louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04414670: Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele
Official title: Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic or Robotic Metroplasty
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: uterine isthmocele status post laparoscopic or robotic metroplasty

Brief summary: To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for uterine isthmocele with the aid of a bending probe.


Eligibility criteria: Inclusion Criteria:

* \> 20 years of women
* uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine sound

Exclusion Criteria:

* Those underwent traditional open surgery.

Primary outcomes:
measure: Change of prolonged menstrual bleeding condition
timeFrame: 10 years
Secondary outcomes:
measure: Change of scar defect size
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT05896670: Safety and Efficacy of Licaminlimab Ophthalmic Solution for the Treatment of Dry Eye Disease
Official title: A Multi-center, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Licaminlimab for the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Keywords: Ophthalmology
Topical Ophthalmic Solution
Eye Drop
DED
Lead sponsor: Oculis
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2023-06-09
Enrollment: 122
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 goal of this clinical trial is to learn about licaminlimab (OCS-02) in the treatment of dry eye disease. The main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease.

Detailed description: This is a Phase 2b, multicenter, randomized, double-masked, active-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age.
* Provide written informed consent.
* Be willing and able to comply with all study procedures.
* Have a history of dry eye disease for at least 6 months prior to Visit 1.

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at least one eye at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters.
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation in at least one eye at Visit 1 or Visit 2.
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses in the study eye during the study.

  * Additional inclusion/exclusion criteria apply.

Primary outcomes:
measure: To evaluate the efficacy of licaminlimab in subjects with signs of dry eye disease
timeFrame: Baseline to Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Oculis Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Oculis Investigative Site
state: Colorado
city: Shelby
country: United States
facility: Oculis Investigative Site
state: North Carolina
city: Erie
country: United States
facility: Oculis Investigative Site
state: Pennsylvania
city: Memphis
country: United States
facility: Oculis Investigative Site
state: Tennessee
Study officials:
affiliation: Oculis
name: Sharon Klier, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04184570: Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
Official title: Audit of International Intraoperative Hemotherapy and Blood Loss Documentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Patient Blood Management
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: International anesthetic records

Brief summary: The investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. Therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained.

Detailed description: The anaesthetic record is the primary way anesthetists document and communicate information regarding hemotherapy. Records vary in content and design. Several organizations published recommendations, but perioperative hemotherapy is not sufficiently detailed for the purpose.

Anesthetic records will be analyzed for 20 defined hemotherapy and monitoring items by two independent investigators. Disagreements will be resolved by a the principle investigator.

Eligibility criteria: Inclusion Criteria:

* Anesthetic records

Exclusion Criteria:

* Incomplete records

Primary outcomes:
measure: Contained items in anesthetic records
timeFrame: 11/01/2019 - 12/01/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University
state: NRW
Study officials:
affiliation: Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
name: Florian Piekarski, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982670: A Study of the Metabolic Syndrome in Patients With Systemic Lupus Erythematosus
Official title: Association of the Metabolic Syndrome and Systemic Lupus Erythematosus in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Cardiovascular Risk Factors
Systemic Lupus Erythematosus
Keywords: Metabolic syndrome
Systemic lupus erythematosus
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons aged 18 and above.

Brief summary: An increased prevalence of the metabolic syndrome has been found in patients with systemic lupus erythematosus in recent years.

Detailed description: This study will investigate the prevalence of the metabolic syndrome in patients with SLE in Taiwan. We expect our study will provide further understanding of the association between SLE and metabolic syndrome, which may give direction to prevent late cardiovascular morbidity and mortality in SLE patients.

Eligibility criteria: Inclusion Criteria:

* Persons aged 18 and above.
* Persons fulfill the diagnostic criteria of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group.

Exclusion Criteria:

* Exclude a history myocardial infarction, angina or stroke.

Primary outcomes:
measure: The prevalence of the metabolic syndrome in patients with systemic lupus erythematosus in Taiwan
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Chiao, Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chun-Chen Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00743470: A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects
Official title: A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: HIV
Tuberculosis
Keywords: HIV co-infected with tuberculosis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Adult Male or Female 18-55 yrs.
* Subject has provided written consent.
* Subject is in general good health.
* If female, subject is postmenopausal.
* If female, subject is not pregnant and is not breast-feeding.
* Subject must use birth control methods or be surgically sterile.

Exclusion Criteria:

* Subject is HAV-IgM, HBsAg or HIV Ab positive.
* Positive screen for drugs of abuse, alcohol, or smoking.
* Cannot be on any medication, including over the counter drugs.
* Cannot have previous history of alcohol or drug abuse.
* Cannot have history of any major diseases or disorders.

Primary outcomes:
measure: Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.
timeFrame: Approximately 0.5 - 1 month
measure: Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
timeFrame: Approximately 0.5 - 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 11441
state: Illinois
Study officials:
affiliation: Abbott
name: Angela Nilius, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02135770: Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis
Official title: Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Sepsis With Septic Shock
Severe Sepsis Without Septic Shock
Keywords: heparin
sepsis
inflammation
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sepsis is a clinical syndrome which infection trigger systemic inflammatory response. Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor necrosis factor alpha.

Aim of this study is to determine effects of low dose unfractionated heparin treatment on inflammation in severe sepsis patient.


Eligibility criteria: Inclusion Criteria:

* Patients with severe sepsis and septic shock define by revised Sepsis Criteria (2001)
* Within 48 hour diagnose sepsis
* Agree to participate

Exclusion Criteria:

* Pregnancy and lactation
* Severe thrombocytopenia, platelet less than 30.000/mm3
* Bleeding or high risk of major bleeding
* During anticoagulant treatment
* After thrombolytic treatment
* Decompensated chronic liver diseases
* Chronic kidney diseases on dialysis treatment
* During high dose corticosteroid treatment
* HIV with CD4 count below 50/mm3
* Indication for high dose heparin treatment

Primary outcomes:
measure: inflammation
timeFrame: 3 days
Secondary outcomes:
measure: clinical outcome
timeFrame: 14 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Dr. Cipto Mangunkusumo General Hospital
Study officials:
References:
Clinical trial NCT02077270: Pretreatment With Electroacupuncture to Reduce Discomfort
Official title: Pretreatment With Electroacupuncture to Reduce Discomfort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: colonoscopy
acupuncture
pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main hypothesis is that performance of electroacupuncture before colonoscopy reduces pain during the exam.

Detailed description: To assess the efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult Patients referred for their first colonoscopy in the department of GI in Sheba, Tel Hashomer

Exclusion Criteria:

1. Ages \<18y \>75y
2. Any prior gastrointestinal endoscopy.
3. History of colonic resection.
4. Known or suspected stenosis of the colon.
5. Pregnancy.
6. Inflammatory bowel disease
7. Neuropsychiatric disorders or receiving psychotropic drugs.
8. Prior knowledge or experience of acupuncture.

Primary outcomes:
measure: Efficacy of pre-colonoscopic electroacupuncture in reducing discomfort during colonoscopy by measuring sedative drug amounts during colonoscopy
timeFrame: during the colonoscopy and in the hour post procedure
Secondary outcomes:
measure: Time of insertion till the cecum.
timeFrame: during colonoscopy
measure: Time of post-colonoscopy recovery as measured by the Aldrete score
timeFrame: up to 1 hour post colonoscopy
measure: Number of intra-examination adverse events.
timeFrame: from the begining of the endoscopy and up to 1 hour post procedure
measure: Patient's total satisfaction with the exam and the analgesia
timeFrame: between the end of the procedure and up to 1 hour post procedure
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02361970: Study on the Role of Gamma Delta T Cells in Sepsis Immunosuppression and Its Molecular Mechanism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
gamma delta T cells
immunosuppression
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in ICUs of West China Hospital

Brief summary: The purpose of the study is to evaluate the status and function of gamma delta T cells in peripheral blood of sepsis patients.

Detailed description: Sepsis therapy is a prominent problem of the modern critical care medicine,and improving the level of sepsis treatment by immune intervention measures is a hot research topic with close attention.Gamma delta T cells is considered as one new T lymphocyte subset in recent years,which playing an important role in resistance to infection,anti-tumor and immune regulating function in the body.First,we played attention to the status and function of gamma delta T cells in peripheral blood of sepsis patients including differentiation marker,subtype and production of related cytokine,and then the molecular mechanism of insufficient gamma delta T cells.At the same time the responsibility of gamma delta T cells of sepsis patients to certain bacteria and viral antigen and the regulation of gamma delta T cells on other natural immune cells including NK cells and mononuclear cells were studied to identify the status and role gamma delta T cells in sepsis immunosuppression by culture in vitro.Further we studied the effect of specific stimulants on proliferation and activation of gamma delta T cells in patients with sepsis and also anti-infection acquired by gamma delta T cells,expecting as an entry point to explore new treatment strategy to sepsis.

Eligibility criteria: Inclusion Criteria:

* clinical symptoms of severe sepsis and septic shock
* age over 18 years

Exclusion Criteria:

* preexisting autoimmune disease
* patients received immuno-suppressive treatment in the previous 6 months
* patients with chronic infection,e.g.tuberculosis,hepatitis or HIV infection,etc.
* pregnancy

Primary outcomes:
measure: The percentage of activated gamma delta T cells
timeFrame: within 24h after recruitment
Secondary outcomes:
measure: The percentage of apoptotic gamma delta T cells
timeFrame: within 24h after recruitment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
Study officials:
References:
Clinical trial NCT04600570: Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers
Official title: Ultrasonographic Measurement of the Optic Nerve Sheath Diameter in the Taiwanese Healthy Volunteers and Its Associating Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Normal Diameter of Optic Nerve
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal volunteers

Brief summary: The investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. We plan to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Detailed description: Ultrasound measurement of optic nerve sheath diameter (ONSD) had been considered as a non-invasive way to distinguish the presence of elevated intracranial pressure (ICP). Besides detecting elevated ICP in various neurological diseases, ONSD can also be applied to cardiac arrest survivors as one of the prognostic factors. It is a simple, quick, repeatable technique without the need of contrast medians. In order to make precise interpretations, the database of the normal distribution of ONSD and its associated factors in healthy volunteers is necessary. The majority of previous reports are from Western countries, and limited reports of ONSD in the Asian population have high variability.

Therefore, collecting local data of ONSD in Taiwan is important. In this study, the investigators aimed to analyze the ONSD diameters and its associated factors in Taiwanese healthy volunteers. The investigators planed to recruit 150 healthy volunteers aged more than 20 years old. The ONSD and its associated factors will be measured and recorded by ultrasound from September 2020 to August 2021.

Eligibility criteria: Inclusion Criteria:

adult volunteer aged more than 20 years

Exclusion Criteria:

aged less than 20 years

Primary outcomes:
measure: optic nerve outer diameter
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Emergency Medicine, National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Wan-Ching Lien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04822870: Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section
Official title: Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section: a Randomized Double-blind Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Quadratus Lumborum Block
Iliohypogastric/Ilioinguinal Nerve Block
Cesarean Section
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 87
Sex: FEMALE
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 compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* gestation of at least 37 weeks
* American Society of Anesthesiologists (ASA) physical status I or II
* finish Pfannenstiel section under combined spinal and epidural anesthesia

Exclusion Criteria:

* pruritus existed before the surgery
* allergic to lidocaine, ropivacaine or dexamethasone

Primary outcomes:
measure: morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: morphine consumption
timeFrame: 6 hours postoperatively
measure: morphine consumption
timeFrame: 12 hours postoperatively
measure: morphine consumption
timeFrame: 48 hours postoperatively
measure: pain score
timeFrame: 6 hours postoperatively
measure: pain score
timeFrame: 12 hours postoperatively
measure: pain score
timeFrame: 24 hours postoperatively
measure: pain score
timeFrame: 48 hours postoperatively
measure: effective analgesia time
timeFrame: 48 hours postoperatively
measure: adverse effect
timeFrame: 6 hours postoperatively
measure: adverse effect
timeFrame: 12 hours postoperatively
measure: adverse effect
timeFrame: 24 hours postoperatively
measure: adverse effect
timeFrame: 48 hours postoperatively
measure: satisfaction score
timeFrame: 48 hours postoperatively
measure: hospital stay
timeFrame: at discharge assessed up to 10 days
measure: hospitalize cost
timeFrame: at discharge assessed up to 10 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, MD
role: STUDY_CHAIR
References: