louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668108: A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer
Official title: Open, Multicenter Observational Study of Paclitaxel Utilized in Mono- or Combination Therapy for the Treatment of Breast Cancer, Non-small Cell Lung Cancer and Ovarial Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Keywords: carcinoma
breast cancer
non-small cell lung cancer
ovarial cancer
ambulant chemotherapy
treatment cycles
Paclitaxel
Paclitaxel onkovis
Quantity of Paclitaxel
Packaging Sizes
Lead sponsor: Onkovis GmbH
Sponsor class: INDUSTRY
Collaborators: name: AKP Freiburg GmbH
First posted: 2012-08-17
Enrollment: 770
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in practices, clinics, hospitals

Brief summary: The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy.

onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.

Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.


Eligibility criteria: Inclusion Criteria:

* Indication for Paclitaxel according to the SmPC and treating physician

Exclusion Criteria:

* according to the Paclitaxel SmPC

Primary outcomes:
measure: the quantity of Paclitaxel onkovis needed pro treatment cycle
timeFrame: the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles).
Secondary outcomes:
measure: adverse events during and after treatment in comparison to Docetaxel onkovis
timeFrame: up to 24 weeks (8 cycles)
Other outcomes:
Locations:
city: Brandenburg
country: Germany
facility: Practice
city: Chemnitz
country: Germany
facility: Practice
city: Dresden
country: Germany
facility: Practice
city: Mühlhausen
country: Germany
facility: Practice
city: Plauen
country: Germany
facility: Practice
Study officials:
References:
Clinical trial NCT04338308: New-DES vs BMS in SVG -1 Year Outcomes
Official title: New-generation Drug Eluting Stent vs. Bare Metal Stent in Saphenous Vein Graft - 1 Year Outcomes by a Propensity Score Ascertainment (SVG Baltic Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Percutaneous coronary intervention
Saphenous vein graft
New generation drug-eluting stent
Bare metal stent
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Wojciech Wojakowski
First posted: 2020-04-08
Enrollment: 792
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing PCI of SVG

Brief summary: Data regarding the efficacy of the percutaneous coronary intervention (PCI) with new-designed drug-eluting stent (new-DES) vs. bare metal stent (BMS) of saphenous vein grafts (SVG) stenosis is scarce. The primary objective was to compare one-year clinical outcomes of PCI in stenosis of SVG using new-DES vs. BMS in a real-world population. We carried out a multi-center registry comparing new-DES with BMS in all consecutive patients undergoing PCI of SVG. The primary composite endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 1 year.


Eligibility criteria: Inclusion Criteria:

* patients after CABG with significant SVG stenosis referred for PCI

Exclusion Criteria:

* patients who had both types of stents implanted in the same procedure
* patients with the old-DES
* patients who had PCI of other vascular territories during the same procedure

Primary outcomes:
measure: major adverse cardiac and cerebrovascular event
timeFrame: 1 year
Secondary outcomes:
measure: death
timeFrame: 1 year
measure: myocardial infarction
timeFrame: 1 year
measure: target vessel revascularization
timeFrame: 1 year
measure: target lesion revascularization
timeFrame: 1 year
measure: stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland
city: Katowice
country: Poland
facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
city: Kraków
country: Poland
facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland
Study officials:
References:
citation: Wanha W, Mielczarek M, Roleder T, Ladzinski S, Milewski M, Gilis-Malinowska N, Chmielecki M, Ciecwierz D, Bachorski W, Kunik P, Trznadel A, Mecka K, Genc A, Januszek R, Paczek P, Dziewierz A, Bartus S, Gruchala M, Smolka G, Dudek D, Navarese EP, Ochala A, Jaguszewski M, Wojakowski W. New-generation drug eluting stent vs. bare metal stent in saphenous vein graft - 1 year outcomes by a propensity score ascertainment (SVG Baltic Registry). Int J Cardiol. 2019 Oct 1;292:56-61. doi: 10.1016/j.ijcard.2019.04.022. Epub 2019 Apr 11.
Clinical trial NCT05928208: The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia
Official title: The Role of Point-of-care Polymerase Chain Reaction in Managing Nosocomial Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Pneumonia
Keywords: polymerase chain reaction
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptoms of nosocomial pneumonia

Brief summary: The study compares a device that is used for the detection of bacteria and MDR pathogens from skin, soft tissue and nose with the gold-standard (microbiological lab). It is a novel use for this device because it has been used in samples from the lower-respiratory tract.

Detailed description: The purpose of this study is to find out if a POC-PCR device can be use in the diagnosis of hospital acquired pneumonia and ventilation-associated pneumonia.

Eligibility criteria: Inclusion Criteria:

* patients that are admitted for at least 48 hours
* radiological findings typical for pneumonia
* signs of infection

Exclusion Criteria:

* patient or patient relatives doesn't accept to enter the study

Primary outcomes:
measure: To determine the sensibility and specificity of the device GeneXpert in diagnosis of pneumonia
timeFrame: 4 years
measure: Utility of POC-PCR in managing pneumonia
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj
state: Cluj
Study officials:
affiliation: Universitatea de Medicina si Farmacie "Iuliu Hatieganu" Cluj-Napoca
name: Andrei Balan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06233708: Association Between Pre-op Non-Selective Beta-Blockers and Hepatocellular Carcinoma Recurrence Post-Liver Transplant
Official title: Association Between Pre-operative Use of Non-selective Beta-blockers With the Risk of Hepatocellular Carcinoma Recurrence Following Liver Transplantation : a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Recurrent
Hepatocellular Carcinoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2024-01-31
Enrollment: 2092
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: Patients who underwent liver transplantation at Asan Medical Center between Jan. 2008 - May 2022. Asan Medical Center is a tertiary, teaching hospital of the University of Ulsan College of Medicine, located in Seoul, South Korea.

Brief summary: The goal of this observational study is to investigate the effect of non-selective beta-blocker (NSBB) on the recurrence of hepatocellular carcinoma (HCC) following liver transplantation in patients who underwent liver transplantation (LT) for treating hepatocellular carcinoma.

The main question\[s\] it aims to answer are:

* Is the usage of non-selective beta-blocker associated with decreased recurrence of hepatocellular carcinoma following liver transplantation?
* Is the usage of non-selective beta-blocker associated with all-cause mortality following liver transplantation?

Researchers will compare the NSBB group, including patients who received non-selective beta-blocker therapy for at least 30 consecutive days within 3 months prior to liver transplantation more than 30 days prior, with the control group to to see if non-selective beta-blocker treatment is associated with decreased recurrence of hepatocellular carcinoma following liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Underwent liver transplantation for treating hepatocellular carcinoma
* Between Jan. 2008 - May. 2022

Exclusion Criteria:

* Pediatric patients (Age under 18 years)
* Re-transplantation
* Multi-organ transplantation

Primary outcomes:
measure: Kaplan-Meier survival analysis of HCC recurrence at 5-year follow-up
timeFrame: Baseline and 5-year follow-up
measure: Multivariate Cox regression analysis of HCC recurrence at 5-year follow-up
timeFrame: Baseline and 5-year follow-up
Secondary outcomes:
measure: Kaplan-Meier survival analysis of overall survival at 5-year follow-up
timeFrame: Baseline and 5-year follow-up
measure: Multivariate Cox regression analysis of overall survival at 5-year follow-up
timeFrame: Baseline and 5-year follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Asan Medical Center
name: Jun-Gol Song, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06706908: Innovative Spinopelvic Solutions with Real-World Evidence
Official title: Innovative Spinopelvic Solutions with Real-world Evidence
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sacroiliac Joint Dysfunction
Sacroiliac Joint Pain
Lead sponsor: SI-BONE, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with an implant manufactured by SI-BONE.

Brief summary: INSPIRE is a prospective decentralized study evaluating post-operative health outcomes in patients who undergo a procedure using implants manufactured by SI-BONE.


Eligibility criteria: Inclusion Criteria:

1. Age \> 21 at time of screening.
2. Patient will undergo a procedure utilizing an iFuse Implant family product.
3. Patient is comfortable communicating in written and spoken English.
4. Patient is willing and able to complete study questionnaires online, using either a smartphone, tablet, or computer.
5. Patient is willing and able to provide informed consent to participate

Exclusion Criteria:

1. Patient has fibromyalgia.
2. Patient has a pain pump.
3. Patient is currently receiving or seeking worker's compensation, disability remuneration, and/or involved in injury litigation

Primary outcomes:
measure: Change in patient reported outcomes
timeFrame: From enrollment and at the following timepoints, 1-, 3-, 6-, and 12-months.
Secondary outcomes:
measure: Change in patient reported outcomes
timeFrame: At the following timepoints: 1-, 3-, 6-, and 12-months.
Other outcomes:
measure: Postoperative incidence of:
timeFrame: At the following timepoints, 1-, 3-, 6-, and 12-months.
Locations:
city: Santa Clara
country: United States
facility: SI-BONE
state: California
Study officials:
affiliation: SI-BONE
name: Robyn Capobianco, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06964308: Thoracoscopic Pleural Biopsy in Sohag University Hospital
Official title: Thoracoscopic Pleural Biopsy, Sohag University Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Diseases
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the diagnostic efficacy, safety, and clinical outcomes of thoracoscopic pleural biopsy in the management of pleural diseases.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected pleural disease who have been referred for thoracoscopic pleural biopsy
* Age: Adults aged 18 years and older
* Patients should have undergone necessary preoperative evaluations, including imaging studies (e.g., chest X-ray, CT scan) that indicate a need for biopsy.

Exclusion Criteria:

* Contraindications to Thoracoscopic Biopsy: Patients with contraindications to thoracoscopic biopsy
* Infeasibility of Procedure: Patients with anatomical or physiological factors that make thoracoscopic biopsy technically unfeasible or unsafe (e.g., severe pleural adhesions or distorted anatomy).
* Alternative Diagnoses: Patients who have been definitively diagnosed with a condition that does not require thoracoscopic biopsy for further evaluation.
* Pregnancy: Pregnant women may be excluded due to potential risks to the fetus and the need for specific procedural considerations.
* Inability to Provide Consent: Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or other reasons.
* Participation in Concurrent Studies: Patients currently participating in other clinical studies that could interfere with the outcomes of this study or affect their eligibility.

Primary outcomes:
measure: early postoperative follow up for thoracoscopic pleural biopsy in the management of pleural diseases.
timeFrame: 3 days after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Solari E, Marcozzi C, Ottaviani C, Negrini D, Moriondo A. Draining the Pleural Space: Lymphatic Vessels Facing the Most Challenging Task. Biology (Basel). 2022 Mar 10;11(3):419. doi: 10.3390/biology11030419.
citation: Yao X, Abd Hamid M, Sundaralingam A, Evans A, Karthikappallil R, Dong T, Rahman NM, Kanellakis NI. Clinical perspective and practices on pleural effusions in chronic systemic inflammatory diseases. Breathe (Sheff). 2020 Dec;16(4):200203. doi: 10.1183/20734735.0203-2020.
citation: Shaikh F, Lentz RJ, Feller-Kopman D, Maldonado F. Medical thoracoscopy in the diagnosis of pleural disease: a guide for the clinician. Expert Rev Respir Med. 2020 Oct;14(10):987-1000. doi: 10.1080/17476348.2020.1788940. Epub 2020 Jul 12.
Clinical trial NCT02517008: The Impact of Non-monetary Incentives on Facility Delivery in Rural Zambia
Official title: Measuring the Impact of Non-monetary Incentives on Facility Delivery in Rural Zambia: A Clustered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Health
Keywords: non-monetary incentive
institutional delivery
Lead sponsor: IDinsight
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Zambia
name: Minister of Community Development, Mother and Child Health, Zambia
name: UNICEF
name: Clinton Health Access Initiative Inc.
First posted: 2015-08-06
Enrollment: 2159
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study measured the impact and cost-effectiveness of a low-cost, non-monetary incentive ("mama kit") on rural facility delivery rates in Zambia.

Detailed description: This clustered randomized controlled trial assessed the impact of providing a package of childcare items (a cloth, baby diaper, and blanket) to women conditional upon delivering at a facility on facility delivery rates in rural Serenje and Chadiza Districts in Zambia. Facilities were randomized to either provide the intervention or not. Facility-level antenatal care (ANC) and delivery registers were used to measure the percentage of women attending antenatal care who delivered at a study facility during the intervention period. Results from the trial were then used to model the cost-effectiveness of mama kits at-scale in terms of cost per death averted.

Eligibility criteria: Inclusion Criteria:

* Had an antenatal care record at one of the study facilities
* Had an estimated date of delivery (as measured by estimated date of last menstrual period, estimated date of delivery, or estimated gestational age in weeks as recorded in the antenatal care register) between June 1, 2013 - Aug 31, 2013.

Exclusion Criteria:

* Did not have an antenatal care record at one of the study facilities
* Had an estimated date of delivery outside of the intervention window (June 1, 2013 - Aug 31, 2013)

Primary outcomes:
measure: Facility delivery ratios
timeFrame: At delivery, up to 10 months after the first antenatal care visit date
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IDinsight
name: Paul Wang, MPAID/MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02474108: Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement
Official title: Pilot, Randomized,Single Blind Trial of Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Rheumatic Heart Disease
Keywords: atrial fibrillation
radiofrequency ablation
prevention of AF
mitral valve
left atrium enlargement
cryoablation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation in patients with valvular heart disease and left atrium enlargement

Detailed description: Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery substantially reduce the number of excellent and good results of the operation in the long-term period, causing circulatory insufficiency, increased pulmonary hypertension, increasing the risk of thromboembolic events and stroke.

Significant predictors of AF after surgery are the initial size of the left atrium more than 6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this group had AF during the first year after operation.

Eligibility criteria: Inclusion Criteria:

* rheumatic mitral valve lesion
* the absence a history of AF
* sinus rhythm
* left atrium size more than 6.0 cm

Exclusion Criteria:

* refusal to participate in the study
* aortic stenosis / regurgitation
* coronary atherosclerosis

Primary outcomes:
measure: composite outcome measure of complications
timeFrame: up to 1 year
Secondary outcomes:
measure: number of participants with freedom from AF according to the long-term ECG monitoring
timeFrame: 1 year
measure: transport function of the left atrium according to TTE (transthoracic echo)
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: MeshalkinRI
Study officials:
References:
Clinical trial NCT01526408: Famvir for Treatment of Hearing in Unilateral Meniere's Disease
Official title: Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Meniere's Disease
Keywords: Meniere's Disease
Vertigo
Hearing loss
Tinnitus
Anti-viral
Famciclovir
Lead sponsor: House Research Institute
Sponsor class: OTHER
Collaborators: name: House Clinic, Inc.
First posted: 2012-02-03
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.


Eligibility criteria: Inclusion Criteria:

* Unilateral Meniere's Disease
* 2 vertigo episodes of at least 20 minutes
* Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
* Less than 45 dB 4-frequency pure-tone average in the affected ear
* Tinnitus and/or aural fullness
* Willing to undergo the clinical trial procedures
* Signed informed consent

Exclusion Criteria:

* Acute or chronic middle ear disease in either ear
* Only hearing ear
* 4-frequency pure-tone average \> 45 dB in either ear
* Known allergy to famciclovir or any of the ingredients in the formulation
* Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study
* Must not have had previous inner ear surgery
* History of immunodeficiency diseases such as HIV
* History of renal insufficiency or other kidney diseases
* A female of child-bearing potential who is pregnant
* History of noncompliance to medical regimens
* Unwilling to or unable to comply with the protocol, including scheduling study evaluations

Primary outcomes:
measure: Pure-tone Threshold Change
timeFrame: 3 months
Secondary outcomes:
measure: Tinnitus and/or Dizziness Handicap Change
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: House Research Institute
name: Jennifer Derebery, MD
role: PRINCIPAL_INVESTIGATOR
References: