louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01091038: Improving Safety by Basic Computerizing Outpatient Prescribing
Official title: Improving Safety by Basic Computerizing Outpatient Prescribing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Adverse Drug Events
Keywords: Adverse drug events
medical errors
computerized physician order entry
clinical decision support
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2010-03-23
Enrollment: 228
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.


Eligibility criteria: Inclusion Criteria:

* provider practicing at sites implementing order entry with basic clinical decision support using either the longitudinal medical record (LMR) or Medical Gopher

Exclusion Criteria:

* provider or practice unwilling to participate

Primary outcomes:
measure: Adverse Drug Events
timeFrame: 6 months
measure: Medical Errors
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Wishard Helath Services
state: Indiana
city: Boston
country: United States
facility: Partner's Healthcare
state: Massachusetts
Study officials:
affiliation: Indiana University
name: Joseph M Overhage, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: David Bates, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Tejal Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Andrew Seger, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hope C, Overhage JM, Seger A, Teal E, Mills V, Fiskio J, Gandhi TK, Bates DW, Murray MD. A tiered approach is more cost effective than traditional pharmacist-based review for classifying computer-detected signals as adverse drug events. J Biomed Inform. 2003 Feb-Apr;36(1-2):92-8. doi: 10.1016/s1532-0464(03)00059-5.
Clinical trial NCT00795938: Study to Compare the Blood Levels of Sildenafil Following Administration of an Experimental Tablet vs. the Conventional Oral Tablet in Healthy Subjects.
Official title: An Open-Label, Crossover Study In Healthy Volunteers To Evaluate The Pharmacokinetics Of Sildenafil Following Administration Of An Experimental Tablet Of Sildenafil With Or Without Water Relative To Viagra® Conventional Oral Tablet With Water.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study to will compare the blood levels of sildenafil following administration of an experimental tablet vs. the conventional oral tablet.


Eligibility criteria: Inclusion Criteria:

Healthy males between the ages of 18 and 55 years. Body Mass Index of 18 to 30 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Smoking in excess of the equivalent of 5 cigarettes per day. Treatment with an experimental drug within 30 days or sildenafil, vardenafil, tadalfil within 4 days before first study dose.

Develop blood pressure lowering or experience dizziness, lightheadedness when going from the laying down position to standing position.

Primary outcomes:
measure: Blood levels of sildenafil
timeFrame: 1 day
Secondary outcomes:
measure: Blood levels of a metabolite of sildenafil
timeFrame: 1 day
measure: Safety
timeFrame: 1 day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04486638: Dengvaxia US Pregnancy Registry
Official title: Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dengue Virus Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-07-24
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry

Brief summary: The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy

Detailed description: Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Eligibility criteria: The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.

Reports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:

* Sufficient evidence to confirm the case qualifies as "exposed during pregnancy";
* Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Percentage of pregnant women with maternal adverse events
timeFrame: From vaccination until end of follow-up (maximum 22 months after cohort entry)
measure: Pecentage of women with obstetrical adverse events
timeFrame: From vaccination until 1 month post-delivery
measure: Percentage of participants with adverse pregnancy outcome
timeFrame: On day of birth
measure: Percentage of offsprings with neonatal adverse events
timeFrame: From day of birth to 28 days post-birth
measure: Percentage of offsprings with infant adverse events
timeFrame: From 29 days to 365 days post-birth
Secondary outcomes:
Other outcomes:
Locations:
city: Puerto Rico
country: Puerto Rico
facility: Investigational Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT04794738: A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Official title: A Phase II/III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia orthopedic surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) \<90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial
9. Pregnant or nursing women

Primary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
timeFrame: 48-hours
Secondary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 6、12、48 、12-24、24-48 Hours under static condition
timeFrame: 48-hours
measure: the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition
timeFrame: 48-hours
measure: Time of first use of remedial analgesic medication
timeFrame: 48-hours
measure: Cumulative use of remedial analgesics from 0h to 48h
timeFrame: 48-hours
measure: Participant ' satisfaction score for analgesia treatment
timeFrame: 48-hours
measure: Investigator satisfaction score for analgesia treatment
timeFrame: 48-hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine,Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04651738: Cell-free DNA Methylation for Endometrial Cancer
Official title: Cell-free DNA Methylation for the Diagnosis and Monitoring of Endometrial Cancer: The Training and Validation Sets in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrial Cancer
Liquid Biopsy
DNA Methylation
Cervical Cytology
Diagnostic Accuracy
Training Set
Validation Set
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible patients accept DNA methylation testing in serum, cervical cytology and endometrial tissues.
Primary purpose: DIAGNOSTIC

Brief summary: Liquid biopsy is challenging for the diagnosis of endometrial cancer. In this study, investigators perform the methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177, in the peripheral serum to discover the diagnostic and supervision roles of DNA methylation in endometrial cancer. The study compromises two stages.

In the training set, DNA methylation testing is performed in the endometrial tissues from patients with endometrial cancer and paired benign uterine lesions. The cut-off values of methylation are produced in this stage. On the meantime, DNA methylation testing is also performed in serum and in cervical cytology to reveal its accordance and accuracy compared with the results of endometrial tissues.

In the validation set, serum DNA methylation testing is performed in unselected patients with definite endometrial histology to validate its accuracy.

In training and validation sets, serum DNA methylation is also performed after major surgeries for endometrial cancer as to illustrate the changes of methylation testing, therefore, reflection the supervision role of DNA methylation.


Eligibility criteria: Inclusion Criteria:

* With definite histological diagnosis of endometrial cancer and paired benign uterine tumor in training set, and with definite histological diagnosis of uterine tumor in validation set.
* With sufficient fresh peripheral serum, cervical cytology, and endometrial samples for DNA methylation testing before with or without after major surgeries.
* Aged 18 years or older.
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all of the inclusion criteria.

Primary outcomes:
measure: Cut-off values of targeted DNA methylation in endometrial cancer
timeFrame: Two years
Secondary outcomes:
measure: Accuracy of serum DNA methylation in endometrial cancer
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02567838: Lidocaine Gel During Transrectal Sonography
Official title: LIdocaine Gel Versus Plain Lubricating Gel for Pain Reduction During Transrectal Sonography (LIPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gynecologic Diseases
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field.

Detailed description: TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. The investigators evaluated a new technique for pain relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and gynecologic department were randomized to receive either lidocaine gel(Instillagel) or placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. The gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.

Eligibility criteria: Inclusion Criteria:

* All virgin women who were scheduled to undergo transrectal sonography invited to participate.

Exclusion Criteria:

* Allergy to lidocaine or other local anesthetics;
* Patients with a chronic pain condition for which they were taking daily pain medications of any kind.
* A bleeding diathesis and/or anticoagulant treatment;
* Underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture;
* An inability to rate a visual analogue scale

Primary outcomes:
measure: Pain assessed by a 10-point visual analogue score
timeFrame: the day of the procedure (transrectal sonography)
Secondary outcomes:
measure: Number of participants with gel-associated side effect
timeFrame: 2 days after the procedure (transrectal sonography)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06904638: Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)
Official title: Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Older People
Keywords: underprescription
START criteria
potential prescriptive omissions
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 374
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients at admission to a geriatric ward or at the time of outpatient geriatric visits

Brief summary: This observational study will determine the prevalence of underprescription in a cohort of elderly patients, recruited at the time of an outpatient geriatric visit, or hospitalized, upon admission to a geriatric ward.

Detailed description: Polypharmacy in older patients is associated with both inappropriate drug prescribing and underprescription or omission of appropriate medications. Potential prescriptive omission (PPO), defined as the underprescription of potentially beneficial drugs, is increasing across all care settings and is associated with adverse clinical outcomes. However, in some cases, PPO may represent a legitimate medical decision.

The aim of this study is to investigate the phenomenon of underprescription by differentiating between justified and inappropriate potential prescriptive omissions (PPOs) in elderly patients in both hospital and outpatient settings, using the Screening Tool to Alert to Right Treatment (START) criteria, version 3.

Eligibility criteria: Inclusion Criteria:

* Geriatric ward admission or outpatient geriatric appointment
* Capacity to provide informed consent by the patient or legal guardian

Exclusion Criteria:

* Limited life expectancy as measured by the Clinical Frailty Scale (CFS) \>8

Primary outcomes:
measure: Rate of potential prescription omissions (PPOs)
timeFrame: at baseline and 3 months later
Secondary outcomes:
measure: Characterisation of the potential prescription omissions (PPOs)
timeFrame: at baseline and 3 months later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Cosenza
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Antonio Cherubini, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03034538: An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
Official title: An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Parkinson Disease
Parkinsonism
Dyskinesias
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 20
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 12-week, open-label pilot study, the investigators will enroll 20 subjects with Parkinson's Disease to determine if two doses of Zonisamide are tolerable and demonstrate clinical benefit for Dyskinesias. The primary outcome measure is tolerability, as determined by number of subjects able to complete the study on their originally assigned dosage. Secondary outcome measures will use the Unified Dyskinesia Rating Scale (UDysRS), comprised of an Objective Section and a Historical Section, to compare baseline to 6 and 12-week measurements. Additional analysis of the effect of Zonisamide on quality of life will be measured by the Parkinson's Disease Quality of Life Questionnaire (PDQ-39).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PD
* Identified dyskinesias of the limbs or trunk as agreed upon by subject and investigator, with dyskinesias considered moderately to completely disabling (UPDRS question 33, greater or equal to 2)
* Able to provide informed consent and swallow capsules
* Stable doses of dopaminergic therapy for 2 weeks before and expected throughout the study.

Exclusion Criteria:

* Atypical parkinsonism
* Concurrent use of amantadine or active DBS where patient has some control over settings
* Prior surgery for PD
* Sulfa allergy or intolerance of zonisamide
* Significant concomitant medical illness in the opinion of the Principal Investigator (renal disease, liver disease)
* Pregnant subject or a subject who plans to become pregnant

Primary outcomes:
measure: Unified Dyskinesia Rating Scale (UDysRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Parkinson's Disease Quality of Life Questionnaire (PDQ-39)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Health System
state: New Jersey
Study officials:
References:
Clinical trial NCT05739838: Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.
Official title: Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients. Clinical and Biochemical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Cancer Metastatic
Orthodontic Tooth Movement
Keywords: Rate of orthodontic tooth movement
Osteiocalsine
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2023-02-22
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ten patients with periodontally affected teeth subjected to low level laser therapy
Primary purpose: DIAGNOSTIC

Brief summary: To investigate the effect of Low Level Laser therapy on orthodontic tooth movement of periodontally compromised patients by evaluating the rate of orthodontic tooth movement and the level of Osteocalcin in the gingival crevicular fluid.

Detailed description: Low-Level laser therapy has been reported as an effective adjunct to non surgical periodontal treatment for inflammation control and tissue reparation in patients with periodontitis. Previous studies have shown that application of low-level laser therapy reduced pocket depth and decreased the inflammatory process through regulatory control of inflammatory cytokines level, therefore this study will investigate the effect of low-level laser on the periodontal tissue .Accelerating orthodontic tooth movement is one of the primary demand in orthodontics to prevent side effects as root resorption, caries and decreased patient compliance . Numerous researchers have also studied the use of LLLT in accelerating orthodontic tooth movement and have considered the laser to be effective while others achieved the opposite . Hence, This study is aiming to investigate the effects of LLLT in accelerating tooth movement.

Eligibility criteria: Inclusion Criteria:

* No systemic disease.
* No history medication (antibiotics and/or anti inflammatory) in the previous 4 months.
* Self motivated patients with acceptable oral hygien.

Exclusion Criteria:

* Previous orthodontic treatment
* Aggressive periodontitis
* Smokers
* pregnant patients

Primary outcomes:
measure: Rate of orthodontic tooth movement
timeFrame: 6 months
Secondary outcomes:
measure: Osteocalcin level in GCF
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine for Girls, AL Azhar University
Study officials:
affiliation: Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University
name: Mohsena A Abdelrazek, Lecturer
role: STUDY_DIRECTOR
References:
citation: Ren C, McGrath C, Gu M, Jin L, Zhang C, Sum FHKMH, Wong KWF, Chau ACM, Yang Y. Low-level laser-aided orthodontic treatment of periodontally compromised patients: a randomised controlled trial. Lasers Med Sci. 2020 Apr;35(3):729-739. doi: 10.1007/s10103-019-02923-0. Epub 2019 Dec 12.