louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05936632: Preferences for Certainty Versus Access When Evaluating New Cancer Drugs. A Discrete Choice Experiment.
Official title: Preferences of Individuals in the United States With Personal Experience of Cancer for Certainty Versus Access When Evaluating New Cancer Drugs. A Discrete Choice Experiment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Discrete Choice Experiment
Lead sponsor: London School of Economics and Political Science
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 998
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Online survey panel consisting of a US nationally representative sample (age, gender, income, race/ethnicity, US state).

Brief summary: To provide timely access to new treatments, some eligible drugs can be approved despite uncertainty surrounding the level of clinical benefit they offer patients.

It is not currently known if (and under which circumstances) people would prefer to wait to access some new drugs in exchange for greater certainty surrounding their clinical benefit.

This study aims to elicit the preferences of people in the US with experience of cancer for wait times and clinical uncertainty of new drugs.

To elicit this information, in a survey format, respondents will be presented with a hypothetical scenario and asked to state their preferences for new treatments, each with different attributes.


Eligibility criteria: Inclusion Criteria:

* Individuals previously or currently diagnosed with any type of cancer.
* Individuals with immediate family members previously or currently diagnosed with any type of cancer.

Exclusion Criteria:

* Individuals without previous or current diagnosis with any type of cancer (themselves or immediate family members).

Primary outcomes:
measure: Preferences for treatment attributes and trade-offs between attributes.
timeFrame: Through study completion, an average of 4-8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London School of Economics
Study officials:
References:
Clinical trial NCT01369732: Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
Official title: Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dissection of Thoracic Aorta
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-06-09
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.

However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.


Eligibility criteria: Inclusion Criteria:

1. Adults above age of 20
2. Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest

Exclusion Criteria:

1. pregnancy or lactation
2. cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis
3. past history of thoracic aortic surgery
4. malignancy 5. preoperative acute kidney injury
5. chronic renal replacement therapy
6. allergy or hypersensitivity to erythropoetin
7. history of erythropoetin treatment
8. death during or one day after surgery
9. no consent
10. reoperation within seven days of the first surgery

Primary outcomes:
measure: Incidence of Acute Kidney Injury Based on RIFLE Criteria
timeFrame: upto 7 days after surgery
measure: Incidence of Acute Kidney Injury Based on RIFLE Criteria
timeFrame: upto 7 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: upto 1 month after surgery
measure: the Duration of Mechanical Ventilation
timeFrame: upto 2 weeks after surgery
measure: the Duration of ICU Stay
timeFrame: upto 2 weeks after surgery
measure: the Duration of Hospital Stay
timeFrame: upto 1 month after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam severance hospital
Study officials:
affiliation: Yonsei University
name: Yon Hee Shim
role: STUDY_DIRECTOR
References:
Clinical trial NCT00155532: Skin Denervation in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Keywords: Peripheral neuropathy;systemic lupus erythematosus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

Detailed description: To address the issues of skin denervation and its clinical and pathological correlations in lupus, we will study a systemic lupus erythematosus (SLE) cohort by evaluating the extent of cutaneous innervation. Patients are recruited from the rheumatologic clinic, and various neuropsychiatric syndromes are diagnosed based on clinical judgement following detailed history taking and neurological examinations. Skin biopsy with PGP 9.5 immunohistochemistry will be performed following established procedures after informed consent is obtained, and punches of 3 mm in diameter will be taken from the lateral side of the distal leg, 10 cm above the lateral malleolus. Intraepidermal nerve fibre densities will be compared with results of immunological, pathological, psychophysical, and electrophysical studies to understand the pathogenesis of peripheral neuropathy in SLE.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus based on the consensus criteria

Exclusion Criteria:

* Conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.

Primary outcomes:
measure: Quantitation of epidermal innervation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Departments of Neurology, National Taiwan University Hospital
Study officials:
affiliation: Department of Neurology, National Taiwan University Hospital, 7 Chung-Shan S Rd., Taipei 100, Taiwan
name: Sung-Tsang Hsieh, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02530632: The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics
Official title: The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microcirculatory Effects of Anesthesia
Inhalation and Intravenous Anesthesia
Keywords: microperfusion
temperature
near-infrared spectroscopy
anesthesia
total intravenous anaesthesia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Effects of different general anesthetics on peripheral microcirculation.

Detailed description: Human keep body temperature in a narrow range by a variety of regulatory mechanism. Peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. In patients undergoing general anesthesia, the regulatory mechanism is altered. General anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. In this study, near-infrared spectroscopy (NIRS) is used to measure the microcirculatory condition. NIRS is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. General anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. Because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. Body temperature and somatic saturation are compared in each group.

Eligibility criteria: Inclusion Criteria:

1. Breast surgeries under general anesthesia
2. BMI 18.5\~30

Exclusion Criteria:

1. Cardiac disease
2. Lung disease
3. Renal disease
4. Neurological disease
5. Autonomic nervous system dysfunction

Primary outcomes:
measure: Somatic saturation
timeFrame: during surgery, approximately 2-4 hr
Secondary outcomes:
measure: Body temperature
timeFrame: during surgery, approximately 2-4 hr
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Anesthesiology, National Taiwan University Hospital
name: Shou-Zen Fan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04709432: ECMO Treatment of Children in China in the Past 10 Years
Official title: Extracorporeal Membrane Oxygenation (ECMO) Treatment of Children in Mainland China in the Past 10 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracorporeal Membrane Oxygenation
Child, Only
Keywords: Extracorporeal membrane oxygenation; children; complication
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children supported by ECMO in mainland China in the past years

Brief summary: It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China.

Detailed description: ECMO treatment in children is still in its infancy in China, and it has made considerable progress in recent years. In order to further understand the development of ECMO treatment in critically ill children, the investigator conduct this cross-sectional research through questionnaires. The investigator collect general information of the hospital and ECMO equipment, etiology, compilation, and mode of ECMO.

Eligibility criteria: Inclusion Criteria:

* age of 1d to 18 years old;
* children supported by ECMO in mainland China in the past 10 years

Exclusion Criteria:

* none

Primary outcomes:
measure: survival rate
timeFrame: from admission to discharge （about 10days）
Secondary outcomes:
measure: time of running ECMO
timeFrame: from admission to discharge（about 10days）
measure: cost of ECMO treatment
timeFrame: from admission to discharge （about 10days）
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Lu Guoping
role: STUDY_CHAIR
References:
Clinical trial NCT03184532: Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients
Official title: Bedside Gastric Ultrasound for Assessment of ASA Preoperative Starving Guidelines Accuracy: Diabetic vs Non Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluation of ASA Fasting Recommendations in Diabetic Patients
Lead sponsor: Healthpoint Hospital
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective orthopedic procedures.

Brief summary: To reduce the risk of perioperative pulmonary aspiration of gastric contents, oral intake of liquids or solids is not allowed for certain periods. Recently, the ultrasound (US) is used to evaluate the volume and the nature of the stomach content. In its latest recommendations, the American Society of Anesthesiologists (ASA) shortened the duration preoperative fasting. The aim of the study is to evaluate the efficacy of ASA recommendations in diabetic patients using ultrasound (US) scanning of the stomach (antrum).


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective orthopedic procedures.

Exclusion Criteria:

* Patients with BMI \> 35 kg.m-2, age \<18y, ASA physical state \>II, fasting more than 6hs, or with gastric diseases will be excluded

Primary outcomes:
measure: gastric volume
timeFrame: bedside test 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03337932: Duration of Doxycycline Treatment in MEM Patients
Official title: Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erythema Chronicum Migrans
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.


Eligibility criteria: Inclusion Criteria:

• multiple erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* extracutaneous manifestations of lyme borreliosis

Primary outcomes:
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
timeFrame: Study point: at 14 days post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
timeFrame: Study point: at 2 months post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
timeFrame: Study point: at 6 months post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
timeFrame: Study point: at 12 months post-enrollment.
Secondary outcomes:
measure: Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with multiple erythema migrans and control subjects
timeFrame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical center Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Daša Stupica, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05332132: Ex Vivo Study of the Heracure Device for Intra-uterine Morcellation After Vaginal or Laparoscopic Hysterectomy
Official title: Evaluation of the Heracure Device for Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal or Laparoscopic Hysterectomy
Lead sponsor: Heracure Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Safety and performance evaluation of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.

Detailed description: The purpose of this clinical investigation is to evaluate the safety and efficacy of the Heracure Device for intra-uterine morcellation after vaginal or laparoscopic hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Subject is undergoing hysterectomy due to benign gynecologic disease

Exclusion Criteria:

* Subject is not suspected of malignancy

Primary outcomes:
measure: Device or procedure related Adverse Event (AE)
timeFrame: Intra-operation
Secondary outcomes:
measure: Device Success
timeFrame: Intra-operation
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Sponsor GmbH
name: Gal Meister
role: STUDY_DIRECTOR
References:
Clinical trial NCT01697332: Functional Applications of Hyperpolarized 129Xe MRI
Official title: Functional Applications of Hyperpolarized 129Xe MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-10-02
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall objectives of our study are to determine the capabilities of hyperpolarized 129Xe MRI to measure lung function and its potential to sensitively detect pulmonary disease and its progression in COPD. We hypothesize that measurement of alveolar surface area, septal thickness, and capillary transit time measured with hyperpolarized 129Xe will correlate better with quality of life measures in COPD subjects than traditional diagnostic measures such as spirometry and Computed Tomography.


Eligibility criteria: Inclusion Criteria:

* Age 20-75

For Healthy nonsmoker subjects:

* No current physician diagnosed medical disease requiring active medication
* No smoking history, defined as less than 100 cigarettes smoked in a lifetime
* Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted

For Subjects who have participated in the COPDGene Study

* Post-bronchodilator spirometry: FEV1 \> 40% predicted

Exclusion Criteria:

* MR contraindications: e.g., electrical implants such as cardiac pacemakers, ferromagnetic implants such as prostheses, claustrophobia
* Pregnancy or suspected pregnancy
* Use of continuous oxygen
* Use of antibiotics and/or systemic corticosteroids (new prescription or increased dose) for an exacerbation of lung disease or any lung infection in the past four weeks
* Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy
* A heart attack in the past three months

Primary outcomes:
measure: Baseline Statistics of Healthy Subjects
timeFrame: 4 years
measure: Differences Between Healthy and Diseased COPD Subjects.
timeFrame: 4 years
measure: Spatial Heterogeneity
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Samuel Patz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00392132: Impact of Screening Patients With HIV for Kidney Disease
Official title: Impact of Screening Patients With HIV for Kidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infections
Renal Insufficiency, Chronic
Proteinuria
Keywords: HIV
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: The Infectious Disease Society of America has recently recommended that patients with Human Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening involves non-invasive urine and blood test and a screening program has already been initiated here in the University of Mississippi HIV clinic. This study looks at the effect of this new screening program. Our Hypothesis is that screening for kidney disease is a cost effective and important addition to the care of patients with HIV.

Detailed description: The Infectious Disease Society of America has recently recommended that patients with Human Immunodeficiency Virus (HIV) be screened for kidney disease on a regular basis. Screening involves non-invasive urine and blood test and a screening program has already been initiated here in the University of Mississippi HIV clinic. However nobody knows for sure whether this will help doctors take better care of patient with HIV.

This study looks at the effect of this new screening program. We want to see how frequently abnormalities are seen on screening, how frequently certain kidney diseases are diagnosed, how often patients are referred to a nephrologist and how often a patient's management is changed by the screening. We will also estimate the cost-benefit ratio of the screening. We will review patient charts to determine what has happened in each case where screening was conducted.

This study will not involve any additional testing.

The benefit of this study will be improving our understanding of kidney disease in HIV. It will help us determine the value of screening for kidney disease and the frequency of certain kidney diseases in HIV in our clinic population.

Eligibility criteria: Inclusion Criteria:

* Adult patients with HIV who are seen by the University of Mississippi Infectious disease clinic at the Jackson Medical Mall or patient seen at the University of Mississippi Nephrology Clinic.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Darren W Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References: