louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01864967: Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
Official title: Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: carbon dioxide infusion
dilatation of peripheral blood vessels
capillaries
macrophags
fibroblasts
Improvement granulation tissue in chronic wounds
Lead sponsor: Institute of Assistance in Plastic Surgery, Sao Paulo
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 49
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 10 patients with chronic wounds on both lower limbs

Brief summary: Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in chronic wounds of the lower limbs.

Detailed description: Ten patients with chronic wounds caused by venous insufficiency at both lower limbs were distributed into groups. Group I was composed by wounds in the right lower limb that received carbon dioxide and group II by wounds in the left lower limb that not received carbon dioxide, both related to the same patient. Carbon dioxide infusion was performed with the needle pointed toward the granulation tissue, 5cm distant from each one at intervals of 4 days. Biopsies were collected from the wounds before carbon dioxide infusion and after the 3rd, 5th and 10th application. Statistical analysis of the data was performed using Wilcoxon's test and Friedman's variance analysis and multiple comparisons test.

Eligibility criteria: Inclusion Criteria:

* chronic wounds caused by venous insufficiency

Exclusion Criteria:

* other diseases of the lower limbs

Primary outcomes:
measure: dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts
timeFrame: 10 sessions (5 weeks) per patient
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instute of Assistance in Plastic Surgery of São Paulo
Study officials:
affiliation: ACA Institute of Assistance in Plastic Surgery Sao Paulo
name: Antonio CA Abramo, PhD M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03045367: Mid-term Evaluation of Metamorphopsia in Epiretinal Membrane Surgery
Official title: Mid-term Clinical Assessment and Correlation Between Metamorphopsia, Visual Acuity and Foveal Thickness in Idiopathic Epiretinal Membrane and Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Cataract Senile
Keywords: Metamorphopsia
Epiretinal membrane
Vitrectomy
Lead sponsor: Clinica Oculistica dell'Università di Torino
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient of all gender, with complain of visual impairment and distortion

Brief summary: This study evaluates the safety and efficacy simultaneous, trans-conjunctival, 25-Gauge vitrectomy and phacoemulsification with intraocular lens implant in patients with metamorphopsia and visual impairment due to idiopathic epiretinal membrane and cataract. All 30 patients recruited underwent complete ocular examination, visual acuity measurement with ETDRS, metamorphopsia assessment with M-Charts and Metamorphometry® and foveal thickness evaluation by sd-OCT preoperatively, at 30, 90, 180 days postoperatively.


Eligibility criteria: Inclusion Criteria:

* age \> 55 years
* visual acuity ≤ 20/40
* idiopathic epiretinal membrane
* cataract
* Amsler test positive for metamorphopsia.

Exclusion Criteria:

* previous ocular interventions
* other ocular diseases.

Primary outcomes:
measure: Metamorphopsia
timeFrame: Change in metamorphopsia from baseline at 180 days.
measure: Visual Acuity
timeFrame: Change in visual acuity from baseline at 180 days
measure: Area of central scotoma
timeFrame: Change in area of central scotoma from baseline at 180 days
measure: Central fovea thickness
timeFrame: Change in fovea thickness from baseline at 180 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02793167: Clinical Values of Automated Electronic Alert for Acute Kidney Injury
Official title: Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
medication alert systems
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.

Detailed description: A prospective, randomly controlled cohort study will be conducted agmong the patients with AKI who are detected by the use of AKI sniffer. The investigators chose to assess all inpatient serum creatinine results using a combination of "KDIGO" criteria.

The investigators randomly divided the patients into two groups:

1. Usual care : patients will receive standard clinical care by the primary physicians
2. AKI alert : an AKI alert will be sent to the the doctor in charge. Our team of kidney experts would give a suggestion if the the doctor in charge issue consultation applications.

Eligibility criteria: Inclusion Criteria:

* adult patients with an Alert for AKI(based on KDIGO guidelines)

Exclusion Criteria:

* patients already on dialysis for AKI at the time of alert
* patients with End stage renal disease
* patients \<18 years of age
* patients dissenting from participation according to the Ethics application

Primary outcomes:
measure: Adverse events during hospitalization
timeFrame: from start of AKI to discharge,up to 4 weeks
measure: Incidence of cardiovascular disease and its occurrence time followed up for 1 years
timeFrame: One year after discharge
measure: The AKI outcome and its occurrence time followed up for 1 years
timeFrame: One year after discharge
measure: AKI recovery/stop renal replacement therapy
timeFrame: from start of AKI to discharge,up to 4 weeks
Secondary outcomes:
measure: Proportion of nephrology referral
timeFrame: from start of AKI to discharge,up to 4 weeks
measure: Diagnostic rate of AKI at discharge
timeFrame: from start of AKI to discharge,up to 4 weeks
measure: Follow-up rate after discharge
timeFrame: One year after discharge
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nephrology Dept,Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06539767: Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
Official title: Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Arterial Aneurysm Wall Enhancement on HRMRI
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

1. be older than 18 years of age; 2. complete a high-resolution magnetic resonance exam

Exclusion Criteria:

1. aneurysm combined with other cerebrovascular diseases; 2. substandard image quality

Brief summary: This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old, male or infertile female;
* Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment
* The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books;
* Patients willing to cooperate with high-resolution magnetic resonance imaging.
* Patients willing to follow up and evaluate according to clinical research protocol requirements

Exclusion Criteria:

* AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms;
* Patients with contraindications for high-resolution magnetic resonance imaging;
* Participants in clinical trials of other drugs or medical devices;
* Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery;
* Patients with poor compliance and inability to cooperate with follow-up;
* Possible or clear history of severe allergy to contrast agents;
* Patients with a life expectancy of less than 2 years;
* Women who are breastfeeding and preparing for pregnancy during the study period

Primary outcomes:
measure: High resolution MRI aneurysm features
timeFrame: 1 year
Secondary outcomes:
measure: postoperative mRS score
timeFrame: 1 year
measure: postoperative aneurysm occlusion rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT04206267: The Effectiveness of Vibrational Applications on Orthodontic Treatment
Official title: The Effectiveness of Vibrational Applications On Orthodontic Treatment: A Randomized-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Control Group
Acceledent Group
Keywords: Tooth movement
AcceleDent
distalizing
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 19
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were randomly allocated to either the AcceleDent group or the control group. The randomization was achieved by coin-tossing by one investigator. This method is equivalent to tossing a coin for each subject that enters a trial, such as Heads = control group, Tails = AcceleDent group.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine whether vibrational applications, as an adjunct to orthodontic forces, increases the rate of tooth movement in patients with fixed orthodontic appliances.

Detailed description: Nineteen patients who had class 2 division 1 malocclusion or severe crowding and needed first premolar extractions as a treatment modality were included to the study. The patients were divided into two groups, 8 in control and 11 in the study. The subjects assigned to study group were applied suplementary vibrational forces for 20 min/daily. 3-dimensional digital models were generated just before canine distalization and after space closure by 3Shape TRİOS R700 (3Shape Inc., Copenhagen, Denmark) device. The linear measurements between molars and canines were evaluated. The results were assessed with SPSS 23.0 programme (lBM SPSS Statistics for Windows, NY, USA). The amount of tooth movement for all samples were measured twice by the responsible investigator at one week interval. Interclass correlation coefficient-ICC was used to asses intraobserver accuracy and reliability.Mann- Whitney U test was used to assess treatment effect in terms of time to reach canine distalization. Correlation between measurements were described with Spearman Correlation Coefficient. Interclass correlation was 95%, which is in the range of excellent measurement agreement.

Eligibility criteria: Inclusion Criteria:

* patients who were planned first premolar extractions
* demonstrated good oral hygiene

Exclusion Criteria:

* patients with poor oral hygiene and have periodontal problem

Primary outcomes:
measure: canine retraction rate
timeFrame: 6 months
Secondary outcomes:
measure: the compliance data on device use
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Akdeniz University Department of Orthodontics
name: Baris Telatar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woodhouse NR, DiBiase AT, Johnson N, Slipper C, Grant J, Alsaleh M, Donaldson AN, Cobourne MT. Supplemental vibrational force during orthodontic alignment: a randomized trial. J Dent Res. 2015 May;94(5):682-9. doi: 10.1177/0022034515576195. Epub 2015 Mar 10.
Clinical trial NCT06234267: Eat, Play, Sleep: A Text Message Approach to Promoting Health Behaviors for Cancer Survivors and Their Caregivers
Official title: Eat, Play, Sleep: A Text Message Approach to Promoting Multiple Health Behaviors for Cancer Survivors and Their Informal Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Neoplasms
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Health behavior text message content will be delivered daily over 4-weeks to cancer survivor/caregiver dyads.


Eligibility criteria: Inclusion Criteria (survivors and caregivers):

1. ≥18 years old
2. have access to a mobile phone with the ability to receive and send text messages
3. English- or Spanish-speaking
4. free of psychiatric or physical disorders that could interfere with participation (e.g., psychosis, delirium)
5. able to give informed consent in English or Spanish

Survivors must also:

1. have been diagnosed with any solid tumor cancer
2. have completed primary curative treatment at least one month prior to enrollment
3. be able to identify a caregiver to enroll in the study with them
4. report difficulty engaging in dietary quality, physical activity, and/or sleep hygiene behaviors at screening.

Exclusion Criteria:

* Does not meet any of the above criteria

Primary outcomes:
measure: Successful receipt of 95% of text messages sent
timeFrame: 4 weeks
measure: Acceptability of text messages measured by self-report 0-4 likert scale of acceptability of each text message, where 5 is greater acceptability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Meghan B Skiba, PhD, MS, MPH, RDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05619367: A Compassionate Use (CU) Program of Odronextamab
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Relapsed or Refractory (R/R) Follicular Lymphoma (FL)
Diffuse Large B-Cell Lymphoma (DLBCL)
B-Cell Non-Hodgkin Lymphoma (NHL)
High-Grade B-Cell Lymphoma (HGBCL)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-11-16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide compassionate use of odronextamab



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02256267: A Study of LY2835219 in Healthy Participants
Official title: Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration \[FDA\] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods.

The study will last about 34 days. Screening is required within 28 days before study drug is given.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy sterile males or surgically sterile females or postmenopausal females
* Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2)

Exclusion Criteria:

* Have participated in a clinical trial involving investigational product within the last 30 days
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure
* Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Have donated blood of more than 500 milliliters (mL) within the last month
* Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219
timeFrame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
measure: PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219
timeFrame: Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05159167: Impact of Baduanjin Qigong Exercise on Fatigue in Patients With NSCLC Undergoing Adjuvant Chemotherapy
Official title: Impact of Baduanjin Qigong Exercise on Fatigue in Patients With Non Small Cell Lung Cancer Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 100
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: OTHER

Brief summary: Baduanjin，a type of Qigong which belongs to aerobic exercise, is very popular in China. There is increasing evidence to support its positive effects on health outcomes in various groups of people with physical and mental disorders. In college students, it may enhance cardio respiratory function, lower limb function, and flexibility compared with usual exercise. However, there is no previous relevant randomized controlled trials on the health promoting effects of Baduanjin exercise in targeted fatigued lung cancer patients. Lung cancer survivors can experience fatigue due to multiple reasons that can strongly impact their quality of life throughout the remainder of their life. Therefore, this randomized controlled trial in China was designed to assess the health promoting effects of Baduanjin exercise in fatigued lung cancer patients with the expectation of improvement in physical and psychological health.


Eligibility criteria: Inclusion Criteria:

* This trial aims to enroll 18- to 75-year-old patients expected to survive \> 3 months and with a Zubrod performance status of 0 to 2. All patients must have diagnosed as lung cancer and have at least one cycle of adjuvant chemotherapy. Enrolled patients should have a minimal ESAS fatigue as 3. Other inclusion criteria are lack of leptomeningeal disease, adequate hepatorenal function and blood counts (red blood cells, \>3.0 \* 1012/L; white blood cells, \> 3.5 \* 109/L; absolute neutrophil count, \> 1.5 \* 109/L; platelets, \> 100 \* 109/L; hemoglobin \> 90 g/L).

Exclusion Criteria:

* Children

Primary outcomes:
measure: Scale of fatigue
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Yuan Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05065567: Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis
Official title: A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cyclic Vomiting Syndrome
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 32
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: The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.


Eligibility criteria: Inclusion Criteria:

* adult patients with clinical diagnosis of cyclic vomiting in the ED

Exclusion Criteria:

* pregnancy, allergy to any of the study medicines

Primary outcomes:
measure: Abdominal Pain
timeFrame: 2 hours
measure: Nausea
timeFrame: 2 hours
measure: Abdominal Pain
timeFrame: 24 hours
measure: Nausea
timeFrame: 24 hours
measure: Abdominal Pain
timeFrame: 48 hours
measure: Nausea
timeFrame: 48 hours
Secondary outcomes:
measure: Treatment Success
timeFrame: 2 hours
measure: Treatment Success
timeFrame: 24 hours
measure: Treatment Success
timeFrame: 48 hours
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Lakeland Regional Healthcare
state: Michigan
Study officials:
References: