louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00198471: Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment
Official title: An Open-label Assessment of Intravitreous Injections of Vitrase (Hyaluronidase for Injection) for Inducing Posterior Vitreous Detachment in Subjects With Moderate to Severe Non-proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitreous Detachment
Diabetic Retinopathy
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 50
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 is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

* Moderately severe to severe non-proliferative diabetic retinopathy
* Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) with pinhole of 20/320 or better in study eye \& 20/50 or better in non-study eye.

Exclusion Criteria:

* Contraindications or hypersensitivities to Vitrase or anesthesia
* Any significant illness that could be expected to interfere with trial
* Prior Vitrase therapy
* Either a past diagnosis of clinically significant macular edema (CME) in study eye that required treatment or current CME that may require focal laser treatment within the next 30 days
* For either eye: ongoing ocular infection, inflammation or history of herpetic corneal lesion; an intravitreous injection within 30 days; glaucoma; intraocular pressure (IOP) of less than 5mmHg; retinal detachment or ocular tumors
* For study eye: vascular occlusive disease of fundus; corneal, lenticular or ocular media abnormalities; a significant ocular trauma within 6 months; previous vitrectomy; any prior laser treatment, cryo-retinopexy or any intraocular surgery; either a partial or complete posterior vitreous detachment (PVD); myopia of 6 or more spherical diopters and/or axial length exceeding 26mm; significant retinal pathology

Primary outcomes:
measure: Vitreous detachment
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Edgar L. Thomas, MD
state: California
city: New York
country: United States
facility: Ronni Lieberman, MD
state: New York
city: McAllen
country: United States
facility: Valley Retina Institute, PA
state: Texas
city: Leesburg
country: United States
facility: The Virginia Retina Center
state: Virginia
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Jon Williams, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06165393: The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery
Official title: The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Athletic Performance
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Innovation Fund Denmark
First posted: 2023-12-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Endurance sport is often characterized by high training loads and significant metabolic demands, including depletion of endogenous fuel stores (e.g. liver and muscle glycogen) and damage to the skeletal muscle proteins. Nutritional interventions that enhance the restoration of endogenous fuel stores and improve muscle damage repair have received a lot of attention. The primary aim of this project is to clinically test the effect of alginate encapsulation technology on performance. Furthermore, we will investigate the substrate utilization profile during exercise and subsequent recovery.

The encapsulation technology presents a nutrient delivery solution, which results in a sustained or slow-release of the nutrients encapsulated. Thus, potentially optimizing the digestion and absorption by promoting an easy ingestion of high concentrations of fx carbohydrates without negatively affecting the gastrointestinal comfort.


Eligibility criteria: Inclusion Criteria:

* males between 18-50 years of age
* moderate to trained individuals with a VO2max \> 50 ml/min/kg
* accustumed to exercising on a bike
* healthy volunteers

Exclusion Criteria:

* persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.
* persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glycogen synthesis and/or performance.

Primary outcomes:
measure: Performance
timeFrame: approx. 90 min-120 min
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Per Bendix Jeppesen
Study officials:
References:
Clinical trial NCT01542593: Evaluating Ureteral Length Using Computed Tomography (CT)
Official title: Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Calculi
Hydronephrosis
Ureteral Obstruction
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length.

Measurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing planned procedure involving ureteroscopy or ureteral stenting
* Abdominal CT scan performed within 6 months prior to intervention

Exclusion Criteria:

* Known iodine sensitivity
* Patients with fever or hemodynamic instability planned for urgent operation
* Severe immune compromized patients
* Severe thrombocytopenia \< 50,000

Primary outcomes:
measure: Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Yuval Freifeld, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01508871: Electrical Interactions in Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathy, Dilated
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ventricular dysfunction

Brief summary: This study will evaluate the relationship of markers of cardiac activation and their determinants. The hypothesis is that these markers will be interrelated.


Eligibility criteria: Inclusion Criteria:

* ventricular dysfunction

Exclusion Criteria:

* normal ventricular function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT02611271: Elimination of Antibiotics During Renal Replacement Therapy and Cytosorb Adsorptive Therapy
Official title: Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients With Sepsis and Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Sepsis
Acute Kidney Injury
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 30
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: Critically ill patients treated for sepsis on surgical intensive care unit undergoing renal replacement therapy.

Brief summary: Cytokine adsorption using the cytosorb adsorber is currently investigated to reduce the levels of proinflammatory cytokines in patients with severe sepsis and septic shock. The adsorber is frequently used in series with continuous renal replacement therapy. Up to date, no data on the removal of antibiotic drugs during combined renal replacement therapy and cytokine adsorptive therapy is available. Therefore, we want to investigate

- whether and to what extent antibiotic drugs (piperacillin/tazobactam and imipenem/cilastatin) are removed during combined continuous renal replacement therapy and cytosorb adsorption in patients with severe sepsis and septic shock

Detailed description: Patients in this trial are undergoing renal replacement therapy as part of their routine care. Thus, this is an observational trial.

Eligibility criteria: Inclusion Criteria:

* Intensive care patients with severe sepsis or septic shock and acute kidney injury requiring continuous renal replacement therapy and cytokine adsorption
* Age \> 18 y

Exclusion Criteria:

* \< 18 y
* Pregnancy
* Contraindications against citrate-anticoagulation or continuous renal replacement therapy or cytokine adsorption

Primary outcomes:
measure: Removal of antibiotic drugs during the first 8 hours of combined continuous renal replacement therapy and cytosorb adsorption
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Interdisziplinäre Intensivstation ZOM 1, UKD
Study officials:
affiliation: Department of Anesthesiology, Duesseldorf University Hospital
name: Detlef Kindgen-Milles, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06973993: A Study to Evaluate the Impact of Classical Music on Perceived Waiting Time and Satisfaction in Emergency Department Patients
Official title: The MORAL (MOzart Recorded And Live) Impact of Classical Music on Perceived Waiting Time and Satisfaction: A Comparative Study in Emergency Department Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergency Room
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 150
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: patient and relatives affering ER

Brief summary: The goal of this study is to evaluate whether classical music in the Emergency waiting room can diminish perception of waiting times. Patients and relatives, after arriving in the ER waiting room will either listen to live classical music, recorded classical music, or no music at all.

Detailed description: The study was submitted to the ethics committee as an interventional clinical trial; however, they advised that it does not qualify as a clinical trial. The project does not collect health-related information from patients, according to the definition provided by swiss research law, and therefore does not require any authorization. They qualify it as a quality control initiative.

Please advise on how we should register it into clinicaltrials.gov, we might need the ID for publication purpose.

Thank you

Eligibility criteria: Inclusion Criteria:

* ER department patients waiting for medical assessment and their relatives
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Patients in situations of high severity and that pose an immediate significant threat to life or physiologic function.

Primary outcomes:
measure: patient satisfaction
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli, Ente Ospedaliero Cantonale
Study officials:
References:
Clinical trial NCT06907693: The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI
Official title: The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI, a Non-Invasive, Functional Respiratory Imaging System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Arterial Hypertension
Keywords: FLUIDDA FRI
FRI
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Cereno Scientific AB
First posted: 2025-04-02
Enrollment: 7
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: Participation in the CS1-004 clinical trial at Prisma Health-Upstate

Brief summary: Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).


Eligibility criteria: Inclusion Criteria:

* Participation in the CS1-004 clinical trial

Exclusion Criteria:

* Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
* Individuals who are pregnant or who become pregnant during the sub-study
* eGFR \<30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
* Allergy to Iodine contrast agents

Primary outcomes:
measure: Ratio of BV5A to BV10A
timeFrame: From baseline CT scan to 12 month CT scan
Secondary outcomes:
measure: Ratio of BV5A to BV5APR
timeFrame: From baseline CT scan to 12 month CT scan
measure: Ratio of BV5A to BV5APRA
timeFrame: From baseline CT scan to 12 month CT scan
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
References:
citation: 1. US EPA O. Frequent Questions: Radiation in Medicine. www.epa.gov. Published December 4, 2023. https://www.epa.gov/radiation/frequent-questions-radiation-medicine
Clinical trial NCT02529293: A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
Official title: A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
* Age ≥ 18 and ≤ 64 years, both inclusive.
* Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
* Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
* Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products.
* Receipt of any investigational medicinal product within 3 months before randomisation in this trial.

Primary outcomes:
measure: AUCLisp (0-inf)
timeFrame: 8 hours
measure: Cmax Lisp
timeFrame: 8 hours
Secondary outcomes:
measure: tmax Lisp
timeFrame: 8 hours
measure: AUCGIR(0-8h)
timeFrame: 8 hours
measure: GIRmax
timeFrame: 8 hours
measure: tGIRmax
timeFrame: 8 hours
measure: Number of Adverse events
timeFrame: Up to 9 weeks
measure: Local tolerability
timeFrame: Up to 9 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut Für Stoffwechselfforschung GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550493: Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder
Official title: Preliminary Efficacy of a Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Abuse
Lead sponsor: Adai Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Huangshui Township Municipal Government, Shuangliu District, Chengdu, Sichuang
First posted: 2022-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One hundred participants were recruited and randomized into a digital therapeutics (DTx) group (n=52) and a treatment as usual (TAU) group (n=48). The DTx group used a smartphone application to deliver cognitive behavioral therapy, approach bias modification, cognitive training, and contingency management for eight weeks. The TAU group received counseling from social workers and psychoterapists. Cue-induced craving, cognitive functions, PHQ-9, and GAD-7 were measured at baseline and post-intervention.


Eligibility criteria: Inclusion Criteria:

* currently undergoing community-based rehabilitation were recruited voluntarily from four community
* meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for methamphetamine dependence.

Exclusion Criteria:

* could not fluently operate an Android or an iOS smartphone
* having mental health conditions other than MUD

Primary outcomes:
measure: Cue induced craving for methamphetamine
timeFrame: baseline, pre-intervention
measure: Cue induced craving for methamphetamine
timeFrame: immediately after the intervetion
measure: Cognitive Function Score
timeFrame: baseline, pre-intervention
measure: Cognitive Function Score
timeFrame: immediately after the intervetion
Secondary outcomes:
measure: PHQ-9
timeFrame: baseline, pre-intervention
measure: PHQ-9
timeFrame: immediately after the intervetion
measure: GAD-7
timeFrame: baseline, pre-intervention
measure: GAD-7
timeFrame: immediately after the intervetion
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Huangshui Township Municipal Government
state: Sichuang
Study officials:
References:
Clinical trial NCT03915171: Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
Official title: Sensitivity and Specificity of NGS in Detecting bMSI in Patients With Gastric, Duodenal and Small Intestinal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Cancer
Keywords: NGS bMSI Gastrointestinal
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To study the sensitivity and specificity of NGS in detecting Microsatellite State in blood and to evaluate its potential application in gastrointestinal cancer.

Detailed description: NGS can not only detect tissue samples, but also blood samples. For some inoperable cancer patients, the acquisition of tissue samples is difficult and traumatic. It is of great significance for the diagnosis and treatment of these patients to determine MSI status by blood testing. In addition, the heterogeneity of malignant tumors is usually strong, blood testing can overcome the heterogeneity of tissue, and can dynamically monitor the patient's condition. 50 patients with gastric cancer, duodenal cancer and small intestinal cancer will be enrolled in the study. Among them, 30 patients with MSI-H and 20 patients with MSS confirmed by IHC/PCR.The investigators will use 520 gene panel for NGS sequencing of tissue and blood samples from selected patients to study the sensitivity and specificity of NGS in detecting Microsatellite State in blood.

Eligibility criteria: Inclusion Criteria:

* Age (\>18 years old).
* Histologically diagnosed as gastric cancer, duodenal cancer or small intestinal cancer (stage III, stage IV).
* The status of dMMR/pMMR was confirmed by IHC/PCR.
* with tissue and blood samples (including ctDNA and white blood cells) that meet the requirements.
* Agree to provide demographic, medical history, pathological diagnosis, imaging diagnosis, TNM staging, ECOG score and other information.

Exclusion Criteria:

* Suffering from other malignant tumors at the same time.
* Others that the investigator consider that is inappropriate for this study.

Primary outcomes:
measure: Sensitivity and specificity of blood MSI detected by NGS
timeFrame: 1 year
Secondary outcomes:
measure: Ideal sequencing depth of MSI in blood test
timeFrame: 1 year
measure: Correlation between MSI status and TMB
timeFrame: 1 year
measure: Correlation between MMR gene and other gene mutations
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
Study officials:
References: