louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06990399: A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
Official title: A Randomized, Double-masked, Sham-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tabirafusp Alfa (KSI-101) in Participants With Macular Edema Secondary to Inflammation (MESI) - PEAK
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Macular Edema Secondary to Inflammation
Keywords: MESI
macular edema
inflammatory macular edema
macular edema associated with inflammation
Lead sponsor: Kodiak Sciences Inc
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 150
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: A Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-101 in Participants with Macular Edema Secondary to Inflammation (MESI)


Eligibility criteria: Inclusion Criteria:

* MESI with a central subfield thickness (CST) of ≥400 microns on SD-OCT in Study Eye.
* BCVA ETDRS score of ≥25 and ≤70 letters (between 20/40 and 20/320 Snellen equivalent) in the Study Eye.
* Diagnosis of active or inactive non-infectious intraocular inflammation, acute or chronic in the Study Eye.

Exclusion Criteria:

* ME in the Study Eye secondary to diabetes, RVO, or wAMD
* Active or suspected ocular or periocular infection in either eye

Primary outcomes:
measure: Mean change in BCVA
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02020499: Predictive Factors Study
Official title: Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 5
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: Adult subjects in hospitals and private practices, suffering from acromegaly who are scheduled to receive ATG or already on treatment with ATG for a maximum of 3 months.

Brief summary: This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Acromegaly.
* Males and females aged 18 years and older.
* Signed informed consent (patient must give consent to the collection of retrospective data).
* Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study.
* With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG.
* If already being treated with ATG:

Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable).

* Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.

Exclusion Criteria:

* The subject has had radiotherapy in the last 5 years.
* The subject has had surgery in the last 3 months.
* The subject has already been included in this study.
* Participation in an interventional trial, or receiving experimental drug.

Primary outcomes:
measure: Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
timeFrame: Baseline, 1 year and 3 years
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: The Austin Hospital
state: Victoria
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06319599: Stellate Ganglion Block in Children With Autistic Disorder
Official title: Stellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autistic Disorder
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-20
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Detailed description: Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as Autistic Disorder.
* Aged between 4 years old and 8 years old.
* No contraindications to stellate ganglion block.

Exclusion Criteria:

* Other significant physical or neurodevelopmental disorders.
* Other significant medical conditions

Primary outcomes:
measure: Childhood Autism Rating Scale
timeFrame: day 1 and day 10
Secondary outcomes:
measure: Children's Communication Checklist
timeFrame: day 1 and day 10
measure: Social Interaction Assessment Scale
timeFrame: day 1 and day 10
measure: Children's Depression Inventory
timeFrame: day 1 and day 10
measure: Childhood Anxiety Sensitivity Index
timeFrame: day 1 and day 10
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: STUDY_CHAIR
References:
Clinical trial NCT03255499: Efficacy of the MovinCog Intervention in Children
Official title: Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Learning Disorders
Learning Disabilities
Cognitive Change
Keywords: cognitive training
physical exercise
brain dynamics
cognitive abilities
physiological markers
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise regimen, based on high-intensity training, and a cognitive training component. The design will contrast the intervention with an active control group, matched for expectancy effects.

Detailed description: Specifically, the investigators will compare both components together (exercise and cognitive training) against either one of the components (exercise alone, or cognitive training alone) and against an active control group. The study will include measures of scholastic aptitude, as well as of working memory and cognitive control (primary outcome measures), two cognitive abilities that are critical to daily life activities, and that respond well to training. In addition, the investigators will measure physiological responses to training, to monitor changes associated with exercise (secondary outcome measures). Finally, the investigators will relate training-specific improvements with transfer gains, to better model the interaction between training and transfer. This will provide a comprehensive understanding of the dynamics associated with the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 7-15

Exclusion Criteria:

* Age outside inclusion criteria
* History of seizures, brain trauma

Primary outcomes:
measure: Change from baseline working memory capacity at 10 weeks
timeFrame: Baseline and 10-week posttest
measure: Change from baseline cognitive control at 10 weeks
timeFrame: Baseline and 10-week posttest
measure: Change from baseline scholastic aptitude at 10 weeks
timeFrame: Baseline and 10-week posttest
Secondary outcomes:
measure: Change from baseline resting heart rate at 10 weeks
timeFrame: Baseline and 10-week posttest
measure: BDNF polymorphism measured by genetic saliva kit
timeFrame: Baseline
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: David Moreau
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moreau D, Kirk IJ, Waldie KE. High-intensity training enhances executive function in children in a randomized, placebo-controlled trial. Elife. 2017 Aug 22;6:e25062. doi: 10.7554/eLife.25062.
Clinical trial NCT02541799: Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
Official title: Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Informed Consent
Keywords: informed consent
telemedicine
research methods
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 130
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 investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent.

The procotol will involve a prospective, randomized control trial to test the effectiveness of a telemedicine medium in obtaining research informed consent. Within a single emergency department, the investigators will conduct a simple, low risk randomized trial (single does of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with expected hospital admission). Prior to being approached for informed consent, potential participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent vs. consent provided by audio-visual telemedicine. After standard clinical care, potential participants will be approached according to their allocation. Comprehension of research informed consent will be the primary outcome, and will be measured using the modified Quality of Informed Consent (QuIC) instrument.


Eligibility criteria: Inclusion Criteria:

* any adult patient presenting to the emergency department, and expected to be admitted to the hospital.

Exclusion Criteria:

* prisoners
* pregnant patients
* non-English speaking patients
* unable to provide informed consent based on mental status.

Primary outcomes:
measure: Comprehension of research informed consent
timeFrame: Immediately
Secondary outcomes:
measure: Consent rate
timeFrame: Immediately
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
References:
Clinical trial NCT02713399: High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study
Official title: High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contact Lens
Tear Film Thickness
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 soft contact lens wearers 15 rigid contact lens wearers

Brief summary: A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia, astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately, cannot be prevented. There are different tools to correct them, like spectacles, contact lenses, and refractive surgery. Many different contact lenses are available, the two large groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the presence of a contact lens in the eye divides the tear film into the prelens and postlens tear film layers. In the present study we want to investigate the variability and reproducibility of prelens and postlens tear film thickness measurements.


Eligibility criteria: Inclusion criteria

* Men and women aged over 18 years
* Soft or rigid contact lenses wearers
* Schirmer Test ≥ 10 mm/5 min
* Tear Breakup Time (TBUT) ≥10 seconds

Exclusion Criteria:

* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating

Primary outcomes:
measure: Pre lens and post lens tear film thickness
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT06586099: Tislelizumab with Azacitidine in the Treatment of R/R AML
Official title: Prospective, Open-label, Single Arm Trial to Evaluate Efficacy and Safety of Tislelizumab with Azacitidine in the Treatment of Refractory/relapsed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Refractory AML
Relapsed Adult AML
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, open label, single arm clinical study
Primary purpose: TREATMENT

Brief summary: Acute myeloid leukemia(AML) is a clonal hematological malignancy. 50%-90% adult AML patients can achieve complete remission(CR) after standard induction chemotherapy,but 10%-25% patients cannot achieve CR, which is called 'primary refractory disease'.Most of patients who achieved CR will relapse during the next 3 years, and the prognosis is poor.So refractory and relapse diseases are still the hotspot of clinical research.Immunologic escape is one of the mechanisms for tumor cells to survive from chemotherapy. Studies have shown that PD1 and PDL1 levels are upregulated in AML patients, the same phenomenon was observed after the treatment of demethylating agents such as azacytidine. Combination of PD1 blockades with azacytidine may improve the efficacy of the treatment.

Detailed description: In this phase 1/2 study, 20 patients will be enrolled and treated with azacytidine and tislelizumab regimen. The primary endpoint is composite complete remission rate.Toxicities of treatment need to be observed. And relationship between PDL1 expression on AML cells and efficacy will be studied. Treatments include azacytidine 75mg/m2/d, subcutaneous injection,day1-7, every 28 days for three cycles tislelizumab 200mg,day 8,every three weeks, for 4 doses.

Eligibility criteria: Inclusion Criteria:

* diagnosis of AML according to FAB or WHO criteria
* refractory or morphological relapsed AML
* age over 18 years old
* ECOG PS 0-2
* written informed consent

Exclusion Criteria:

* acute promyelocyte leukemia
* solitary extramedullary relapsed disease
* other hematological diseases
* antecedent stem cell transplantation
* AML with BCR_ABL positive
* acute panmyelosis with myelofibrosis or sarcoma
* with other active organ malignancy(needing treatment)
* active heart diseases
* unfit for enrollment after investigator's evaluation

Primary outcomes:
measure: composite complete remission rate
timeFrame: up to 2 years
Secondary outcomes:
measure: overall survival
timeFrame: up to 4 years
measure: disease free survival
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: HBDH
state: Tianjin
Study officials:
References:
Clinical trial NCT00658099: Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®
Official title: Change in Weight on Insulin Detemir (Levemir®) or Isophane (NPH) Insulin (Insulatard®) in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 699
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes patiens failing on oral anti-diabetic agents

Brief summary: This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1c greater than 7.0% and/or hypoglycaemia
* variable FBG and/or weight increase
* the selection of the subjects will be at the discretion of the participating physician

Exclusion Criteria:

* non-type 2 diabetes
* current treatment with Levemir® or Insulatard®
* hypersensitivity to Levemir® or Insulatard® or to any of the excipients
* women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Primary outcomes:
measure: Change in weight
timeFrame: after 6 months of treatment
Secondary outcomes:
measure: The effect on metabolic control assessed by the changes in glycaemic parameters: HbA1c and blood glucose values
timeFrame: after 6 months of treatment
measure: The incidence of hypoglycaemic events
timeFrame: after 6 months of treatment
measure: Safety parameters by collecting (serious) adverse drug reactions, pregnancies and technical complaints.
timeFrame: after 6 months of treatment
measure: The general well-being by using the WHO-5 well-being questionnaire.
timeFrame: after 6 months of treatment
measure: The treatment satisfaction of subjects treated with insulin detemir or NPH insulin by using insulin treatment satisfaction questionnaire
timeFrame: after 6 months of treatment
measure: The satisfaction of physicians who treat the subjects with either insulin detemir or NPH insulin by using 4 questions, which are included in CRF, at the final visit.
timeFrame: after 6 months of treatment
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Doina Catrinoiu; Effect of Once-Daily Detemir vs NPH Insulin on Body Weight and Metabolic Control When Added to OADs in Type 2 Diabetes; 2029-PO; 69th Scientific Sessions (2009); American Diabetes Association
Clinical trial NCT01864499: Perioperative Evaluation of Intracranial Hypertension by Ultrasound Measurement of Variations in the Diameter of the Sheath of the Optic Nerve in the Excision of a Tumor or Biopsy Supratentorial Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supratentorial Brain Tumor
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2013-05-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: Neurosurgery for supratentorial brain tumor is frequently associated with preoperative intracranial hypertension. The evaluation of intracranial pressure is available noninvasively by measuring the diameter of the optic nerve sheath ultrasound.

The evaluation of intracranial pressure by measuring the DNO in perioperative is not described in the literature. The investigators propose a pilot study to assess intracranial pressure perioperative surgery for supratentorial brain tumor. The investigators consider a diameter of the optic nerve sheath as normal and predictive of intracranial pressure below 20 mm Hg when less than 5.7 mm (on the average of two measurements on each eye). DNO the normal healthy adult unanesthetized is 5 mm.

The main objective of the study is to compare the mean change in diameter of the optic nerve between the postoperative and D2 between groups of patients undergoing resection of a brain tumor and patients undergoing biopsy brain tumor.

Pilot Study: Prospective, single-center, controlled, non-randomized, the number of patients is estimated according to the recruiting capabilities of neurosurgery for this type of patient in the institution, A total of 40 patients: 20 patients Tumor Resection, control group: 20 patients Biopsy Brain Tumor.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized for surgery of intracerebral tumors in the study group.
* Hospitalized for a biopsy of intracerebral tumor lesion in the control group.

Exclusion Criteria:

* Age \<18 years
* Enucleation Prohibited to the achievement of an ocular ultrasound
* Hypersensitivity to gel
* Eye Wound
* Massive facial fracture
* Skin Infection Site

Primary outcomes:
measure: Difference in mean changes that the sheath of postoperative optic nerve
timeFrame: 2 days
Secondary outcomes:
measure: Difference in diameter of the sheath of the pre-and postoperative optic nerve
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Poitiers University Hospital
name: Bertrand DEBAENE
role: PRINCIPAL_INVESTIGATOR
References: