louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01992302: Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
Official title: Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Rapid cycling
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bipolar I and II disorder patients

Brief summary: In this study we tried to elucidate the factors associated with the development of a rapid cycling course in bipolar disorder patients, in a prospective and longitudinal design, and the role of antidepressants. The identification of risk factors is extremely relevant from the clinical point of view. We hypothesized that rapid cycling bipolar disorder is associated with more chronicity, poor outcome, and more antidepressant prescription.


Eligibility criteria: Inclusion Criteria:

* Bipolar I and II disorder patients according to DSM-IV criteria

Exclusion Criteria:

* Major medical comorbidities, voluntary drop-out from study

Primary outcomes:
measure: Number of patients who develop rapid cycling
timeFrame: 8 years
Secondary outcomes:
measure: Factors associated with the development of a rapid cycling course in bipolar disorder patients
timeFrame: 8 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barcelona Bipolar Disorders Program, Hospital Clinic Barcelona
state: Catalonia
Study officials:
References:
Clinical trial NCT04697602: Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Gout
Official title: Low-dose Colchicine With or Without Stepwise Dose Titration of Febuxostat for Flare Prophylaxis in Patients With Gout and Hyperuricemia During the Initial Phase of Urate-lowering Therapy: an Open-label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gout
Keywords: gout,febuxostat,flare prophylaxis,stepwise dose titration,colchicine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2021-01-06
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
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 incidence rate of gout flare for subjects with gout and hyperuricemia treated by two different starting doses of febuxostat.

Detailed description: A prospective randomized open-label study comparing dose titration group (stepwise dose titration of febuxostat and low-dose colchicine) and standard treatment group (fixed dose febuxostat and low-dose colchicine) in the subjects with gout and hyperuricemia. The incidence rate of gout flare will be compared between two groups during the first 12 week of febuxostat treatment.

Eligibility criteria: Ages Eligible for Study: more than 20 years

Inclusion Criteria:

1. Hyperuricemia (serum urate ≥7.0 mg/dL and gout by 1977 American College of Rheumatology Criteria
2. Acute gout attack during the last 12 months

Exclusion Criteria:

1. Acute gout attack in the last 2 weeks
2. Urate-lowering therapy in the last 4 weeks
3. Secondary hyperuricemia
4. Creatinine ≥2.0 mg/dL
5. AST or ALT ≥2x upper limits of normal
6. Heart failure (NYHA III-IV)
7. Hypersensitivity to colchicine, NSAID or febuxostat
8. Use of NSAID, glucocorticoid, cyclosporine, clarithromycin, mercaptopurine, azathioprine, pyrazinamide, ethambutol, chemotherapy, tacrolimus, losartan, and fenofibrate
9. Inability to comply with the protocol requirements
10. The judgement of the investigator that the patient was not an appropriate candidate

Primary outcomes:
measure: The incidence rate of gout flare during the first 12 weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: The number of gout flares per patient during the first 12 weeks
timeFrame: 12 weeks
measure: The number of gout flares per patient during the second 12 weeks
timeFrame: 12 weeks
measure: The percentage of patients with serum urate <6.0mg/dL in 12, 24 weeks
timeFrame: 12, 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Yi-Min Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753102: Efficacy and Safety Of Spil's Estradiol Vaginal Tablet
Official title: EFFICACY AND SAFETY OF SPIL'S ESTRADIOL VAGINAL TABLET, 10 MCG ESTRADIOL IN SUBJECTS WITH VULVAR AND VAGINAL ATROPHY: A RANDOMIZED, OBSERVER BLIND, PARALLEL GROUPS, ACTIVE AND PLACEBO CONTROLLED, CLINICAL ENDPOINT BIOEQUIVALENCE STUDY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Vulvar Atrophy
Vaginal Atrophy
Keywords: Estradiol
Vulvar atrophy
vaginal atrophy
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 49
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17ß-estradiol.

The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen.

The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem®)which is approved and marketed in the US.

Detailed description: Estradiol vaginal tablet is indicated for use in the treatment of symptoms of atrophic vaginitis due to estrogen deficiency.

This is a randomized, observer blind, parallel groups, active and placebo controlled study to test the clinical endpoint bioequivalence of test product (Estradiol vaginal tablet, 10mcg of Sun Pharmaceutical Industries Ltd. India) relative to reference (Vagifem®, Estradiol vaginal tablet, 10mcg estradiol of Novo Nordisk) in treatment of vulvar and vaginal atrophy.

The patients will be administered with one tablet intravaginally daily for 14 days.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman
* At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy
* ≤ 5% superficial cells on vaginal smear cytology
* Vaginal pH \> 5.0

Exclusion Criteria:

* Consumption of estrogen alone or estrogen/progestin containing drug products.
* Allergy to estradiol or related products
* History of breast cancer and significant risk factors for endometrial cancer
* Abnormal genital bleeding

Primary outcomes:
measure: Vaginal pH
timeFrame: 14 days
Secondary outcomes:
measure: Symptoms of vulvar and vaginal atrophy
timeFrame: 14 days
Other outcomes:
Locations:
city: Pune
country: India
facility: Biniwale Clinic Pvt. Ltd,
state: Maharashtra
Study officials:
References:
Clinical trial NCT04700202: Identifying Risk Factors for Gram-negative Resistance for HAP/VAP in the Intensive Care Unit
Official title: Identifying Risk Factors for Gram-negative Resistance for HAP/VAP in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-associated Pneumonia
Hospital-acquired Pneumonia
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.

Brief summary: Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.

Detailed description: Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP. Patients with respiratory culture data signifying a Gram-negative organism as the cause of HAP/VAP will be analyzed as described below if study inclusion criteria is met. Minimum inhibitory concentration (MIC) data will interpreted per Clinical \& Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine risk factors for piperacillin-tazobactam, cefepime or meropenem resistant Gram-negative isolates. Project target date of completion and close-out is May 2021.

Eligibility criteria: Inclusion Criteria:

* ICU, Neuro critical care unit admission
* Diagnosis of HAP or VAP
* Respiratory culture positive for Gram-negative organism

Exclusion Criteria:

* ICU length of stay \<48 hours prior to HAP/VAP
* Culture or MIC data unavailable
* Pregnant

Primary outcomes:
measure: Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem
timeFrame: April 2017 - May 2020
Secondary outcomes:
measure: Rate of susceptibility to non-beta lactam antipseudomonal agents
timeFrame: April 2017 - May 2020
measure: in-hospital mortality
timeFrame: April 2017 - May 2020
measure: need for mechanical ventilation
timeFrame: April 2017 - May 2020
measure: duration of mechanical ventilation
timeFrame: April 2017 - May 2020
measure: development of septic shock
timeFrame: April 2017 - May 2020
measure: ICU length of stay
timeFrame: April 2017 - May 2020
measure: hospital length of stay
timeFrame: April 2017 - May 2020
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Matthew Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699802: Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)
Official title: Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose is to investigate how the adsorptive capacity of the active carbon filter to carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled anaesthetic agent.

The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon dioxide.


Eligibility criteria: Inclusion Criteria:

* elective coronary artery by-pass graft surgery
* elective valve replacement surgery
* normal left ventricular ejection fraction on preoperative echocardiography

Exclusion Criteria:

* obstructive lung disease
* restrictive lung disease

Primary outcomes:
measure: Volume of carbon dioxide rebreathing from an anesthetic gas reflector
timeFrame: 2 hours
Secondary outcomes:
measure: Quantification of ventilatory requirements to maintain isocapnia with the use of an anesthetic gas reflector.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skane University Hospital Lund, Cardiothoracic Intensive Care
Study officials:
affiliation: Divison of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
name: Mikael Bodelsson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04838002: The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis
Official title: Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis: A Randomised Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Pain
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 87
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: To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of lateral epicondylitis
* be aged ≥18 at the time of diagnosis
* be give informed consent

Exclusion Criteria:

* be have not completed the assessment process.
* elbow deformity
* psychological illness

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 1 min.
measure: Patient-Rated Tennis Elbow Evaluation
timeFrame: 5 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University
Study officials:
affiliation: Yuzuncu Yıl University
name: Şeyhmus Kaplan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03301402: Air Purifier to Improve Endothelial Function and Carotid Intima Thickness
Official title: A Randomized Controlled Trial of Air Purifier to Improve Endothelial Function and Carotid Intima Thickness in Older Diabetic People With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Function
Cognitive Impairment
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 61
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: There is epidemiological evidence or link ambient air pollution exposure to the incidence of dementia.

Aims or hypotheses: It is hypothesized that reduction in indoor pollutants from air purification improves endothelial function and carotid intima thickness in older diabetic people with cognitive impairment.

Subjects and method: People with clinically diagnosis mild cognitive impairment or early dementia will be recruited. After obtaining written consent, the subjects will be assessed cognitive function and arterial health. After baseline measurements, the subjects are randomly assigned to have either filter or no filter installed in the air purifier. The air purifier will be placed in living room of the household of the subject for one year. At one year, the measurements will be repeated.

Statistical analysis: Intention to treat analysis will be adopted.


Eligibility criteria: Inclusion Criteria:

* Diabetic people
* Mild cognitive impairment or early dementia

Exclusion Criteria:

* Current smoker
* The presence of a smoker in the household
* The absence of a reliable family caregiver
* The lack of mental capacity to give informed consent

Primary outcomes:
measure: FMD%
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Timothy Kwok
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02934802: Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
Official title: Non-Interventional Consecutive and Prospective Study of e.Motion® PS Pro Prosthesis in the Total Knee Artroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthroplasty
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 140
Sex: ALL
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: Patients for which a Total Knee Prosthesis with e.motion® PS Pro was decided by the surgeon

Brief summary: This post-market clinical follow-up study intends to investigate the survival rate at 5 years of the e.motion® PS Pro System.


Eligibility criteria: Inclusion Criteria:

* Patient having signed informed consent
* Patients over 18 for which a Total Knee Prosthesis with e.motion® PS Pro was decided
* Patients willing to participate in a 5 years follow-up

Exclusion Criteria:

* Active or suspected infection
* Tumor on the concerned knee
* Patient vulnerable and under legal protection

Primary outcomes:
measure: Survival rate at 5 years of the e motion PS Pro
timeFrame: the survival rate will be evaluated 6-12 weeks; 1; 2; 3; 4 and 5 years after the knee arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier Paris-St Joseph
Study officials:
affiliation: Groupe hospitalier Paris-St Joseph
name: François Boillot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01393002: Perception and Prevalence of Fungal Infections in Berlin - Brandenburg
Official title: Web-based Structured Survey of Retrospective Data of Invasive Mycosis in Intensive Care Patients in Berlin - Brandenburg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Mycosis
Keywords: intensive care
candidemia
fungal infection
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 25
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: Intensive care units of different primary and secondary care hospitals in the region of Berlin-Brandenburg.

Brief summary: This is a structured web-based survey in selected hospitals with intensive care units in Berlin- Brandenburg that will focus on the analysis of current knowledge in ICUs in the field of invasive mycoses.

Detailed description: Intensive care patients with invasive mycosis require a special clinical expertise especially in light of a high lethality. Early identification of patients at risk to develop a fungal infection is of utmost importance to start effective antifungal therapy. The implementation of current knowledge into clinical practice to fight fungal infection is not clear.

Eligibility criteria: Inclusion Criteria:

* Intensive care units of hospitals in the INABBRA alliance.
* Patients with invasive mycosis.

Exclusion Criteria:

* Hospitals without intensive care unit.

Primary outcomes:
measure: Perception and prevalence of fungal infections
timeFrame: 4 months
Secondary outcomes:
measure: Practice - Surrogate markers for diagnosis and therapy of fungal infection and retrospective analysis of cases of invasive mycosis in a peer-review setting.
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
name: Claudia Spies, Prof., MD
role: STUDY_DIRECTOR
References:
citation: Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5. doi: 10.1128/AAC.49.9.3640-3645.2005.
Clinical trial NCT01777802: Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy
Official title: Observational Study of Immune Responses in Prostate, Lung, Melanoma and Breast Cancer Patients Following Stereotactic Body Radiotherapy (SBRT), Intensity Modulated Radiotherapy (IMRT) or Brachytherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Breast Cancer
Lung Cancer
Melanoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-01-29
Enrollment: 97
Sex: ALL
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: Oligometastatic prostate, lung, breast and melanoma patients

Brief summary: Success of cancer immunotherapy is limited by the ability of solid tumors to evade local and systemic antitumoral immune responses. Several mechanisms of tumor immune evasion have been identified, including low intratumor expression of antigens and elevated expression of inhibitory co-regulatory molecules. An effective immunotherapy is one which would induce necrotic cell death and accompanying proinflammatory cytokine induction. Stereotactic Body Radiotherapy (SBRT) or Intensity Modulated Radiotherapy (IMRT) or brachytherapy, which is capable of delivering high, conformal radiation doses (\>8 Gy) of tumor ablative radiation may be an effective means of conditioning a tumor bed to a state favorable to the initiation of robust antitumoral immune responses.


Eligibility criteria: Inclusion Criteria:

* Hormone Refractory, Metastatic Prostate Cancer, Lung Cancer, and Melanoma or Breast Cancer

Exclusion Criteria:

-Life expectancy of less than 3 months

Primary outcomes:
measure: Change in immune biomarkers from baseline and after radiation treatments for breast, prostate, and lung cancers.
timeFrame: Before and after SBRT, IMRT, or brachytherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sean S Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans JD, Morris LK, Zhang H, Cao S, Liu X, Mara KC, Stish BJ, Davis BJ, Mansfield AS, Dronca RS, Iott MJ, Kwon ED, Foote RL, Olivier KR, Dong H, Park SS. Prospective Immunophenotyping of CD8+ T Cells and Associated Clinical Outcomes of Patients With Oligometastatic Prostate Cancer Treated With Metastasis-Directed SBRT. Int J Radiat Oncol Biol Phys. 2019 Jan 1;103(1):229-240. doi: 10.1016/j.ijrobp.2018.09.001. Epub 2018 Sep 8.