louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01722721: Physicians Work Distribution in a Danish Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Time Usage of ED Physicians
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 9
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: Emergency Department physicians

Brief summary: physicians in the Emergency Department spend their time on interviewing and examining patients, file documentation, communication with colleagues about the patients.

Introduction of IT technology aims to reduce the administrative workload. However it is the impression that more and more time are used behind the PC rather than at the side of the patient.

The aim of this study is to describe how the time is distributed between different task for an ED physician, and to analyse whether there are differences in time distribution if the physician is working in the outpatient area versus admission area of the ED.


Eligibility criteria: Inclusion Criteria:

ED physicians employed in the ED department

Exclusion Criteria:

-

Primary outcomes:
measure: time in minutes used by Emergency Department (ED) physician on direct patient contact, documentation, communication about the patient.
timeFrame: first 24 hours after patient arrival to ED
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fuchtbauer LM, Norgaard B, Mogensen CB. Emergency department physicians spend only 25% of their working time on direct patient care. Dan Med J. 2013 Jan;60(1):A4558.
Clinical trial NCT02172521: Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Proven Hyperinflation
Official title: Effect of Spiriva® 18 Microgram on Health-related Quality of Life and Physical Functioning in Patients With COPD and Proven Hyperinflation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 1536
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: * Primary objective of this observational study was to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) 18 microgram on the health-related quality of life and physical functioning in patients with chronic obstructive pulmonary disease (COPD) and demonstrated hyperinflation.
* Secondary objective was to obtain safety data regarding adverse events.


Eligibility criteria: Inclusion Criteria:

* Women and men with diagnosis of chronic obstructive pulmonary disease (COPD) with a thoracic gas volume (TGV) \> = 120% as measured by body plethysmography
* Only patients who have not yet been treated with Spiriva® 18 micrograms can be included in the study.

Exclusion Criteria:

* Patients who presenting the general and specific contraindications mentioned in the Patient Information and Prescribing Information

Primary outcomes:
measure: Change from baseline for assessment of the health-related euro quality of life 5 dimensions questionnaire (EQ-5D) time trade off (TTO) score
timeFrame: At baseline (visit 1) and after 4 weeks (visit 2)
measure: Change from baseline for assessment of the health-related EQ-5D questionnaire linear rating scale
timeFrame: At baseline (visit 1) and after 4 weeks (visit 2)
measure: Change from baseline for assessment of physical functioning in every day life (PF-10)
timeFrame: At baseline (visit 1) and after 4 weeks (visit 2)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02619721: Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Refractory Overactive Bladder
Keywords: PINS SNS OAB
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Hospital
First posted: 2015-12-02
Enrollment: 7
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.


Eligibility criteria: Inclusion Criteria:

* Age greater than 16 years OAB and/or OAB symptoms Refractory to standard medical therapy 100ml bladder capacity with normal upper urinary tract Good surgical candidate Able to complete study documentation and return for followup evaluation

Exclusion Criteria:

* Neurological conditions Stress urinary incontinence OAB symptoms caused by urinary tract infections

Primary outcomes:
measure: Changes in voiding frequency from baseline to the voiding frequency evaluvation period 6 month
timeFrame: 6 month of stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00641121: Bethaherpesviruses in Children Who Are Immune Suppressed
Official title: Bethaherpesviruses in Children Who Are Immune Suppressed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Suppressed Children
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 80
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chilren that are Immune suppressed

Brief summary: Unexplained fever in children with cancer is a common occurrence, often requiring hospital admission for evaluation and treatment with intravenous antibiotics. While empiric use of intravenous antibiotics is the norm in this population, between 48-70% of febrile and neutropenic episodes remain without an identifiable source. An understudied area is the potential role of betaherpesvirus infections in such febrile episodes. These viruses are significant pathogens in patients who become immunocompromised in conjunction with organ transplantation or acquired immune deficiency syndrome (AIDS). It is possible that they are similarly pathogenic in children who become immunocompromised due to cancer chemotherapy.

Thus, we will investigate the association between the betaherpesviruses and fever in children with cancer. The betaherpesviruses include cytomegalovirus (CMV), human herpesvirus 6A (HHV-6A), human herpesvirus 6B (HHV-6B), and human herpesvirus 7 (HHV-7). These viruses are grouped based on shared biological and genetic properties. Each is commonly acquired in childhood, persists in the human host, and can reactivate. Reactivation occurs intermittently throughout life in healthy individuals and is seldom associated with disease. Immune suppression is associated with a higher likelihood of reactivation and clinical disease. Latency of these viruses involves highly regulated processes that result in the viruses evading destruction and persisting within the host. Should balance be disrupted, as with cancer and anticancer therapy altering the normal host state, the environment may become favorable for betaherpesvirus reactivation, leading to disease and further alterations of the immune system.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed with cancer (leukemia, lymphoma, or solid tumor)
2. Undergoing solid organ pre-transplantation evaluation
3. Age birth to 21 years

Exclusion Criteria:

1. Unwilling to participate in the study
2. Unwilling to have specimens stored for future research
3. Clinical conditions preclude the required amount of blood to be drawn for the study
4. Patient has malignancy that has relapsed
5. Patient is not a primary transplant candidate (ie. has already had a solid organ transplant) -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Johanna Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06738121: Cosmetic Outcomes of Umbilical Hernia Incisions
Official title: Cosmetic Outcomes of Umbilical Hernia Incisions; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Umbilical Hernia
Keywords: Umbilical Hernia
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 170
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a single institution, prospective, randomized controlled trial. Patients presenting as an outpatient for repair of umbilical hernias who meet our inclusion criteria, whose parents provide permission to participate in the study, will receive the umbilical hernia repair that they are randomized to. The appropriate data will be collected on day of surgery, and patients will be followed with a delayed parental submission of incisional photograph.


Eligibility criteria: Inclusion Criteria:

* Patient presenting with umbilical hernia that is \<1.5cm in size based on physical exam for outpatient repair
* Treated at CMH Adele Hall or CMHK from 09/11/24 - 09/11/25
* Subjects \<10 years of age

Exclusion Criteria:

* Umbilical hernia \> 1.5 cm in size
* Patients with prior umbilical surgery
* Subjects ≥10 years of age

Primary outcomes:
measure: Cosmetic Outcome
timeFrame: 4 - 6 weeks and 2 years post operation
Secondary outcomes:
measure: Operative times
timeFrame: Up to 2 years
measure: Surgical site infections
timeFrame: 30 days
measure: Wound complications
timeFrame: 30 days
measure: Recurrence
timeFrame: 2 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
Study officials:
affiliation: Division Chief, Pediatric General Surgery
name: Tolulope A Oyetunji, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234921: Pilot Study of DRibble Vaccine for Prostate Cancer Patients
Official title: A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adenocarcinoma of the Prostate
Keywords: Prostate
Adenocarcinoma
Metastatic
DRibble
Immunotherapy
Microbiome
Lead sponsor: UbiVac
Sponsor class: INDUSTRY
Collaborators: name: Providence Health & Services
name: Providence Cancer Center
name: Providence Cancer Center, Earle A. Chiles Research Institute
First posted: 2014-09-09
Enrollment: 3
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Detailed description: The primary objective of this pilot study is to assess the safety and tolerability of DRibble vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer.

This study will also assess:

* the immune profile of tumor biopsy specimens if sites amenable to biopsy are present
* humoral and cellular responses to cancer antigens after DRibble vaccination
* the response to a reporter antigen vaccine (Ceravix) after DRibble vaccination

An exploratory objective is to characterize the microbiome before and after study drugs administration and correlate prostate cancer responses.

Eligibility criteria: Inclusion Criteria:

* Subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of the prostate with progression after chemotherapy, combined androgen blockade and/or peripheral androgen or androgen receptor suppression. Either histologic or serum marker diagnosis is acceptable.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Ability to give informed consent and comply with the protocol.
* Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment.
* Patients must have normal organ and marrow function as determined by routine blood tests

Exclusion Criteria:

* Active autoimmune disease except vitiligo or hypothyroidism.
* Active other malignancy.
* Known HIV positive and/or Hepatitis B or C positive.
* Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.

Primary outcomes:
measure: Safety Assessment
timeFrame: 28 Weeks
Secondary outcomes:
measure: Immune Response
timeFrame: 28 weeks
measure: Prostate Cancer Response to DRibble vaccine
timeFrame: 28 weeks
Other outcomes:
measure: Microbiome identification
timeFrame: 12 weeks
Locations:
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: Brendan Curti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04276064: Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
Official title: Modulation of Sleep Perception Through Auditory Closed-loop Stimulation of Brain Oscillatory Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Insomnia
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-02-19
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: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Sleep is ubiquitous in animals and humans, and disruptions are of high clinical importance. Still, the neural basis of sleep perception is insufficiently understood, which limits the development of new treatments. The current project is designed to further contribute to the understanding of the neural basis of sleep perception and to the development of innovative treatments for disrupted sleep (insomnia).


Eligibility criteria: Inclusion Criteria:

* For patients: diagnosis of ID according to DSM 5 criteria; for controls: mentally and somatically healthy
* Age 18 to 65 years
* Written informed consent

Exclusion Criteria:

* Relevant current or past serious medical disorder, including but not limited to cardiac arrhythmia, diabetes mellitus, and chronic pain conditions.
* Neurological conditions including epilepsy, history of brain injury, encephalitis or any organic brain syndrome
* Current or past mental disorders (life time prevalence), e.g. depressive disorder, attention deficit disorder, psychotic disorders, anxiety disorder, posttraumatic stress disorder
* Sleep disorders (except ID for patients), including movement-related sleep disorders (PLMS index with arousal \> 5) or breathing-related sleep disorders (AHI \> 15)
* Intake of CNS active medication (except appropriate thyroid hormone substitution)
* Current or past substance abuse or dependency
* Smoking \> 5 cigarettes per day
* Excessive caffeine consumption (\> 500 mg or 5 cups coffee per day)
* Irregular sleep schedules resulting from shift work, travelling or personal habits, defined as a sleep/wake time deviation \> 4 hours in the weekly routine or as a habitual total sleep time \< 4.5 hours or \> 10 hours per night
* Known pregnancy

Primary outcomes:
measure: Modulation Index
timeFrame: Averaged across NREM sleep of the baseline night (about 6 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Christoph Nissen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mikutta C, Feige B, Maier JG, Hertenstein E, Holz J, Riemann D, Nissen C. Phase-amplitude coupling of sleep slow oscillatory and spindle activity correlates with overnight memory consolidation. J Sleep Res. 2019 Dec;28(6):e12835. doi: 10.1111/jsr.12835. Epub 2019 Mar 7.
Clinical trial NCT03802864: Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Official title: Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Male Infertility
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2019-01-14
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study model is a randomized double blind control trial.
Primary purpose: TREATMENT

Brief summary: The study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.


Eligibility criteria: Inclusion Criteria:

* Men scheduled for surgical sperm retrieval for infertility
* Men 18 years and older who can provide informed consent
* No documented allergy to bupivacaine or celecoxib

Exclusion Criteria:

* Prior history of substance abuse
* Any narcotic use within the last 3 months
* Concomitant use of aspirin
* Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject

Primary outcomes:
measure: Pain Scores 48 Hours After Surgery
timeFrame: First 48 hours after surgery
Secondary outcomes:
measure: Pain Scores 60 Hours After Surgery
timeFrame: First 60 hours after surgery
measure: Pain Scores 7 Days After Surgery
timeFrame: First 7 days after surgery
measure: Narcotic Requirement
timeFrame: First 7 days after surgery
measure: Time to Narcotic Rescue
timeFrame: First 7 days after surgery
measure: Pain Control Satisfaction
timeFrame: 7th day after surgery
measure: Percentage of Patients Not Requiring Any Narcotics
timeFrame: 7th day after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine Department of Urology
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Russell Hayden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05150964: Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users
Official title: Measuring Comfort and Clarity Using Low Gain Feature in Pediatric Hearing Aid Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Arizona State University
First posted: 2021-12-09
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
* Must use oral mode of communication
* must speak English

Exclusion Criteria:

-

Primary outcomes:
measure: Speech Reception Threshold
timeFrame: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)
measure: Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
timeFrame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
measure: Multi-word Recognition at 40 dB SPL and 70 dB SPL
timeFrame: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)
measure: Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
timeFrame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
measure: Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
timeFrame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
measure: Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
timeFrame: 2nd appointment (day 14 of study)
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT00200564: Ketamine and Postoperative Analgesia in Children
Official title: Ketamine and Postoperative Analgesia in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Analgesia
Keywords: Pediatrics
ketamine
postoperative analgesia
nalbuphine
Postoperative analgesia in children
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.


Eligibility criteria: Inclusion Criteria:

* Children between 6 months to 6 years of age
* American Society of Anesthesiologists (ASA) I or II
* Undergoing elective surgery with intraoperative caudal analgesia

Exclusion Criteria:

* ASA III or IV
* Contraindication to caudal anesthesia
* Allergy to drugs used in the study
* Failure in caudal puncture
* Administration of morphine derivative

Primary outcomes:
measure: Area under the curve of pain scores (CHEOPS) measured
timeFrame: every 2 hours during the first 24 hours after eyes open
Secondary outcomes:
measure: Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10
timeFrame: at the 24th hour
measure: Number of painful episodes requiring additional boluses of nalbuphine
measure: Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
measure: Percentage of children with side effects related to injection of ketamine
measure: Time to complete feeding
measure: Percentage of children with nausea or vomiting
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Véronique Bazin, MD
role: PRINCIPAL_INVESTIGATOR
References: