Lead sponsor: Kansas State University
Sponsor class: OTHER
Collaborators: name: United Sorghum Checkoff Program
First posted: 2017-08-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Given the interest in gluten-free foods and discovering dietary means to prevent metabolic disorders, this study was designed to determine the glycemic responses of four (4) grains and flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects and blood glucose will be collected prior to and after eating over the course of two hours. A dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as the control treatment.

Detailed description: Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a stove/heating unit). The gruel was allowed to cool for 3-5 minutes before eating. The consistency of the gruel was similar to oatmeal. Subjects had a resting blood sample collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose, 22g) that was assigned for that day -- they returned for the other gruel meals or sucrose control determined by Latin Square randomization. Finger stick blood samples where then collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy with no known diseases

Exclusion Criteria:

* Known metabolic, cancer, cardiovascular disease/condition

Primary outcomes:
measure: Blood glucose
timeFrame: Before eating (time 0) and 30, 60, 90, and 120 minutes after eating to measure the change in blood glucose due to the different food.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kansas State University
name: Mark Haub, PhD
role: PRINCIPAL_INVESTIGATOR
References: