louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04775849: Intraoperative Berger Space Imaging (IBSI)
Official title: Intraoperative Berger Space Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Macula Edema
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cataract surgery will be performed in individuals with age-related cataract.
Primary purpose: DIAGNOSTIC

Brief summary: The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

The laser will be reduced to image the Berger space. If not visible, the space will be enhanced with BSS and Volon A to visualize the BS.

Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.

Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination and retinal oct imaging.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
* Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
* Preoperative pupil size in mydriasis ≥ 6.0 mm

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Pseudoexfoliation
* Recurrent intraocular inflammation of unknown etiology
* Uncontrolled glaucoma
* Uncontrolled systemic or ocular disease
* Blind fellow eye
* Microphthalmus
* Corneal abnormality
* History of uveitis/iritis
* Iris neovascularization
* Proliferative diabetic retinopathy
* Macular degeneration or any other relevant macular diseases
* Pregnancy

Primary outcomes:
measure: The primary objective is a Berger Space larger than 400μm
timeFrame: intraoperative
Secondary outcomes:
measure: Difference of central macular thickness between time points
timeFrame: Baseline to 1day, 1 week, 3 weeks
measure: Intraocular pressure in different timepoints
timeFrame: Baseline to 1day, 1 week, 3 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical Universitiy of Vienna
name: Rupert Menapace, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00327249: Safety and Efficacy Study of Imexon for Treatment of Multiple Myeloma Patients
Official title: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) for Patients With Previously Treated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: AmpliMed Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: AMP-007 is a Phase 1/2 study for the treatment of advanced, previously treated multiple myeloma. The first phase of the study is designed to determine a safe dose of imexon that can be given to patients with advanced, previously-treated multiple myeloma. The Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether imexon can improve the outcome for patients with multiple myeloma


Eligibility criteria: Inclusion Criteria:

* Advanced myeloma, with measurable disease as defined in the protocol.
* Prior treatment, at least 2 prior regimens are required. This may include prior treatment with investigational products.
* Able to perform the activities of daily living.
* Off prior therapy for at least 2-4 weeks depending on the drug.
* Blood counts and blood chemistries in or near normal range.
* If female, neither pregnant nor nursing.
* Willing to use contraceptives to prevent pregnancy.
* No other serious illnesses.
* No other active malignancy.
* No serious infections.
* No current other drug therapy for the myeloma except for steroid therapy under certain circumstances. Biphosphonate therapy is permitted.
* Prior radiation is permitted.

Exclusion Criteria:

* Use of corticosteroids for amyloid disorders, or high dose chronic steroids.

Primary outcomes:
measure: Determine the maximally tolerated dose of imexon in multiple myeloma patients
measure: evaluate the toxicity of imexon
measure: Preliminarily evaluate efficacy in terms of response and progression free survival.
Secondary outcomes:
measure: Evaluate biomarker responses.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Investigational Site 025
state: Arkansas
city: Houston
country: United States
facility: Investigational Site 008
state: Texas
Study officials:
References:
Clinical trial NCT03314649: Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
Official title: Prospective Observational Study of Peritoneal Lavage for Early Detecting Gene Mutation of Peritoneal Metastasis of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Peritoneal Lavage, Gene Mutation, Peritoneal Metastasis,Gastric Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 200
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: PROBABILITY_SAMPLE
Study population: Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.

Brief summary: Our study aims to improve sensitivity and accuracy of detecting abdominal free cancer cells in patients with gastric cancer.

Detailed description: Gastric cancer (GC) remains one of the most common causes of cancer-related mortality worldwide. Surgery has always been considered as the most effective treatment for GC. Peritoneal metastasis is the common pattern of postoperative recurrence, especially patients with T4 stage or serosal invasion. What is worse, patients with peritoneal metastasis have a poor prognosis. However, it is often difficult to diagnose peritoneal metastasis at an early stage. As we know, the implantation of peritoneal free cancer cells exfoliating from serosa-invasive tumors is main reason of peritoneal seeding. Cytological examination of peritoneal lavage fluid is always performed to predict peritoneal micrometastases. However, more than half of patients with negative cytological results develop peritoneal recurrence. Low sensitivity and poor negative predictive value of this method have heralded the development of advanced techniques in detecting peritoneal free cancer cells.

In this study, novel genetic techniques will be used to detect mutated DNA of shed cancer cells in abdominal cavity. The present clinical trial aims to find a better tool to detect abdominal micrometastasis in GC patients, which may become a valid clinical index to predict postoperative relapse and direct treatment.

Eligibility criteria: Inclusion Criteria:

1. Lower age limit of research subjects 18 years old and upper age limit of 80 years old.
2. PS (ECOG) of 0 or 1 and expected to survive more than 6 months.
3. Written informed consent from the patient.
4. Patients suffering gastric cancer and non-cancerous disease planned to have laparotomy.

Exclusion Criteria:

1. Female in pregnancy or lactation. 2. Patients participating in any other clinical trials currently，or participated in other trails within 1 months. 3. Patients with poor compliance or considered to be poor compliance.

-

Primary outcomes:
measure: prognostic molecular markers
timeFrame: 3-year
Secondary outcomes:
measure: OS
timeFrame: 3-year
measure: DFS
timeFrame: 3-year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03796949: Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model
Official title: Threatened Preterm Birth and Time of Subsequent Delivery; Prediction Model Based on Biomarkers and Maternal/Obstetrical Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Immunologic Activity Alteration
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2019-01-08
Enrollment: 204
Sex: FEMALE
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: 80 women with threatened preterm labor before 34 weeks of gestation, 40 women with preterm prelabor rupture of the membranes before 34 weeks of gestation, 40 women with normal pregnancies in labor at term, 44 women with normal pregnancies during pregnancy (before labor)

Brief summary: This study investigates immunological and clinical markers in threatened preterm birth aiming to create a prediction model for preterm birth.

Detailed description: Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm birth it is difficult to identify the true high risk cases ultimately leading to preterm birth. These women are often overtreated.

In this study blood samples are taken from women with threatened preterm birth and from women with normal pregnancies before and during labor.

Differences in clinical characteristics and immunological markers between the groups are studied in order to design a prediction model for preterm birth.

Eligibility criteria: Inclusion Criteria:

* Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor and/or preterm prelabor rupture of the membranes
* Age \> 18 years
* Swedish-speaking (understanding study information)

Exclusion Criteria:

* Multiple gestation
* Blood borne infections

Primary outcomes:
measure: Time of delivery
timeFrame: Outcome noted at delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden
name: Marie Blomberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06266949: Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
Official title: Perimetry Based on Eye-movements in Patients With (Supra)Sellar Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pituitary Tumor
Visual Fields Hemianopsia
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a (supra)sellar tumour and healthy controls

Brief summary: The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.

Detailed description: The objective of this study is to determine whether SONDA is non-inferior in predicting visual field limitations compared to the SAP in patients with a (supra)sellar tumor. The study population will be made up of patients with a (supra)sellar tumor complicated by compression of the optic chiasm as well as healthy controls. The patients will be asked to join the study when the patients are referred to the UMCG for further diagnostics and treatment. In case the patients show signs of visual field loss the patients will be asked to participate in the study. The researchers will reuse data from healthy controls collected in previous studies where possible and, if necessary for age matching, recruit new participants. Participants will be asked to perform the SONDA test before and after surgery. The first time the participants will perform the test twice and will also perform routine eye test and be asked to fill in a questionnaire to evaluate the experience.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a (supra)sellar tumor
* Visual field loss based on the most recent SAP; False positive rate \<15%; fixation losses \<20%
* Informed written consent

Exclusion Criteria:

* Neurological disorders
* Eye disease not related to a (supra)sellar tumor

Primary outcomes:
measure: Convert validity
timeFrame: Baseline
measure: Test-retest reliability
timeFrame: baseline 1, baseline 2, 6-8 weeks post-operative
Secondary outcomes:
measure: Experience
timeFrame: Baseline
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: University Medical Center Groningen
name: Jos MA Kuijlen, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506649: Improved ICU Outcomes With Protocolized Management of Analgesia, Sedation and Delirium
Official title: Comparison of no Protocol vs Protocolized Approach to Pain, Sedation and Delirium Management in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Keywords: protocol
analgesia
sedation
delirium
coma
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.


Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to ICU

Exclusion Criteria:

* Repeat admission within the same hospitalisation; moribund patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Yoanna Skrobik, MD FRCP(c)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05761249: BIOSTREAM.HF HeartInsight
Official title: Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices - HeartInsight Substudy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2023-03-09
Enrollment: 100
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: HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.

Brief summary: The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.


Eligibility criteria: Inclusion Criteria:

* Patient willing and able to give consent
* Participation in BIO\|STREAM.HF
* HeartInsight-capable CRT-D device implanted or planned to be implanted
* Symptomatic heart failure NYHA class II or III within 45 days prior to enrollment
* HeartInsight score available or planned use of HeartInsight
* History of worsening of heart failure hospitalization or unscheduled outpatient visit with intravenous diuretic therapy for acute worsening of heart failure
* Patient is willing and able to utilize BIOTRONIK Home Monitoring via CardioMessenger and has sufficient mobile network coverage

Exclusion Criteria:

* Patient with permanent atrial fibrillation or 100% atrial pacing
* Patient is not implanted with an atrial or DX lead or atrial sensing is deactivated
* History of patient incompliance

Primary outcomes:
measure: Rate of WHF hospitalization after HeartInsight activation
timeFrame: through study completion, an average of 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: České Budějovice
country: Czechia
facility: Nemocnice Ceske Budejovice, a.s.
city: Brest
country: France
facility: CHU de Brest
city: Budapest
country: Hungary
facility: Semmelweis University
city: Pécs
country: Hungary
facility: The University of Pécs
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
Study officials:
References:
Clinical trial NCT00913549: To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets
Official title: Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Antihistamine
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 19 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harris Laboratories, Incorporated
name: James C. Kisicki, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03669549: Nevanimibe HCl for the Treatment of Classic CAH
Official title: A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Congenital Adrenal Hyperplasia
Keywords: CAH
nevanimibe
Lead sponsor: Millendo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, intra-subject dose-titration open-label study of nevanimibe hydrochloride (HCl) for the treatment of classic congenital adrenal hyperplasia (CAH). Following a Screening Period of approximately 2-14 weeks, eligible subjects will enter a Baseline Period of approximately 2-8 weeks and then a 16-week Treatment Period. It is anticipated that the overall duration of the study per subject will range from 24-42 weeks.


Eligibility criteria: Inclusion Criteria:

* Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency and/or historical documentation of elevated 17-OHP
* Chronic glucocorticoid replacement therapy for at least 6 consecutive months prior to screening
* Stable glucocorticoid and mineralocorticoid regimen for at least 4 weeks prior to screening and throughout the treatment period of the study

Exclusion Criteria:

* Nonclassic CAH
* Other causes of adrenal insufficiency
* HIV, hepatitis B, or hepatitis C
* AST or ALT \>2x ULN, bilirubin or serum creatinine \>1.5x ULN

Primary outcomes:
measure: Percentage of Subjects Achieving Serum 17-OHP Targets
timeFrame: Through Day 113
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Ribeirão Preto, Medicine Faculty (Faculdade de Medicina) of Ribeirão Preto
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo, Escola Paulista de Medicina
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP - Prédio do Instituto Central
city: Praha 1
country: Czechia
facility: Institute of Endocrinology
city: Paris
country: France
facility: Hospital Pitié-Salpetrière
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Petach Tikva
country: Israel
facility: Beilinson Hospital
city: Tel Aviv
country: Israel
facility: Tel-Aviv-Sourasky Medical Center
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: University Hospital La Fe
Study officials:
References:
citation: White PC. Emerging treatment for congenital adrenal hyperplasia. Curr Opin Endocrinol Diabetes Obes. 2022 Jun 1;29(3):271-276. doi: 10.1097/MED.0000000000000723.
Clinical trial NCT05106049: Serum Adiponectin as an Early Marker for Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease.
Official title: Early Detection of Renal Impairment in Patients With Non-alcoholic Fatty Liver Disease by Measuring Serum Adiponectin Level.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cases are Non-alcoholic fatty liver patients who do not having any other health problem.

control group is healthy individuals.

Brief summary: Early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum Adiponectin level.

Detailed description: Detection of serum Adiponectin by ELISA technique using (EIA-3418) KIT, DRG international inc., USA

Eligibility criteria: Inclusion Criteria:

* Patients with fatty liver aged from 18 to 60 yrs either diabetic or not .
* Patient with normal echogenic kidney in ultrasound and eGFR more than 60 mL/min/1.73m2.
* The Control group are completely healthy subjects without any systemic or liver and kidney affection

Exclusion Criteria:

* Patients less than 18 yrs \& more than 60 yrs .
* All patients having any other causes of renal and hepatic disease rather than Diabetes and having any other systemic problem.

Primary outcomes:
measure: Correlate serum Adiponectin level with renal impairment in non-alcoholic fatty liver disease.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Hassan, Profissor.as
role: STUDY_DIRECTOR
References:
citation: Stefan N, Stumvoll M. Adiponectin--its role in metabolism and beyond. Horm Metab Res. 2002 Sep;34(9):469-74. doi: 10.1055/s-2002-34785.