louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05085054: Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)
Official title: Induction Therapy With Targeted Therapy Followed by Surgery for Stage IIIB and IV Non-small Cell Lung Cancer: a Multi-center, Single-arm, Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: Unresectable
Advanced NSCLC
Targeted Therapy
Salvage Surgery
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 evaluate the safety and efficacy of neoadjuvant targeted therapy followed by surgery in participants with advanced non-small cell lung cancer.

Detailed description: Advanced non-small cell lung cancer (NSCLC) accounts for a high proportion of lung cancer cases. Targeted therapy improve the survival in these patients, but acquired drug resistance will inevitably occur. If tumor downstaging is achieved after targeted therapy, could surgical resection before drug resistance improve clinical benefits for patients with advanced NSCLC? Here, the investigators conducted a clinical trial showing that for patients with advanced driver gene mutant NSCLC who did not progress after targeted therapy, salvage surgery (SS) could improve progression-free survival (PFS).

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of NSCLC with confirmed activation of driver gene mutation (EGFR mutant: exon 19 deletion or exon 21 L858R mutation; ALK-rearrangement) by amplification refractory mutation system (ARMS);
* stage IIIB-IV according to the eighth edition of the American Joint Committee on Cancer staging system confirmed by pathological diagnosis and positron emission tomography-computed tomography (PET-CT) and biopsy
* Written informed consent provided；
* Age 18-70 when signing the consent form, both male and female;
* The ECOG score is 0 or 1;
* Adequate hematological function, liver function and renal function;
* Female participants should not be pregnant or breast-feeding.

Exclusion Criteria:

* Previously received systemic anti-tumor therapy for non-small cell lung cancer;
* Subjects who have received chest radiotherapy in the past;
* Known human immunodeficiency virus (HIV) infection;
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
* Pregnancy or breast-feeding women;
* Ingredients mixed with small cell lung cancer patients.

Primary outcomes:
measure: PFS
timeFrame: 3 year
Secondary outcomes:
measure: OS
timeFrame: 3 year
measure: Resectability rate
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03894254: Predictive Factors of Autonomy Loss in Real-life Cohort
Official title: Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory Disorders
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 5400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments.

The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France.

The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and older, undergoing a medical visit in a memory center or neuro-cognition service
* Patients living at home or in housing
* Patients with memory impairment, at all stage of the disease

Exclusion Criteria:

* Patients in institution
* Patients under legal protection
* Patients with a hearing or visual impairment, which prevents carrying out examinations

Primary outcomes:
measure: Functional autonomy level
timeFrame: from 6 months to 12 months interval
measure: Functional autonomy level
timeFrame: from 6 months to 12 months interval
measure: Functional autonomy level
timeFrame: from 6 months to 12 months interval
Secondary outcomes:
Other outcomes:
Locations:
city: Caluire-et-Cuire
country: France
facility: Hôpital Dugoujon
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Lyon
country: France
facility: Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Villeurbanne
country: France
facility: Centre Mémoire de Ressources et de Recherche de Lyon
Study officials:
affiliation: Centre Mémoire de Ressources et de Recherche
name: Pierre Krolak-Salmon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02946554: Phase II Safety Study of 2 Dose Regimens of HepaStem in Patients With ACLF
Official title: Multicenter Phase II Safety and Preliminary Efficacy Study of 2 Dose Regimens of HepaStem in Patients With Acute on Chronic Liver Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute-On-Chronic Liver Failure
Keywords: Acute-On-Chronic Liver Failure
ACLF
Lead sponsor: Cellaion SA
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the safety of different dose regimens of HepaStem in cirrhotic Patients with ACLF or with acute decompensation at risk of developing ACLF up to Day 28 of the active study period.


Eligibility criteria: Main Inclusion Criteria:

* Diagnosed cirrhosis
* Patient with Acute Decompensation of cirrhosis
* Serum total Bilirubin ≥ 6 mg/dL (≥100 umol/L)
* The INR measurement has to be : 1.2 ≤ INR \< 2

Main Exclusion Criteria:

* Absence of portal vein flow
* Known or medical history of thrombotic events
* Gastrointestinal hemorrhage requiring blood transfusion
* Variceal bading or sclerosis within 4 weeks before infusion
* Septic shock or non-controlled bacterial infection
* Clinical evidence of aspergilus infection.
* Circulatory failure
* Respiratory disordered
* Coagulation disorders defined as INR ≥ 2, Fibrinogen \< 100 mg/dL or Platelets \< 50.000/mm3
* MELD score \> 30.
* Major invasive procedure within 4 weeks before infusion
* Previous organ transplantation and/or ongoing immunosuppressive treatments.
* Renal failure due to chronic kidney disease.
* Clinically significant left-right cardiac shunt.

Primary outcomes:
measure: Safety assessed by occurence of Adverse Events (AE) up to Day 28 of the active study period
timeFrame: up to 28Day post first infusion day
Secondary outcomes:
measure: Efficacy assessed by clinical parameters
timeFrame: 28Day, 3 month and 1 year post first infusion day
measure: Efficacy assessed by biological parameters
timeFrame: 28Day, 3 month and 1 year post first infusion day
measure: Long term safety Follow up assessed by the occurence of Adverse Event of Special Interest
timeFrame: 3 month and 1 year post first infusion day
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: CHU Brugmann
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: KU Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Woluwe-Saint Lambert
country: Belgium
facility: Cliniques St Luc
city: Clichy
country: France
facility: Hôpital Beaujon
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Villejuif
country: France
facility: Hôpital Paul Brousse
Study officials:
References:
Clinical trial NCT05096754: OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
Official title: OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects transplanted in the OCS Liver PROTECT CAP

Brief summary: Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.


Eligibility criteria: Inclusion Criteria:

* Subjects transplanted in the OCS Liver PROTECT CAP

Primary outcomes:
measure: Graft Survival
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Dallas
country: United States
facility: University of Texas Southwest
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
References:
Clinical trial NCT06624254: Ventilator Mode and Respiratory Physiology
Official title: Ventilator Mode and Respiratory Physiology
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Disease
Respiratory Failure
Respiratory Effort
Breathing Mechanics
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
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: Human subjects admitted to the intensive care unit requiring invasive mechanical ventilation for acute respiratory failure on adaptive pressure control modes of ventilation

Brief summary: Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. APC can inadvertently deliver high tidal volumes, which maybe harmful. High tidal volumes may be unrecognized by the provider, due to the complexities of ventilator algorithms and patient interactions. The objective of this aim is to identify risk factors for excess tidal volumes in patients on adaptive pressure control.


Eligibility criteria: Inclusion Criteria:

* Admitted to ICU with acute respiratory failure
* On adaptive pressure control mode of ventilation
* Tidal volumes set between 5-8 cc/kg ideal body weight

Exclusion Criteria:

* Current use of neuromuscular blockade
* Inability to obtain consent from patient or surrogate decision maker
* Treating clinician refusal

Primary outcomes:
measure: Excess tidal volume
timeFrame: From enrollment to end of monitoring at 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Health
state: California
Study officials:
affiliation: University of California, San Diego
name: Alex Pearce, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06373354: Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
Official title: Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Architectural Distortions
Breast Tomosynthesis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2024-04-18
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Screening mammography population at MD Anderson

Brief summary: To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.

Detailed description: Primary Objectives

- The primary objective of this proposed study is to show that bWBT (B.brilliant wide-angle breast tomosynthesis) images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging.

Secondary Objectives

* The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging.
* Additional secondary objectives include radiologist feedback on the B.brilliant images, technologist experience with B.brilliant, and a participant comfort survey.

Eligibility criteria: Inclusion Criteria:

* Women undergoing standard screening mammography.
* Ability to understand and sign consent.

Exclusion Criteria:

* Pregnant women.
* Women unable to consent.
* Male patients.

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Beatriz Adrada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830154: A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering
Official title: A 3 Arm, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy,Safety and Tolerability of Pagoclone for Adults With Stuttering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stuttering
Keywords: stutter
stuttering
Adults with a history of stuttering
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2009-01-27
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.

Detailed description: A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.

Eligibility criteria: Inclusion Criteria:

* Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.
* Stuttering severity must be notable for \> 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.

Exclusion Criteria:

* Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.

Primary outcomes:
measure: To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo.
timeFrame: Weeks 8, 16 and 24
Secondary outcomes:
measure: Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
Study officials:
References:
Clinical trial NCT00317954: Spironolactone in Diabetic Nephropathy
Official title: Spironolactone in Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Nephropathy
Keywords: Diabetic nephropathy
Spironolactone
Aldosterone antagonism
Renoprotection
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus
* Diabetic Nephropathy
* Glomerular filtration rate \> 30 ml/min/1.73 m2
* Blood pressure \> 130/80 mm Hg

Exclusion Criteria:

* Child bearing potential
* Plasma-potassium \>4.5 mmol/l
* Breastfeeding
* Abuse of alcohol or drugs
* Non-diabetic kidney disease

Primary outcomes:
measure: Changes in albuminuria
measure: Changes in blood pressure
Secondary outcomes:
measure: Changes in glomerular filtration rate
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Hans-Henrik Parving, MD,DMSc,Prof
role: STUDY_CHAIR
affiliation: Steno Diabetes Center Copenhagen
name: Katrine J Schjoedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schjoedt KJ, Rossing K, Juhl TR, Boomsma F, Rossing P, Tarnow L, Parving HH. Beneficial impact of spironolactone in diabetic nephropathy. Kidney Int. 2005 Dec;68(6):2829-36. doi: 10.1111/j.1523-1755.2005.00756.x.
citation: Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabetes Care. 2005 Sep;28(9):2106-12. doi: 10.2337/diacare.28.9.2106.
Clinical trial NCT06204354: Construction of Gynecological Tumor Sample Library
Official title: Construction of Gynecological Tumor Sample Library
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gynecologic Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with gynecologic cancer, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and other rare type gynecologic cancer.

Brief summary: Constructing a gynecological tumor samples library, which is open and can be accessed.

Detailed description: This project is the construction and maintenance of a gynecological tumor sample library. It is supported by the National Key Laboratory of Difficult, Severe, and Rare Diseases at Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences. This project will lay a clinical specimen foundation for exploring the molecular mechanisms of gynecological tumors in the future.

Eligibility criteria: Inclusion Criteria:

1. An informed consent form was obtained. If the age is less than 18 years old, the consent form should be signed by the guardian.
2. Preoperative tumor burden assessment and intraoperative evaluation by the supervising physician (professor) suggest sampling is acceptable.
3. The research team believes that sampling is possible.
4. Having the relevant requirements for sample library storage.
5. Surgical treatment is performed at Peking Union Medical College Hospital.

Exclusion Criteria:

1. Not meeting all inclusion criteria.
2. The research team considers any circumstances or considerations that may hinder normal pathological evaluation.

Primary outcomes:
measure: construction of Biobank
timeFrame: 3 years
Secondary outcomes:
measure: Exploring the molecular mechanism based on biobank
timeFrame: 3 year
measure: Drug sensitivity detection based on biobank
timeFrame: 3 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04477733: Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
Official title: Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colonoscopy
Keywords: Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 203
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 total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This clinical study aims to explore the effectiveness and safety of butorphanol combined with propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for improving the quality of surgery and comfortable medical treatment for patients.


Eligibility criteria: Inclusion Criteria:

* ASA status I-11
* patients performing colonoscopy
* sign the informed consent

Exclusion Criteria:

* BMI\>30, pregnant
* diabetes
* depression
* patients dependent on opioids
* hypertension poorly controlled
* serious complications of important organs
* obvious abdominal pain before colonoscopy

Primary outcomes:
measure: visceral pain
timeFrame: 10 minutes after recovery
Secondary outcomes:
measure: visceral pain at 20 and 30 minutes after recovery
timeFrame: 20 and 30 minutes after recovery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: