louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00581165: Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept
Official title: Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.


Eligibility criteria: Inclusion Criteria:

1. Informed consent signed by patients prior to study entry
2. 18 years of age or older at screening visit
3. Patients with moderate to severe psoriasis
4. Patients who have failed conventional systemic treatment
5. Patients who have a contraindication to conventional systemic therapy
6. Patients who are intolerant to conventional systemic therapy
7. A negative serum pregnancy test at screening in women of childbearing potential
8. Able to self-inject study drug or have a designee who can do so
9. In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol

Primary outcomes:
measure: Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment
timeFrame: 18 months
Secondary outcomes:
measure: Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03864965: Advance Care Planning in Cognitive Disorders Clinic
Official title: Responses to a Standardized Approach to Advance Care Planning in Cognitive Disorders Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Keywords: Alzheimer's disease
Dementia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2019-03-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Advance care planning among patients with cognitive disorders poses unique challenges to clinicians. To improve planning in patients with Alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. The main outcome measure is the rate of entry of Advance Directive completion in the patient's Electronic Health Record (EHR). A control group of similar patients from another provider specializing in cognitive disorders will be used to tease out confounding variable effects.


Eligibility criteria: Inclusion Criteria:

* Patients having mild cognitive impairment (MCI) or very mild to mild dementia (CDR 0.5-1).

Exclusion Criteria:

* Patients with moderate to severe dementia (CDR 2-3).

Primary outcomes:
measure: Change in rate of advance directive completion during or following the visit
timeFrame: Baseline; Month 6; Month 12; Month 18
measure: Change in the rate of completed advance directives that are uploaded to the patient's electronic medical record
timeFrame: Baseline; Month 6; Month 12; Month 18
Secondary outcomes:
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline; Month 2; Month 3
measure: Change in Beck Hopelessness Scale (BHS)
timeFrame: Baseline; Month 2; Month 3
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Department of Neurology, College of Medicine, UF Health Medical Plaza
state: Florida
city: Gainesville
country: United States
facility: UF Health Fixel Center for Neurological Diseases
state: Florida
Study officials:
affiliation: University of Florida
name: Neal Weisbrod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00293865: Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Official title: Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast infiltrative cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Previous conservative surgical biopsy
* Secondary pathological diagnosis of infiltrative cancer
* No clinically involved axillary node (N0)
* No previous neoadjuvant treatment
* Performance status European Cancer Conference (ECCO) Grade ≤ 1
* Patient's written informed consent to participate in the study according to French law
* Surgeon must have performed its learning curve

Exclusion Criteria:

* Lack of infiltrative breast carcinoma (in situ) pT4d \> N0
* Breast cancer relapse
* Pregnancy
* Known patent blue allergy
* Indication for radical or partial mastectomy
* Patient unable to understand the trial

Primary outcomes:
measure: false negatives
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Hospîtal
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: Hospital
city: La roche sur yon
country: France
facility: Centre Hospitalier
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: centre Léon Berard
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Nancy
country: France
facility: Centre Alexis Vautrin
city: Nancy
country: France
facility: Hospital
city: Paris
country: France
facility: Hopital Lariboisière
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Tenon
city: Poitiers
country: France
facility: Hospital
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Toulouse
country: France
facility: Centre Claudius Regaud
Study officials:
affiliation: Centre Rene Gauducheau
name: Jean Marc Classe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Renaudeau C, Lefebvre-Lacoeuille C, Campion L, Dravet F, Descamps P, Ferron G, Houvenaeghel G, Giard S, Tunon de Lara C, Dupre PF, Fritel X, Ngo C, Verhaeghe JL, Faure C, Mezzadri M, Damey C, Classe JM. Evaluation of sentinel lymph node biopsy after previous breast surgery for breast cancer: GATA study. Breast. 2016 Aug;28:54-9. doi: 10.1016/j.breast.2016.04.006. Epub 2016 May 20.
Clinical trial NCT00700765: Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes
Official title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 1531
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: Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

* Subjects who are unlikely to comply with the protocol
* Subjects who are currently being treated with Levemir®
* Subjects who previously were enrolled into the study
* Subjects with hypersensitivity to Levemir® or any of its excipients

Primary outcomes:
measure: Incidence of serious adverse drug reactions (SADRs)
timeFrame: during treatment
measure: Major hypoglycaemic events
timeFrame: during treatment
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: during treatment
measure: Number of all adverse events
timeFrame: during treatment
measure: Number of all hypoglycaemic events
timeFrame: the last 4 weeks of treatment
measure: Weight changes
timeFrame: after 12 weeks
measure: HbA1c
timeFrame: after 12 weeks and 26 weeks of treatment
measure: Variability in fasting blood glucose (FBG) and average plasma glucose level
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03695965: Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability
Official title: Magnetic Resonance Imaging Evaluation of Lateral Ankle Instability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle Injuries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with history of ankle trauma or chronic lateral ankle pain that will be evaluated using magnetic resonance imaging.

Brief summary: Lateral ankle instability may be acute or chronic. Acute instability usually occurs due to extreme rear foot supination with planter-flexion trauma leads to injury of lateral collateral ligament complex especially the anterior talofibular ligament. Most ankle ligamentous injuries are treated conservatively. However, 20% to 40% of patients complain of chronic instability and persistent discomfort. Structural instability, loss of proprioceptive capabilities, and the weakness of peroneal muscles seem to induce chronic instability


Eligibility criteria: Inclusion Criteria:

- Patients with any sex, age, complaining of chronic lateral ankle pain.

Exclusion Criteria:

1. Tumors at ankle region.
2. Postoperative status around the ankle.
3. Rheumatoid arthritis.
4. Comminuted fracture at the ankle.
5. Congenital anomalies of the ankle.

Primary outcomes:
measure: The percentage of patients with ankle or ligaments abnormalities by examination
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05059665: Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
Official title: Specimen Collection for Multi-Analyte Blood-Test for Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma by AJCC Stage
Lead sponsor: Helio Genomics
Sponsor class: INDUSTRY
Collaborators: name: Laboratory for Advanced Medicine, Guangzhou
name: Helio Health Inc., Irvine, CA
First posted: 2021-09-28
Enrollment: 290
Sex: ALL
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: Subjects who have been clinically diagnosed with HCC, or are negative for HCC after regular surveillance, or have been clinically diagnosed with non-HCC cancers will be enrolled. Approximately 500 subjects will be enrolled.

Brief summary: De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).

Detailed description: The purpose of this study is to define the performance characteristics (sensitivity and specificity) of the Helio Liver Test within a study population of subjects that have been diagnosed with liver cancer at various stages (I to IV) and for control subjects who have been confirmed to not have liver cancer by at least one imaging technique, such as ultrasound, MRI or CT. Control subjects will include patients who are at high-risk for liver cancer and have been recommended to undergo liver cancer surveillance, as well as patients who have non-HCC cancers to determine analytical specificity.

Eligibility criteria: Inclusion Criteria:

* 18 Years and Older (Adult, Older Adult)

Exclusion Criteria:

* None

Primary outcomes:
measure: Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for early stage HCCs (Stage I and II)
timeFrame: 15 months
measure: Evaluate the performance (sensitivity/specificity) of the HelioLiver Test for all stage HCCs
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: University of California, Irvine
name: RIchard Van Etten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901965: Contralateral Strength-training After Anterior Cruciate Ligament (ACL) Reconstruction
Official title: Could Contralateral Quadriceps Strength Training Attenuate the Strength Loss in the ACL-operated Knee?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness After Anterior Cruciate Ligament Reconstruction
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main aims of the study are (1) to examine the impact of contralateral strength training on the quadriceps muscle function after ACL surgery and (2) to compare the magnitude of cross-education induced by NMES versus eccentric strength training.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for ACL reconstruction surgery

Exclusion Criteria:

* Concomitant lower limb injury or disorder
* previous lower extremity open surgery on the contralateral lower limb
* cardiac disease
* pregnancy

Primary outcomes:
measure: Change in bilateral quadriceps muscle strength [Nm]
timeFrame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6month
measure: Change in quadriceps muscle activation
timeFrame: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
Secondary outcomes:
measure: Change in muscle architecture
timeFrame: 1-2 weeks preoperative/ 2weeks/ 8weeks/ 6month
measure: Change in self-reported questionnaire outcomes (KOOS, WOMAClk)
timeFrame: 1-2weeks preoperative/ 2weeks/ 8weeks/ 6 month
measure: functional test outcomes
timeFrame: 6month postop
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Neuromuscular Research Laboratory, Schulthess Klinik
state: ZH
Study officials:
affiliation: Schulthess Klinik
name: Nicola A Maffiuletti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feil S, Newell J, Minogue C, Paessler HH. The effectiveness of supplementing a standard rehabilitation program with superimposed neuromuscular electrical stimulation after anterior cruciate ligament reconstruction: a prospective, randomized, single-blind study. Am J Sports Med. 2011 Jun;39(6):1238-47. doi: 10.1177/0363546510396180. Epub 2011 Feb 22.
citation: Hortobagyi T, Scott K, Lambert J, Hamilton G, Tracy J. Cross-education of muscle strength is greater with stimulated than voluntary contractions. Motor Control. 1999 Apr;3(2):205-19. doi: 10.1123/mcj.3.2.205.
Clinical trial NCT04361565: Frequency and Clinical Evolution of Olfactory and Taste Disorders in COVID-19 Patients
Official title: Prevalence and Clinical Evolution of Olfactory and Taste Disorders in Patients Infected by SARS-CoV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 by SARS-CoV-2 Infection
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals that responded to a online form

Brief summary: A novel coronavirus SARS-CoV-2 HAS arose in 2019 in Wuhan, China. Beside the classical semiology of this infection, numerous patients described olfactory and teste disorders. These symptoms are not described in this coronavirus, neurotropism of coronaviridae has been documented before. The aim of the study is to evaluate prevalence of anosmia and dysgeusia (olfactory and taste disorders) in coronavirus diagnosed patients and compare with different clinical conditions. The second endpoint is to evaluate the duration of these symptoms in order to better understand the semiology of this infection.


Eligibility criteria: Inclusion Criteria:

* COVID-19 diagnosed

Primary outcomes:
measure: Anosmia
timeFrame: 45 days
measure: Ageusia
timeFrame: 45 days
measure: Duration of the loss of anosmia ageusia
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT05740865: Risk Factors Associated With Infection After Spine Surgery
Official title: Predicting Deep Surgical Site Infection in Patients Receiving Open Posterior Instrumented Thoracolumbar Surgery--- A-DOUBLE-SSI Risk Score: a Large Retrospective Multicenter Cohort Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Surgical Site Infection
Spine Surgery
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 3419
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population included patients who previously receceived open posterior instrumented thoracolumbar surgery due to spine disease (except that spine infection or revision surgery)

Brief summary: Surgical site infection (SSI), particularly deep SSI, is one of the most serious complications after spinal surgery. evaluating the risk of SSI and, correspondingly, prescription of prophylactic measures are extremely important to prevent SSI and avoid potentially devastating consequences. A retrospective study was conducted aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery.

Detailed description: Data of 3,419 patients in 4 hospitals from Jan 1, 2012 to Dec 30, 2021 were retrospectively collected and were evaluated aiming to develop a point-based prediction model of deep surgical site infection in patients receiving open posterior instrumented thoracolumbar surgery. Clinical knowledge-driven, data-driven and decision tree model was used to identify predictive variables of deep SSI. Internal validation was performed by using bootstrapping methods.

Eligibility criteria: Inclusion Criteria:

patients who previously received open posterior instrumented thoracolumbar surgery

Exclusion Criteria:

1. were aged \< 18 years;
2. underwent surgery for the spinal infection, spine revision surgery, or cervical operation;
3. were diagnosed as superficial SSI;
4. died in hospital;
5. diagnosis of SSI was not determined;
6. had missing data more than 10% were excluded.

Primary outcomes:
measure: deep surgical site infection
timeFrame: within 30 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, China International Neuroscience Institute, Capital Medical University
name: Fengzeng Jian
role: STUDY_DIRECTOR
References:
Clinical trial NCT03855865: Study of Rapastinel as Monotherapy in Major Depressive Disorder (MDD)
Official title: A Randomized, Double-blind, Placebo- and Active- Controlled, Multicenter Study of Rapastinel as Monotherapy in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).


Eligibility criteria: Inclusion Criteria:

* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
* Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
* Have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
* If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

* DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
* Lifetime history of meeting DSM-5 criteria for:

  1. Schizophrenia spectrum or other psychotic disorder
  2. Bipolar or related disorder
  3. Major neurocognitive disorder
  4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  5. Dissociative disorder
  6. Posttraumatic stress disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the Investigator

Primary outcomes:
measure: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at the End of the Double Blind Treatment Period (DBTP) (end of Week 6)
timeFrame: Baseline to end of Week 6
Secondary outcomes:
measure: Change from Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment
timeFrame: Baseline to Day 1 post-first dose
Other outcomes:
Locations:
Study officials:
affiliation: Allergan
name: Marc Debelle
role: STUDY_DIRECTOR
References: