louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03110900: Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
Official title: A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Agitation,Psychomotor
Haloperidol Causing Adverse Effects in Therapeutic Use
Lorazepam Causing Adverse Effects in Therapeutic Use
Loxapine Causing Adverse Effects in Therapeutic Use
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Mount Sinai Hospital, Chicago
First posted: 2017-04-12
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Detailed description: The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Eligibility criteria: Inclusion Criteria:

1. Requires treatment for agitation in the judgment of a physician
2. Patient either pre-consented, has surrogate consent, or able to consent (in cases of mild agitation).
3. The patient is at least 18 years of age and less than 65 years of age.
4. Patients with known or presumed schizophrenia or bipolar 1 disorder.

Exclusion Criteria:

1. Patients with acute respiratory signs/symptoms (eg, wheezing).
2. Known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma or taking meds for asthma or COPD.
3. Female patients who are obviously pregnant or breast-feeding.
4. Medically unstable patients.
5. Patients or surrogates who object to being in the study (even if previously pre-consented).
6. Physician objection to patient enrollment in the study.
7. Prisoners or incarcerated.

Primary outcomes:
measure: Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: Michael P Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03884400: Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
Official title: iSpecimen Network Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cancer
Pregnancy Related
Gastro-Intestinal Disorder
Cardio-Respiratory Distress
Women's Health: Endometriosis
Autoimmune Diseases
Nephritis
Healthy
Neuro-Degenerative Disease
Keywords: Observational
Lead sponsor: iSpecimen Inc
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diverse group of biorepositories with focus on cancer, neurodegenerative, pediatric, women's health and other cohorts.

Brief summary: This protocol seeks to assist biorepositories/biobanks in distributing their stored specimens and data to researchers that will actually utilize them to advance medicine and technology.

Detailed description: iSpecimen has built a partner network comprised of supplying institutions that have ethically acquired human biospecimens and created biorepositories/biobanks to store the specimens and data.

Many of these biorepositories have protocols allowing for the collection of their samples but require an additional IRB or ethics review for the distribution of their samples.

This protocol establishes a method of such supply sites to allow their specimens to be distributed and used for research via iSpecimen's technology and network of research clients.

Eligibility criteria: Inclusion Criteria:

* Specimens and/or data from Biorepositories that have enrolled subjects that have provided consent for the specimens and de-identified data to be collected, stored and distributed.
* Specimens from biobanks that have collected materials and de-identified data under a waiver of consent
* Specimens from a biobank that meet the criteria for non human subject research under the common rule.

Exclusion Criteria:

* Specimens and/or that have been obtained from subjects without informed consent, nor waiver of consent or that do not meet the criteria for non human subject research under the common rule.

Primary outcomes:
measure: Distribution of Biospecimens From Biorepositories/Biobanks for Research Use
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: iSpecimen
state: Massachusetts
Study officials:
References:
Clinical trial NCT01635400: Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
Official title: Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Small Cell Carcinoma of Lung
Keywords: Irinotecan
UGT1A1 Gene Polymorphisms
Small Cell Carcinoma of Lung
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the correlation between uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer.

Detailed description: In multiple studies of metastatic colorectal cancer,uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and its correlation with irinotecan-associated side effects have been confirmed.Data from several studies indicated an improved clinical outcome of patients who had received an irinotecan-based regimen.In order to find out the correlation between UGT1A1 gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer,we designed this study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of refractory or relapsed small cell lung cancer
* Physical examination and routine laboratory tests show no contraindications to chemotherapy

Exclusion Criteria:

* Pregnant and nursing women
* Brain metastasis with symptoms

Primary outcomes:
measure: Side effect of chemotherapy
timeFrame: within the first 30 days (plus or minus 3 days) after chemotherapy
Secondary outcomes:
measure: response rate of chemotherapy
timeFrame: tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Fan Yun
role: STUDY_CHAIR
References:
Clinical trial NCT05551000: Functional Training to Improve Everyday Performance in Elderlies
Official title: Effects of Functional and Traditional Groups Class Training on Function and Health Among Female Older Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain, Low
Knee Pain Chronic
Hip Pain Chronic
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2022-09-22
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: To investigate how elderlies (+65 years old) everyday movements, general strength and dynamic balance are affected after an 8-12-week training period using the "SSA Elderly Performance system" or "Strong and Steady".


Eligibility criteria: Inclusion Criteria:

* Elderlies aged 65 to 75 years old.
* Have been participating and physical training for at least six months before the start of the intervention.
* The participants must be highly motivated for the project, which will be measured using the likard scale.

Exclusion Criteria:

* Illness or injury within the last three months.
* Do not have the ability to complete the test battery concerning set minimum criteria

Primary outcomes:
measure: Mobility test
timeFrame: Day 1
measure: Mobility test
timeFrame: 2 months
measure: Y-Balance Test
timeFrame: Day 1
measure: Y-Balance Test
timeFrame: 2 months
measure: Strength Test
timeFrame: Day 1
measure: Functional Strength Test
timeFrame: 2 months
measure: Time up-and-go test
timeFrame: Day 1
measure: Time up-and-go test
timeFrame: 2 months
measure: 6-minute walking test
timeFrame: Day 1
measure: 6-minute walking test
timeFrame: 2 months
measure: SF-36 questionnaire
timeFrame: Day 1
measure: SF-36 questionnaire
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Steinkjer
country: Norway
facility: SSA Steinkjer
Study officials:
References:
Clinical trial NCT00175500: Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation
Official title: A Randomized Multi-Centre Controlled Trial of Large Diameter (36/40 mm) Versus Conventional Diameter (32 mm) Femoral Heads for the Prevention of Post Revision Arthroplasty Dislocation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Dislocation
Keywords: Post-Arthroplasty Hip Dislocation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.


Eligibility criteria: Inclusion Criteria:

1. Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
2. Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
3. The acetabular component must have a minimum outer diameter of 50 mm.
4. The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
5. Patients must be able to reply to questionnaires in either French or English.

Exclusion Criteria:

1. Patients who are undergoing revision for recurrent dislocation.
2. Revision of the acetabulum requiring structural allograft or reconstruction ring.
3. Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
4. Revision of the acetabulum using a liner cemented into an existing metal shell.
5. Intra-operative decision to use a constrained liner.

Primary outcomes:
measure: To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty
timeFrame: at two years
Secondary outcomes:
measure: To compare polyethylene wear in the two groups
measure: To compare the difference in functional and quality of life measures in the two groups
timeFrame: at 3, 12 and 24 months post surgery
measure: To compare radiographic findings in the two groups
measure: To estimate the rate of re-revision in the two groups
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Donald Garbuz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238900: Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures
Official title: Prospective Evaluation of the Clinical Utility of Placement of Metal Stent for Benign Biliary Strictures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Biliary Strictures
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a medical indication for endoscopic therapy of benign biliary stictures and are referred for the procedure as part of their standard medical care will be considered for the study.

Brief summary: The purpose of this study is to study the evaluation of the use of metal stents as part of the treatment of benign biliary strictures.

Detailed description: In patients with benign biliary strictures, the use of fully covered self-expandable metal stents (SEMS) has been proposed as an alternative to plastic stenting, but high quality prospective data is sparse. This study was performed to evaluate the long -term effectiveness and safety of a new fully covered SEMS for benign biliary strictures.

Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has benign biliary stricture
3. Subject must be able to give informed consent

Exclusion Criteria:

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
2. The subject is unable to give informed consent

Primary outcomes:
measure: Short Term Success Rate in the Resolution of Biliary Strictures
timeFrame: 6 months
measure: Long-term Success Rate in Resolution of Biliary Strictures
timeFrame: at least 12 months after stent removal
Secondary outcomes:
measure: Number of Endoscopic Treatments Per Patient
timeFrame: At time of procedure
measure: Ease of Stent Removal
timeFrame: at time of procedure
measure: Frequency and Severity of Adverse Events (Including Stent Migration)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at UF endoscopy center
state: Florida
Study officials:
affiliation: University of Florida
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagh MS, Chavalitdhamrong D, Moezardalan K, Chauhan SS, Gupte AR, Nosler MJ, Forsmark CE, Draganov PV. Effectiveness and safety of endoscopic treatment of benign biliary strictures using a new fully covered self expandable metal stent. Diagn Ther Endosc. 2013;2013:183513. doi: 10.1155/2013/183513. Epub 2013 May 11.
Clinical trial NCT05882500: Osteopontin as a Biomarker in Pancreatitis
Official title: Osteopontin and Other Potential Biomarkers and Factors Important for Prognosis in Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatitis
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2023-05-31
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of pancreatitis

Brief summary: In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.

Detailed description: In the early phase of pancreatits, factors that can give information about the development of severety are still lacking. In this study patients will be included prospectively upon the diagnosis of pancreatits and clinical as well as labarotory and radiological factors will be sampled. The aim is do identifiy factors that may aid in the risk stratification for development of different severity grades of pancreatitis.

Patients admitted and diagnosed with pancreatitis (according to the Atlanta criteria) will have serial testing of se-osteopontin in addiation to rutine blood work. Computet tomograpy and chest x-ray are mandatory as is blood culture.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pancreatitis

Exclusion Criteria:

* Pregnancy, lactation, unable to understand the study

Primary outcomes:
measure: Se-osteopontin
timeFrame: Within 3 days from diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linkoping University Hospital
Study officials:
References:
Clinical trial NCT04855500: A Single Center Registry of Coronary OCT
Official title: A Registry of Coronary Artery Optical Coherence Tomography of Hainan General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Optical Coherence Tomography
Registry
Lead sponsor: Hainan People's Hospital
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who recieved intracoronary OCT imaging during cardiac catheterization are eligible for this registry.

Brief summary: This registry started January 1,2020 to collect patients who recieve coronary OCT imaging in Hainan General Hospital.All enrolled patients will receive 1 year followed-up.

Detailed description: This registry started January 1,2020.Patients \>= 18 years old who recieve coronary OCT imaging in Hainan General Hospital are included in current registry.

Eligibility criteria: Inclusion Criteria:

* Subjects who recieved intracoronary OCT imaging during cardiac catheterization are eligible for this registry.

Exclusion Criteria:

* None

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
Study officials:
References:
Clinical trial NCT01912300: Nutritional Adaptations to Physical or Sedentary Activities in Youth
Official title: Nutritional Adaptation to Contemporary Sedentary Behaviors and Physical Exercise in Youth: Effect of Weight Status
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Passive Video Games (PVG)
Active Video Games (AVG)
Exercise (EX)
Lead sponsor: Université Blaise Pascal, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 0
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes

Brief summary: Sedentary behaviors have been shown to increase food consumption among youth and adults. The recent active video games devices have been suggested to compensate for the increased energy intake they induce by the increased energy expenditure they generate. To date no study has been conducted to question whether or not such modern sedentary activities induce energy consumption modification in youth. The aim of this work is to compare the impact of a passive video games vs. active video games vs. physical exercise in terms of subsequent energy intake and appetite feelings in normal weight and obese youth.

Detailed description: After a medical inclusion, the adolescents will have to realise a DXA to assess their body composition and a submaximal exercise to evaluate their aerobic capacities.

They will have then to enter the laboratory on three different occasions in a randomized order from 8am to 730pm: At 8am they will receive a calibrated breakfast. then, at 1045; they will have to complete one of the experimental condition: 1) one hour of passive video game; 2) one hour of active video game; 3) a cycling exercise. at 1215 and 0630pm, they will be offered ad libitum meals. At regular intervals through the day, their appetite feelings will be assessed using Visual analogue scales.

Energy expenditure will be assessed thanks to cardiofrequencemeters during the 1h PVG and and by indirect calomitery (K4b2) during the active video game.

Ad libitum energy consumption will be assessed by investigators and recorded for each participants.

Eligibility criteria: Inclusion Criteria:

* male
* 12-15 years old
* BMI defining obesity (Cole et al., 2000)
* Not being under diet restriction
* Information and consent forms have to be signed by the adolescent and his legal representative
* being registered to the national social security system

Exclusion Criteria:

* Being under medication
* contraindication to exercise
* smokers
* dieting

Primary outcomes:
measure: ad libitum energy intake in kcal during the different experimental sessions: AVG, PVG and EX
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aubiere
country: France
facility: Laboratory AME2P
Study officials:
References: