louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04144153: Opioid Free Anesthesia and Bariatric Surgery
Official title: Opioid Free Total Intravenous Anesthesia Within an Enhanced Recovery After Surgery Pathway for Bariatric Surgery: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Quality of Recovery
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Non-pregnant
* Undergoing laparoscopic bariatric surgery for weight loss.

Exclusion Criteria:

* Unable to obtain informed consent or consent withdrawn.
* Patients who are pregnant or nursing.
* ASA IV-V
* Alcohol or narcotic misuse or dependence in the last 2 years.
* Preoperative daily opioid use for one year for pain management.
* Egg or soy product allergy
* Active liver disease
* Patients with left ventricular assist devices
* Abnormal renal function
* Any contraindication to any opioid or non-opioid pain analgesics
* Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.

Primary outcomes:
measure: Quality of Recovery
timeFrame: Up to two postoperative weeks
Secondary outcomes:
measure: Pain Intensities
timeFrame: Up to postoperative day one
measure: Opioid Consumption
timeFrame: Up to postoperative day one
measure: Time to Aldrete Score of 9
timeFrame: Up to postoperative day one
Other outcomes:
measure: Postoperative Nausea and Vomiting
timeFrame: Up to postoperative day one
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: Judith Aronsohn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825353: Endoscopic Guided PCNL Versus Standard PCNL
Official title: Endoscopic Combined Intrarenal Surgery for Management of Large Renal Stones: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stones, Kidney
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: currently, percutaneous nephrolithotomy (PCNL) is the standard procedure of choice for management of large renal more than 2 cm.

the pivotal step in performing PCNL is creation of proper tract. this step can be done monitored under guidance of different modalities such as fluoroscopy, ultrasonography, endoscopy or combined in ECIRS, tract creation is controlled under endoscopic vision with a flexible ureteroscope .

Detailed description: Aim: compare safety and efficacy and adverse events of ECIRS in comparison of standard fluoroscopic guided PCNL.

patients \& methods: Patients will randomly be divided into two equal groups:

Group A: Patient will undergo ECIRS.

Group B: Patient will undergo standard PCNL

Eligibility criteria: Inclusion Criteria:

* patients with renal stones diameter of at least 2 cm.
* American Society of Anesthesiology score ≤ 2.

Exclusion Criteria:

* patients with renal anomalies.
* transplanted kidney.
* uncorrected coagulopathy.
* active infection.

Primary outcomes:
measure: Stone Free Rate
timeFrame: 1day after operation.
measure: Stone Free Rate
timeFrame: 1 months post operative
measure: Stone Free Rate
timeFrame: 3 months post-operative
Secondary outcomes:
measure: operative time
timeFrame: intra oprative
measure: blood loss
timeFrame: pre-operative and 1 day post-oprative
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha university hospital
state: Qalubia
Study officials:
References:
Clinical trial NCT06580353: Viscoelastic Properties of Respiratory and Peripheral Muscles of COPD Patients
Official title: Comparison of Viscoelastic Properties of Respiratory Muscles and Peripheral Muscles in Chronic Obstructive Pulmonary Disease Patients With Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Muscle Tone Abnormalities
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD who visited the chest diseases clinic and had symptoms of cough, sputum, and/or shortness of breath, along with tachypnea and/or tachycardia, that had not worsened in the past 14 days were classified as the 'Stable COPD group'.

Brief summary: The aim of this study was to compare the viscoelastic properties of auxiliary respiratory muscles and peripheral muscles of chronic obstructive pulmonary disease patients with healthy subjects. Myotonometry was used to evaluate the viscoelastic properties of the muscles. The viscoelastic properties of the sternoclaidus mastoid, pectoralis major, upper trapezius, deltoid, biceps brachii, rectus femoris, gastrocinemius, and tibialis anterior muscles were evaluated.

Detailed description: muscle viscoelastic properties; muscle tone, stiffness and elasticity. These features may vary due to muscle overuse, lack of relaxation and recovery. The aim is to investigate these differences in COPD patients and healthy individuals.

Eligibility criteria: Inclusion Criteria:

* male gender,
* body mass index (BMI) between 18.5-29.9 kg/m2,
* stable COPD patients

Exclusion Criteria:

* being in the acute exacerbation period for COPD patients,
* having undergone any neurological, orthopaedic or thoracic surgery,
* presence of malignancy in any organ,
* presence of comorbidities affecting muscle atrophy (myasthenia gravis, muscular dystrophy, etc.).

Primary outcomes:
measure: Respiratory functions (PEF)
timeFrame: 1 Day
measure: The Medical Research Council Scale
timeFrame: 1 Day
measure: The COPD Assessment Test
timeFrame: 1 Day
measure: Viscoelastic properties of muscles
timeFrame: 1 Day
measure: Respiratory functions (FEV1)
timeFrame: 1 Day
measure: Respiratory functions (FVC)
timeFrame: 1 Day
measure: Respiratory functions (FEV1/FVC)
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep İslamic Science and Technology University
state: Şahinbey
Study officials:
References:
Clinical trial NCT01304953: Tropisetron on Postoperative Pain
Official title: Tropisetron on Postoperative Pain in Women After Gynaecological Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: General anaesthetics
gynaecological laparoscopy
anaesthetic i.v.
propofol
anaesthetic volatile
evoflurane
antiemetics
reopisetron
postoperative pain
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 296
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The role of 5-HT3A receptors in nociceptive processing has been demonstrated in several animal models. However, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. Previous studies demonstrated that patients anaesthetized with sevoflurane have more pain than those anaesthetized with propofol. And we further posit that the difference is due to the nociceptive processing induced by the action of 5-HT3A receptors.

In this prospective, randomized, double-blind, placebo-controlled study, we assessed the analgesic action of a 5-HT3A receptor antagonist (tropisetron) in women after gynaecological laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.


Eligibility criteria: Inclusion Criteria:

* female patients
* American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
* undergoing selective gynaecological laparoscopies for infertilities

Exclusion Criteria:

* aged under 18 years old
* body mass index (BMI) \> 30
* history of cardiovascular disease
* history of respiratory disease
* history of neurologic disease
* history of chronic antidepressants
* history of anxiolytics
* history of chronic analgesics intake
* participating in other studies

Primary outcomes:
measure: Postoperative pain at rest
timeFrame: At 0.5 postoperative hour
Secondary outcomes:
measure: Postoperative pain at rest
timeFrame: At 2,4,6,8,10,12,14,16,18,20,22,24 postoperative hours
measure: Intraoperative hemodynamic values
timeFrame: At 5, 10,15,20,25,30 min after induction and 30, 25, 20, 15,10,5 min before last suture
measure: Postoperative shivering
timeFrame: At 24 hour postoperativelly
measure: The incidence of postoperative nausea and vomiting (PONV)
timeFrame: At 24 hour postoperativelly
measure: Quality of Recovery Score 40
timeFrame: At 24 postoperative hour
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
name: Wei Mei
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
name: Yuke Tian, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT01971853: Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry
Official title: Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Analgesia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 88
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.

Detailed description: To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.

Eligibility criteria: Inclusion Criteria:

* We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.

Exclusion Criteria:

* Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

Primary outcomes:
measure: Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description
timeFrame: 60 minutes treatment started
Secondary outcomes:
measure: Difference in Heart Rate as Measured by Numerical Delta Value
timeFrame: From state of treatment (time 0) 60 minutes
Other outcomes:
measure: Time of Administration of Nitrous Oxide and Oxygen as Measured by Minutes and Percent of Nitrous Oxide Administered
timeFrame: From start of treatment (time 0) to 60 minutes
measure: Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description
timeFrame: 60 minutes after start of treatment
measure: Complications During Treatment and Recovery
timeFrame: 2 hours in clinic
measure: Post Operative Problems
timeFrame: 4 hours after patient is discharged
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jeffrey O Young, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT02185053: A Phase II Study of CPC-201 to Treat Alzheimer's Disease Type Dementia
Official title: A Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients With Alzheimer's Disease Type Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Chase Pharmaceuticals Corporation, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 41
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II, Single-Blind, Placebo-Controlled, Sequential Treatment, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of CPC-201 in Patients with Alzheimer's Disease Type Dementia.


Eligibility criteria: Inclusion Criteria:

* Aged 50 - 79 years inclusive.
* Meeting the diagnosis of probable Alzheimer's Disease
* Of moderate severity (Mini-Mental Status Exam \[MMSE\] score 10 - 20 inclusive).
* Patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ECG), and standard laboratory tests.

Exclusion Criteria:

* Women of child bearing potential.
* History or presence of a seizure disorder.
* History of peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease.
* History or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced GI motility, or narrow-angle glaucoma.
* History or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
* History or presence of myasthenia.
* Known hypersensitivity to donepezil, solifenacin or related drugs.
* Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
* Patients who have participated in another clinical trial with an investigational drug within previous 30 days.

Primary outcomes:
measure: Donepezil Maximum Tolerated Dose (MTD)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Subjects With Any TEAEs
timeFrame: 6 months
measure: Donepezil Plasma Concentration at Maximum Tolerated (MTD) or Maximum Allowable Dose
timeFrame: Day 1 (baseline) to end of study
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: CPC1
state: Florida
Study officials:
affiliation: Allergan
name: Lynn James
role: STUDY_DIRECTOR
References:
Clinical trial NCT06891053: Studio TIARA: Alessitimia ed Emicrania Cronica
Official title: Studio TIARA: Alessitimia ed Emicrania Cronica
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Migraine
Alexithymia
Lead sponsor: Azienda Sanitaria Locale di Alessandria
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 350
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients, aged 12-65 years, diagnosed with episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria

Brief summary: The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria;
* Patients aged 12-65 years;
* Female patients

Exclusion Criteria:

* Ongoing major depressive episode;
* Comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.);
* Alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens);
* Language barrier;
* Low cultural/cognitive level;
* No informed consent.

Primary outcomes:
measure: Degree of alexithymia
timeFrame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
measure: Migraine frequency
timeFrame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Secondary outcomes:
measure: Number of "drug days" in patients diagnosed with MOH
timeFrame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
measure: Degree of alessithymia in patients diagnosed with MOH
timeFrame: In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda Sanitaria Locale di Alessandria (ASL AL)
Study officials:
affiliation: Azienda Sanitaria Locale di Alessandria (ASL AL)
name: Eugenia Rota
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021353: Contralateral Study of WaveLight® Femtosecond Laser Devices for Corneal Flap Creation
Official title: Contralateral Study of the WaveLight® Ultraviolet Femtosecond Laser, Model 1026 Versus the WaveLight® FS200 Infrared Femtosecond Laser, Model 1025 for Corneal Flap Creation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 47
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 assess the WaveLight Ultraviolet Femtosecond Laser System, Model 1026 (UV fs-Laser) corneal flap creation accuracy as compared to the already marketed WaveLight FS200 Infrared Femtosecond Laser, Model 1025 (IR fs-Laser).

Detailed description: Subjects who qualify to participate will have both eyes treated in the study (one eye with the UV fs-Laser and the other eye with the IR fs-Laser) and will attend a total of 5 study visits over a period of approximately 2 months. This study will be conducted outside the United States.

Eligibility criteria: Key Inclusion Criteria:

* Good ocular health;
* Natural lens with no evidence of cataract;
* Eligible for LASIK;
* Stable refraction;
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Presence of dry eye;
* Contraindicated systemic disease or ocular conditions;
* Treatment with a contraindicated medication;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Maximum deviation of corneal flap thickness at the margins from achieved central flap thickness at 1 month
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Personaleyes
state: New South Wales
Study officials:
affiliation: Alcon Research, LLC
name: Principal Clinical Trial Lead, CRD Surgical
role: STUDY_DIRECTOR
References:
Clinical trial NCT01602653: Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Official title: Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraspinatus Calcifying Tendonitis
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 46
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 two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.


Eligibility criteria: Inclusion Criteria:

* no visible clinical benefits by previous conservative treatment
* medium and large calcific deposits, according to Bosworth classiﬁcation
* type I and II Gartner deposits

Exclusion Criteria:

* presence of tiny calcific deposits, according to Bosworth classiﬁcation
* type III, according to the Gartner classification
* age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases

Primary outcomes:
measure: Constant Murley Scale
timeFrame: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint.
Secondary outcomes:
measure: Visual Analogic Scale
timeFrame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
Other outcomes:
Locations:
Study officials:
References:
citation: Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.