louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01423773: Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
Official title: Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Comfort
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Bascom Palmer Eye Institute
First posted: 2011-08-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Detailed description: The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Eligibility criteria: Inclusion Criteria:

* Be of legal age of consent and sign Informed Consent document.
* Normal binocularity.
* Be able to wear soft contact lenses.
* Willing to comply with the wear and study visit schedule.
* Spherical contact lens prescription within 0.50 diopter of the available lens powers.
* Spectacle cylinder less than or equal to 1.50 diopter.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks of enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Final Comfort
timeFrame: Day 2, Hour 10
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: McKnight Building, Bascom Palmer Eye Institute
state: Florida
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Jianhua Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06875973: Pelacarsen Roll-over Extension Program
Official title: A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Atherosclerotic Cardiovascular Disease
Keywords: TQJ230
Lp(a)
ASCVD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Rollover extension program (REP)
Primary purpose: TREATMENT

Brief summary: This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).

Detailed description: This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in patients with elevated Lp(a) and established ASCVD. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study.

Eligibility criteria: Inclusion Criteria:

* Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
* Participants who have completed the parent study and received the assigned study treatment at the time of its completion

Exclusion Criteria:

* Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study
* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation
* Participants who are receiving another investigational drug or device before the open-label treatment period
* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Incidence of Adverse events (AEs) or serious adverse events (SAEs)
timeFrame: 36 months
Secondary outcomes:
measure: Observed value and change in Lipoprotein(a) (Lp(a)) compared to baseline of the parent study
timeFrame: Baseline of the core study, Month 3, 12, 24, 36, 48
measure: Observed value and change in Lp(a) compared to baseline of the rollover extension program (REP) study
timeFrame: Baseline of the REP study, Month 3, 12, 24, 36, 48
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05040373: Patisiran-Lipid Nanoparticle (LNP) Pregnancy Surveillance Program
Official title: Patisiran-LNP Pregnancy Surveillance Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Transthyretin-mediated (hATTR) Amyloidosis
Polyneuropathy
Keywords: Hereditary neuropathic amyloidosis
Familial amyloidosis
Amyloidosis
Amyloidosis senile
Cardiac amyloidosis
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any woman exposed to patisiran-LNP 12 weeks prior to their last menstrual period (LMP) or at any time during pregnancy.

Brief summary: The purpose of this study is to collect and evaluate pregnancy outcomes, pregnancy complications, and fetal/neonatal/infant outcomes in women exposed to patisiran-LNP.


Eligibility criteria: Inclusion Criteria:

* Documentation that the patient was exposed to patisiran-LNP at any point starting from 12 weeks before LMP or at any point during pregnancy

Exclusion Criteria:

* There are no exclusion criteria for participation in this program.

Primary outcomes:
measure: Prevalence of Major Congenital Malformations
timeFrame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Secondary outcomes:
measure: Prevalence of Minor Congenital Malformations
timeFrame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
measure: Prevalence of Pregnancy Outcomes
timeFrame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
measure: Prevalence of Other Adverse Fetal/Neonatal/Infant Outcomes
timeFrame: From 12 weeks prior to last dose of patisiran through one year after birth (Up to 21 months)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Clinical Trial Site
state: Iowa
city: Nantes
country: France
facility: Clinical Trial Site
city: Münster
country: Germany
facility: Clinical Trial Site
city: Pavia
country: Italy
facility: Clinical Trial Site
city: Groningen
country: Netherlands
facility: Clinical Trial Site
city: Lisboa
country: Portugal
facility: Clinical Trial Site
city: Madrid
country: Spain
facility: Clinical Trial Site
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02296073: The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
Official title: The Efficacy and the Safety of Dexmedetomidine Sedation on the PICU Patients-A Randomized, Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Failed Conscious Sedation During Procedure
Keywords: Pediatric intensive care unit
Sedation
Dexmedetomidine
mechanical ventilation
Lead sponsor: Anhui Provincial Children's Hospital
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.


Eligibility criteria: Inclusion Criteria:

1. written informed consent；
2. pediatric patients admitted to intensive care unit after general anesthesia;
3. expected mechanical ventilation time \>6 hours; （4）1 months to 16 years old; -

Exclusion Criteria:

1. congenital heart disease, arrhythmias and heart failure;
2. Alanine transaminase（ALT） and (or) Aspartate aminotransferase（AST） level is more than twice the upper limit of normal;
3. Creatinine and (or) Blood urea nitrogen（BUN） is more than the upper limit of normal;
4. central nervous system disease;
5. spinal analgesia or muscle relaxants is used during PICU;
6. the drug that affects the nerve conduction is used in one month;
7. allergy to the test drug or having other contraindications;
8. participated in other studies 30 days prior to admission of PICU; -

Primary outcomes:
measure: percentage of time at target sedation score
timeFrame: up to 24 hours
measure: the number of patients requiring the sedation remedy
timeFrame: up to 24 hours
measure: the dosage of midazolam that need for the sedation remedy
timeFrame: up to 24 hours
Secondary outcomes:
measure: change of blood pressure
timeFrame: up to 24 hours.
measure: change of heart rate
timeFrame: up to 24 hours
measure: change of respiratory rate
timeFrame: up to 24 hours
measure: change of blood oxygen saturation
timeFrame: up to 24 hours
measure: extubation time
timeFrame: up to 24 hours
measure: change of hepatic function
timeFrame: up to 24 hours
measure: change of renal function
timeFrame: up to 24 hours
measure: the dosage of sedation and analgesia drug
timeFrame: up to 24 hours
measure: the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used
timeFrame: up to 24 hours
measure: the dosage of fentanyl in and after 6 hours from study drug used
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06092073: Bilateral Recto-Intercostal Fascial Plane Block in Epigastric Hernia Repair
Official title: Efficacy and Safety of Bilateral Recto-Intercostal Fascial Plane Block on Perioperative Analgesia in Epigastric Hernia Repair : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recto-intercostal Fascial Plane Block
Epigastric Hernia
Analgesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 40
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 aim of this study is to evaluate the efficacy and safety bilateral recto-intercostal fascial plane block (RIFPB) in epigastric hernia.

Detailed description: Epigastric hernias are usually occult in obese patients, and their symptoms may mimic peptic ulcer or gallbladder disease . Hernia repair is associated with considerable postoperative pain.

The recto-intercostal fascial plane block (RIFPB) is a new novel approach that was developed by Tulgar et al., 2023 who hypothesized that when we inject a local anesthetic into the interfacial plane just inferolateral to the xiphoid, between the rectus abdominis muscle and the 6-7th costal cartilages (hence, between the cartilages and the intercostal muscles between them), blockade of the anterior branches of the nerves passing through this area can be guaranteed.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for elective epigastric hernia repair.

Exclusion Criteria:

* Obese patients with body mass index (BMI) \>35 kg/m2.
* Patients with a large hernia containing bowel.
* Patients with local anesthetic allergy.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total morphine consumption in the 1st 24hr
timeFrame: 24 hours postoperatively
measure: Pain score
timeFrame: 24 hours postoperatively
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively.
measure: Intraoperative mean arterial pressure
timeFrame: Till the end of surgery.
measure: Intraoperative heart rate
timeFrame: Till the end of surgery.
measure: Complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT04766073: Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
Official title: Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Uterine Bleeding
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 183
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the last decade we have been exposed to the complication of a caesarean section called a "niche". A niche is an anaerobic defect in the location of the cesarean section, which represents the discontinuity of the endometrium and myometrium. A niche is usually diagnosed by ultrasound, and can also be diagnosed by hysterosalpingogram or hysteroscopy. In the presence of a niche women suffer more frequently from irregular bleeding, dysmenorrhea, chronic pelvic pain, and dyspareunia. We believe that a combination of tissue ischemia and thinning of the scar tissue that forms, causes a niche to form. Large randomized studies regarding the preferred surgical technique in cesarean section, including various methods of incision closure have found that there is no single method that is obviously superior. However, these studies did not examine niche formation as a complication of cesarean section.

In this study we will examine whether a unique incision closure method reduces post-cesarean niche formation.


Eligibility criteria: Inclusion Criteria:

* Women at first cesarean delivery
* Women who consent to the study

Exclusion Criteria:

* Women who are having a repeat caesarean section
* Refusal to participate in the study
* Urgent or emergent cesarean delivery

Primary outcomes:
measure: Formation of a uterine niche
timeFrame: At least 12 weeks after delivery.
Secondary outcomes:
measure: Duration of surgery
timeFrame: At surgery
measure: Blood loss over 1000 mL
timeFrame: At surgery
measure: Postoperative infection
timeFrame: Up to 6 weeks after intervention
measure: Need for repeat laparotomy
timeFrame: Up to 6 weeks after intervention
measure: Formation of a n abscess/hematoma
timeFrame: Up to 6 weeks after intervention
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Hila Hochler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05904873: Cold Press Test and Post Operative Pain Relationship
Official title: Can a Preoperative Cold Press Test be a Predictor of Pain After Third Molar Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain, Acute
Pain Threshold
Keywords: Cold Pressor Test
Post-operative Pain
Mandibular Third Molar
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 30
Sex: MALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to investigate whether it is possible to get a preliminary idea about the postoperative pain in the patient with the results of a practical cold press test applied to American Society of Anesthesiologists(ASA) 1 and 2, healthy, male patients aged 16-35 before extraction of the lower third molar. The main question it aims to answer are:

• Can post-operative pain be predicted with an cold test that can be applied more practically than conventional quantitative sensory tests applied preoperatively? Participants will need to keep their hands on ice for 240 seconds prior to third molar surgery. When they take their hands off the ice, they will be asked to describe their pain on the visual analog scale. After the operation, the participants are required to mark whether they use painkillers every 8 hours in their pain follow-up forms and the pain they feel according to the visual analog scale.

Depending on the endurance time of the participants to keep their hands on the ice; Two different groups were determined as less than 240 sec and equal to 240 sec. The pain scores and the amount of painkiller use between these two groups were compared with each other.


Eligibility criteria: Inclusion Criteria:

* The impacted third molar should be class 1 or 2 and position B according to Pell \& Gregory classification.
* The impacted third molar should be asymptomatic.
* The impacted third molar should be located in the mandible and be in the mesioangular or vertical position.
* To be male gender
* To be in American Society of Anesthesiologists 1 or 2 classification
* To be between the ages of 16-35

Exclusion Criteria:

* Intolerance to non-steroidal anti-inflammatory drugs
* Smoking more than 10 cigarettes a day
* Operation time exceeding 20 minutes
* Individuals who have performed third molar tooth extraction

Primary outcomes:
measure: Measurement of Post-Operative Pain
timeFrame: 4 days
Secondary outcomes:
measure: Measurement of Painkiller Use In The Post Operative Period
timeFrame: 4 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: Sinem Busra Kirac Can
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Gülcan Berkel, Asist Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01249573: The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain
Official title: The Effect of Fascia Therapy and Transcutaneous Fibrolysis on Acute Ankle Sprain in Young Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ankle Distortion
Keywords: fascia therapy
transcutaneous fibrolysis
acute ankle distortion
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the immediate effect of fascia therapy and transcutaneous fibrolysis in the treatment of an acute ankle sprain. These treatments will be compared to a placebo group.

Detailed description: Ankle sprain is the most occurring sport related injury. In spite of the high prevalence of this injury and the often residual symptoms, there is a large variety in diagnostic approach and therapeutic protocols. Concerning the treatment of an acute ankle sprain, it remains a challenge to minimize injury consequences on short and long term.

In this study we investigate the immediate effect of two therapeutic techniques: fascia therapy and transcutaneous fibrolysis. They will be compared to a third group, who receives a placebo treatment. Muscle strength, muscle vascularisation, muscle tenderness and joint position sense are measured before and after treatment.

The purpose of this study is to contribute to the knowledge of treating acute ankle sprains.

Eligibility criteria: Inclusion Criteria:

* acute ankle sprain

Exclusion Criteria:

* none

Primary outcomes:
measure: effect of fascia therapy
timeFrame: baseline measurements and within 1 hour after treatment
Secondary outcomes:
measure: complaints registration
timeFrame: baseline, 1 hour after treatment and 3 days later
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Ghent
name: Philip Roosen, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01395173: Position Changes During Colonoscope Withdrawal and Polyp Detection
Official title: Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Keywords: detection
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 776
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate.


Eligibility criteria: Inclusion Criteria:

* Outpatients undergoing colonoscopy
* Age 40 or greater

Exclusion Criteria:

* Inpatient colonoscopy
* Unable to provide informed consent
* Unable to complete colonoscopy to cecum
* Previous bowel resection, inflammatory bowel disease, polyposis syndrome
* Musculoskeletal disorder or other mobility issue limiting effective patient position changes
* Inadequate bowel preparation

Primary outcomes:
measure: Polyp detection rate
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jennifer Telford, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ou G, Kim E, Lakzadeh P, Tong J, Enns R, Ramji A, Whittaker S, Ko HH, Bressler B, Halparin L, Lam E, Amar J, Telford J. A randomized controlled trial assessing the effect of prescribed patient position changes during colonoscope withdrawal on adenoma detection. Gastrointest Endosc. 2014 Aug;80(2):277-83. doi: 10.1016/j.gie.2014.01.032. Epub 2014 Mar 12.