louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01072487: Capnography During Colonoscopy
Official title: Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoxemia
Complications
Keywords: Safety
Sedation
Gastrointestinal endoscopy
Colonoscopy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the study the value of capnography for avoiding complications during sedation for colonoscopy is evaluated.

Detailed description: In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Eligibility criteria: Inclusion Criteria:

* Age\>=18
* Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion Criteria:

* No informed consent
* ASA IV or V
* Pregnancy
* Prexisting hypotension, bradycardia or hypoxemia

Primary outcomes:
measure: Hypoxemia
timeFrame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
Secondary outcomes:
measure: Further complications
timeFrame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München
state: Bavaria
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus der Ruhr-Universität Bochum
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
Study officials:
affiliation: Technical University of Munich
name: Stefan von Delius, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
Clinical trial NCT02516787: Coherence Between Brain Cortical Function and Neurocognitive Performance During Changed Gravity Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or bone demineralization, extended stays in weightlessness also cause cognitive dysfunction. However, the studies on this subject during space missions short or long term could not determine how these cognitive dysfunction resulted from a direct effect of weightlessness or a stress-related effect.

Analysis of electro-encephalography (EEG) using a standardized mapping method is used to study the changes of operation of the cerebral cortex as the near infrared spectroscopy (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a relatively simple and economical method for studying brain changes in an environment where the normal brain imaging techniques can not be used.

The main objective of this experiment is to evaluate the alterations in brain cortical activity and brain oxygenation level induced by micro- and hypergravity conditions.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers (men or women),
* aged from 18 to 65,
* affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
* who accept to take part in the study,
* who have given their written stated consent,
* who already participated in parabolic flights (even in the same campaign)
* All subjects will pass a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Exclusion Criteria:

* Persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
* Persons with prior serious injuries to their head
* Persons who take any medication or drugs influencing their central nervous system or cognitive performance
* Pregnant women.

Primary outcomes:
measure: alterations in brain cortical activity (EEG)
timeFrame: baseline
measure: brain oxygenation level (NIRS)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT01367587: Safety and Gastrointestinal Effects of Intravenous Methylnaltrexone
Official title: Safety and Gastrointestinal Effects of Multiple-Dosed Intravenous Methylnaltrexone in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety of multiple doses of IV MNTX in normal healthy adults.


Eligibility criteria: Inclusion Criteria:

1. Must be male or non-pregnant female volunteers
2. Must be 18 to 65 yrs of age
3. Must have no significant active disease states

Exclusion Criteria:

1. History or current evidence of disease (cardiovascular, respiratory, endocrine, renal, hepatic, hematological, or psychiatric)
2. Illicit drug users
3. Subjects who received an experimental new drug in the past 30 days
4. Subjects with any laboratory findings outside normal limits

Primary outcomes:
measure: Peak Plasma Concentration of IV MNTX
timeFrame: 3 weeks
Secondary outcomes:
measure: Time to Maximum Plasma Concentration of IV MNTX
timeFrame: 3 weeks
measure: Clearance of IV MNTX
timeFrame: 3 weeks
measure: Half-life of IV MNTX
timeFrame: 3 weeks
measure: Volume of Distribution of IV MNTX
timeFrame: 3 weeks
measure: Area Under the Plasma Concentration versus Time Curve (AUC) of IV MNTX
timeFrame: 3 weeks
measure: Percentage of IV MNTX Excreted in Urine
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00289887: Obese Hypertension Study (0954-315)
Official title: A Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination With Hydrochlorothiazide Versus Placebo in Obese Patients With Elevated Systolic and Diastolic Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 261
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 16-week study to evaluate high systolic and diastolic blood pressure following treatment in obese, hypertensive, adult patients.


Eligibility criteria: Inclusion Criteria:

* Obese male and female patients, ages 21-75 years, with high blood pressure

Exclusion Criteria:

* Patients cannot have any other severe cardiac conditions

Primary outcomes:
measure: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
timeFrame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
measure: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
timeFrame: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
measure: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
timeFrame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
measure: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12
timeFrame: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
measure: Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16
timeFrame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
measure: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16
timeFrame: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Oparil S, Abate N, Chen E, Creager MA, Galet V, Jia G, Julius S, Lerman A, Lyle PA, Pool J, Tershakovec AM. A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Curr Med Res Opin. 2008 Apr;24(4):1101-14. doi: 10.1185/030079908x280716. Epub 2008 Mar 6.
Clinical trial NCT02181387: Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?
Official title: Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: labor pain
acetaminophen
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.

Detailed description: Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups

Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age not allergic to study medications

Exclusion Criteria:

* pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects

Primary outcomes:
measure: Neuraxial Analgesic Drug Consumption Per Hour
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter H Pan, MD, MSEE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149187: Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
Official title: Usefulness of Interferon-gamma Release Assay in Diagnosing Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solitary Pulmonary Nodule
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 400
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: Among the inpatients who got percutaneous needle biopsy for pulmonary nodule during the study periods are going to be enrolled.

Brief summary: Among the causes of the solitary pulmonary nodule (SPN), benign causes including tuberculosis was noted on 15 to 60 percents in various studies.

Although the characteristics of chest imaging is helpful in diagnosis and percutaneous needle biopsy for pulmonary nodule has been represented high diagnostic yield in many reports, but still surgical biopsy has been needed in definite diagnosis of pulmonary nodules in many cases.

The aim of this study is to evaluate the usefulness of interferon-gamma release assay in addition to the percutaneous needle biopsy, in diagnosis of pulmonary nodules.

Detailed description: Among the patients who failed to diagnosis by percutaneous needle biopsy and needed to have Surgical biopsy, thirty percents of the patients were diagnosed as benign nodules and about six percents were diagnosed as tuberculosis in Seoul National University Hospital during 2007-2008.

The investigators want to know whether conducting an interferon-gamma release assay in addition to percutaneous needle biopsy is helpful in diagnosis of lung nodules.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* in patients with solitary pulmonary nodule
* who had percutaneous needle biopsy for diagnosis of lung nodule

Exclusion Criteria:

* patients who do not agree the study enrollment

Primary outcomes:
measure: Positive rate of the interferon-gamma release assay
timeFrame: within 36hrs after blood sampling
Secondary outcomes:
measure: Positive rate of the Tuberculin skin test
timeFrame: 48hours after tuberculin skin test
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Young Whan Kim
city: Seoul
country: Korea, Republic of
facility: Young Whan Kim
Study officials:
References:
Clinical trial NCT06623487: The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer
Official title: The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer: a Prospective, Observationa Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma, Non-Small-Cell Lung
PET / CT
Neoadjuvant Immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients are enrolled from Department of Respiratory and Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine in China.

Brief summary: Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions.


Eligibility criteria: Inclusion Criteria:

1. Patients with stage III NSCLC, after assessment according to clinical guidelines, require neoadjuvant immunotherapy;
2. Fully-informed written consent obtained from patients;
3. Patient ability to comply with protocol requirements;
4. Age 18-75 years;
5. Life expectancy of at least 6 months.

Exclusion Criteria:

1. Patients with serious diseases that the investigator deems unsuitable for participation in the clinical study. Such as severe cardiopulmonary insufficiency, severe bone marrow suppression, severe hepatic or renal insufficiency, etc;
2. Intestinal perforation, complete intestinal obstruction;
3. Patients with uncontrolled diabetes mellitus or a fasting blood glucose value of ≥11 mmol/L on the day of the test;
4. Pregnant women and women who are potentially pregnant, as well as nursing mothers;
5. Patients with poor compliance.

Primary outcomes:
measure: Predictive performance 1
timeFrame: up to the end of surgery
Secondary outcomes:
measure: Predictive performance 2
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01120587: Videofluoroscopic of Deglutition Study of the Initiation of Pharyngeal Phase in Young Adults
Official title: The Start of Pharyngeal Phase of Swallowing in Healthy Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Young
Healthy
Keywords: Deglutition
Fluoroscopy
Lead sponsor: Fortaleza University
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 Young adults and healthy, individuals with ages ranging between 20 and 30 years without, mean age 23.5 years, ranging between 20 and 30 years 87.5% (35/40) female 12.5% (5/40) male.

Brief summary: This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition.

Detailed description: Quantitative study, transverse and observational study, in the period January to March 2010, in the Center Advanced Diagnosis and Treatment Trajan Almeida, in the city of Fortaleza, Ceará. The sample was composed by 40 individuals, with mean age 23.5 years, 35 (87.5 %) female and five (12.5%) male gender. was carried out an assessment videofluoroscopy swallowing in net consistencies (15 ml of water added to 15 ml of barium net), liquid paste (25ml of barium net), paste (two spoons of 5ml of thickening for 30ml of barium net) and solid (1/2 cracker waffer immersed the barium net), where the individuals remained seated and the images were carried out in the lateral position. From the beginning of the rapid movement of hyoid bone, verified the beginning of pharyngeal phase of swallowing in each consistency.

Eligibility criteria: Inclusion Criteria:

* Individuals with ages ranging between 20 and 30 years
* Without complaint of deglutition
* Not submitted to surgeries and/or other treatments in the region of head and neck, with the exception of dental equipment.

Exclusion Criteria:

* Individuals submitted to cardiac surgeries, chest and/or abdominal prior
* Patients with diabetes mellitus and/or neurological diseases beyond craniofacial abnormalities.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fortaleza University
name: Rita de Cássia A Almeida, Graduate
role: PRINCIPAL_INVESTIGATOR
affiliation: University Fortaleza
name: Izabella SN Andrade, Master
role: STUDY_CHAIR
affiliation: University Fortaleza
name: Renata CB Haguette, Master
role: STUDY_CHAIR
References:
Clinical trial NCT06658587: A Novel Serological Risk Model for Early Non-invasive Diagnosis of Cholangiocarcinoma
Official title: Clinical Study on the Accuracy of Novel Serological Risk Model in Early Diagnosis of Cholangiocarcinoma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholangiocarcinoma
Keywords: Hilar Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma
Early Diagnosis
Non-invasive Diagnosis
Serological
Prognosis
Chemotherapeutic Benefits
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had suspected cholangiocarcinoma and completed the blood collection before surgery

Brief summary: This is a prospective, observational and exploratory clinical study. The object of this study is to evaluate the accuracy of a novel serological risk model on blood samples in early diagnosis of cholangiocarcinoma patients.

Detailed description: A reliable and accurate preoperative tool capable of early diagnosing malignant cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a novel serological risk model on blood samples for non-invasively diagnosing cholangiocarcinoma. The study includes the construction of capable novel serological risk model and the validation of the diagnosis model.

Eligibility criteria: Inclusion Criteria:

* 1. The patient must sign an informed consent form;
* 2. Age 18-75 years old, both male and female;
* 3. ECOG performance status score (PS score) 0-2;
* 4. Cholangiocarcinoma with resectable tumor lesions;
* 5. Complete the blood collection before treatment;

Exclusion Criteria:

* 1. Accompanied with other primary malignant tumors;
* 2. Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
* 3. Incomplete serological examinations or medical history data.

Primary outcomes:
measure: Malignant/Benign status of enrolled suspected cholangiocarcinoma patients by pathological examination
timeFrame: 4 weeks
measure: Malignant/Benign status of enrolled suspected cholangiocarcinoma patients evaluated by the novel serological risk model
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
name: Chao Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: