louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01686984: Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease
Official title: Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Gas Exchange
Carbon Dioxide
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate how inspiratory flow pattern influences CO2 elimination in people without primary lung disease.

The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause and high end-inspiratory flow, will promote CO2 exchange in the alveoli.


Eligibility criteria: Inclusion Criteria:

* No known primary lung disease

Exclusion Criteria:

* Primary lung disease

Primary outcomes:
measure: Carbon dioxide elimination in a ventilator assisted breath.
timeFrame: 30 minutes
Secondary outcomes:
measure: Blood CO2 concentration.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Division of Brain, Heart and Lungs, Neurosurgical Clinic, Skane University Hospital, Lund
state: Skane
Study officials:
affiliation: Division of Anesthesia, Skane University Hospital, Lund, Sweden
name: Mikael Bodelsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sturesson LW, Malmkvist G, Allvin S, Collryd M, Bodelsson M, Jonson B. An appropriate inspiratory flow pattern can enhance CO2 exchange, facilitating protective ventilation of healthy lungs. Br J Anaesth. 2016 Aug;117(2):243-9. doi: 10.1093/bja/aew194.
Clinical trial NCT03205384: Morbimortality in Older Patients Undergoing Urgent Abdominal Surgery
Official title: Analysis of Morbimortality and Functional Status in Older Patients(>65 Years Old) Undergoing Urgent Abdominal Surgery Using CRISTAL Score Modify
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Keywords: Urgent abdominal surgery. Quality of life, functional status, frailty, nutritional status
Lead sponsor: Hospital of Navarra
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patiens\>65 years old

Brief summary: Morbimortality in older patients undergoing abdominal surgery.

Detailed description: The aim of this study is to validate the modified CriSTAL tool for 30 mortality in elderly patients undergoing urgent abdominal surgery. To provide a new tool that could be used in conjunction with clinical judgment to aid in decision-making.

The second objective of our study was to assess the quality of life, frailty, functional status and nutritional status in elderly patients that survive six months after an urgent abdominal surgery.

Eligibility criteria: Inclusion Criteria:

* \>65 years old, accepted in emergency department

Exclusion Criteria:

* not sign the consent

Primary outcomes:
measure: Barthel index, questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Clavien- Dindo Modified
timeFrame: 1 year
Other outcomes:
measure: FRAIL scale, Fried score
timeFrame: 6 months
Locations:
city: Pamplona
country: Spain
facility: UPNA
state: Navarra
Study officials:
affiliation: UPNA
name: javier Herrera, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03348384: [11C]NOP-1A and Cocaine Use Disorders
Official title: Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Cocaine Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-11-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: \[C-11\]NOP-1A
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to compared \[C-11\]NOP-1A binding in recently abstinent cocaine use disorders and controls.

Detailed description: This will allow for understanding brain stress and anti-stress mechanisms that underlie abuse of cocaine in humans.

Eligibility criteria: \[A\]Cocaine use disorders

Inclusion criteria:

1. Males or Females 18-50
2. Fulfill DSM-5 Diagnosis for Cocaine use disorder
3. Medically Healthy

Major exclusion criteria:

1. Pregnancy or lactation
2. Comorbid medical, psychiatric, drug use disorders (other than cocaine, tobacco use, and recreational marijuana/alcohol use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain (e.g., morphine, suboxone, SSRIs, etc.)

\[B\] Healthy controls

Inclusion criteria:

1. Males or Females 18-50
2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
3. A negative urine drug screen
4. Medically Healthy

Major exclusion criteria

1. Pregnancy or lactation
2. Medical, psychiatric or drug \& alcohol use disorders
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain
6. Family history of a psychotic disorder, manic episode, drug use disorders in first-degree relatives.

Primary outcomes:
measure: [C-11]NOP-1A VT
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04337684: Long Term Follow-up on Menkes Disease Patients
Official title: Long Term Follow-Up and Collection of Historical Control Data on Menkes Disease Patients
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Menkes Disease
Lead sponsor: Cyprium Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Any subject previously identified and/or enrolled in either Protocols 09-CH-0059 or 90-CH-0149.
2. Any new untreated Menkes disease patient born after 1999.

Brief summary: This study will collect long term follow-up data regarding overall survival and neurological parameters from patients previously identified and/or enrolled in Protocols 09-CH-0059 and 90-CH0149 and Historical Control data on Menkes disease patients.

Detailed description: Primary Objective:

1. To provide additional clinical and safety data on long term following administration of Copper Histidinate treatment in patients treated with Copper Histidinate under Protocols 09-CH-0059 and 90-CH0149 and untreated patients previously identified and/or enrolled in Protocol 09-CH-0059.
2. To provide additional Historical Control data on Menkes disease patients.

Eligibility criteria: Inclusion Criteria:

* The subject must have been previously identified and/or enrolled under Protocols 09-CH-0059 or 90-CH-0149; or An untreated Menkes disease patients for whom data collection is incomplete under Protocols 09-CH-0059 (Amendment M); or Other untreated Menkes disease patients.
* Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study. If the patient is \> 18 years of age, the patient must sign the informed consent.
* Male or female, aged 0 to \< 65 years of age.

Exclusion Criteria:

- Unwillingness/unable to participate in the study.

Primary outcomes:
measure: Long Term Follow-Up on Survival
timeFrame: 12/01/2019 - 12/31/2022
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cyprium Study Team
state: New York
Study officials:
References:
Clinical trial NCT00125684: Bioavailability and Effectiveness of Transdermally Administered Morphine
Official title: Bioavailability and Effectiveness of Transdermally Administered Morphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Pain
Keywords: transdermal morphine
cancer
pain
bioavailability
pharmacokinetics
cancer related pain
stable baseline pain
currently taking opioids
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Tom Baker Cancer Centre
First posted: 2005-08-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will participate in two arms of the trial, one in which morphine will be administered transdermally, and, after a 3 day wash out period, one in which morphine will be administered subcutaneously.

Detailed description: Patients will participate in two arms of the trial, one in which morphine will be administered transdermally, and, after a 3 day wash out period, one in which morphine will be administered subcutaneously. Blood draws will be done after both dosing methods in order to compare blood levels of morphine by the different routes.

Eligibility criteria: Inclusion Criteria:

* Chronic cancer pain
* Minimum baseline pain of 3/10
* No change in medications over 3 days prior to study period
* Ability to give informed consent
* Willingness to undergo repeated blood sampling

Exclusion Criteria:

* Use of morphine or codeine in 3 days prior to study
* Known sensitivity to morphine
* Prior anaphylactic reaction to any opioid
* Clinically significant anemia

Primary outcomes:
measure: detectable morphine levels in serum
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Cancerboard
name: Neil Hagen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07019584: "Wai Ji Match Fun" Card Games for People With Intellectual Disabilities
Official title: Feasibility, Acceptability and Benefits of "Wai Ji Match Fun" Card Games on Cognitive Performance and Psychosocial Wellbeing for People With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adults With Intellectual Disability
Keywords: Card game
intellectual disability
cognition
psychosocial wellbeing
feasibility and acceptability
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one-group repeated-measures design
Primary purpose: TREATMENT

Brief summary: A new set of card game, Wai Ji Match Fun (WJMF), has been developed by Wai Ji Christian Service (WJCS), a non-governmental organization in Hong Kong, specifically designed for individuals with intellectual disabilities (ID). The game aims to enhance cognitive performance and psychosocial well-being while facilitating daily participation.

Detailed description: This study evaluates the feasibility and acceptability of WJMF for individuals with ID, and its immediate and carry-over impacts on psychosocial well-being and cognitive function. Sixty-four adult participants with mild to moderate ID were recruited for the study. Each participant attends a weekly 60-minute WJMF group program over an 8-week period. Groups of four participants are facilitated by occupational therapists or rehabilitation assistants. Outcome measures include the Personal Wellbeing Index - Intellectual Disability (PWI-ID) (Chinese-Cantonese version), the short version of the Prudhoe Cognitive Function Test (PCFT), attendance rates, and staff feedback on feasibility and acceptability.

Eligibility criteria: Inclusion Criteria:

* service users attending residential or day training service units
* aged 18 years or older
* diagnosed with mild or moderate intellectual disability
* able to engage in a 60-minute group session

Exclusion Criteria:

- exhibit disruptive behaviours that could hinder group progress

Primary outcomes:
measure: Feasibility by measuring the attendance rate
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Staff acceptability
timeFrame: end of the treatment at 8 weeks
Secondary outcomes:
measure: The Personal Wellbeing Index - Intellectual Disability (PWI-ID) (Chinese - Cantonese version) (Cummins & Lau, 2005)
timeFrame: Enrollment, one week after the end of treatment, seven weeks after the end of treatment
measure: Prudhoe Cognitive Function Test (PCFT) short version (Tyrer et al., 2010)
timeFrame: Enrollment, one week after the end of treatment, seven weeks after the end of treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Karen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591084: Ginsenoside-Rd for Acute Ischemic Stroke
Official title: Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Keywords: randomized trial
ischemic stroke
Ginsenoside-Rd
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.

Detailed description: A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* between 18 to 75 years
* the first episode
* from onset to admission within 72 hours
* NIHSS scores:5\~22

Exclusion Criteria:

* had other intracranial pathologies (e.g., tumor, infection)
* had a neurologic or psychiatric disease
* had a coexisting condition that limited their life expectancy
* had significant drug or alcohol misuse
* had high-grade carotid artery stenosis for which surgery was planned
* were pregnant or nursing
* participated in a clinical trial with an investigational drug or device within the past 3 months
* were unlikely to be available for follow-up

Primary outcomes:
measure: NIHSS scores
timeFrame: 15±1 days
Secondary outcomes:
measure: NIHSS scores
timeFrame: 8 days
measure: the Barthel index
timeFrame: 8 days
measure: the Barthel index
timeFrame: 15 days
measure: the modified Rankin scale
timeFrame: 15 days
measure: the modified Rankin scale
timeFrame: 90 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the Department of Neurology , Xijing Hospital
state: Shaanxi
Study officials:
affiliation: the Department of Neurology , Xijing Hospital;
name: Gang Zhao, MD
role: STUDY_DIRECTOR
affiliation: the Department of Neurology, Xijing Hospital;
name: Xuedong Liu, MD
role: STUDY_CHAIR
References:
citation: Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G. Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial. Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19.
Clinical trial NCT01139684: Development of Field Test for Assessing the Human Anaerobic Capability
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Exercise test
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-06-08
Enrollment: 20
Sex: MALE
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: A test of the validity of repeated sprint test (RST) 4x 30 meters, against the Wingate Anaerobic Test, which is the gold standard for measuring human anaerobic capacity. The following variables will be used: peak power, mean power and fatigue index. In addition, it will be tested against a 50 meter and a 200 meter shuttle run.


Eligibility criteria: Inclusion Criteria:

* Healthy Students

Exclusion Criteria:

* Not healthy

Primary outcomes:
measure: Human anaerobic capacity
timeFrame: Ten weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Givatayim
country: Israel
facility: Telma Yellin High School
Study officials:
References:
Clinical trial NCT03769584: Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
Official title: Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: quality of life
treatment outcome
sexuality
partnership
surgery of endometriosis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women with endometriosis undergoing surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)

Brief summary: Follow-up of treatment outcome, quality of life, sexual life and partnership after surgery of endometriosis by means of a questionnaire 1 year after surgical Intervention.


Eligibility criteria: Inclusion Criteria:

* surgery of endometriosis at Frauenklinik of University Hospital Basel (from 01.01.2017 until 31.12.2017)
* sufficient German language skills in order to be able to complete questionnaires

Exclusion Criteria:

* incapable of consenting

Primary outcomes:
measure: Endometriosis- associated symptoms assessed by questionnaire
timeFrame: 1 year after surgery of endometriosis
measure: Treatment outcome of surgery of endometriosis assessed by VAS questionnaire
timeFrame: 1 year after surgery of endometriosis
measure: Change in Quality of life assessed by questionnaire
timeFrame: before surgery of endometriosis and 1 year after surgery of endometriosis
measure: Change in sexual life assessed by questionnaire
timeFrame: before surgery of endometriosis and 1 year after surgery of endometriosis
measure: Change in conduct of life assessed by questionnaire
timeFrame: before surgery of endometriosis and 1 year after surgery of endometriosis
measure: Change in wish for child assessed by questionnaire
timeFrame: before surgery of endometriosis and 1 year after surgery of endometriosis
Secondary outcomes:
measure: Follow-up of Treatment outcome of surgery of endometriosis assessed by interview
timeFrame: 1 year after surgery of endometriosis
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Frauenklinik University Hospital Basel
Study officials:
affiliation: Frauenklinik Universitätsspital Basel
name: Sibil Tschudin, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01294384: Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 305
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: This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Current use of an artificial tear product at least twice daily for at least 3 months, on average
* Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Exclusion Criteria:

* Anticipated contact lens wear during study or contact lens use within 6 months
* Active ocular infection or allergy
* Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
* Use of any topical cyclosporine products within 3 months

Primary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
timeFrame: Baseline, Day 90
Secondary outcomes:
measure: Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
timeFrame: Baseline, Day 90
measure: Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
timeFrame: Baseline, Day 90
measure: Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
timeFrame: Baseline, Day 90
measure: Change From Baseline in Tear Break-Up Time (TBUT)
timeFrame: Baseline, Day 90
measure: Change From Baseline in Corneal Staining
timeFrame: Baseline, Day 90
measure: Change From Baseline in Conjunctival Staining
timeFrame: Baseline, Day 90
measure: Change From Baseline in Schirmer Test
timeFrame: Baseline, Day 90
Other outcomes:
Locations:
city: Randwick
country: Australia
state: New South Wales
city: St. John's
country: Canada
state: Newfoundland and Labrador
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.