louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06249724: Noninvasive Modulation of Chronic Neuropathic Pain
Official title: Noninvasive Modulation of Chronic Neuropathic Pain With Focused Ultrasonic Waves
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Neuropathic Pain
Chronic Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. The stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The level of pain will be evaluated using the Numerical Rating Scale (NSR-11) and the Patient-Reported Outcomes Measurement Information System (PROMIS) numerical rating scales of pain.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of chronic pain
* Moderate-to-severe chronic pain lasting at least 2 months
* Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
* For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
* Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria:

* Poorly managed general medical condition
* Pregnant or breast feeding
* Implanted device in the back
* Lifetime history of a serious suicide attempt
* Clinically inappropriate for participation in the study as determined by the study team

Primary outcomes:
measure: Pain intensity: momentary change
timeFrame: During the intervention, and every day thereafter, for 7 days
measure: Pain intensity: subjective state
timeFrame: Immediately after the intervention, and every day thereafter, for 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jan Kubanek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Daniel Odell, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05381324: Fistula-associated Anal Adenocarcinoma
Official title: Fistula-associated Anal Adenocarcinoma - a Twenty Years' Single-center Experience.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 1004
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients receiving surgery for an anal fistula at a tertiary university referral hospital. Of those, patients suffering from fistula-associated anal cancer were eligible for further clinical and histopathological analysis

Brief summary: The fistula-associated anal adenocarcinoma is rare in patients suffering from anal fistulas. There is only little data available for this patient collective making characterization and management of this disease difficult. Late diagnosis and advanced tumor stage at diagnosis result in poor clinical outcome. It is the purpose of this study to evaluate patients clinically diagnosed with a FAAC and to further perform a histopathological characterization of the available tumor specimen.

Detailed description: All patients receiving surgery for an anal fistula in the years 1999 to 2019 at a tertiary university referral hospital were included in the analysis. A retrospective review of patients' charts was performed. Patients suffering from FAAC were eligible for histopathological analysis including immunohistochemistry and molecular profiling.

Eligibility criteria: Inclusion Criteria:

* anal fistula

Exclusion Criteria:

* previous cancer of the anal canal

Primary outcomes:
measure: fistula-associated anal adenocarcinoma (FAAC)
timeFrame: 1999-2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00814424: Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation
Official title: Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilatory Status of Deeply Sedated ERCP Patients
Keywords: EtCO2
supplemental oxygen delivery
ERCP
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Oridion
First posted: 2008-12-24
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypothesis is that a modified smart bite block system can deliver up to 10 liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially equivalent to the currently marketed smart bite block that delivers oxygen up to 5 liters/minute


Eligibility criteria: Inclusion Criteria:

* For the Adults Bite Bloc:Adults \>18 years old and able to understand and give consent per the Ethics committee requirements,or younger patients requiring an Adult size Bite Bloc in the opinion of the PI for whom the legal guardians consented for the participation of the trial.
* Patients consented or which their legal guardians consented for the participation of this trial.
* Clinical need to use a Bite Bloc to maintain an open mouth and protect the endoscope.
* Pediatric patients:patients with small mouth that the PI thinks require a Pediatric Bite Bloc (36 French),which their legal guardians consented for the participation of this trial.

Exclusion Criteria:

* Patients who are pregnant.
* Patients who in the opinion of the investigator should not participate.
* For Pediatric Bite Bloc:patients who need an Adult Bite Bloc to the investigators opinion or above the age of 12.
* Patients receiving oral or intravenous anticoagulants other than Aspirin or Plavix.

Primary outcomes:
measure: EtCO2 measurement on the investigational device is equivalent to measurement on the control device
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: DAVID GOZAL, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04645524: Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
Official title: Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

Detailed description: The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Eligibility criteria: Inclusion Criteria:

* Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit
* AHI 10 to 55 events/h if meets other PSG criteria

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
timeFrame: 1 night (treatment duration)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Intrepid research, LLC
state: Ohio
Study officials:
affiliation: Intrepid Research
name: Bruce Corser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070524: Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma
Official title: A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

Detailed description: A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma

Eligibility criteria: Inclusion Criteria:

* Moderate or severe asthma partly controlled with ICS or ICS/LABA
* FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value

Exclusion Criteria:

* Diagnosis of COPD
* History or current evidence of significant cardiovascular disease
* Uncontrolled concomitant disease

Primary outcomes:
measure: Trough FEV1 (mean 23h-24h FEV1)
timeFrame: after day 28 dose
Secondary outcomes:
measure: Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)
timeFrame: after day 1 dose
measure: Trough FVC (mean 23-24h)
timeFrame: after day 28 dose
measure: Peak FEV1 and FVC
timeFrame: on day 1 and day 28
measure: FEV1 AUC0-24
timeFrame: after day 1 and day 28
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road
Study officials:
affiliation: The Medicines Evaluation Unit Ltd
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06781424: University of Central Florida BEEAST
Official title: University of Central Florida Biobank for Extreme Environments, Aviation and Space Travel
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Biospecimen Donation
Environmental Impact
Keywords: donate
biobank
biospecimen
astronaut
pilot
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population comprises of persons from many countries. Therefore, enrollees can be from other countries. However, biospecimen collection will occur in the USA.

Brief summary: Since the inception of aerospace travel, NASA has been collecting biospecimens from professional astronauts for research. With the recent growth of civilian aerospace travelers, there is a need for biospecimen banking for civilian astronauts. This protocol addresses this gap by being a biobank for civilian astronauts, their family members (to be controls) and others who are also doing travel to extreme environments (pilots, submariners).

Detailed description: The objective of the University of Central Florida College of Medicine's Biobank for Extreme Environments, Aviation and Space Travel (BEEAST) is to acquire, store, and distribute identifiable human biospecimens and health information for medical research purposes only. The target population are astronauts, aviators, submariners, persons living in extreme environments (such as Antarctica), and their families, and people from the general population who can serve as matching controls.

Eligibility criteria: Inclusion Criteria:

* Primary Enrollees: adults, ages 18 and older, and persons who travel (such as space travel) or live in extreme environments (such as Antarctica).
* Secondary Enrollees: Referred adult family members (such as siblings and spouses) of primary enrollees.
* Tertiary Enrollees: Adult persons from the general public can enroll to serve as matching controls. Tertiary enrollees will be screened based on age, gender, race and ethnicity, country of residence, disease/ conditions and employment history.
* Pregnant women may choose to enroll.

Exclusion Criteria:

* adults unable to consent,
* minors (under age 18)
* prisoners

Primary outcomes:
measure: Receipt of donated biospecimen for aerospace research
timeFrame: 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT01595724: Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life
Official title: Study to Characterize Patients Treated With Visanne for Their Endometriosis Under Real-life Practice Conditions and Evaluate Their Quality of Life at Baseline and After 6 Months of Treatment With Visanne.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: Non-interventional study
Endometriosis,
Quality of life
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-05-10
Enrollment: 3006
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gynecological patients

Brief summary: The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.


Eligibility criteria: Inclusion Criteria:

* Female patients older than 18 years of age
* Clinical or laparoscopic diagnosis of endometriosis
* Having endometriosis related pain as leading symptom
* Decision taken by physician to prescribe Visanne
* Signed Informed Consent Form

Exclusion Criteria:

* Contraindications listed in the local summary of product characteristics (SPC) have to be considered.

Primary outcomes:
measure: Percentage of patients, who show an improvement of the EHP-5 items
timeFrame: after 6 months of treatment
measure: Mean changes of EHP-5 items by using scores for pre-defined categories
timeFrame: after 6 months of treatment
Secondary outcomes:
measure: Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne
timeFrame: Baseline
measure: Patient reported severity of endometriosis related pain
timeFrame: Baseline and after 6 months of treatment
measure: Reasons for treatment discontinuation
timeFrame: after 6 months of treatment
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: after 6 months of treatment
Other outcomes:
Locations:
city: Many Locations
country: Belarus
city: Many Locations
country: Egypt
city: Many Locations
country: Jordan
city: Many Locations
country: Kazakhstan
city: Many Locations
country: Kuwait
city: Many Locations
country: Lebanon
city: Many Locations
country: Qatar
city: Many Locations
country: Russian Federation
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Ukraine
city: Many Locations
country: United Arab Emirates
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01061424: The Community United to Challenge Asthma
Official title: A Community-Academic Partnership to Improve Asthma Management in Latino Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: pediatric asthma
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2010-02-03
Enrollment: 51
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education in high-risk Puerto Rican children in elementary school. The primary outcomes are asthma medication adherence and trigger reduction.


Eligibility criteria: Inclusion Criteria:

* Puerto Rican
* In elementary school
* Diagnosed with asthma

Exclusion Criteria:

* Not in school
* Mild intermittent asthma
* Well controlled asthma

Primary outcomes:
measure: medication adherence
timeFrame: 1 year
Secondary outcomes:
measure: trigger reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Molly A Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago. J Asthma. 2015 Feb;52(1):59-70. doi: 10.3109/02770903.2014.950426. Epub 2014 Aug 27.
citation: Martin MA, Thomas AM, Mosnaim G, Greve M, Swider SM, Rothschild SK. Home asthma triggers: barriers to asthma control in Chicago Puerto Rican children. J Health Care Poor Underserved. 2013 May;24(2):813-27. doi: 10.1353/hpu.2013.0073.
citation: Martin MA, Olson D, Mosnaim G, Ortega D, Rothschild SK. Recruitment, asthma characteristics, and medication behaviors in Midwestern Puerto Rican youth: data from Project CURA. Ann Allergy Asthma Immunol. 2012 Aug;109(2):121-7. doi: 10.1016/j.anai.2012.06.005. Epub 2012 Jun 26.
Clinical trial NCT01509924: Cognitive and Physical Functions in Patients With Transient Ischemic Attack. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event
Official title: Cognitive and Physical Functions in Patients With TIA. A Randomized Controlled Trial of Physical Activity on Prescription up to One Year After the Event
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Attack, Transient
Keywords: Walking capacity
Mental Fatigue
Quality of Life
Cognition
Motor activity
Exercise
Lead sponsor: Tiohundra AB
Sponsor class: INDUSTRY
Collaborators: name: Karolinska Institutet
First posted: 2012-01-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Physical Activation on Prescription can help patients with TIA to become more physically active.

One group will receives Physical Activation on Prescription (PaP)and the other group will receives usual care.

And to identify if persons with TIA presents with cognitive impairments.

Detailed description: Transient ischemic attack (TIA) is a transient episode of neurologic dysfunction caused by ischemia, i.e. loss of blood flow. The symptoms of a TIA typically resolve within 24 hours. Attacks lasting more than 30 minutes are unusual. TIAs and strokes present with the same symptoms such as sudden weakness, numbness, sudden dimming or loss of vision, aphasia, slurred speech, facial palsy and mental impairments. Subtle problems with cognitive functions and fatigue may not always be addressed before discharge. However, even subtle mental impairments are important to identify, given the problems they might pose.

Eligibility criteria: Inclusion Criteria:

* Understand Swedish language (also in and writing), living in Norrtälje community,
* To participate in the assessment of cognitive function: no known cognitive impairments before the TIA event and history of stroke.

Exclusion Criteria:

* Presence of contraindications to exercise, and no history of stroke

Primary outcomes:
measure: Change in Physical activity over time
timeFrame: at discharge from hospital, 3, 6 and 12 month after the event
Secondary outcomes:
measure: Change in Cognition and Mental Fatigue
timeFrame: All measures at baseline 3, 6 and 12 month after the event
measure: Change in 6 MWT
timeFrame: 3, 6 and 12 months
measure: Change in self reported stages of change
timeFrame: 3, 6, 12 months
measure: Change from baseline in systolic blood pressure at 12 months
timeFrame: 3, 6, 12 months
measure: BMI
timeFrame: 12 months
measure: Change in mental capacity over a period of time
timeFrame: 3, 6,12 months
measure: Change in mental capacity over a period of time
timeFrame: 3, 6, 12 months
Other outcomes:
Locations:
city: Norrtälje
country: Sweden
facility: Tiohundra
state: Stockholms Läns Landsting
Study officials:
affiliation: Karolinska Institutet
name: Disa Sommerfeld
role: STUDY_DIRECTOR
References: