louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05395975: Different Preoxygenation Methods In Cesarean Section
Official title: Assessment of Different Preoxygenation Methods With Oxygen Reserve Index In Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Hyperoxia
Keywords: Oxygen Reserve Index
Preoxygenation
General Anesthesia
Cesarean Section
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-45 who had cesarean section under general anesthesia

Brief summary: The study aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and 4 deep breaths) in pregnant women with oxygen reserve index (ORI).

After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45, different preoxygenation methods will be applied, and the oxygen status of the patients will be compared with ORI monitoring.


Eligibility criteria: Inclusion Criteria:

* The average operation time is 30 minutes-1.5 hours.
* ASA II risk class
* All pregnant women with a gestational week \>36

Exclusion Criteria:

* preeclampsia
* eclampsia
* fetal distress
* morbid obesity
* a history of malignant hyperthermia
* opioid sensitivity
* alcohol or drug addiction
* congestive heart failure
* chronic obstructive pulmonary disease
* coronary artery disease
* anemia, liver and kidney disease
* hypovolemia, hypotension, sepsis
* Those who are allergic to the drugs used in the study and who are suspected of difficult intubation

Primary outcomes:
measure: Preoxygenation Methods
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Faculty of Medicine
state: Kozlu
Study officials:
References:
Clinical trial NCT04384575: Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology
Official title: Study on the Effectiveness of Gastroscope Operation Quality Control Based on Artificial Intelligence Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric cancer
artificial intelligence
endoscopy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 1570
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 meet the criteria for gastroscopy examination.

Brief summary: This study aims to construct a real-time quality monitoring system based on artificial intelligence technology.

Detailed description: Gastroscopy plays an important role in the detection and diagnosis of upper gastrointestinal diseases. It is necessary for endoscopists to operate gastroscope according to the standardized process, in order to avoid missing early lesions. However, with the rapid increase in the number of endoscopies, the workload of endoscopists increases further. High workload reduces the quality of endoscopy, resulting in incomplete observation of anatomical parts that are easy to be missed in the process of gastroscopy. There are significant differences in the operation level of different endoscopists. Therefore, carrying out artificial intelligence methods has good academic research and practical value for improving the quality of endoscopic diagnosis and treatment.

Artificial intelligence devices need to use a large number of endoscopic images, based on this, we intends to collect endoscopic image data from our hospitals for training and validation of the model.

Eligibility criteria: Inclusion Criteria:

1. Patiens aged 18 years or above undergoing gastroscopy；
2. Be able to read, understand and sign informed consent；

Exclusion Criteria:

1. Patients with absolute contraindications to endoscopy examination;
2. pregnant women;
3. previous history of gastric surgery;
4. the researcher considers that the subject is not suitable for clinical trial.

Primary outcomes:
measure: Accuracy
timeFrame: 2020.2.22-2020.7.1
measure: Sensitivity
timeFrame: 2020.2.22-2020.7.1
measure: Specificity
timeFrame: 2020.2.22-2020.7.1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Haidian
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Qi Wu, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT06734975: Effect of Superior Laryngeal Nerve Blocks on Patient Outcomes in Laryngeal Surgery
Official title: Effect of Intraoperative Superior Laryngeal Nerve Blocks on Patient Outcomes in Microdirect Laryngoscopy for Benign Vocal Fold Lesions: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Vocal Cord Disease
Vocal Cord Polyp
Vocal Cord Cyst
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing surgery on their vocal cord will either receive a numbing injection to their throat or a saline injection during surgery. Symptoms such as how much coughing or pain patients have after surgery, as well as whether patient's voice gets better will be interrogated.


Eligibility criteria: Inclusion Criteria:

* Patient is aged 18 years or older at time of consent
* Patient has suspected or confirmed benign vocal fold lesion
* Patient is planning to undergo direct laryngoscopy with excision of the vocal fold lesion
* Patient is English or Spanish speaking
* Patient is not pregnant per self report
* Patient is not incarcerated

Exclusion Criteria:

* Patient is not 18 years of age or older at consent date
* Patient does not speak English or Spanish
* Patient is currently pregnant or plans to become pregnant prior to their study procedure
* Patient has a laryngeal malignancy or found to find a laryngeal malignancy on final pathology
* Patient will not be undergoing direct laryngoscopy with excision of lesion
* Patient is unable to provide consent or complete study activities
* Patient is incarcerated

Primary outcomes:
measure: Postoperative pain
timeFrame: 1, 3 and 7 days after surgery
measure: Postoperative cough
timeFrame: Follow up appointment 2-4 weeks after surgery
measure: Postoperative voice outcome
timeFrame: Postoperative appointment 2-4 weeks after surgery
Secondary outcomes:
measure: Post-extubation cough
timeFrame: 5 minutes postoperative
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Kenneth Yan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456075: Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19
Official title: Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV2
COVID
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 100
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 with SARS-CoV-2 infection / COVID 19

Brief summary: Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 infection / COVID 19

Exclusion Criteria:

* invasive ventilation
* respiratory failure at admission

Primary outcomes:
measure: TLCO
timeFrame: 3-5 days intervals (inpatients)
measure: TLCO
timeFrame: 1-6 months (outpatients, follow up)
measure: D5-20
timeFrame: 3-5 days intervals (inpatients
measure: D5-20
timeFrame: 1-6 months (outpatients, follow up)
measure: FEV1/FVC
timeFrame: 3-5 days intervals (inpatients)
measure: FEV1/FVC
timeFrame: 1-6 months (outpatients, follow up)
Secondary outcomes:
measure: comorbidities
timeFrame: at hospital admission and each follow (every 1-6 months)
measure: clinical symptoms
timeFrame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
measure: St. George's Respiratory Questionnaire total score
timeFrame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik at Heidelberg University
Study officials:
affiliation: Thoraxklinik at Heidelberg University
name: Frederik Trinkmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoraxklinik at Heidelberg University
name: Felix JF Herth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01508975: Satiety Response of White and Brown Rice Compared to Glucose Control
Official title: Satiety Response of White and Brown Rice Compared to Glucose Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Keywords: satiety
obesity
food intake
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that consumption of either white or brown rice will be more satiating than glucose control.

Detailed description: This study is an acute, randomized, repeated measures design with 20 subjects. Subjects will consume 3 test breakfasts, white rice, brown rice, or glucose control, each containing 400 calories. Treatments will be one week apart. After consumption of the controlled breakfast, subjects will complete visual analogue scales (VAS) for satiety response. Additionally, they will consume a pizza lunch and record food intake for the next 24 hours. Breath gas samples will be collected to estimate fermentation of fiber in the large intestine. Also, subjective data on gastrointestinal tolerance will be collected.

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* inability to consume rice for breakfast

Primary outcomes:
measure: Satiety
timeFrame: 4 hours following breakfast
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04329975: Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)
Official title: Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet 25μg / 50μg in Treatment for Male Nocturia Due to Nocturnal Polyuria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia Due to Nocturnal Polyuria
Keywords: Hyponatremia
Long-term treatment
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-04-01
Enrollment: 1087
Sex: MALE
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: Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.

Brief summary: To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year \[52 weeks\]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal polyuria in men in daily clinical practice, and to confirm the compliance with proper use of this drug in clinical practice and to investigate the effectiveness of risk minimization activities.


Eligibility criteria: Inclusion Criteria:

* Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.

Exclusion Criteria:

* No exclusion criteria defined for this study.

Primary outcomes:
measure: Occurrence of Hyponatremia
timeFrame: 1 year
measure: Time to Onset of Hyponatremia
timeFrame: 1 year
measure: Distribution of Serum Sodium Levels
timeFrame: 1 year
measure: Factors Affecting the Occurrence of Desmopressin-induced Hyponatremia
timeFrame: 1 year
Secondary outcomes:
measure: Onset Situation of Adverse Drug Reaction/Infectious Disease
timeFrame: 1 year
measure: Onset Situation of Serious Adverse Events (SAEs)
timeFrame: Up to 1 year
measure: Factors Affecting Safety
timeFrame: 1 year
measure: Compliance with proper use of drug
timeFrame: 1 year
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Survey Site (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT04082975: Efficacy and Safety of NVP-1203 and NVP-1203-R in Patients With Acute Low Back Pain
Official title: A Randomized, Double-blind, Active Controlled, Parallel, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Low Back Pain
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 421
Sex: ALL
Minimum age (years): 19
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 evaluate the efficacy and safety NVP-1203 in patients with acute low back pain.

Detailed description: This study is a randomized, double-blind, active-controlled, parallel, phase 3 study to evaluate efficacy and safety of NVP-1203 in patients with acute low back pain.

Eligibility criteria: Inclusion Criteria:

* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
* Subjects who have symptom of acute low back pain

Exclusion Criteria:

* Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
* Inadequate subject for the clinical trial by the investigator's decision

Primary outcomes:
measure: Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
timeFrame: Baseline and Day 7
Secondary outcomes:
measure: Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
timeFrame: Baseline and Day 3
measure: Change from baseline in Finger to Floor Distance(FFD)
timeFrame: Baseline, Day 3 and Day 7
measure: Change from baseline in Oswestry Disability Index(ODI)
timeFrame: Baseline, Day 3 and Day 7
measure: Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)
timeFrame: Baseline and Day 7
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Navipharm
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: Seong-Hwan Moon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jin Hwan Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Tae Kyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390075: The Effect of Shelf Nutrition Labels on Purchases
Official title: Identifying the Effect of Shelf Nutrition Labels on Consumer Purchases, Results of a Natural Experiment and Consumer Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: shelf nutrition label, NuVal
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US grocery shoppers

Brief summary: NuVal® shelf nutrition labels rate the nutritional quality of foods on a scale of 1 (worst) to 100 (best). In 2014, NuVal updated their nutrient profiling system which changed the NuVal score on many foods. The investigators took advantage of this "natural experiment" to assess the extent to which a change in the NuVal score at a grocery chain influenced yogurt purchases, a category with a wide range of more and less healthy alternatives. The investigators supplemented the retail scanner data with a survey of consumers in stores using NuVal labels to obtain their experience with the labels and the extent to which they state it influences their purchases.


Eligibility criteria: Inclusion Criteria:

* US adults regularly shopping at one of two retail chains using NuVal

Exclusion Criteria:

-

Primary outcomes:
measure: Diet quality as measured by the NuVal scores of yogurt purchased
timeFrame: From 12/30/12 to 8/22/15
Secondary outcomes:
measure: Knowledge and stated use of NuVal labels by participants of an online survey
timeFrame: June 2016
Other outcomes:
Locations:
Study officials:
References:
citation: Finkelstein EA, Li W, Melo G, Strombotne K, Zhen C. Identifying the effect of shelf nutrition labels on consumer purchases: results of a natural experiment and consumer survey. Am J Clin Nutr. 2018 Apr 1;107(4):647-651. doi: 10.1093/ajcn/nqy014.
Clinical trial NCT04196075: The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
Official title: The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Squamous Cell Carcinoma of Esophagus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective cohort study on the effect of Andrographis Paniculata (AP) on palliative management of patients with advanced or metastatic esophageal cancer. A total of 30 patients with locally advanced or metastatic squamous esophageal cancer will be recruited for the trial.


Eligibility criteria: Inclusion Criteria:

1. Aged over 18
2. Locally advanced esophageal cancer with invasion or adherent to surrounding organs including trachea, recurrent laryngeal nerves and descending aorta;
3. Presence of distant metastasis;
4. Extensive lymph node metastasis to beyond surgical therapy

Exclusion Criteria:

1. Patients who cannot receive palliative stenting for dysphagia or under other conventional treatment including chemotherapy or chemoradiotherapy
2. Patients who are not willing to receive Chinese herbal medicines
3. Patients who do not consent for the study

Primary outcomes:
measure: Symptomatic relief and quality of life after AP
timeFrame: 4 months
Secondary outcomes:
measure: Difficulty to swallow
timeFrame: 4 months
measure: Survival
timeFrame: up to 36 months
measure: Adverse events
timeFrame: up to 36 months
measure: AP side effects
timeFrame: 4 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
state: Outside Of US & Canada
Study officials:
affiliation: Chinese University of Hong Kong
name: Philip WY Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01076075: A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)
Official title: A Phase III, Randomized, Clinical Trial to Evaluate the Safety and Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on a Sulfonylurea in Combination With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate whether the addition of Sitagliptin treatment provides a greater decrease in A1C levels compared to placebo in participants with inadequate glycemic control on sulfonylurea and metformin combination therapy.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Hemoglobin A1C of ≥7.5% and ≤10.5%
* Currently taking a stable dose of metformin (at least 1500 mg/day) and either glimepiride (at least 2 mg/day) or gliclazide (at least 50% of maximum registered dose) for at least 10 weeks prior to study start
* Male, or a female who is highly unlikely to conceive

Exclusion Criteria:

* Type 1 diabetes mellitus or ketoacidosis
* Taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin) or a glucagon-like peptide-1 (GLP-1) mimetic (such as exenatide or liraglutide) or required insulin therapy within 12 weeks prior to study start
* On a weight loss program not in the maintenance phase or on a weight loss medication
* History of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
* HIV positive
* Pregnant

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1C (%) at Week 24
timeFrame: Baseline and Week 24
measure: Number of Participants With One or More Adverse Events (AEs) - Week 0 to Week 54
timeFrame: Week 0 to Week 54
measure: Number of Participants Discontinuing Study Drug Due to An Adverse Event
timeFrame: Week 0 to Week 54
Secondary outcomes:
measure: Change From Baseline in 2-hour Post-Meal Glucose at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Fasting Plasma Glucose at Week 24
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Moses RG, Round E, Shentu Y, Golm GT, O'neill EA, Gantz I, Engel SS, Kaufman KD, Goldstein BJ. A randomized clinical trial evaluating the safety and efficacy of sitagliptin added to the combination of sulfonylurea and metformin in patients with type 2 diabetes mellitus and inadequate glycemic control. J Diabetes. 2016 Sep;8(5):701-11. doi: 10.1111/1753-0407.12351. Epub 2016 Feb 3.