louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01538589: Special Survey for Patients With Type 1 or Type 2 Diabetes
Official title: Special Survey for Type 1 or Type 2 Diabetic Patients
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: 2012-02-24
Enrollment: 1582
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: Patients with diabetes requiring insulin therapy with no treatment history of insulin aspart (NovoRapid®)

Brief summary: This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with no treatment history of insulin aspart (NovoRapid®)

Primary outcomes:
measure: Occurrence of severe hypoglycaemic symptoms
timeFrame: Year 1
measure: Occurrence of severe hypoglycaemic symptoms
timeFrame: Year 2 for patients who had an antibody titre test performed
measure: Antibody titre findings
timeFrame: Year 1
measure: Antibody titre findings
timeFrame: Year 2 for patients who had an antibody titre test performed
measure: Adverse events
timeFrame: Year 1
measure: Adverse events
timeFrame: Year 2 for patients who had an antibody titre test performed
Secondary outcomes:
measure: Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
timeFrame: Year 1
measure: Response rate assessed by the investigator: Ability or failure to achieve expected glycaemic control
timeFrame: Year 2 for patients who had an antibody titre test performed
measure: HbA1c (glycosylated haemoglobin)
timeFrame: Year 1
measure: HbA1c (glycosylated haemoglobin)
timeFrame: Year 2 for patients who had an antibody titre test performed
measure: Total dose of insulin infused subcutaneously
timeFrame: Year 1
measure: Total dose of insulin infused subcutaneously
timeFrame: Year 2 for patients who had an antibody titre test performed
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05870189: Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Official title: Remotely Delivered Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 22
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: So far, therapies have limited success in functional recovery in adults with chronic SCI. By introducing remote cognitive multisensory rehabilitation (CMR), which has shown significant functional improvements due to neurological recovery when delivered in-person, transformative results that (i) provide a potentially effective new therapy within the healthcare system, accessible to more patients, and (ii) demonstrate brain function changes alongside improved function in chronic SCI are anticipated. The results will inform and justify a large scale federally funded clinical trial.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old, with an incomplete or complete SCI/D of ≥ 3months, medically stable.
* be recruited from Hospitals within the Minnesota Regional Spinal Cord Injury Model System (MN Regional SCIMS), HealthPartners Neuroscience Center, Minneapolis VA Healthcare System, Duluth, and in the community.

Exclusion Criteria:

* adults with MRI contra-indications (stabilizing hardware is typically MRI safe);
* adults with uncontrolled seizure disorder;
* adults with cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevent them from following directions or from learning;
* adults with with ventilator dependency;
* adults with other major medical complications
* pregnant women

Primary outcomes:
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
timeFrame: baseline
measure: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Neurologic Exam
timeFrame: 12 weeks
measure: the Neuromuscular Recovery Scale (NRS)
timeFrame: baseline
measure: the Neuromuscular Recovery Scale (NRS)
timeFrame: 12 weeks
measure: The SCI-FI/AT
timeFrame: baseline
measure: The SCI-FI/AT
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT00473889: A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
Official title: A Phase II/III Randomized, Double-Blind Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat or Placebo in Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Stage IIIB or IV Non-Small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin


Eligibility criteria: Inclusion Criteria:

* Males and females at least 18 years of age who have confirmed diagnosis of Non-small Cell Lung Cancer
* Patients with no systemic prior systemic treatment for lung cancer except patients at least 12 months from prior adjuvant therapy
* Adequate bone marrow,kidney and liver function
* Must be recovered and at least 4 weeks from major surgery or radiation
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
* Men and women must agree to use birth control during the study
* Women able to have children must have a negative pregnancy test 14 days before study enrollment

Exclusion Criteria:

* Patients with prior treatment with other investigational agents less than 4 weeks before study enrollment
* Pregnant or nursing female patients
* Patients who are HIV positive
* Patients who have Hepatitis A, B, or C
* Patients unable to take study medication by mouth
* Patients with untreated brain cancer
* Patient eligible for treatment with bevacizumab and for whom bevacizumab is available

Primary outcomes:
measure: Overall Survival
timeFrame: Start of treatment to death
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Start of treatment to disease progression or death
measure: Number of Participants Who Had a Disease Response to Treatment
timeFrame: Every 42 days from start of treatment until disease response
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Beaumont H, Souchet S, Labatte JM, Iannessi A, Tolcher AW. Changes of lung tumour volume on CT - prediction of the reliability of assessments. Cancer Imaging. 2015 Oct 31;15:17. doi: 10.1186/s40644-015-0052-2.
Clinical trial NCT00488189: Study Evaluation Tazocin Intervention
Official title: Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) Producing Bacteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an antibiotic intervention study to determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.


Eligibility criteria: Inclusion Criteria:

* All patients admitted or transferred to ICU/Pulmonary units
* Patients of either sex, 18 years of age or older

Exclusion Criteria:

- Patients who stay in units less than 48 hours will not be enrolled.

Primary outcomes:
measure: 1. The acquisition rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase)
timeFrame: 9 months
Secondary outcomes:
measure: The infection rate due to ESBL producing E. coli or K. pnumoniae at the end of phase I (pre-intervention) and phase II (last 3 months of intervention phase)
timeFrame: 9 months
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: For China, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04476589: Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
Official title: Prognostication of Recovery in Early Disorders of Consciousness After COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Coma
Consciousness Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of severe COVID-19 who have disorders of consciousness

Brief summary: The primary aim of this research proposal is to use multimodal metrics (e.g., clinical data and advanced neuroimaging) in the early (i.e., acute hospitalization) phase of recovery from COVID-19-related disorders of consciousness to predict outcome at 3, 6, and 12 months post-hospitalization. We aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.


Eligibility criteria: Inclusion Criteria:

1. age 18 or older,
2. positive diagnosis of COVID-19,
3. diagnosis of coma, vegetative state or minimally conscious state per Glasgow Coma Scale (GCS) at time of enrollment (excluding confounders such as sedation) and
4. clinical team plan for an MRI for clinical management.

Exclusion Criteria:

A subject with any of the following MRI contraindications will not be eligible for this study:

* electrical implants such as cardiac pacemakers or perfusion pumps
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
* ferromagnetic objects such as jewelry or metal clips in clothing that cannnot be easily removed for scanning
* pregnant volunteers

Primary outcomes:
measure: Disability Rating Scale score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Fischer D, Threlkeld ZD, Bodien YG, Kirsch JE, Huang SY, Schaefer PW, Rapalino O, Hochberg LR, Rosen BR, Edlow BL. Intact Brain Network Function in an Unresponsive Patient with COVID-19. Ann Neurol. 2020 Oct;88(4):851-854. doi: 10.1002/ana.25838. Epub 2020 Aug 6.
citation: Fischer D, Snider SB, Barra ME, Sanders WR, Rapalino O, Schaefer P, Foulkes AS, Bodien YG, Edlow BL. Disorders of Consciousness Associated With COVID-19: A Prospective Multimodal Study of Recovery and Brain Connectivity. Neurology. 2022 Jan 18;98(3):e315-e325. doi: 10.1212/WNL.0000000000013067. Epub 2021 Dec 3.
Clinical trial NCT04449289: Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
Official title: Influence of Local Anesthetic Administration on the Cancer Recurrence Rate After Pancreatic Oncologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 100
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: Study aims to compare the influence of intravenous lidocaine and peridural ropivacaine on postoperative long and short term outcome in patients with pancreatic cancer undergoing surgery.

As short term endpoints: postoperative complications and resumption of bowel function.

Long term endpoints include: 1 and 3 year recurrence and mortality.


Eligibility criteria: Inclusion Criteria:

* diagnosis of pancreatic cancer
* American Society of Anesthesiologists (ASA) risk I - III

Exclusion Criteria:

* chronic pain
* chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
* contraindications for any of the study medications
* significant psychiatric disorders (major depression, bipolar disorders, schizophrenia, etc.)
* Convulsive disorders requiring medication during the last 2 years
* liver cirrhosis/chronic kidney disease stage IV or V/chronic heart failure class III or IV/ decompensated diabetes
* Corticoid dependent asthma
* Autoimmune disorders
* Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
* Refusal for study participation

Primary outcomes:
measure: 1- and 3-years recurrence rate after surgery
timeFrame: 3 years
Secondary outcomes:
measure: 1- and 3-years survival after surgery
timeFrame: 3 years
measure: Lidocaine and ropivacaine concentration
timeFrame: Intraoperatively
measure: Complication rate after surgery
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Institute of Gastroenterology and Hepatology "Prof. Dr. O. Fodor"
Study officials:
affiliation: Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor
name: Daniela Ionescu, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02074189: Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer
Official title: Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bladder Cancer
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Detailed description: Effect of adjuvant chemotherapy based on Gemcitabine and Cisplatin to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
2. Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy.
3. Transitional cell carcinoma of bladder, stage pT3N0M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
4. Electrocorticography(ECOG) performance status 0-2.
5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,
6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase(SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x upper limit of normal (ULN).
7. Creatinine clearance rate,Ccr ≥ 60%
8. ECG：no arrhythmias, no myocardial infarction.

   * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
   * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.

Exclusion Criteria:

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.
4. Evidence of distant metastasis beyond the pelvis.

Primary outcomes:
measure: cancer progressive free survival rate
timeFrame: 60 months
Secondary outcomes:
measure: overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest hospital,China
state: Chongqing
Study officials:
affiliation: Southwest Hospital, China
name: Zhiwen Chen, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01130389: CONDOR Study of Osteonecrosis of the Jaws (TMJ)
Official title: Trans-PBRN Case-control Study of Osteonecrosis of the Jaws
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis of the Jaw
Keywords: ONJ
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-05-26
Enrollment: 309
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The human subjects involved in this study were patients of dentists from the dental practice-based research networks (DPBRN, PEARL, PRECEDENT) who identified (ONJ) cases and chose to particpate in the study.

Brief summary: The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ), including the possible association with bisphosphonates (BPs). This study used the research infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN, PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for analysis.

Detailed description: The aims of this study were to (1) test the hypothesis that (BP) treatment is a risk factor for (ONJ); (2) to test the hypothesis that dental diseases (particularly periodontal disease), and invasive dental procedures such as dental extractions are true risk factors for (ONJ).

Eligibility criteria: Inclusion Criteria:

* participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT).

Exclusion Criteria:

* participants with a history of sickle cell anemia
* participants with a history of external severe trauma to the jaws

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Minneapolis
country: United States
facility: Health Partners Dental Group
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Research Foundation
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: Permanente Denrtal Associates
state: Oregon
Study officials:
affiliation: Dental Practice-Based Research Network (DPBRN)
name: Gregg H. Gilbert, DDS, MBA
role: STUDY_CHAIR
affiliation: Dental Practice-Based Research Network (DPBRN)
name: Andrei Barasch, DMD, MDSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06182189: Protocollo N 2014 - Benign Prostatic Hyperplasia
Official title: Studio Osservazionale Sulla qualità di Vita di Pazienti Affetti da IPB in Terapia Medica e/o Sottoposti a Intervento Chirurgico
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia; urology
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 8000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery

Brief summary: Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.

Detailed description: Prospective observational study on the quality of life of patients with BPH under medical therapy and/or undergoing surgery.

Data relating to the clinical conditions (state of the disease, psychological and related to the quality of life) of patients suffering from BPH under medical therapy and/or undergoing surgery will be collected within a specially designed database which will allow us to easily and secure extraction of data used for statistical analyzes in clinical research.

Eligibility criteria: Inclusion Criteria:

* subjects suffering from benign prostatic hyperplasia undergoing medical therapy and/or undergoing surgery
* subjects \>= 18 years old
* signature of informed consent

Exclusion Criteria:

* subjects \< 18 years
* presence of mental or physical disability that may prevent the patient from answering the questionnaires.

Primary outcomes:
measure: Medical history
timeFrame: Baseline
measure: Psycho-behavioural data - male sexual health
timeFrame: Baseline and up to 6 months
measure: Physical examination - Body temperature
timeFrame: Baseline
measure: Psycho-behavioural data - erectile function
timeFrame: Baseline and up to 6 months
measure: Prostatic Symptoms
timeFrame: Baseline and up to 6 months
measure: Incontinence Symptoms
timeFrame: Baseline and up to 6 months
measure: Physical examination - Body temperature pulse rate
timeFrame: Baseline
measure: Physical examination - respiration assessment
timeFrame: Baseline
measure: Physical examination - blood pressure
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
affiliation: IRCCS Ospedale San Raffaele
name: Andrea Salonia, MD
role: PRINCIPAL_INVESTIGATOR
References: