louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00845273: Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Official title: Special Investigation For Long-term Use Of Macugen (Regulatory Post Marketing Commitment Plan).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Subfoveal choroidal neovascularization secondary to age-related macular degeneration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 3538
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A5751033 prescribes the Macugen®).

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

Detailed description: All the patients whom an investigator prescribes the first Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria: Inclusion Criteria:

* Patients need to be administered Macugen® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Macugen®.

Primary outcomes:
measure: Factors considered to affect the safety and/or efficacy of this drug.
timeFrame: 2 years
measure: The incidence of adverse drug reactions in this surveillance.
timeFrame: 2 years
measure: Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04337073: The Effect of Propofol on Dexamethasone-induced Perineal Pruritus
Official title: The Effect of Propofol on Dexamethasone-induced Perineal Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pruritus
Keywords: propofol; Dexamethasone; pruritus
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 40
Sex: FEMALE
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: propofol (P) group and normal saline (N) group
Primary purpose: PREVENTION

Brief summary: patients may appear serious perineal itching, after injection of dexamethasone sodium phosphate injection its incidence is about 25% \~ 100%, and the incidence of the discomfort in females was much higher than that of the maleTo investigate the effect of propofol pretreatment on perineal pruritus induced by dexamethasone sodium phosphate injection and explore the possible machanisms.

Detailed description: 40 patients scheduled for selective surgery,aged 18-65years,ASA physical status I\~II,BMI 18\~30kg/m2 were selected in this study.The patients were equally randomized into two groups: propofol (P) group and normal saline (N) group, 20 cases in each group. Before anesthesia induction, M group received intravenous injection of 0.3mg/kg propofol , while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg. The anesthesiologist assessed perineal irritation in both groups and recorded Ramsay scores,the number of cases, visual analogue scale(VAS) scores ,duration of itching and observed the occurrence of adverse reactions such as dizziness, hypotension and respiratory depression in the two groups.

Eligibility criteria: Inclusion Criteria:

* Elective female surgery patients, ages 18 to 65 years old, ASA Ⅰ or Ⅱ level, body mass index (BMI) of 18 \~ 30 kg/m2.

Exclusion Criteria:

* diabetes mellitus, paresthesia, allergy to narcotic drugs, routine preoperative use of narcotic analgesics, long-term use of hormones, drug and alcohol abuse, communication disorders in psychiatric disorders, pregnancy or lactation, and patients with severe systemic diseases and unwilling to undergo the trial.

Primary outcomes:
measure: visual analogue scale(VAS) scores
timeFrame: in 3min
Secondary outcomes:
measure: the occurrence of adverse reactions
timeFrame: in 3min
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Affiliated hospital of yangzhou university
state: Jiangsu
Study officials:
References:
Clinical trial NCT04064073: Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults (Phase 1 Study)
Official title: A Randomized, Open Label, Single / Multiple Dose, Crossover Phase 1, Study to Evaluate Drug-Drug Interaction of DWP16001 in Combination With Metformin in Healthy Male Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 34
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate drug-drug interaction of DWP16001 in combination with metformin IR 1000mg in Healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male adults aged 19 to 50 years at the time of screening test
* 55.0 kg ≤ Body weight ≤ 90.0 kg and 18.0 ≤ Body Mass Index (BMI) ≤ 27.0
* Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study
* Eligible to participate in the study at the discretion of the investigator by physical examination, laboratory test, and history taking, etc.

Exclusion Criteria:

* Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
* Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
* Hypersensitivity or medical history of clinically significant hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin, Metformin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.)
* Clinical laboratory test values are outside the accepted normal range at screening
* Other exclusive inclusion criteria, as defined in the protocol

Primary outcomes:
measure: Cmax of DWP16001
timeFrame: 0-72 hours
measure: AUClast of DWP16001
timeFrame: 0-72 hours
measure: Cmax,ss of Metformin
timeFrame: 0-144 hours
measure: AUCτ,ss of Metformin
timeFrame: 0-144 hours
Secondary outcomes:
measure: Tmax of DWP 16001, Metformin, DWP16001 Metabolites
timeFrame: 0-144 hours
measure: AUC of DWP 16001, Metformin, DWP16001 Metabolites
timeFrame: 0-144 hours
measure: T1/2 of DWP 16001, Metformin
timeFrame: 0-144 hours
measure: CL/F of DWP 16001, Metformin
timeFrame: 0-144 hours
measure: fe of DWP 16001, DWP16001 Metabolites
timeFrame: 0-72 hours
measure: CLR of DWP 16001
timeFrame: 0-144 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05912673: Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome
Official title: Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Keywords: renal doppler
nephrotic syndrome
steroid resistance
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 children and adolescents with nephrotic syndrome who will be diagnosed and followed at our nephrology Unit and Clinic at TUH during the period of the study.

Brief summary: The use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome to detect steroid resistance and to use it as a prognostic instrument of the progression of the disease.

Detailed description: Renal Doppler will be done for all children in supine and lateral positions using Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity) at diagnosis, after one month, 3 months and 6months, in which these values will be obtained by the ultrasound machine based on the computer algorithm. Also the kidneys will be scanned firstly for length, width, cortical thickness and echogenicity.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients with primary nephrotic syndrome aged from 1 to 18 years

Exclusion Criteria:

* - Patients with congenital nephrotic syndrome.
* Patients with secondary causes of nephrotic syndrome.

Primary outcomes:
measure: detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome
timeFrame: 6 weeks
Secondary outcomes:
measure: progression of nephrotic syndrome
timeFrame: six months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sara Mabrouk Mohamed Elghoul
Study officials:
affiliation: Tanta University
name: Sara Mabrouk Mohamed Elghoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04951973: Deep Learning Based Early Warning Score in Rapid Response Team Activation
Official title: Comparison of Deep Learning Based Early Warning Score and Conventional Screening System in Rapid Response Team Activation in General Ward Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospital Rapid Response Team
Hospital Medical Emergency Team
Keywords: deep learning based early warning score
rapid response team
in-hospital cardiac arrest
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
name: VUNO Inc.
name: Inha University Hospital
name: Mediplex Sejong Hospital, Incheon
name: Sejong General Hospital
name: Dong-A University
First posted: 2021-07-07
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to general ward

Brief summary: The objective of this study is to evaluate the safety and clinical usefulness of the Deep learning based Early Warning Score (DEWS).

Detailed description: SPTTS is the representative trigger tracking system. In addition to the conventional SPTTS, DEWS will be calculated at each time point by the previously developed algorithm. SPTTS and DEWS will be shown simulataneously on the screening board. The rapid response team performs the rescue activity as before, using both SPTTS and DEWS simultaneously.

The alarm threshold setting of DEWS will be changed to 70 points, 75 points, and 80 points every month.

The primary and secondary outcomes will be evaluated to compare SPTTS and DEWS (based on each threshold).

Eligibility criteria: Inclusion Criteria:

* Patients admitted to general ward and monitored by in-hospital rapid response system

Exclusion Criteria:

* patients admitted to pediatric ward
* patients in emergency room, intensive care unit, and operating room

Primary outcomes:
measure: In-hospital cardiac arrest
timeFrame: 3 month
Secondary outcomes:
measure: Alarm coincidence
timeFrame: 3 month
measure: Total alarm count.
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
citation: Kwon JM, Lee Y, Lee Y, Lee S, Park J. An Algorithm Based on Deep Learning for Predicting In-Hospital Cardiac Arrest. J Am Heart Assoc. 2018 Jun 26;7(13):e008678. doi: 10.1161/JAHA.118.008678.
citation: Cho KJ, Kwon O, Kwon JM, Lee Y, Park H, Jeon KH, Kim KH, Park J, Oh BH. Detecting Patient Deterioration Using Artificial Intelligence in a Rapid Response System. Crit Care Med. 2020 Apr;48(4):e285-e289. doi: 10.1097/CCM.0000000000004236.
Clinical trial NCT06708273: Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function
Official title: Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Constraint Induced Movement Therapy on Burned Dominant Hand Function
Hand Burn
Keywords: Hand function - CIMT - Constraint - Dominant
hand
function
constraint induced movement therapy
burn
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Effect of constraint induced movement therapy on burned dominant hand function

Detailed description: Effect of constraint induced movement therapy on burned dominant hand function

We investigate the Effect of constraint induced movement therapy on burned dominant hand function by using various measurement tools :

* Hand grip strength by Hand held dynamometer
* Metacarpophalangeal joint flexion (MCP) by goniometer
* Function by michgan hand questionnaire A randomised controlled trial (2 groups) First group will receive constraint induced movement therapy (glove mitt) on sound hand .

Second group will receive the traditional treatment ( stretching - positioning ) We do the assessment before treatment and (4-8) after the start of treatment process.

Eligibility criteria: Inclusion Criteria:

* Age of patient 20 to 35
* both male and female
* suffer from dorsal hand dominant burn healed spontaneously or by graft
* TBSA less than 20%
* All patient active before injury.

Exclusion Criteria:

* patient with fracture
* patient with crush injuries
* patient with contralateral hand burn
* Patient with cardiovascular injury

Primary outcomes:
measure: Hand grip strength
timeFrame: 8 weeks for each case
measure: Metacarpophalangeal joint flexion
timeFrame: 8 weeks for each case
measure: Hand function
timeFrame: 8 weeks for each case
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT01947673: Mechanisms of Intradialytic Hypertension
Official title: Sympathetic Regulation in Intradialytic Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure Chronic Requiring Hemodialysis
Haemodialysis-induced Symptom
Hypertension
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Satellite Healthcare
First posted: 2013-09-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and whether mindfulness meditation might improve BP during dialysis in these patients. The investigators will first determine if increased adrenaline levels during volume removal contributes to IDH. The investigators will then determine lack of suppression of adrenaline levels in the setting of a high BP also contributes to IDH. This will be done by manipulating blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate response in adrenaline levels occurs. Lastly, the investigators will determine if an intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD patients with IDH.


Eligibility criteria: Inclusion Criteria:

* ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis

Exclusion Criteria:

* drug or alcohol abuse
* any serious systemic disease that might influence survival
* severe anemia with hgb level \<8 g/dL
* clinical evidence of congestive heart failure
* ejection fraction below 35%
* myocardial infarction or cerebrovascular accident within the past six months
* symptomatic heart disease determined by electrocardiogram, stress test, and/or history
* treatment with central alpha agonists or monoamine oxidase (MAO) inhibitors
* peripheral neuropathy
* autonomic dysfunction
* pregnancy
* surgery within the past 3 months

Primary outcomes:
measure: Blood Pressure during dialysis
timeFrame: 8 weeks
measure: Cardiopulmonary baroreflex Sensitivity
timeFrame: 8 weeks
Secondary outcomes:
measure: Kidney Disease Quality of Life (KDQOL) Symptom Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Dialysis Clinics
state: Georgia
Study officials:
affiliation: Emory University
name: Jeanie Park, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01766973: Decoding Chronic Pain With fMRI
Official title: Observational Study to Determine Abnormalities in Resting State fMRI in Chronic Back Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Back Pain
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2013-01-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with \>6 months of mechanical lower back pain, not sue to any major systemic disease

Brief summary: Recent evidence suggests that chronic pain is associated with abnormal connectivity between brain regions associated with the processing of pain. We aim to test the diagnostic power of resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic back pain. Using new methods of image acquisition and analysis we aim to develop a computational method to correctly classify patients and matched control subjects.


Eligibility criteria: Inclusion Criteria:

* age 18-60
* pain \> 6months
* right-handed
* non-smoking
* mechanical back pain

Exclusion Criteria:

* significant neurological or psychiatric disease
* major systemic illness
* MRI exclusion criteria

Primary outcomes:
measure: Functional brain connectivity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: University of Cambridge
name: Ben Seymour, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151773: Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Special Drug Use Surveillance of Vaccinees After the First Vaccination
Official title: Freeze-dried Live Attenuated Measles and Rubella Combined Vaccine "Takeda" Special Drug Use Surveillance of Vaccinees After the First Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measles/Rubella
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-05-30
Enrollment: 3493
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Measles/rubella

Brief summary: The purpose of this survey is to assess the safety freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.

Detailed description: This survey was designed to assess the safety of live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) (freeze-dried live attenuated measles and rubella combined vaccine "Takeda") in terms of the occurrence of unknown/known adverse drug reactions and factors that may influence the safety of vaccinees after the first vaccination.

Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) is dissolved in 0.7 mL of accompanying reconstitution fluid (water for injection \[Japanese Pharmacopoeia\]), wherein a 0.5-mL portion is typically administered subcutaneously as a single dose.

In addition, freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) should be used in accordance with the "Regulations for Vaccination" and the "Guidelines for Routine Vaccination."

Eligibility criteria: Inclusion Criteria:

-Vaccinees who meet both of the following conditions \[1\] and \[2\]:

1. Vaccinees who have no prior history of either measles or rubella vaccination and who received freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) as the initial vaccination.
2. Vaccinees whose guardians are able to participate in a questionnaire survey on the health status of vaccinees after vaccination with freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain).

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants With Serious Adverse Drug Reactions
timeFrame: Baseline up to Day 28
Secondary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References:
Clinical trial NCT05191173: Perioperative Three-dimensional Echocardiography in Cardioanesthesia.
Official title: Perioperative Three-dimensional Echocardiography in Cardioanesthesia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Disease
Vascular Diseases
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 2000
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: Mixed population of adult patients undergoing cardiac surgery.

Brief summary: The aim of this study is to investigate the significance of intraoperative echocardiography on the surgical course and association with patient outcome. Of particular interest is the three-dimensional assessment of cardiac and valvular function. The patient course from surgery to the time of hospital discharge will be followed up.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery or surgery on the vessels near the heart

Exclusion Criteria:

* Pregnant patients
* Unfeasibility of intraoperative echocardiography in contraindications to transesophageal echocardiography: esophageal carcinoma, varices, diverticula, strictures, acute esophagitis, previous esophageal or gastric bleeding, symptomatic hiatal hernia.
* No written consent obtainable.

Primary outcomes:
measure: In Hospital Mortality
timeFrame: up to 90 days
measure: 1-year Mortality
timeFrame: 1 year
Secondary outcomes:
measure: ICU Length of Stay
timeFrame: up to 90 days
measure: Days on Mechanical Ventilation
timeFrame: up to 90 days
measure: Days with Circulatory Support
timeFrame: up to 45 days
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
References: