louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00610116: Electronic Repositioning With Acuity and Easytrak Leads
Official title: Electronic Repositioning With Acuity and Easytrak Leads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-02-07
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate appropriate performance of Electronic Repositioning™ (ER) in the clinical routine, cumulative incidence of phrenic nerve stimulation (PNS) \& success rates of Electronic Repositioning (ER) to remove it, various incl. left ventricular pacing (LVP) thresholds and PNS

Detailed description: Bipolar leads for left ventricular pacing (LVP) such as the newly available ACUITY™ or the standard EASYTRAK™ II and EASYTRAK™ III leads from GUIDANT in combination with suitable devices for cardiac resynchronization therapy (CRT) allow for the non-invasive programming of different Left Ventricular Pacing (LVP) configurations. Hence, this Electronic Repositioning (ER) may help physicians to overcome problems in cardiac resynchronization therapy (CRT) such as ineffective biventricular pacing, high Left Ventricular Pacing (LVP) thresholds and phrenic nerve stimulation (PNS) without the need for an additional patient's operation to reposition LV leads. The ERACE study it a multi-center, prospective, non-randomized clinical study to document and evaluate appropriate performance of GUIDANT's Electronic Repositioning™ in the clinical routine with respect to the following major aspects:

avoidance of PNS and low LVP thresholds (for low battery consumption and extended device longevity) in standard cardiac resynchronization therapy (CRT)

Eligibility criteria: Inclusion Criteria:

* Patients receiving their FIRST implantation of a Left Ventricular (LV) lead in combination with a CRT device with implantable cardioverter defibrillator (ICD) backup and the possibility for Electronic Repositioning™
* Patients willing (= signed written consent) and capable to participate in all procedures of the study"

Exclusion Criteria:

* Patients who will not be available for routine Follow up
* 18 years old
* Known pregnancy.

Primary outcomes:
measure: Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
timeFrame: From implant until first follow up (occurred between 3 or 6 month after implant procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital
Study officials:
References:
Clinical trial NCT00597116: An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma
Official title: A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA ™) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Mesothelioma
Keywords: Mesothelioma
inoperable
relapsed
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 25
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: A clinical study to assess if a new investigational drug is effective in treating malignant mesothelioma, compared to a chemotherapy treatment (Navelbine®). In this study the patients will be assigned by chance to receive either the new drug or a chemotherapy treatment (Navelbine®). Treatment will continue as long as the cancer does not worsen and the patient wishes to continue in the study. The study will recruit approximately 66 patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with mesothelioma
* Previously treated with only one course of chemotherapy for mesothelioma
* No previous treatment with vinorelbine
* No serious heart problems within the last 3 months

Exclusion Criteria:

* Serious abnormal laboratory values
* Severe or uncontrolled disease or condition as judged by the Investigator
* Pregnant or breast-feeding women
* Other cancers within the last 5 years
* Major surgery or radiation therapy within 4 weeks prior to starting study therapy
* Receipt of any investigational agents within 30 days prior to commencing study treatment.

Primary outcomes:
measure: Number of Participants With Disease Control.
timeFrame: Assessed at 2 months.
Secondary outcomes:
measure: Number of Participants With Objective Response.
timeFrame: Assessed at 2 months.
measure: Progression-free Survival (PFS)
timeFrame: Assessed from baseline to 12 months.
measure: Overall Survival (OS)
timeFrame: Assessed from baseline to 12 months.
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Research Site
city: Halle-Dolau
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT02671916: Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU)
Official title: Health and Quality of Life One Year After Discharge From the ICU: in Time Not Limited Quality Control After Intensive Medical Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critically Ill
Keywords: QoL and Survival one year after ICU stay
Lead sponsor: Klinik Hirslanden, Zurich
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 55
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: all patients with conditions that lead to an ICU stay

Brief summary: The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together.

Detailed description: no detailled description necessary

Eligibility criteria: Inclusion Criteria:

* patients who are at least 5 days or longer without interruption at the ICU

Exclusion Criteria:

* patients with less than 4 days at the ICU

Primary outcomes:
measure: Survival
timeFrame: 1 year after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Klinik Hirslanden
state: Kanton Zurich
Study officials:
affiliation: Klinik Hirslanden, Zurich
name: Christoph Haberthür, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04551716: Noninvasive Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population
Official title: Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population Using ATI / SWE / SWD: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the results of HBV surface antigen, the patients were divided into two subgroups: (1) HBV surface antigen negative group: pure mafld group; (2) HBV surface antigen positive group: mafld combined with hepatitis B group

Brief summary: Attenuation imaging (ATI) technology independently developed by Canon medical is a non-invasive examination technology for quantitative detection and analysis of liver steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI combined with SWD / SWE detection can quantitatively diagnose different pathological stages (steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as to provide an important basis for treatment.


Eligibility criteria: Inclusion Criteria:

1. being a Chinese citizen aged 18 to 85 years;
2. meeting the diagnostic criteria for MAFLD;
3. willing and able to provide informed consent;
4. having a platelet count of at least 50 × 109/L and prothrombin activity of ≥50%.

Exclusion Criteria:

1. The pregnant.
2. Patients who have received or are undergoing systemic chemotherapy.
3. Patients with hepatitis C, alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 40g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
4. Those who re fuse to sign informed consent;
5. There was a significant risk of bleeding (platelet \< 50x109 / L, prothrombin activity \< 50%).

Primary outcomes:
measure: Correlation between ATI / SWD / SWE parameters and the degree of steatosis, inflammation and fibrosis in MAFLD patients
timeFrame: from October 2020 to june 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Ping Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04170816: Dry Needling With And Without Kinesio Taping® in The Non-Specific Chronic Low Back Pain
Official title: Comparing Dry Needling With And Without Kinesio Taping® in The Treatment of Non-Specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Spesific Chronic Low Back Pain
Keywords: Dry needling
Kinesiotape
Low-back pain
Lead sponsor: Kars State Hospital
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We wiil evaluate the efficiency of adding kinesio taping (KT) therapy to dry needling (DN) therapy on pain, functionality and depression parameters in 60 patients with nonspecific chronic low back pain (nCLBP).

Detailed description: A total of 60 patients will be included in the study. 30 patients will be in the treatment group and 30 patients will be in the control group. Both groups will be underwent 3 sessions with 1-week intervals on active myofascial trigger points in lumbar multifidus, quadratus lumborum and gluteus medius muscles in DN therapy. KT application will be performed after every DN session in the study group. Pain will evaluate with visual analog scale, functionality was evaluated with Oswestry Disability Index and the status of depression will be evaluated with Beck Depression Index before the treatment and at the first month.

Eligibility criteria: Inclusion Criteria:

* having no abnormal results in routine blood tests
* having no known acute or chronic inflammatory disease
* an education level required for understanding the applied treatment, interventions

Exclusion Criteria:

* malignancies
* active infection
* history of common inflammatory rheumatic disease
* trauma in spinal area, skin lesion, presence of infection or open wounds
* radiculopathy
* peripheral circulation disorder
* use of warfarin due to coagulopathy
* arthropathy
* congenital or acquired spinal pathology
* pregnancy

Primary outcomes:
measure: Pain pressure threshold
timeFrame: 3 week
measure: Pain by visual analog scale (VAS)
timeFrame: 3 week
measure: Oswestry disability Index (ODI)
timeFrame: 3 week
measure: Beck Depression Inventory
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02683616: Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Official title: Fatty Acid Metabolism in Obstructive Sleep Apnea (FAMOSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Fatty Acid Metabolism
Continuous Positive Airway Pressure
Lead sponsor: Faculty Hospital Kralovske Vinohrady
Sponsor class: OTHER_GOV
First posted: 2016-02-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea syndrome (OSA) is a disease affecting 5-15% of population and 50-80% of type 2 diabetes mellitus (T2DM) and obese subjects. OSA causally contributes to the development of glucose intolerance and T2DM. The project is targeting the gap in providing effective treatment of metabolic impairments associated with OSA, particularly T2DM. In contrast to proved benefits of OSA treatment with CPAP (continuous positive airway pressure) on cardiovascular morbidity/mortality, studies on the impact of CPAP on diabetes control are disappointing. In fact, OSA-induced metabolic impairments might not be reversible with CPAP treatment, as investigators suggested recently. Clearly, the search for additional treatments, probably pharmacological, is warranted. Investigators hypothesize that elevated levels of free fatty acids (FFA), as detected in OSA patients, are linking OSA with the T2DM development. The aim of the study is to target adipose tissue and muscle dysfunction leading to elevated FFA and develop thus novel pharmacological treatments based on lipolysis inhibition and stimulation of FFA oxidation.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes mellitus
* Age 18 - 85 years
* BMI 22-40 kg/m2
* moderate or severe OSA diagnosed by home sleep study

Exclusion Criteria:

* treatment with insulin
* other acute or chronic endocrine or inflammatory disease

Primary outcomes:
measure: Glycerol release (lipolysis) in adipose tissue
timeFrame: Baseline and 6 months
measure: Palmitate oxidation in skeletal muscle
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: FN Kralovske Vinohrady
Study officials:
References:
Clinical trial NCT03585816: Composition of the Exhaust Gas of Pneumoperitoneum During Laparoscopic Surgery
Official title: Qualitative Assessment of the Composition of the Exhaust Gas of Pneumoperitoneum During Laparoscopic Surgery: Prospective Gas Chromatographic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumoperitoneum
Keywords: Pneumoperitoneum
Exhaust gas
chromatographic study
Nitrous oxide
Nitrogen dioxide
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who will benefit from a laparoscopic surgery at Strasbourg University Hospitals

Brief summary: This research aims to study the composition of the peritoneal exhaust gas during laparoscopic surgery to detect and possibly quantify the presence of air and / or N2O. This purely descriptive work is part of other experimental work that the investigators have already published.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient who will benefit from a laparoscopic surgery at Strasbourg University Hospitals
* Patient who has consented to the use of her medical data for research purposes.

Exclusion Criteria:

- Refusal of the patient to participate in the study

Primary outcomes:
measure: to quantify the composition of the exhaust gas of pneumoperitoneum during laparoscopic surgery by gas chromatography
timeFrame: 1 day after laparoscopic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d' Anesthésie Réanimation Chirurgicale
Study officials:
References:
Clinical trial NCT01293916: Spica Casting in Pediatric Femur Fractures: Study of Single Leg Versus Double Leg Spica Casts
Official title: Spica Casting in Pediatric Femur Fractures: A Prospective Randomized Controlled Study of Single Leg vs Double Leg Spica Casts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Keywords: pediatric
femur
femoral
fracture
spica
cast
diaphyseal
single
double
patient age 2 to 6 years old
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.

Detailed description: Introduction

* double-leg spica casting is the treatment of choice at many centers for the treatment of diaphyseal femur fractures in children 2 to 6 years old.
* Investigators hypothesize that these patients can be effectively treated with single-leg spica casting and that such treatment will result in easier care and better patient function during treatment.

Methods

* Prospective randomized controlled study of patients between 2 and 6 years old with diaphyseal femur fractures
* patients randomly assigned to either immediate single or double-leg spica casting groups after consent was obtained
* Radiographs serially evaluated for maintenance of reduction with respect to length, varus/valgus angulation and procurvatum/recurvatum angulation
* After casts removal, the Activity Scale for Kids (Performance Version) questionnaire and a custom written survey were given to parents evaluating ease of care and function of children during treatment.

Eligibility criteria: Inclusion Criteria:

* diaphyseal femur fracture
* age between 2 and 6 years old

Exclusion Criteria:

* underlying bone disorder
* neuromuscular disease

Primary outcomes:
measure: Acceptable fracture healing
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dirk Leu, MD
role: STUDY_DIRECTOR
affiliation: Johns Hopkins University
name: Paul D Sponseller, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01446224: Cardiovascular and Torsades de Pointes Monitoring for Pazopanib
Official title: Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: adverse events
pazopanib
Torsades des Pointes
renal cell carcinoma
anti-VEGF agents
observational data
cardiac ischemia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study cohorts will be created in two healthcare databases to follow the outcomes of interest in (i) Pazopanib users, and (ii) users of other marketed anti-VEGF drugs (Bevacizumab, Sorafenib, Sunitinib).

Brief summary: This observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for Pazopanib use outside of the clinical trial setting. The aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients treated with marketed anti-VEGF agents \[Pazopanib (VOTRIENT), Bevacizumab (AVASTIN), Sorafenib (NEXAVAR), and Sunitinib (SUTENT)\].

Two databases will be utilized for this study: a large healthcare claims database in the U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and Torsades des Pointes.


Eligibility criteria: Inclusion Criteria:

The anti-VEGF cohorts will include patients with the following characteristics:

* Adult patients (age ≥18 years)
* Prescribed or administered an anti-VEGF agent: Pazopanib, Bevacizumab, Sorafenib or Sunitinib on or after approval date of Pazopanib
* Diagnosed with renal cell cancer

Exclusion Criteria:

* Patients with multiple primary cancer diagnoses

Primary outcomes:
measure: Cardiovascular ischemia
timeFrame: Over four years from approval of pazopanib
Secondary outcomes:
measure: Torsades de Pointes
timeFrame: Over four years from approval of pazopanib
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: