louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03777592: Perioperative Erector Spinae Plane Block in Thoracoscopic Surgery
Official title: Correlation Between Perioperative Erector Spinae Plane Block and Postoperative Pain in Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Regional Block
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The erector spinae plane block (ESPB) is a novel myofascial plane block. The ESPB is targeted at anterior surface of the erector spinae plane, which is oriented cephalocaudally to the spinal transverse process. Local anaesthetic injected in this plane can block the dorsal rami and ventral rami and intercostal nerves. The aim of this study was to evaluate the effect of ESPB on postoperative pain in thoracic surgery.

Detailed description: The erector spinae plane block (ESPB) is a newly defined regional anesthesia technique for thoracic analgesia. The blocks were performed at the T5 level of the spine using an in-plane approach.Previous studies were not designed as randomized controlled trial. In this study, the efficacy of ESPB is to confirm with randomized controlled trial design. ESPB will be performed in video assisted thoracoscopy preoperatively. After the surgery, the efficacy of ESPB will be assessed.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Patients with physical class 1, 2
* Patients undergoing video assisted thoracoscopic surgery

Exclusion Criteria:

* Patients who experienced side effects on local anesthetics
* Patients with abnormal blood coagulation tests (INR\> 1.5)
* Pregnant or lactating patients

Primary outcomes:
measure: Pain scale
timeFrame: the first 5 min after arriving at the recovery room
measure: Pain scale
timeFrame: 20 min after arriving at the recovery room
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KangbukSamsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Sung Hyun Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01340989: CO2 Absorption During Laparoscopy
Official title: Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Keywords: women undergoing laparoscopic surgery for: hysterectomy, colpopexy, endometriosis, adhesions or myomas
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2011-04-25
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures. Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion through prevention of mesothelial hypoxia. We want to prove this concept in human and expand it to the use of full conditioning.

Detailed description: In order to confirm the animal data in the human, a first RCT was performed in which 20 women undergoing a laparoscopy for at least 60 minutes were randomised to a pneumoperitoneum with either 100% carbon dioxide or 96% carbon dioxide plus 4% of oxygen. Insufflation pressure and Trendelenburg were standardised at 15 mm Hg and 30° respectively. In a second trial women were randomized to either 100% carbon dioxide or 86% carbon dioxide plus 4% of oxygen + 10% nitrous oxide + humidification and set temperature of 32°C of the peritoneal cavity.

Eligibility criteria: Inclusion Criteria:

* Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent

Exclusion Criteria:

* Pregnancy
* Immunodeficiency
* Refuse or unable to sign informed consent
* Chronic disease (i.e. COPD, Crohn, cardiac...)

Primary outcomes:
measure: CO2 absorption
timeFrame: measurements for 60 to 240 minutes on average during surgery
Secondary outcomes:
measure: hemodynamic alterations
timeFrame: measurements for 60 to 240 minutes on average during surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven, campus Gasthuisberg
Study officials:
References:
Clinical trial NCT05837689: Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
Official title: Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric BCP-ALL patients who were treated in our institution since Oct 2021

Brief summary: A retrospective analysis to investigate pediatric B-cell acute lymphoblastic leukemia patients who were treated with blinatumomab for consolidation, and who were detected as minimal residual disease (MRD) positive by next generation sequencing (NGS). The efficacy of blinatumomab clearing MRD detected by NGS will be analyzed, in order to see the potential of using NGS to guide MRD eradication by blinatumomab.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with B cell precursor acute lymphoblastic leukemia
* Patients who received blinatumomab for consolidation
* Patients who were detected MRD positive by NGS before initiation of blinatumomab treatment

Exclusion Criteria:

* Patients without data of NGS detection after receiving blinatumomab treatment

Primary outcomes:
measure: MRD clearance rate (MRD<0.00001%)
timeFrame: before blinatumomab initiation (baseline), Day 15 of blinatumomab treatment, Day 29 of blinatumomab treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06252389: Degenerative Achilles Tendon Rupture Repair With Regeneten Augmentation
Official title: Treating Achilles Tendon Rupture Complicated by Pre-existing Tendinopathy With Repair Augmented With a Bioinductive Collagen Implant
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Achilles Tendon Rupture
Achilles Tendinopathy
Keywords: Achilles
Regeneten
Tendinopathy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals admitted with an acute Achilles tendon rupture

Brief summary: Retrospective Case Series to investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy

Detailed description: Retrospective Case Series. Investigate the effect a bovine collagen patch to augmented repair in acute Achilles tendon rupture with pre-existing tendinopathy.

Acute Achilles tendon rupture patients all underwent pre-operative ultrasound; those with tendinopathy enrolled into study.

Standard Achilles tendon repair performed; augmented with a bioinductive collagen patch (Regeneten)

Eligibility criteria: Inclusion Criteria:

* Pre-operative ultrasound confirmation of tendinopathy

Exclusion Criteria:

* Underwent lower limb intervention with past 3 months
* Physical or psychological condition impairing ability to consent
* Physical or psychological condition impairing ability to adhere to rehabilitation protocol
* allergy to bovine material
* pregnant individuals

Primary outcomes:
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
Secondary outcomes:
measure: Victoria Institute of Sports Assessment - Achilles (VISA-A)
timeFrame: 2 weeks, 6 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: SAR
Study officials:
References:
Clinical trial NCT05456789: Catheter-interventional Treatment of Pulmonary Embolism
Official title: A Randomized Trial for Catheter-interventional Treatment of Intermediate High Risk Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 20
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: Recent evidence supports the use of catheter-interventional techniques for the treatment of intermediate-high-risk pulmonary embolism. While there is evidence supporting the use of catheter-thrombectomy and alternatively local fibrinolysis, less is known on the combination of both approaches.

The investigators aim to assess the effects of a combined interventional local fibrinolysis and catheter-thrombectomy and to compare them with conventional treatment in a cohort of patients with intermediate-high-risk pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

* confirmed intermediate high-risk pulmonary embolism
* age \>= 18 years

Exclusion Criteria:

* high-risk pulmonary embolism
* contraindications for catheter-based treatment
* known allergy to anticoagulant treatment or fibrinolytics
* pregnancy
* participation in other randomized trials
* patients under legal supervision or guardianship

Primary outcomes:
measure: RV-LV-Ratio
timeFrame: Day 1 after randomization
measure: clinical efficacy
timeFrame: Day 1 after randomization
Secondary outcomes:
measure: Mortality
timeFrame: 1 day, 30 days, 1 year after randomization
measure: Right heart failure
timeFrame: 30 days and 1 year after randomization
measure: pulmonary artery pressure
timeFrame: 1 day, 30 days and 1 year after randomization
measure: RV/LV-ratio
timeFrame: 30 days and 1 year after randomization
measure: TAPSE
timeFrame: 1 day, 30 days and 1 year after randomization
measure: difference in RA volume between the groups
timeFrame: 1 day, 30 days and 1 year after randomization
measure: Bleeding
timeFrame: 1 day, 30 days and 1 year after randomization
measure: Troponin and NT-proBNP
timeFrame: 30 days and 1 year after randomization
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig
state: Saxony
Study officials:
References:
Clinical trial NCT01417689: Eyedrop Instillation Technique
Official title: Eyedrop Instillation Technique: A Randomizaed Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Glaucoma Suspect
Keywords: glaucoma
randomized controlled trial
eye drops
instillation
compliance
Lead sponsor: Oftalmologia Hospital Sotero del Rio
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 230
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: Eye drop instillation is a problem from glaucoma patients. Studies reveal that 30-50% of glaucoma patients have problems instilling their eyedrops. These problems include not hitting the eye, spending many drops to get a single successful instillation and bottle contamination.

The present study will evaluate the effect of encouraging patients to put their eyedrops using one of 2 techniques, randomly assigned, to determine which is more successful at instilling the eye drop into the eye while spending the least amount of drug.

In one of the techniques the patient instills the eye drop with their eyes open in the inferior cul de sac. In the other technique the patient instills the eye drop with the eyes closed near the inner canthal region.

Patients will be randomized to encouragement to use the drops with either of the techniques. Encouragement will take place over a visit where they will be subjected to:

* Baseline evaluation of eye drop instillation using their usual technique.
* Short (2-5 minute) educational session session for the assigned technique.
* Followup evaluation immediately after the educational session.


Eligibility criteria: Inclusion Criteria:

* Glaucoma or glaucoma suspect
* Use of topical glaucoma medication in both eyes for at least 1 year prior to enrollment
* VA of 20/60 or better with habitual correction in at least one eye

Exclusion Criteria:

* Previous history of allergy to fluorescein
* Received topical anesthesia for IOP measurement or other reason within the last 2 hours.
* Rejects participation

Primary outcomes:
measure: Complete success
timeFrame: Day 1. Immediately after intervention.
Secondary outcomes:
measure: Qualified success
timeFrame: Day 1. Same day as intervention.
measure: Number of drops
timeFrame: Day 1.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Sotero del Rio
state: RM
Study officials:
affiliation: Pontificia Universidad Catolica de Chile. Hospital Sotero del Rio.
name: Eugenio A Maul, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331689: EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE
Official title: EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Mortality Rate
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with postoperative hip fractures in intensive care

Brief summary: Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.

Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation.

Detailed description: The proportion of elderly individual aged 65 and over in the global populatin is currently %9 and hip fractures (HFs) are a leading injury in this population worldwide. We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with postoperative hip fractures hospitalized in the intensive care unit of our hospital

Exclusion Criteria:

* Patients who do not have a hip fracture operation will not be included.

Primary outcomes:
measure: mortalite ratio
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University
Study officials:
affiliation: Kutahya HSU
name: EMEL YILDIZ, Ass. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01272089: A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Official title: A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.


Eligibility criteria: Inclusion Criteria:

* History (within the past 24 months) of allergic conjunctivitis.
* Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.
* Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the study medication or its components.
* Inability or unwillingness to follow all study instructions and complete study visits as required.
* Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.
* A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).
* Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Patient Satisfaction
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Kolkata
country: India
Study officials:
References:
Clinical trial NCT04477889: Methodist Health System COVID-19 Patient Registry
Official title: Methodist Health System COVID-19 Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who are treated at MHS facilities for COVID-19.

Brief summary: This is a prospective cohort observational registry study that will include data on all patients who are treated at MHS facilities for COVID-19.

Detailed description: This is a prospective cohort observational registry study that will include data on all patients who are treated at MHS facilities for COVID-19. Data including, but not limited to demographics, comorbidities, medications, treatment, and clinical outcomes will be collected from February 2020 to December 2025. Subjects will undergo no additional tests or procedures as part of this registry study. All patient data will be obtained from the patient's electronic health records (EHR) of the hospital or clinic in a retrospective manner. The process for gathering the data will not influence treatment decisions. There will be no direct patient contact associated with inclusion in this registry study.

Eligibility criteria: Inclusion Criteria:

* Patient tested positive for COVID-19 (SARS-CoV-2)
* Patient sought care for COVID-19 at a MHS facility
* Aged 18 years or older

Exclusion Criteria:

* Patient that do not have COVID-19
* Non-confirmed COVID-19 patients
* Aged 17 years or younger

Primary outcomes:
measure: Patient Characteristics
timeFrame: June 2020 - Dec 2025
measure: Treatment Measures and Intervention strategies
timeFrame: June 2020 - Dec 2025
measure: Clinical and survival outcomes
timeFrame: June 2020 - Dec 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Research Institute Methodist Health System
state: Texas
Study officials:
affiliation: Methodist Health System
name: Crystee Cooper, DHEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02596789: Cortical Excitability Using Transcranial Magnetic Stimulation and Neuronavigation Device
Official title: Study of Cortical Excitability in Healthy Subjects With Transcranial Magnetic Stimulation (TMS) and a Neuronavigation Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study has two main goals :

* to investigate the impact of aging on cortical excitability (CE)
* to investigate the impact of "state dependency" on CE, using a cognitive task and an emotional one.

A Neuronavigation system of transcranial magnetic stimulation is used, and electromyographic response are recorded.


Eligibility criteria: Inclusion Criteria:

* male or female
* age 18-75
* signed informed consent
* normal physical examination

Exclusion Criteria:

* less 18 or more 75 years of age
* contra indication to TMS: epilepsia or seizures, metallic head devices, cardiac pacemaker, pregnancy, jet lag or severe insomnia the night before
* severe physical disease
* treatment with psychotropic drugs
* overt psychiatric disease
* alcohol consumption before the examination

Primary outcomes:
measure: Amplitudes of Motor evoked Potentials (µV) for ICI and ICF.
timeFrame: Participants will be followed for an expected average of one month
measure: Durations of Cortical Silent Period (ms)
timeFrame: Participants will be followed for an expected average of one month
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Department of Psychiatry & Neurology - University Hospital Grenoble
Study officials:
affiliation: University of Grenoble
name: Thierry BOUGEROL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: