louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00222001: Telephone Triage Study
Official title: Outcome Evaluation of Triage for Health Maintenance Organization (HMO) Patients Performed by Doctors in a Medical Telemedicine Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Any Medical Condition Presented by Patient
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Medgate AG, Switzerland
name: HMO Gesundheitsplan Basel, Switzerland
First posted: 2005-09-22
Enrollment: 100
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: Regular HMO patients

Brief summary: The advance of communication technology has changed medical practice. The concept of medical telemedicine centers receiving, assessing and managing calls from patients or their carers on a 24 hour, 7 days a week basis is spreading in the US as well as in European countries. Usually specially trained nurses using dedicated decision support software provide the service. One aspect is the so-called triage, i.e. the decision on urgency and optimal treatment path of a stated medical problem, which has the potential to contain overall treatment costs.

Despite proliferation of these services, little is known about the quality of the services provided.

In October 2000 the first 24-hour medical telemedicine centre staffed by medical doctors started operating in Switzerland. The aims of this study are to assess the quality of service provided by doctors using decision support software and to determine potential predictors of incorrect triage.


Eligibility criteria: Inclusion Criteria:

* Adult
* Insured with HMO Basel
* Patient of HMO practise Sternengasse
* First call to Medgate for a given medical problem
* Call is a telephone triage
* Informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Correctness of triage decision
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Basel
country: Switzerland
facility: Medgate
Study officials:
affiliation: University Hospital Basel and Medgate AG
name: Serge O Reichlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245401: CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)
Official title: CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 2070
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing approval, when used in normal clinical practice within the labeled indications.


Eligibility criteria: Inclusion Criteria:

* Cypher stent

Exclusion Criteria:

* N/A

Primary outcomes:
measure: MACE at 30 days, 6 months and 1 year.
Secondary outcomes:
measure: There is no pre-specified secondary outcome.
Other outcomes:
Locations:
Study officials:
affiliation: Texas Heart Institute
name: Emerson Perin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bezerra H, Perin E, Berger P, Block P, Ramee S, Katz S, Kellet M, Dippel E, Schaer G, Britto S, Cohen S, Costa M. Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry. J Invasive Cardiol. 2010 Feb;22(2):48-55.
Clinical trial NCT02841501: Genetic Susceptibility Factors for Candidemia.
Official title: Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Candidiasis
Candidemia
Genetic Predisposition to Disease
Keywords: Gene Expression Profiling
Genome-Wide Association Study
Polymorphism, Single Nucleotide
Drug Resistance, Fungal
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Seventh Framework Programme
name: University of Lausanne Hospitals
First posted: 2016-07-22
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients exhibiting a positive blood culture with isolation of Candida sp.

Brief summary: This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years.
* Informed consent.
* Positive blood culture with isolation of Candida sp.

Exclusion Criteria:

* No informed consent.
* Patient younger than 18.
* No insurance coverage.

Primary outcomes:
measure: Frequency of the polymorphisms between the groups
timeFrame: In the 48-72 hours following the positive blood culture
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Salengro, Intensive care departement, CHRU
Study officials:
affiliation: University Hospital, Lille
name: Julien Poissy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370201: Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rhegmatogenous Retinal Detachment
Keywords: retinal detachment
proliferative vitreoretinopathy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-31
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: This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment


Eligibility criteria: Inclusion Criteria:

* Rhegmatogenous retinal detachment

Exclusion Criteria:

* PVR grade C
* Duration of retinal detachment ≥ one month
* History of cataract surgery
* History of RD surgery

Primary outcomes:
measure: proliferative vitreoretinopathy
measure: retinal reattachment rate
Secondary outcomes:
measure: visual acuity
measure: reoperation
measure: macular pucker
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh,MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04265001: Topical Hyaluronic Acid and Recurrent Aphthous Stomatitis.
Official title: Effectiveness of Topical Hyaluronic Acid Versus Chlorhexidine Mouthwashes in the Treatment of Recurrent Aphthous Stomatitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Aphthous Stomatitis
Keywords: recurrent aphthous stomatitis
chlorhexidine
hyaluronic acid
pain
topical
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to estimate the hypothesis that the topical hyaluronic acid mouthwash have no role in the treatment of recurrent aphthous stomatitis

Detailed description: Recurrent aphthous stomatitis (RAS) is a common and widely recognized disorder involving the oral mucosa. It occurs typically as a single or multiple well-defined painful self-limiting ulcerative lesions influencing the nonkeratinized oral mucous membrane surrounded by red halo. The prevalence of RAS is up to 25% in the world population, with recurrence rate of 50% every 3 mouths. The exact cause of RAS is uncertain, and accordingly numerous components are as yet being implicated such as genetic, hormonal, traumatic, nutritional, allergic, immunological, and psychological factors.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria were as follows:

* Age 18-30 years.
* Minimum of 2 years of RAS history, with active ulcer less than 48 hours of recurrent aphthous stomatitis.

Exclusion Criteria:

* known history of hypersensitivities to Chlorhexidine or hyaluronic acid.
* Use of any medication as a treatment for the present active ulcer.
* Smoking and presence of systemic diseases such as Behçet disease, anemia, Crohn's disease, ulcerative colitis, acquired immune deficiency syndrome, and liver or kidney disease.
* Pregnant or breast-feeding women.
* Stomach ulcer, duodenal ulcer, and inflammation of the stomach or the esophagus.
* Treatment with systemic nonsteroidal anti-inflammatory drugs, systemic steroids or other immune modulatory agents, oral antihistamines, or systemic antibiotics in the previous 3 months.

Primary outcomes:
measure: Pain score
timeFrame: one week
Secondary outcomes:
measure: Ulcer size
timeFrame: one week
measure: Duration of healing
timeFrame: one week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT00727701: Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development
Official title: Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Varicose Ulcer
Keywords: varicose ulcer
veteran
recurrence
aftercare
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-08-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.

Detailed description: Venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. Preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. An aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. They have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. We propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.

Eligibility criteria: Inclusion Criteria:

* Confirmed venous ulcer (ICD-9: 454.0, 454.2, 459.11, 459.13, 459.31, 459.33);
* Documented healing of all lower extremity ulcers;
* Ankle-brachial index (ABI) \> 0.8 to rule out arterial insufficiency

Exclusion Criteria:

* Unwilling or unable to sign informed consent;
* No plans to seek care at VA Puget Sound within 6 months;
* Limbs with ulcers or threatened viability

Primary outcomes:
measure: Ulcer-free survival period
timeFrame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm)
Secondary outcomes:
measure: Change in quality of life
timeFrame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
measure: Change in satisfaction with care
timeFrame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
measure: Adherence with self-management goals
timeFrame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System, Seattle
name: Gayle E. Reiber, MPH PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02874001: French Validation of an Interview Guide to Cancer Announcement : the Psycho Oncology Basic Documentation
Official title: French Validation of an Interview Guide to the Announcement of Cancer: the Psycho Oncology Basic Documentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
With Caregiver Support Time
18 Years and Over
Keywords: psychology
caregiver support time
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: Ligue contre le cancer, France
First posted: 2016-08-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of cancer and having a caregiver support time

Brief summary: Validation of the PO-BADO in its short and long versions that need a standardized validation process with the inclusion of 450 Patients

Detailed description: In the case of confirmation of the PO- Bado long version, that means for 240 patients a caregiver support time longest 15 minutes than usually suggested, since in 6 items of the Po- Bado usually explored in the caregiver support time, add 6 other additional items provided in the long version. This further time, can be considered as an additional contribution to the free expression.

For the 120 patients seen during the validation of the short version , there is no change in the duration of the caregiver support time.

Eligibility criteria: Inclusion Criteria:

* cancer
* having a caregiver support time
* Aged 18 years and over

Exclusion Criteria:

* without known psychiatric history

Primary outcomes:
measure: Validation of a questionnaire concerning psychosocial status
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03553901: The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain
Official title: The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain - A Crossover Randomized Single-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Injection
Needle Phobia
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular injection pain.The study was designed as a prospective, single-blind, crossover study. The study included 72 volunteer students attending Faculty of Health Sciences, Nursing Department.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 18.5 to 29.9kg/m2
* Voluntariness

Exclusion Criteria:

* history of IM injection within 2 weeks

Primary outcomes:
measure: Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale)
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sultan Abdulhamid Han
name: Gökhan inangil
role: STUDY_DIRECTOR
References:
citation: Suhrabi Z, Taghinejad H. Effect of acupressure (UB32) on pain intensity in intramuscular injections. Iran J Nurs Midwifery Res. 2014 Jan;19(1):24-7.
citation: Hosseinabadi R, Biranvand S, Pournia Y, Anbari K. The Effect of Acupressure on Pain and Anxiety Caused by Venipuncture. J Infus Nurs. 2015 Nov-Dec;38(6):397-405. doi: 10.1097/NAN.0000000000000065.
citation: Chung JW, Ng WM, Wong TK. An experimental study on the use of manual pressure to reduce pain in intramuscular injections. J Clin Nurs. 2002 Jul;11(4):457-61. doi: 10.1046/j.1365-2702.2002.00645.x.
Clinical trial NCT06355401: Maintenance Hormonal Therapy and DLBCL
Official title: Effect of Maintenance Hormonal Therapy on the Outcome of Patients With DLBCL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Diffuse Large B Cell Lymphoma
Keywords: DLBCL
maintenance hormonal therapy
tamoxifen
ERB
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 100
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: the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL

Detailed description: Diffuse large B-cell lymphoma (DLBCL) is the most common form of aggressive non-Hodgkin lymphoma. The standard immuno-chemotherapy (R-CHOP) markedly improves the prognosis of DLBCL, but up to 40% of patients still experience relapse or incomplete remission . So, there is a need for new targeted therapy for such malignancy. Recent studies identified a potential novel target in DLBCL, the ESR2 gene, which codes for the estrogen receptor beta (ERβ) protein, a receptor that can be targeted with selective ER modulators (SERMs) such as tamoxifen. Recent data shows that exposure of DLBCL cell lines to tamoxifen (either alone or in combination with CHOP chemotherapy) results in apoptosis and growth inhibition in vitro and in vivo. these data suggest the potential importance of ERβ in the pathogenesis of DLBCL as well as a potential role for tamoxifen in the treatment of DLBCL.50-100 patients with newly diagnosed DLBCL will be treated with standard immuno-chemotherapy according to disease stage with detection of ERB and ERA on the tissue samples using IHC. After the end of chemotherapy treatment patients who achieve CR will be randomized to either receive tamoxifen maintenance (20 mg daily) versus follow up to evaluate possible tamoxifen effect on disease recurrence, DFS and OS.

PT who achieve CR after 2nd line chemotherapy versus post BMT will also be recruited.

Eligibility criteria: Inclusion Criteria:

adults 18-75 years old newly diagnosed DLBCL patients who achieve CR after conventional primary treatment can be included PS 0-2

Exclusion Criteria:

less than 18 years or older than 75 years other types of lymphoid neoplasms cardiac comorbidity

Primary outcomes:
measure: disease free survival
timeFrame: 2-5 years
measure: overall survival
timeFrame: 2-5 years
Secondary outcomes:
measure: side effects
timeFrame: 2-5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06082401: Evaluating the Addition of Hemodiafiltration to EVLP - Impact on the Regeneration of Marginal Donor Lungs
Official title: Evaluating the Addition of Hemodiafiltration to Ex-vivo Lung Perfusion - Impact on the Regeneration of Marginal Donor Lungs: a Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: XVIVO Perfusion
First posted: 2023-10-13
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is the evaluation of the effect of hemodiafiltration during ex vivo lung perfusion in marginal donor lungs, and its feasibility. The hypothesis of this study is that this therapy could stabilize perfusate electrolyte composition, remove toxins and waste products, normalize pH levels and prevent edema formation, thereby reconditioning marginal donor lungs for transplantation.

The proposed pilot study addresses the unmet clinical needs in several aspects: a) for the first time a homeostatic device will be introduced in EVLP to reach stable perfusate composition; b) the proposed modification of the standard EVLP could lead to longer perfusion times, making elective transplantation possible and setting the base for possible ex vivo lung treatments; c) the ultimate effect of the proposed study is to increase organ availability through reconditioning of marginal donor lungs.


Eligibility criteria: Inclusion Criteria:

* Marginal donor lungs according to the ISHLT criteria (18)

  * PaO2/FiO2 ratio \< 400 (with FiO2=1.0 and PEEP=5-8cmH2O)
  * Donor age ≥ 55 years
  * Smoking history ≥ 20 pack-years
  * Infiltrates in chest radiograph
  * Significant secretions in bronchoscopy
  * Organisms on sputum gram stain
* Donor age \> 18 years

Exclusion Criteria:

For donor organs:

* Bilateral consolidations in donor lungs
* Lungs from donors with chest trauma
* Lungs from drowned donors

For patients receiving lung transplantation:

* Inclusions in other interventional studies
* Patients on the intensive care unit (ICU) prior to transplantation, with mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) support
* Re-transplantations

Primary outcomes:
measure: suitability for transplantation of the lungs after 6 hours of EVLP with HDF
timeFrame: 6 hours
measure: PGD grade 3 at 72 hours after transplantation
timeFrame: 72 hours
Secondary outcomes:
measure: survival
timeFrame: months
measure: Length of mechanical ventilation
timeFrame: up to 100 days
measure: length of ICU stay
timeFrame: up to 100 days
measure: length of hospital stay
timeFrame: up to 200 days
measure: lung function parameters (MEF50)
timeFrame: 24 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Alberto Benazzo, MD
role: PRINCIPAL_INVESTIGATOR
References: