louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02209571: Breath Analysis in in Adults With Cystic Fibrosis (CF)
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS) in Adults With Cystic Fibrosis: An Exploratory Matched Case-Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Breath Tests
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Exploratory comparative evaluation of exhaled breath composition in cystic fibrosis patients with age and gender-matched healthy adults in order to identify a disease-specific exhaled breath pattern as well as to gain insight into pathophysiological and microbial contributions to exhaled breath composition.

Detailed description: Although there is some evidence that breath composition reflects aspects of CF pathology, so far a disease-specific molecular breath profile has not been identified. Real-time, whole breath analysis incorporating all of the thousands of potentially relevant volatile compounds is needed in order to identify reliable CF-specific breath patterns. These may be used in future clinical applications to greatly enhance cost-effectiveness and simplicity of diagnostic testing for CF.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of cystic fibrosis (for CF-patients)
* Age ≥ 18 years

Exclusion Criteria:

* Previous lung transplantation (for CF-patients)
* Pulmonary exacerbation within the preceding 6 weeks (for CF-patients)
* Moribund or severe disease prohibiting protocol adherence (for CF-patients)
* Respiratory illness requiring physician consultation within the preceding 6 weeks (for controls)
* Chronic respiratory illness (for controls)
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnancy

Primary outcomes:
measure: Molecular composition of exhaled breath analysed by Secondary Electrospray Ionisation Mass Spectrometry (SESI-MS)
timeFrame: up to 2 years
Secondary outcomes:
measure: Composite of clinical records
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06093971: Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy
Official title: Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Tumor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 112
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure \<65mmHg is defined as hypotension).


Eligibility criteria: Inclusion Criteria:

Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.

Exclusion Criteria:

1. emergency surgery
2. If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.)
3. cognitive dysfunction
4. Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less
5. Patients who did not take renin-angiotensin system blockers on the day of surgery

Primary outcomes:
measure: Hypotension occurrence (unit: number of patients)
timeFrame: during the total anesthesia duration
measure: Amount of hypotension (unit: mmHg)
timeFrame: during the total anesthesia duration
measure: Vasopressor dose (unit: mcg for norepinephrine)
timeFrame: during the total anesthesia duration
measure: Vasopressor dose (unit for vasopressin)
timeFrame: during the total anesthesia duration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: So Yeon Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05515471: Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment of Dry Eye Disease With Meibomian Gland Dysfunction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-25
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR8058 eye drops compared with placebo
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.


Eligibility criteria: Inclusion Criteria:

1. Signed ICF (Informed Consent Form)
2. Subject-reported history of Drye Eye Disease (DED) in both eyes
3. Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

1. clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
2. Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
3. underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
4. received or removed permanent lacrimal plug within 3 months before baseline;
5. DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
6. ocular or periocular malignancy;
7. active ocular allergies, or allergy to the study drug or its components;
8. ongoing ocular or systemic infection;
9. use of contact lenses within 1 month before screening;
10. intraocular surgery or ocular laser surgery within 6 months before enrollment;
11. uncontrolled systemic disease or history of herpetic keratitis;
12. use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;
13. used any known oral drugs that could have caused eye dryness within 1 month before screening;
14. participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
15. inappropriate to participate for other reasons judged by the investigators.

Primary outcomes:
measure: Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
timeFrame: Baseline, Day 57
measure: Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
timeFrame: Baseline, Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06530771: Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Evaluate the Malignancy Risk Value of Thyroid Nodules
Official title: Multimodality US Based on Angio Planewave Ultrasensitive Imaging and Shear Wave Elastography to Guide the Fine-Needle Aspiration Management of Thyroid Lesions: Focus on the Innovative Microvascular Classification
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multimoda Lultasound
Thyroid Cancer
Microvascular Classification
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population data for this prospective single-center cohort study were gathered at the Fifth Affiliated Hospital of Sun Yat-sen University.

Brief summary: The goal of this clinical trial is to explore the value of a multimodal ultrasound model based on Angio Planewave Ultrasensitive Imaging, Shear Wave Elastography and grayscale ultrasound in the differential diagnosis of benign and malignant thyroid nodules. The main questions it aims to answer are:

Can an innovative ultra-microvascular classification system based on Angio Planewave Ultrasensitive Imaging distinguish between benign and malignant thyroid nodules? How about the performance of multimodal ultrasound model to Guide the Fine-Needle Aspiration Management of Thyroid Lesions?

Participants will:

Undergo grayscale ultrasound, SWE, and Angio Planewave Ultrasensitive Imaging multimodal thyroid ultrasound examination within one week before surgery Undergo surgery and obtain the postoperative pathological diagnosis


Eligibility criteria: Inclusion Criteria:

1. age more than 18 years;
2. Voluntarily signed informed consent;
3. Have 1 or more thyroid nodules detectable by ultrasound;
4. participant underwent surgical procedure to confirm the pathologic results

Exclusion Criteria:

1. Nodules are accompanied by large calcifications followed by acoustic shadows
2. History of previous neck surgery or cancer, thyroid medications, radiation or surgical treatment;
3. Poor quality of retained images or non-standard operations (such as intermittent scanning and improper probe compression), and incomplete pathological results.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: one week
measure: Diagnostic efficacy
timeFrame: one week
measure: positive predictive value (PPV), and negative predictive value (NPV)
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00314171: A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Official title: A Study of a Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: open-angle glaucoma
ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 437
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: The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosis of open-angle glaucoma or ocular hypertension
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Under 18
* Pregnant
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean IOP
Secondary outcomes:
measure: Percent patients with IOP < 18 mmHg
Other outcomes:
Locations:
Study officials:
References:
citation: Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.
Clinical trial NCT06862271: Comparison of Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Surgeries
Official title: Comparison of Postoperative Analgesia, Delirium, and Parental Satisfaction Between Caudal Block Combined With General Anesthesia and Penile Block and Intravenous Fentanyl in Pediatric Urogenital Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caudal Block
Pediatric Urologic Surgeries
Fentanyl
Pediatric Delirium
Analgesia
Keywords: pediatric urologic surgeries
pediatric delirium
caudal block
penile block
FLACC Scale
PAED Scale
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-06
Enrollment: 120
Sex: MALE
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Urogenital surgery is one of the most frequently performed surgical procedures in the pediatric patient population. There is no consensus on which analgesic method is most effective for pain control in these patients. In clinical practice, if there are no contraindications, caudal block or penile block combined with intravenous fentanyl can be preferred as an analgesic method.

In this study, the results of these two analgesia methods will be compared with the research.Randomly selected participants will be compared by looking at parameters such as postoperative questionnaire results, walking time and urination time.


Eligibility criteria: Inclusion Criteria:

* 4 months - 12 years old male patient
* Acceptance of participation in the study
* Patients Planned for Urogenital Surgery
* ASA I-II Patients

Exclusion Criteria:

* \<4 months, \>12 years male patient
* Female patient
* Not accepted to be included in the study
* ASA status III-IV
* History of bleeding disorder
* Spinal cord disease
* Obstructive sleep apnea
* Developmental delay
* Behavioral disorder
* Allergy to any drug in the protocol

Primary outcomes:
measure: Pediatric Anesthesia Emergence Delirium (PAED) Scale
timeFrame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
Secondary outcomes:
measure: Face Leg Activity Cry Consolability (FLACC) Scale
timeFrame: The first evaluation will be made after extubation, the second evaluation will be made at the 15th minute after surgery.
measure: LİKERT Scale
timeFrame: 24th hour after surgery
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT03434171: Effect of Aerobic Exercises With Selected Phytoestrogens on Hot Flushes in Menopausal Women
Official title: Effect of Aerobic Exercises With Selected Phytoestrogen Product on Hot Flushes in Post-menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hot Flashes
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: What is the effect of aerobic exercises with diet modification on hot flushes, lutenizing hormone (L.H) and follicle stimulating hormone (F.S.H) in post-menopausal women
Primary purpose: TREATMENT

Brief summary: 50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups

Group (A):

It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks.

Group (B):

It consists of 25 women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only.

Detailed description: 50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups

Group (A):

It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks.

Group (B):

It consists of 25 women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only.

Eligibility criteria: Inclusion Criteria:

* menopausal women minimum 2 years after menopause Patients were required to have at least moderate hot flashes at time of randomization, having a score ≥ 40 in Hot Flash-Related Daily Interference Scale (HFRDIS)

Exclusion Criteria:

* women with BMI \> 30kg/m2 ingestion of any psychotropic and antidepressant medications, any Selective Estrogen Receptor Modulator medications (e.g., tamoxifen and raloxifen), any Aaromatase inhibitor medications (e.g., anastrozole, letrozole, and exemestane), leuprolide acetate, clonidine, gabapentin, pregabalin, amino acid supplements, over the counter (OTC) medications that reduced hot flashes during the last 4 weeks, ingestion of estrogen and progesterone based medications, history of suicidal thoughts, substance or alcohol dependence (with the exception of nicotine dependence) during the last 3 months and Electroconvulsive therapy (ECT) during the last 2 months.

Primary outcomes:
measure: Heat sensation changes
timeFrame: 12 weeks after excercise
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00948571: Influence of Posture and Gas Insufflation on Perioperative Lung Function
Official title: Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumoperitoneum
Keywords: Vital capacity, FEV1, airway resistance
perioperative changes in lung function
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
First posted: 2009-07-29
Enrollment: 60
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: 20 patients scheduled for "robotic" prostatectomies 20 patients scheduled for open prostatectomies 20 patients scheduled for open hemicolectomies

Brief summary: Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity.

Detailed description: Lung function, upper and lower airway resistance measurements are performed in patients in prone horizontal or head tilted down (40°) position. Half of the patients with head down position will have surgery in laparoscopic technique (including gas insufflation to achieve a pneumoperitoneum). Measurements are performed on the day prior to surgery, on the morning of surgery, 30 - 45 minutes, 2 hours, and 24 hours after extubation.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age.
* Patients with normal lung function with respect to age, gender and weight. -Patients scheduled for Prostatectomies, robotic Prostatectomies, and open hemicolectomies.

Exclusion Criteria:

* Patients younger than 18 years.
* Patients with pathological lung function.
* Patients with with major cardiac disease.

Primary outcomes:
measure: Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio
timeFrame: 18 months
Secondary outcomes:
measure: Changes in nasal airway resistance
timeFrame: 18 months
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Prof. Dr. Harald Groeben
Study officials:
affiliation: Klniken Essen-Mitte
name: Harald Groeben, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
citation: Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.
citation: Chiu KL, Ryan CM, Shiota S, Ruttanaumpawan P, Arzt M, Haight JS, Chan CT, Floras JS, Bradley TD. Fluid shift by lower body positive pressure increases pharyngeal resistance in healthy subjects. Am J Respir Crit Care Med. 2006 Dec 15;174(12):1378-83. doi: 10.1164/rccm.200607-927OC. Epub 2006 Sep 22.
Clinical trial NCT05948371: High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
Official title: Effects of High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of high intensity aerobic interval training versus continuous aerobic training in heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Patient with heart failure including both male and female
* Patients who can perform 6 MWT.
* According to classification of American heart association, class 1 heart failure patients are included.

Exclusion Criteria:

* Heart failure patients along with orthopedic problems.
* Patients who have use pacemaker.
* Patient who have recent acute myocardial infraction or revascularization less than 3 months.

Primary outcomes:
measure: 6MWT Distance
timeFrame: 8 week
measure: Minnesota living with heart failure questionnaire
timeFrame: 8 week
measure: Pulse Rate
timeFrame: 8 week
measure: Oxygen Saturation (SpO2)
timeFrame: 8 week
measure: Modified Borg dyspnea scale
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, PhD*
role: PRINCIPAL_INVESTIGATOR
References: