louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06963034: NBI-1117568-SCZ3029: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1117568 in Adults With Schizophrenia Who Warrant Inpatient Hospitalization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2025-05-08
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective for this study is to evaluate the efficacy of NBI-1117568 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults.


Eligibility criteria: Key Inclusion Criteria:

* Participant has a primary diagnosis of schizophrenia
* Participant is experiencing an acute exacerbation or relapse of symptoms and currently warrants hospitalization.
* Participants taking prohibited medications, including antipsychotics, must discontinue before study participation
* Participant is willing and able to remain in an inpatient setting for the study duration, follow instructions, and comply with the protocol requirements

Key Exclusion Criteria:

* Participant has known hypersensitivity to any component of the formulation of NBI-1117568.
* Participant has an unstable or poorly controlled medical condition or chronic disease
* Participant is considered by the investigator to be at imminent risk of suicide or injury to self or others
* Participant has a diagnosis of moderate or severe substance use disorder (with the exception of nicotine or caffeine dependence) within 6 months prior to screening
* Participant has a positive alcohol test or drug screen for disallowed substances
* Participants have a history of poor or suspected poor compliance in clinical research studies and/or in the investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 5
timeFrame: Baseline, Week 5
Secondary outcomes:
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 5
timeFrame: Baseline, Week 5
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Pico Rivera
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: Miami Lakes
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Marlton
country: United States
facility: Neurocrine Clinical Site
state: New Jersey
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT03844334: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Official title: CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-18
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The decision to use a WEB device to treat the patient has been made before and independently of the decision to include the patient in this study

Brief summary: The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

Detailed description: All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.

Subjects will be followed per Institution's standard of care.

Eligibility criteria: Inclusion Criteria:

1. Subject must be ≥ 18 years of age and ≤80 years of age
2. Subject must have an intracranial aneurysm (IA),
3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
4. For ruptured aneurysm, Subject with Hunt \& Hess Score ≤ III

Exclusion Criteria:

1. Subject has an IA with characteristics unsuitable for endovascular treatment
2. Subject's index IA was previously treated
3. Subject has stroke-in-evolution within the prior 30 days
4. An additional aneurysm must be treated during the procedure

Primary outcomes:
measure: Aneurysm occlusion
timeFrame: 12 months
measure: Incidence of major stroke or neurological deaths
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Toulouse
country: France
facility: Hôpital Purpan
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus
city: Budapest
country: Hungary
facility: National Institute of Clinical Neurosciences
Study officials:
References:
Clinical trial NCT00684034: Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
Official title: Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Insufficiency
Keywords: Redox state in the course of chronic renal insufficiency and hemodialysis.
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and on the redox state of lymphocytes should be clarified as well as the putative relationships between all these parameters.

Detailed description: Up to now, no anti-oxydative treatment has been able to reduce the mortality of the patients with Kidney Failure. Thus it is necessary to have a better knowledge of oxydative stress mechanisms in patients with KF in order to find more efficacious treatments. The influence of hemodialysis upon oxidative stress is not well known.

Eligibility criteria: Inclusion Criteria:

* 18 and 80 years old man or woman dialysing at least 3 times a week for at least 6 months and having no residual renal function
* Rate of haemoglobin \> 11 g / dl
* Clinically stable patient that is having had no considerable event (cardiovascular problem, infection, surgical operation) with the exception of angioplasty of fistula or prosthesis vascular, in the previous 3 months the entrance to the study
* Patient capable of understanding and of following the essay, in particular knowing how to read the note of information.

Exclusion Criteria:

* Pregnant woman
* Treatment by corticoids or immunosuppresseurs
* hemopathy sly
* chronic cancer or infection in evolution
* Cardiovascular event (infarct, unstable angor, coronary bypasses, confusions of the rhythm, AVC, amputation) or infectious (blood-poisoning, pneumopathie, meningitis) or surgical operation in the previous 3 months the inclusion in the study.

Primary outcomes:
measure: This study should allow to clarify the redox state some plasma by quantification of thiols membranous on the surface of lymphocytes at the hemodialysis and insufficient renal chronic not dialysed patients.
timeFrame: 48 months
Secondary outcomes:
measure: This study should allow to estimate in a forward-looking longitudinal plan the possible involvement of the parameters of the redox state and the morbidity and the cardiovascular and global mortality in 2 years in 2 studied populations.
timeFrame: 48 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital de la Conception- Service de Néphrologie et de transplantation rénale
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Bertrand DUSSOL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06666634: Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Official title: Validation of ICG-99mTc-nanoscan as Hybrid Tracer for Sentinel Node Biopsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Penile Cancer
Melanoma
Oral Cancer
Keywords: Fluorescence
Radioactivity
Indocyanine green
Clinical node negative patients
Surgical staging
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.

Detailed description: The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.

Eligibility criteria: Inclusion Criteria:

* Patient who will undergo a sentinel node procedure in routine care.
* Patients \> 18 years;
* Patients presenting with:
* a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;
* OR patients presenting with a primary oral cavity malignancy T1-2N0
* OR patients with primary penile cancer
* Patients with clinical N0 stage;
* Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion;
* Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting

Exclusion Criteria:

* Patients with known allergy to patent blue dye or nanocolloid;
* Patients who are pregnant or breast-feeding mothers;
* History of hypersensitivity reactions to products containing human serum albumin;
* History of iodine allergy
* Hyperthyroid or thyroidal adenoma
* Kidney insufficiency
* Incapacity or unwillingness of participant to give written informed consent;

Primary outcomes:
measure: Concordance between tracers
timeFrame: Measured at pre-operative imaging
Secondary outcomes:
measure: Higher echelon nodes
timeFrame: Measured at pre-operative imaging
measure: Concordance between intraoperative fluorescence and radioactive findings
timeFrame: Measured at pre-operative imaging
measure: Concordance between intraoperative fluorescence and radioactive findings
timeFrame: Measured at pre-operative imaging
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
References:
Clinical trial NCT03133234: Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
Official title: An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T790M Positive NSCLC Patients
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.

Brief summary: To assess the effectiveness and safety of osimertinib treatment in a real world setting.

Detailed description: The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.

Eligibility criteria: Inclusion Criteria:

* Above 18 years of age;
* Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
* Confirmed T790M mutation
* Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
* Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016

Exclusion Criteria:

• Enrolment in studies that prohibit any participation in this observational study

Primary outcomes:
measure: ORR
timeFrame: Followed up with 6 months after last patient in
Secondary outcomes:
measure: PFS
timeFrame: Followed up 10 months after last subject in
measure: T790M mutation testing time
timeFrame: Within 14 days after enrollment date
measure: Treatment patterns
timeFrame: Followed up 10 months after last patient in
measure: Adverse events
timeFrame: Follow up 10 months after last patient in.
measure: Adverse event intensity
timeFrame: Follow up 10 months after last patient in.
measure: T790M mutation testing sample
timeFrame: Within 14 days after enrollment date
measure: T790M mutation testing platform
timeFrame: Within 14 days after enrollment date
measure: EGFR testing mutation subtype
timeFrame: Within 14 days after enrollment date
Other outcomes:
Locations:
city: Macau
country: China
facility: Kiang Wu Hospital
Study officials:
affiliation: Kiang Wu Hospital
name: Yabing Cao
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao Y, Qiu X, Xiao G, Hu H, Lin T. Effectiveness and safety of osimertinib in patients with metastatic EGFR T790M-positive NSCLC: An observational real-world study. PLoS One. 2019 Aug 23;14(8):e0221575. doi: 10.1371/journal.pone.0221575. eCollection 2019.
Clinical trial NCT00843934: Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Official title: Randomized Controlled Trial of Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular
Trans arterial chemoembolization
Epirubicin
Cisplatin
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of cisplatin (CDDP) and epirubicin (EPI) in the treatment of transcatheter chemoembolization for Hepatocellular Carcinoma (HCC).


Eligibility criteria: Inclusion Criteria:

* Subject must be histologically or clinically proven HCC, inoperable, no indication of local treatment and has measurable lesions.
* Subject must to be the first experience of TACE.
* Subject has no extra-hepatic tumor and no obstruction of main portal vein.
* Subjects must have fully recovered from previous treatment (at least 4 weeks interval is needed from prior chmotherapy or radiation therapy).
* ECOG performance status 0-2
* Child-pugh Class A or B
* Subject must have adequate functions of bonemarrow, renal, circulatory organs and appropriate examination results as below:

  1. Serum Total Bilirubin 2.0mg/mL
  2. WBC 3000/mm3
  3. PLT 50000/mm3
  4. Hb 9.0g/dL
  5. Creatinine ; upper normal limit (UNL)
  6. BUN 25mg/dL
* Written informed consent

Exclusion Criteria:

* Subject has extra hepatic metastasis.
* Tumor thrombosis exists at main portal vein.
* Remarkable artery-portal vein shunt or veno-arterial shunt.
* Uncontrollable ascites or pleural effusion.
* History of severe hypersensitivity.
* Any previous TACE or TAE for HCC.
* Any previous chemotherapy using epirubicin or CDDP.
* Complications as below (except chronic hepatitis or liver cirrhosis)

  1. Severe heart disease
  2. Myocardial infarction within 6 months
  3. Renal insufficiency
  4. Active infections (except virous hepatitis)
  5. Gastrointestinal bleeding
  6. Active double cancer
  7. Hepatic encephalopathy or heavy mental disorder.
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant.
* Any subject judged by the investigator to be unfit for any reason to participate in the study.

Primary outcomes:
measure: response rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Itabashi
country: Japan
facility: Department of Digestive Surgery, Nihon University School of Medicine
state: Tokyo
Study officials:
affiliation: Digestive Surgery Nihon University School of Medicine
name: Tadatoshi Takayama, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387334: The Effectiveness of Resistance Exercise for Glycemic Control in Type 2 Diabetes Mellitus Patients
Official title: The Effectiveness of a Home-Based Resistance Exercise Training Program With Rubber Bands for Glycemic Control in Individuals With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: resistive exercise
Resistance Exercise Training Program
Rubber Bands
Glycemic Control
Type 2 Diabetes Mellitus
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Resistance exercise is effective in improving glycemic control in diabetes patients. The effectiveness of a home-based resistance exercise program has not been establish.

Detailed description: Exercise play an important role in diabetes control. The American Diabetes Association (ADA) approved of resistive exercise as an effective method in controlling blood sugar of type 2 diabetes patients. Few community-based intervention has been establish. So the authors developed the low-cost community based resistance exercise program to promote exercise in of type 2 diabetes patients.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes was diagnosed by physician using fasting plasma glucose not less than 126 mg/dl and/or HbA1c not less than 7 %.
* Type 2 diabetes was diagnosed at least 6 months previously.
* The subject was ongoing treatment in primary care unit of prince of Songkla University.

Exclusion Criteria:

* Gestational diabetes and type 1 diabetes patients
* History of cardiovascular disease within the pass 6 months or any unstable chronic condition including dementia, proliferative diabetic retinopathy, retinal hemorrhage or detachment, dialysis and diabetic foot patients.

Primary outcomes:
measure: HbA1c
timeFrame: 3 months
Secondary outcomes:
measure: compliance of home-based resistive exercise training
timeFrame: 3 years
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Department of Community Medicine, Faculty of Medicine, Prince of Songkla University
name: Thanitha Sirirak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154034: Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation
Official title: Cardiopulmonary Exercise Testing in Severe Mitral Regurgitation - a Single Center, Observational Echocardiographic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Regurgitation
Pulmonary Hypertension
Keywords: Stress echocardiography
Cardiopulmonary exercise testing
ergospirometry
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 38
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: Symptomatic, severe mitral regurgitation. Aetiology and treatment of mitral regurgitation do not affect enrollment.

Brief summary: The purpose of this study is the evaluation of cardiac and pulmonary response to cardiopulmonary exercise in severe mitral regurgitation and its variation under treatment (surgical mitral valve repair, percutaneous mitral valve repair, optimal medical treatment). The study is conducted as a prospective, observational, single-center study. Patients suffering from symptomatic severe mitral regurgitation will be eligible, if they are referred to the University Hospital of Regensburg, Germany, for further diagnostic procedures and heart team discussion. Cardiopulmonary exercise testing is performed comprising standardized stress echocardiography as well as ergospirometry. Additional detailed assessment will be conducted including standardized questionary, clinical examination, transesophageal echocardiography and measurement of biomarkers.


Eligibility criteria: Inclusion Criteria:

* symptomatic, severe mitral regurgitation
* referral for diagnostic work-up and heart team discussion
* declaration of informed consent

Exclusion Criteria:

* contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation)
* pregnancy
* exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities)
* no acceptable acoustic window at rest

Primary outcomes:
measure: exercise-induced systolic pulmonary arterial pressure
timeFrame: Change from Baseline Exercise-Induced Systolic Pulmonary Arterial Pressure at 1 year
Secondary outcomes:
measure: peak oxygen uptake (peakVO2)
timeFrame: Change from Baseline peakVO2 at 1 year
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg - Department of Internal Medicine II
Study officials:
affiliation: University Hospital Regensburg
name: Alexander Dietl, MD
role: PRINCIPAL_INVESTIGATOR
References: