louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06885073: Non-invasive Central Venous Pressure Estimation in Pediatric Patients
Official title: Non-invasive Central Venous Pressure Estimation in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Central Venous Pressure
Keywords: central venous pressure
venous hypertension
Lead sponsor: Compremium AG
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 100
Sex: FEMALE
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Central Venous Pressure (CVP) is a standard parameter for hemodynamic monitoring and is currently measured through the insertion of a catheter. The pediatric population is especially vulnerable to risks associated to this invasive procedure, including infection, thrombosis, and pneumothorax. The proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (VOP) monitoring device (CPMX2) in children equipped with an invasive catheter for CVP monitoring as part of standard of care.


Eligibility criteria: Inclusion Criteria

* Provision of signed and dated informed consent form
* Male or female
* Age: birth to 21 years of age
* Equipped with a central venous catheter (CVC) for central venous pressure (CVP) monitoring indication as part of standard of care, or undergoing cardiac catheterization.

Exclusion Criteria:

* Weight less than 2.5kg at the time of enrollment.
* Bilateral external jugular veins not accessible due to vascular access or dressing.
* Bilateral skin lesion contraindicating neck Ultrasound
* Active bleeding
* Clinically unstable, per clinical assessment by attending physician and/or surgeon

Primary outcomes:
measure: Safety of external jugular venous occlusion pressure measured non-invasively with CPMX2 to estimate CVP in pediatric patients.
timeFrame: Up to 4 days
Secondary outcomes:
Other outcomes:
measure: Preliminary accuracy of external jugular venous occlusion pressure measured with CPMX2 to estimate CVP
timeFrame: Up to 4 days
Locations:
Study officials:
References:
citation: Thalhammer C, Aschwanden M, Jaeger KA. Letter by Thalhammer et al regarding article, "External carotid artery-internal jugular vein fistula: a complication of internal jugular cannulation". Circulation. 2006 Sep 26;114(13):e517; author reply e518. doi: 10.1161/CIRCULATIONAHA.106.636571. No abstract available.
Clinical trial NCT00304473: Fast Titration in the Treatment of Schizophrenia, Taiwan
Official title: Fast Titration of Quetiapine Versus Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-20
Enrollment: 40
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: Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score \>=4.

Exclusion Criteria:

* Pregnancy or breast-feeding, patients treated with Clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion criteria.

Primary outcomes:
measure: Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
Secondary outcomes:
measure: Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Taiwan Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00115973: A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump
Official title: An Open-Label, Stepwise Basal Insulin Dose Titration Study Using Continuous Subcutaneous Insulin Infusion (CSII) in Oral Antidiabetic Drug-Treated Type 2 Diabetes Mellitus Subjects Followed by a 10-Week Out-Patient Maintenance Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Delivery Systems
Keywords: Pump
Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-06-27
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosis at least 2 years ago
* Body Mass Index (BMI): 26-40 kg/m\^2 (both inclusive)
* HbA1c: 7.5-10% (both inclusive)
* FPG values at least 140 mg/dl (7.8 mmol/l)

Exclusion Criteria:

* Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers)
* Current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use
* Known or suspected allergy to trial products or related products

Primary outcomes:
measure: HbA1c
timeFrame: after 3 months
Secondary outcomes:
measure: Fasting plasma glucose
measure: Plasma glucose profiles
measure: Frequency of hypoglycemic events
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Witchita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Willingboro
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Fargo
country: United States
facility: Novo Nordisk Investigational Site
state: North Dakota
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01739673: Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
Official title: Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Keratitis
Keywords: Infectious Keratitis
Lead sponsor: Cxlusa
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 13
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: This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.


Eligibility criteria: Inclusion Criteria:

1. Subjects must be 18 years of age or older.
2. Ability to provide written informed consent.
3. Likely to complete all study visits.
4. Subjects must have one eye that with a diagnosis of infectious keratitis.

Exclusion Criteria:

1. A corneal perforation.
2. Descemetocele.
3. Pregnancy or breastfeeding.
4. Active Herpes corneal disease.
5. Patient is unwilling or unable to comply with a medication regimen and follow up appointments.

Primary outcomes:
measure: Resolution of Signs and Symptoms of Infectious Keratitis
timeFrame: Subjects will be followed until resolution of signs and symptoms, an expected average of 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: West Hills
country: United States
facility: Davidorf Eye Group
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado, PC
state: Colorado
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Minneapolis
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
Study officials:
affiliation: Center For Excellence In Eye Care
name: William Trattler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05057273: Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease
Official title: A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: NImmune Biopharma
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).


Eligibility criteria: Key Inclusion Criteria:

1. Male and female subjects age 18 to 75 years, inclusive.
2. Diagnosis of CD for at least 6 weeks prior to screening
3. Moderate to severely active CD as defined by all of the following:

   * CDAI score of 220-450
   * PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
   * SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader

Key Exclusion Criteria:

1. Participant has ulcerative colitis
2. Participant is at imminent risk of ileo-colectomy
3. Prior enrolment in the current study and had received study treatment.

Primary outcomes:
measure: Biomarkers of reponse
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00767273: Investigate Role of Metabolic Imaging in Predicting Tumor Response/Outcome After Pancreatic CA Tx
Official title: Pilot Study to Investigate the Role of Metabolic Imaging in Predicting Tumor Response and Outcome After Therapy for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To test the ability of new imaging techniques to monitor and predict response of pancreatic cancer to radiation and/or chemotherapy.


Eligibility criteria: Inclusion Criteria:- Adult patients (\>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery.

* Negative urine pregnancy test if a woman of child-bearing potential (WOCBP).
* WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study period.
* All patients will be evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board to determine eligibility. Exclusion Criteria:1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

  2. Any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. Patients with a previous malignancy without evidence of disease for \>5 years will be allowed to enter the trial.

  3. WOCBP who is pregnant or breastfeeding. 4. Inability to sign written consent.

Primary outcomes:
measure: Evaluate the performance of the novel imaging methods
Secondary outcomes:
measure: Correlate FLT activity with clinical outcomes
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Albert Koong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02519673: Comparison of Corneal Stromal Tissue Consumption (LATAC)
Official title: Comparison of Corneal Stromal Tissue Consumption Values Estimated When Programming the Intervention Versus the Values Measured by Pre and Postoperative Topography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders, Refractive
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-08-11
Enrollment: 50
Sex: ALL
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: Patients having a refractive disorder and for whom a refractive surgery by LASIK is programmed.

Brief summary: In refractive surgery, stromal ablation depth is fundamental because it determines the thickness of the residual posterior wall. The posterior wall is an essential element that guarantees the refractive stability and the long term prevention of corneal ectasia after corneal refractive surgery. A minimum thickness of more or less 300 microns is universally accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.

With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new treatment option called "wavefront optimized" is offered for myopia, astigmatism and hyperopia. The ablation profile has been developed to save stromal tissue consumption and to favor the quality of vision, by optimizing connections between the optical zone and the transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the depth of ablation may be defined by differential ultrasonic pachymetry or by topographical analysis pre and postoperatively. The latter is currently the method of reference to assess the corneal thickness.


Eligibility criteria: Inclusion Criteria:

* Patients having a refractive disorder and for whom a refractive surgery is programmed.

Exclusion Criteria:

* Patient opposed to participation in the study
* Another refractive surgery technique
* Hyperopic patient
* Pregnant or lactating woman
* Patient under a measure of legal protection
* Absence of affiliation to social security or universal health coverage (CMU)

Primary outcomes:
measure: Difference between stromal tissue consumption, expressed in micrometers, estimated before surgery by WaveLight Allegretto EX-500 laser and measured one month after surgery by Pentacam
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT00608673: Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus
Official title: Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discoid Lupus Erythematosus
Keywords: discoid lupus erythematosus
pimecrolimus 1% cream
betamethasone valerate 0.1% cream
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore, an alternative medication with the same efficacy, but without the side-effects is sought after.

Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its efficacy in treating discoid lupus erythematosus has not been studied extensively yet. However studies performed till now show promising results. Long-term topical use of this medication has not shown any serious side-effects in other skin diseases.

In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an alternative medication in treating discoid lupus erythematosus.


Eligibility criteria: Inclusion Criteria:

* Patients harboring discoid lupus erythematosus lesions on their face or neck

Exclusion Criteria:

* Patients with discoid lupus erythematosus in the setting of systemic lupus erythematosus
* Patients having a more disseminated disease

Primary outcomes:
measure: Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation
timeFrame: 1st day, after 2, 4, 6 and 8 weeks of treatment
Secondary outcomes:
measure: Secondary outcome: Safety assessments included monitoring of adverse events
timeFrame: 1st day, after 2, 4, 6 and 8 weeks of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shohada'e Tajrish Hospital
Study officials:
affiliation: Skin Research Center of Shahid Beheshti medical University
name: Behrooz Barikbin, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05946473: Development of a Novel Anti-caries Chewing Gum
Official title: Development of a Novel Anti-caries Chewing Gum
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Plaque
Dental Caries
Periodontal Disease
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study is designed to evaluate the chewing gum's ability to modulate the oral microbiome in human participants, in addition to its safety.

Detailed description: The goal of this project is to develop a pre-biotic chewing gum that is designed to promote a healthy oral microbiome. The gum will contain compounds that will: a) be unable to be converted to acids; b) target the cariogenic S. mutans population; c) promote the stability of a healthy environment by modulating plaque pH via base-generating compounds; d) promote tooth remineralization by increasing saliva flow and by addition of calcium phosphate.

Eligibility criteria: Inclusion Criteria:

* In good general health, no relevant medical history
* No dental treatment in the previous 3 months
* Willing to participate and give written informed consent

Exclusion Criteria:

* Patients undergoing fixed or removable orthodontic treatment
* Patients using removable prosthesis
* History of head and neck radiation therapy
* History of adverse reaction or allergies to xylitol or other additives
* Antibiotics use in the last four weeks
* Patients with any systemic diseases
* Xerostomia (also medication-induced)
* Smokers
* Currently using any mouth rinse
* Pregnant or breastfeeding women

Primary outcomes:
measure: Change in target species of the oral microbiome
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02916173: Triggering of Follicular Maturation
Official title: Triggering of Follicular Maturation Using Human Chorionic Gonadotrophin With Gonadotrophin Releasing Hormone Agonist Versus Human Chorionic Gonadotrophin Alone in Antagonist Protocol in Assisted Reproductive Technology : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Increase Pregnancy Rate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The follicular phase of the menstrual cycle involves the hourly release of gonadotropin-releasing hormone, which binds to receptors on the gonadotropes. This results in the secretion of follicle stimulating hormone and luteinizing hormone in hourly pulses that regulate follicular growth. At midcycle, rapidly rising estradiol from the dominant follicle and a small rise in progesterone lead to a gonadotrophic surge. An increase in the amplitude of Luteinizing hormone and Follicle stimulating hormone pulses initiates oocyte maturity and triggers ovulation approximately


Eligibility criteria: Inclusion Criteria:

1. Infertile couples wishing to do intracytoplasmic injection trial .
2. first intracytoplasmic injection trial
3. Body mass index:18-30.

5-Antral follicular count: more than 5 follicles in one ovary 6-normal, mild or moderate male factor infertility. 7- Antimullerian hormone \>1 ng/ml

Exclusion Criteria:

1. Azoospermic male.
2. Body mass index more than 29.
3. Patients with endometriosis .
4. Antimullerian hormone \< 1 ng/ml

Primary outcomes:
measure: Number of M II oocytes in both groups
timeFrame: 24 hours
Secondary outcomes:
measure: Fertilization rate in each group
timeFrame: 3 days
measure: Clinical pregnancy rate in each group
timeFrame: 15 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References: