louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01824927: Pain Expression in the Perioperative Period of Cataract Surgery
Official title: Pain Expression in the Perioperative Period of Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Surgery
Eye Pain
Lead sponsor: Evidence Based Cataract Study Group
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.


Eligibility criteria: Inclusion Criteria:

* Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
* Pupil dilation ≧7 mm after mydrisis;
* VA prognosis ≧6/12

Exclusion Criteria:

* Unable to give informed consent;
* Patients with history of ocular pathology or diabetic retinopathy;
* Patients with traumatic, subluxated and posterior polar cataract;
* Patients had other ocular surgery (not cataract surgery) in the past 6 months;
* Patients with significant intra-operative complications

Primary outcomes:
measure: Post operative pain level
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye and ENT Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: Zhu XJ, Wolff D, Zhang KK, He WW, Sun XH, Lu Y, Zhou P. Molecular Inflammation in the Contralateral Eye After Cataract Surgery in the First Eye. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5566-73. doi: 10.1167/iovs.15-16531.
Clinical trial NCT00830427: A Study To Examine The Safety And Efficacy Of PF-00610355 In Moderately Asthmatic Subjects
Official title: A Phase Iib Randomised Double Blind, Placebo Controlled Parallel Group Study To Investigate The Efficacy And Safety Of Pf-00610355 Over 4 Weeks In Moderate Asthmatic Subjects.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Asthma, Bronchial
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Keywords: asthma bronchial diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study (A7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of PF-00610355 when subjects take PF-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.


Eligibility criteria: Inclusion Criteria:

* Subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to Screening Visit 1.

Trough FEV1 must be 50-100% of predicted at Screening Visit 1.

Subjects who have been maintained on a stable dose of ICS over the previous month prior to screening.

Exclusion Criteria:

* Subjects who have had a severe asthma exacerbation in the 2 months prior to screening.

Subjects meeting any of the criteria of 'very poorly controlled' according to the NIH EPR 3 guidelines.

Subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (SBP \> 160 mmHg or DBP \>100mmHg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).

Primary outcomes:
measure: Change from baseline trough (24 hours post-dose) FEV1.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in heart rate.
timeFrame: week 0, week 4
measure: Change from baseline in trough FEV1.
timeFrame: week 4
measure: Maximum change from baseline in FEV1 from 0 to 6 hours post-dose.
timeFrame: week 0,week 4
measure: Change from baseline in Asthma Quality of Life Questionnaire (AQLQ-S) score.
timeFrame: week 2, week 4
measure: Pharmacokinetics of PF-00610355.
timeFrame: week 0, week 4
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01307527: Riboflavin Corneal Crosslinking for Brittle Cornea Syndrome and Ehlers-Danlos Syndrome Type VI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brittle Cornea Syndrome
Ehlers-Danlos Syndrome Type 6
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Brittle Cornea Syndrome and Ehlers-Danlos Syndrome (EDS) type VI are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. Clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. Given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. It is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. The purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with Brittle Cornea Syndrome or Ehlers-Danlos Syndrome type VI.


Eligibility criteria: Inclusion Criteria:

Adult Patient with:

1. Genetic diagnosis of either Brittle Cornea Syndrome or EDS-VI, and
2. Either:

   * Personal History of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or
   * Immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma

Exclusion Criteria:

* Any patient that is deemed to be unable to fully cooperate during the crosslinking procedure

Primary outcomes:
measure: Adverse Events from Cornea Riboflavin Crosslinking in Brittle Cornea Syndrome or Ehlers Danlos Type VI
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT04839627: Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates.
Official title: Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: serum progesterone
embryo transfer
pregnancy rate
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 250
Sex: FEMALE
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: all patients who need an embryo transfer in the center.

Brief summary: Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen).

The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* planned embryo transfer
* signed informed consent

Exclusion Criteria:

* patients falsely included, major inclusion criteria not respected
* lack of social insurance
* refusal to participate in the research

Primary outcomes:
measure: Serum progesterone levels on the day of embryo transfer
timeFrame: During the procedure
Secondary outcomes:
measure: pregnancy rate
timeFrame: 1 month after procedure
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Saint Joseph Marseille
Study officials:
References:
Clinical trial NCT02343627: Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail
Official title: A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Safety and Efficacy of NVXT Solution in Patients With Mild-to-Moderate Fungal Infection of the Toe Nail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Onychomycosis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Detailed description: This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed onychomycosis
* Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy
* Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions
* Positive potassium hydroxide mount preparation
* Positive fungal culture for a dermatophyte

Exclusion Criteria:

* Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance

Primary outcomes:
measure: Number of Participants With Negative Fungal Culture
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taro Pharmaceuticals USA Inc.
name: Taro Pharmaceuticals USA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05830227: Evaluation of Infrared Thermal Imaging in Diagnosis of OSAHS in Children
Official title: Evaluation of Infrared Thermal Imaging in Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infrared-thermal-imaging
Lead sponsor: State Key Laboratory of Respiratory Disease
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: -Children ages 2 to 14 with SDB related symptoms

Brief summary: OSAHS is a common sleep breathing disorder in children, with the same incidence as childhood asthma, and is mainly caused by upper airway stenosis caused by tonsil/adenoid hyperplasia. Clinical findings show that children with OSAHS often present rhinitis symptoms and like rubbing eyes, but there is no evidence to suggest a correlation. Children with OSAHS suffer from recurrent hypoxemia during sleep, and the existing detection methods such as lateral nasopharyngeal radiographs and electronic nasopharyngoscopy can only reflect the structural and morphological changes of the oral, nasal and pharyngeal tissues, but cannot prove their functional status. Previous studies have found that infrared thermal imaging can reflect the oral, nasal and pharyngeal inflammation of patients, and the infrared expression of patients' frontal region and eyes can also reflect the physiological changes caused by sleep deprivation.

Detailed description: In this project, the children were divided into four groups: primary snoring, critical OSAHS, mild OSAHS and moderate to severe OSAHS, and the tests were completed, including lateral nasopharyngeal radiographs, infrared detection of oropharynx and pharynx, infrared detection of frontal area and eye area, intelligence and behavior scale assessment, etc. Furthermore, the correlation between infrared detection and obstructive sleep apnea hypopnea index, peripheral blood oxygen saturation, adenoid hyperplasia degree of nasopharyngeal lateral film as parameters were analyzed, and the sensitivity and specificity of infrared detection was determined to confirm the diagnostic value of OSAHS. It provides a theoretical basis for finding a convenient, non-damaging, non-radiation, visual and suitable for children functional image detection method.

Eligibility criteria: Inclusion Criteria:

* Children ages 2 to 14 with SDB related symptoms

Exclusion Criteria:

* 1) Congenital abnormalities of the nose and throat or airway;

  2) craniofacial deformity

  3) Neuromuscular dysregulation

  4) History of adenoids and/or tonsillectomy.

Primary outcomes:
measure: Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity
timeFrame: 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Lijun Zeng [lzeng]
state: Uangdong
Study officials:
References:
Clinical trial NCT02958527: Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)
Official title: DRUG USE INVESTIGATION OF EFFEXOR(REGISTERED) SR CAPSULES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression/Depressed State
Keywords: Effexor
Depression
Depressed state
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-11-08
Enrollment: 1408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study

Brief summary: SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE

Detailed description: This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. 12 weeks from the start date. The patients who completed the 12-week treatment with this product will be observed up until Week 52.

Eligibility criteria: Inclusion Criteria:

* Patients with no experience of using this product who will be administered this product for the first time

Exclusion Criteria:

* Exclusion criteria are not provided in this study

Primary outcomes:
measure: Number of Participants With Adverse Drug Reactions
timeFrame: 12 weeks from the start date (up until 52 weeks)
Secondary outcomes:
measure: Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points
timeFrame: 12 weeks from the start date ( up until 52 weeks)
measure: Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points
timeFrame: 12 weeks from the start date ( up until 52 weeks)
measure: Clinical Global Impressions-Severity
timeFrame: 12 weeks from the start date (up until 52 weeks)
measure: Changes in the Clinical Global Impressions-Improvement
timeFrame: 12 weeks from the start date (up until 52 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06451627: Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery
Official title: Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esketamine
Sleep Disturbance
Spinal Surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are:

* To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery.
* To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old,
* American Society of Anesthesiologist (ASA) Physical Status classification I to III ;
* Patients scheduled to undergo elective spinal surgery under general anesthesia;
* Signed informed consent ;

Exclusion Criteria:

* BMI \> 35kg / m2 ;
* Severe lesions of important organs and systems ;
* The estimated duration of surgery is more than 4 hours
* Patients who were retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively.
* History of adverse reactions or contraindications to ketamine and esketamine ;
* Cognitive dysfunction, communication disorders ;
* Refused to participate in this study.

Primary outcomes:
measure: The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery
timeFrame: during the first three days after surgery
Secondary outcomes:
measure: objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment.
timeFrame: on the postoperative day 1 and postoperative day 3 after surgery
measure: The pain scores
timeFrame: within 72hours after surgery
measure: dosage of analgesics
timeFrame: within 72 hours after surgery
measure: Postoperative hospital anxiety and depression scale ( HADS ) score.
timeFrame: on the postoperative day 1 and postoperative day 3 after surgery
Other outcomes:
measure: The incidence of all drug-related adverse events
timeFrame: within 72hours after surgery
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital
Study officials:
References:
Clinical trial NCT02291627: Pediatric Intubation With Difficult Airway
Official title: Comparison of the Macintosh, Coopdech and AirTraq Laryngoscopes Using a Rigid Neck Collar in Pediatric Patients With Simulated Difficult Laryngoscopy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Intubation, Endotracheal
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 120
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: TREATMENT

Brief summary: The aim of this study was to compare time, success rates of different video laryngoscopes for the emergency intubation with an immobilized cervical spine in a standardized pediatric manikin model.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Intubation time
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434727: Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures.
Official title: A Retrospective Multicenter Study for Intuitive 3D Models (I3DM), During Simulated Preoperative Surgical Planning for Anatomic Lung Resection and Lower Anterior Resection Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic
Colorectal Disorders
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure will be considered for this study.

Brief summary: The Study Objective: To evaluate the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.

Detailed description: This is a Retrospective study evaluating the clinical utility of a 3D model with 2D CT/MRI scans during simulated preoperative surgical planning of open, laparoscopic, or robotic-assisted anatomic lung resection (segmentectomy, lobectomy) or Lower Anterior Resection (LAR) procedures.

Eligibility criteria: Inclusion Criteria:

- DICOM images from Subjects 18 years or older who have undergone either anatomic lung resection (segmentectomy, lobectomy) or a Lower Anterior Resection procedure

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Clinical Utility of 3D Model vs standard 2D in Preoperative Surgcial Planning
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center
state: Louisiana
city: Manhasset
country: United States
facility: The Feinstein Institutes for Medical Research
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: