louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02259452: Radiation Induced Cardiopulmonary Injury in Humans
Official title: Radiation Induced Cardiopulmonary Injury in Humans
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thoracic
Pulmonary Injury
Heart Injuries
Keywords: Radiation Therapy
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-10-08
Enrollment: 91
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: Patients who are to receive 3D-planned RT for lung cancer (conformal or IMRT) or other tumors in/around the thorax.

Brief summary: The purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and predict RT-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT lung and heart assessments to better understand RT-induced regional heart/lung changes.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Patients who are to receive 3D-planned RT for tumor within and around the thorax.
3. Patients receiving incidental RT to portions of the heart are eligible.
4. Estimated minimum expected life expectancy of one year
5. Able to undergo the required study-related tests for regional lung injury and regional heart injury
6. Patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study.
7. Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.

Exclusion Criteria:

1. Patients who are anticipated to have thoracic surgery post-RT are ineligible.
2. Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function
3. Pregnant or nursing women.

Primary outcomes:
measure: Changes in Regional Lung Function
timeFrame: Up to 4 years post CRT
measure: Changes in Regional Heart Function
timeFrame: Up to 4 years post CRT
measure: Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes
timeFrame: Up to 4 years post CRT
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill, Department of Radiation Oncology
name: Kyle Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06392152: Efficacy of Focal Primaquine Mass Administration for Eliminating Plasmodium Vivax Malaria in Northern Myanmar
Official title: G6PD Deficiency Prevalence and Targeted Elimination of Residual Plasmodium Vivax Hypnozoites in Community: Township Level Implementation in Banmauk and Moe Mauk, Myanmar
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malaria
Mass Drug Administration
Myanmar
Plasmodium Vivax
Primaquine
Lead sponsor: Myanmar Health Network Organization
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: Mahidol University
First posted: 2024-04-30
Enrollment: 1208
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Plasmodium vivax has become the predominant species in the Greater Mekong Subregion and is a major challenge for regional malaria elimination. Mass primaquine administration has played a decisive role in malaria elimination in many temperate zone countries, but its efficacy in tropical areas remains to be evaluated. This study aims to assess the efficacy of targeted primaquine mass treatment (TPT) for eliminating P. vivax malaria in northern Myanmar.

Detailed description: This study employed a cluster-randomized crossover design in which two groups of villages received TPT at different times. In August-September 2019, Group 1 received TPT (0.25 mg/kg/day primaquine base for 14 days), while Group 2 was the control. In June-July 2020, Group 2 received TPT, while Group 1 served as the control. To evaluate the effectiveness of TPT for preventing relapses of vivax malaria, two indicators were utilized: infection prevalence at 3-month intervals estimated through cross-sectional surveys and monthly malaria incidence by passive case detection. The data were analyzed using descriptive statistics, chi-squared test, cumulative hazard function, and mixed model logistic regression.

Eligibility criteria: Inclusion Criteria:

* Residents in study villages
* Male/ female
* Consent to participate

Exclusion Criteria:

* Low Hb%
* G6PD deficiency
* pregnant women,
* breastfeeding mothers and
* children under 7 years

Primary outcomes:
measure: Infection prevalence at 3-month intervals estimated through cross-sectional surveys
timeFrame: upto 24 months
measure: Monthly malaria incidence by passive case detection
timeFrame: upto 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Myanmar Health Network Organization
Study officials:
affiliation: Myanmar Health Network Organization
name: Myat Phone Kyaw, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508052: Sequential Compression Device on Body Temperature
Official title: The Effects of Sequential Compression Device on Body Temperature During Propofol Anaesthesia: A Comparison With Elastic Stockings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Keywords: core temperature
sequential compression device
total intravenous anesthesia
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesized that sequential compression device (SCD) compression system might induce more decreases on core temperature by increasing lower extremity blood flow. And, this study investigated the effects of SCD compression system on body temperature in patients during total intravenous anesthesia (TIVA) with propofol and remifentanil.

Detailed description: Anaesthesia was induced and maintained with propofol and remifentanil. During the surgery, temperature was measured and recorded using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient, respectively.

Eligibility criteria: Inclusion Criteria:

* ASA I or II
* 20-65 year
* patient who undergoing elective thyroidectomy

Exclusion Criteria:

* coronary occlusive disease
* peripheral vascular disease
* BMI \> 30 kg/m2
* abnormal thyroid function test
* laparoscopic assisted thyroidectomy

Primary outcomes:
measure: Core Body Temperature
timeFrame: from baseline record core temperature every 15 minutes up to operative end
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: HKwak
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center
name: Hyun Jeong Kwak
role: STUDY_DIRECTOR
References:
Clinical trial NCT05448352: Asking People With Psoriasis About Lifestyle and Eating
Official title: The APPLE Study; a Cross-sectional Study Exploring Diet, Life-style Patterns and Psoriasis Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Diet
Lifestyle
Sleep
Physical Acitivty
Wellbeing
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Psoriasis Association
First posted: 2022-07-07
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will comprise of adults, with a medical diagnosis of psoriasis living in the UK and who are fluent in the English language. This is a nationwide study to obtain responses from participants representative of the psoriasis population in the UK.

Brief summary: The APPLE Study aims to understand if specific diet and lifestyle patterns are present in individuals with psoriasis and if these factors are correlated with psoriasis severity.

Detailed description: Prospective participants will be invited to read an information sheet and provide informed consent. Once informed consent is obtained, participants will be screened for eligibility with a short online screening questionnaire. Upon successful completion, participants will be directed to start the online multiple-choice survey with questions on psoriasis, diet and lifestyle patterns and complete a 4-day diet diary.

Eligibility criteria: Inclusion Criteria:

Adults (18 years of age or older) Dermatologist diagnosis of psoriasis Residents in the United Kingdom (UK) Fluent in English

Exclusion Criteria:

Minors (17 years of age or younger) Not medically diagnosed with Psoriasis Non-UK residents

Primary outcomes:
measure: self-assessed Simplified Psoriasis Index
timeFrame: Baseline
measure: The Dermatology Life Quality Index (DLQI)
timeFrame: Baseline
measure: Diet
timeFrame: Baseline
measure: Diet
timeFrame: 4 day 24-hour dietary recall
Secondary outcomes:
measure: Sleep
timeFrame: Baseline
measure: Physical Activity (PA)
timeFrame: Baseline
measure: Alcohol
timeFrame: Baseline
measure: Smoking
timeFrame: Baseline
measure: Meal timings
timeFrame: Baseline
measure: Demographic characteristics
timeFrame: Baseline
measure: General Health
timeFrame: Baseline
measure: Dietary habits
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
Clinical trial NCT00906152: Association Between Low Back Pain and Quality of Sleep
Official title: Study of the Association Between Low Back Pain and the Quality of Sleep
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Sleep
Subacute or Chronic Low Back Pain
Disability
Catastrophizing
Depression
Keywords: quality of sleep
low back pain
disability
catastrophizing
depression
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 437
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen for low back pain in the primary care centers participating in the study.

Brief summary: A prospective study to assess the association between the change in quality of sleep and the change in intensity of pain in Spanish patients seen for subacute or chronic low back pain. The objective is to determine the prevalence of sleep alterations, the association between quality of sleep and intensity of pain, degree of disability, intensity of catastrophizing and depression.


Eligibility criteria: Inclusion Criteria:

* patients with non-specific low back pain of more than 14 days duration
* seen in health centers participating in the study
* who accept to participate and sign the consent form
* without age limits and regardless of gender

Exclusion Criteria:

* inability to complete the questionnaires (illiteracy, dementia)
* inflammatory rheumatologic disease, fibromyalgia, cancer in last 5 years

Primary outcomes:
measure: Assessment of the association between low back pain and quality of sleep in patients with subacute or chronic low back pain.
timeFrame: 3 months
Secondary outcomes:
measure: Assessment of the association between quality of sleep and disability, catastrophizing and depression in patients with subacute or chronic low back pain.
timeFrame: 3 months
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Ramón y Cajal, Unidad de Bioestadística Clínica, Madrid, Spain
name: Víctor Abraira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansson EK, Hansson TH. The costs for persons sick-listed more than one month because of low back or neck problems. A two-year prospective study of Swedish patients. Eur Spine J. 2005 May;14(4):337-45. doi: 10.1007/s00586-004-0731-3. Epub 2004 May 19.
citation: Moldofsky H. Sleep and pain. Sleep Med Rev. 2001 Oct;5(5):385-396. doi: 10.1053/smrv.2001.0179.
citation: Tang NK, Wright KJ, Salkovskis PM. Prevalence and correlates of clinical insomnia co-occurring with chronic back pain. J Sleep Res. 2007 Mar;16(1):85-95. doi: 10.1111/j.1365-2869.2007.00571.x.
Clinical trial NCT00825552: Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation
Official title: Pharmacological Treatment of Children and Adolescents With Severe Mood Dysregulation. An Open Trial With Risperidone.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Mood Dysregulation
Keywords: Risperidone
Severe mood dysregulation
bipolar
children
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether Risperidone is effective in children and adolescents with severe mood dysregulation.

Detailed description: Severe Mood Dysregulation(SMD) is a new construct in children and adolescents characterized by persistent and non episodic irritability, hyperarousal and emotional reactivity.

This is an open label trial using Risperidone in children and adolescents( 7-17 years old) diagnosed with SMD.

We hypothesized that Risperidone would improve externalizing symptoms as well as depressive and/or maniac symptomatology. We also consider the effect of the pharmacological intervention in the co-morbid disorders especially ADHD.

Eligibility criteria: Inclusion Criteria:

* Diagnose of Severe Mood Dysregulation
* 7-17 years
* IQ \> 70

Exclusion Criteria:

* Bipolar disorder
* IQ\<70
* Psychosis

Primary outcomes:
measure: We use as the primary outcome the subscale of irritability of the Aberrant Checklist Behavior which measures the intensity of irritability, temper tantruns and hyperarousal symptoms
timeFrame: 11/2010
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Rohde A Luis, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT03208452: The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation
Official title: The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation After Pediatric Ophthalmic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation,Psychomotor
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 92
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study designed to evaluate the correlation between the effect of intraoperative magnesium sulfate infusion and the incidence of emergence agitation after pediatric ophthalmic surgery

Detailed description: Emergence agitation (EA) is a frequent postoperative complication in pediatric patients after general anesthesia. There are several suggested causes of EA and pain has been considered one of them. Magnesium is an N-methyl-D-aspartate (NMDA) receptor antagonist and increasingly used as an analgesic-adjuvant. We evaluate the Pediatric Anesthesia Emergence Delirium (PAED) Scale to investigate whether the intraoperative infusion of magnesium sulfate reduces the incidence of EA in pediatric patients who undergo ophthalmic outpatient surgery.

Eligibility criteria: Inclusion Criteria:

* pediatric patients who are planned to operate ophthalmic surgery under general anesthesia aged 4-7 years

Exclusion Criteria:

* ASA class ≥ III
* imbalance of electrolyte
* myocardial damage or conduction abnormality on ECG
* myasthenia gravis or any other neuromuscular disease
* impaired renal function
* denial to participate in study or not be able to give informed consent

Primary outcomes:
measure: the incidence of emergence agitation (EA)
timeFrame: 15 minute interval at the post-anesthetic care unit (PACU)
Secondary outcomes:
measure: the severity of EA
timeFrame: 15 minute interval at the post-anesthetic care unit (PACU)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: YEA JI LEE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01414452: Role of Adiponectin and Endothelial Progenitor Cells in Reperfusion Injury in Patients With Acute Myocardial Infarction
Official title: Reperfusion Injury and Cardiac Remodelling After Myocardial Infarction in Relation to Adiponectin Level, Circulating Endothelial Progenitor Cells and Endothelial Microparticles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Reperfusion Injury
Keywords: Myocardial Infarction
Reperfusion injury
Adiponectin
endothelial progenitor cells
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ST elevetion myocardial infarction patients

Brief summary: There is experimental evidence that low levels of adiponectin are associated with more reperfusion injury. In addition experimental studies have demonstrated that endothelial progenitor cells may have a favorable effect on remodeling, mainly through stimulation of neo-revascularisation. Clinical data on these issues are lacking. This clinical project studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a population of 250 infarction patients treated with primary PCI. If the role of these factors could be confirmed in this clinical setting, those factors might represent a new target for therapeutic interventions in AMI patients.


Eligibility criteria: Inclusion Criteria:

* STEMI treated with primary PCI

Exclusion Criteria:

* ischemia time \>12h
* use of immunosuppressive therapy
* unsuccessful recanalisation
* not-interpretable ST-T segment

Primary outcomes:
measure: occurrence of reperfusion injury after succesfull primary PCI
timeFrame: within 90 min after PCI
Secondary outcomes:
measure: Major cardiovascular event rate
timeFrame: at 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Marc Claeys, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410652: Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
Official title: A Multicenter Clinical Study of Helicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Helicobacter Pylori gyrA Levofloxacin Resistance Mutation
Fecal Drug Resistance Gene Detection
Helicobacter Pylori Infection, Susceptibility to
Keywords: Fecal gene detection
Levofloxacin resistance gene
Clarithromycin resistance gene
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 1176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will collect patients aged 18-70 years with or without Helicobacter pylori infection who have the need for gastroscopy.

Brief summary: The purpose of this study was to evaluate the detection ability of Helicobacter pylori 23S rRNA/gyrA gene mutation detection kit (fluorescent PCR fusion curve method) for Helicobacter pylori gene mutation.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requriment will be included in this simultaneous blind test.

Eligibility criteria: Inclusion Criteria:

* 1. patients with Helicobacter pylori infection who need gastroscopy; 2. patients with positive Helicobacter pylori culture in gastric mucosa 3. Helicobacter pylori negative patients

Exclusion Criteria:

* 1.Patients with insufficient fecal samples collected 2.Patients with contraindication of gastroscopic biopsy

Primary outcomes:
measure: Evaluation of consistency between fecal gene detection kit and Drug sensitivity test
timeFrame: 4 weeks
measure: Evaluation of consistency between fecal gene detection kit and first generation sequencing
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Zhenyu Zhang, Master
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of Nanchang University
name: Yong Xie, Docter
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Bin lv, Master
role: STUDY_DIRECTOR
affiliation: Jiangsu Taizhou People's Hospital
name: Bin Yang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: