louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02063490: Nurse-led Intervention to Improve Phosphate Binder Adherence
Official title: A Nurse-led Multifactorial Intervention to Improve Phosphate Binder Adherence: Results From a One-year Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Keywords: Adherence
dialysis
intervention
nurse-led
phosphate binders
trial
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aim is to test the efficacy of one-year nurse-led interventions to improve the medication intake behaviour of chronic dialysis patients. The investigators hypothesis is the interventions leading to a 15% mean increase in intake, compared to standard care.

Detailed description: Background Phosphate binder nonadherence is ubiquitous. The results of adherence enhancing interventions are often disappointing. The aim is to test a nurse-led multifactorial intervention to enhance phosphate binder adherence.

Methods In a quasi-experimental clinical trial, phosphate binder adherence was measured electronically in 135 hemodialysis patients for one year and phosphatemia measured monthly. For all patients, months 1-2 were baseline (no interventions were performed). The intervention arm was given 1 "preparatory" intervention and then monthly 8 "maintenance" individualized management sessions. The control arm received standard of care.

Eligibility criteria: Inclusion Criteria:

* adult (≥18)
* chronic hemodialysis ≥1 month
* treated with phosphate binders
* Dutch-speaking

Exclusion Criteria:

* receiving professional medication care
* cognitive impairment
* nursing home residents

Primary outcomes:
measure: Medication adherence
timeFrame: One year
Secondary outcomes:
measure: Serum phosphate
timeFrame: Monthly for one year
measure: Patient knowledge
timeFrame: At study start and end (after one year)
measure: Social support
timeFrame: At study start and end (after one year)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Dialysis hospital unit 1
city: Antwerpen
country: Belgium
facility: Dialysis hospital unit 3
city: Turnhout
country: Belgium
facility: Dialysis hospital unit 2
Study officials:
affiliation: Universiteit Antwerpen
name: Yoleen PM Van Camp, MScN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786690: The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption
Official title: The Effect of Microprocessor Controlled Prostheses on Walking Pattern and Energy Consumption in Above Knee Ampute Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation, Traumatic
Gait
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lower limb amputation

Brief summary: The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

Detailed description: Background: The use of microprocessor controlled (MIC) prostheses has increased in recent years, but the number of studies on gait pattern and energy consumption in above-the-knee amputee patients is very low.

Objective: The aim of this study was to investigate MIC and non-MIC prostheses in terms of gait pattern and energy consumption in above-the-knee amputee patients.

Methods: This observational clinical study included 34 unilateral above-the-knee amputees, separated into two groups as Group 1 (n:17) using MIC prosthesis, and Group 2 (n:17) using non-MIC prosthesis. The patients were compared in terms of gait pattern, gait capacity, energy consumption, mobility, quality of life, and prosthesis satisfaction levels according to the type of prosthesis. 3D gait analysis, exercise tolerance test, Short Form 36 (SF-36) Health Survey Questionnaire, Locomotor Capabilities Index-5 (LCI-5), Satisfaction with Prosthesis Questionnaire (SAT-PRO) and six-minute walk test (6MWT) were used as evaluation criteria.

Eligibility criteria: Inclusion Criteria:

* as voluntary participation in the study
* age ≥18 years
* having a unilateral above-the-knee amputation
* the ability of independent ambulation in the community
* at least 6 months since the amputation
* use of the current prosthesis for at least 8 weeks

Exclusion Criteria:

* unwillingness to participate in the study
* age \<18 years
* limb length discrepancy of ≥2 cm
* the presence of contracture or deformity
* additional amputation
* neuromuscular disease or comorbidity that may interfere with the study follow-up period of \< 6 months since the amputation
* use of the current prosthesis for \< 8 weeks
* being uncooperative

Primary outcomes:
measure: 6MWT
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gaziler PMR ER Hospital Ankara Turkiye
name: Yasin Demir, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04186390: Learning Small Bowel Capsule Endoscopy
Official title: Learning Small Bowel Capsule Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopy
Education
Simulation
Small Bowel Disease
Small Bowel Capsule Endoscopy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 20
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: Medical Doctors in medical gastroenterology or surgery with no prior experience in the evaluation of small bowel capsule endoscopies.

Brief summary: This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity \>90%


Eligibility criteria: Inclusion Criteria:

* Medical Doctors in medical gastroenterology or surgery

Exclusion Criteria:

* Prior experience with evaluation of small bowel capsule endoscopy.

Primary outcomes:
measure: Diagnostic sensitivity >90%
timeFrame: 1.5 year
Secondary outcomes:
measure: Diagnostics
timeFrame: 1.5 year
measure: Clinical consequence
timeFrame: 1.5 year
measure: Total time
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region Of Southern Denmark
Study officials:
References:
Clinical trial NCT06249490: Stellate Ganglion Block in Obstructive Sleep Apnea
Official title: A Randomized Controlled Trial to Explore the Effect of Stellate Ganglion Block in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 80
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: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Detailed description: Obstructive Sleep Apnea is of increasingly high prevalence.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:

• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years diagnosed with Obstructive Sleep Apnea by polysomnography
* Patients with moderate to severe Obstructive Sleep Apnea
* Patients who have undergone continuous positive airway pressure treatment for at least 3 months but have not achieved satisfactory therapeutic effects
* Patients who voluntarily agree to receive stellate ganglion block treatment and sign the informed consent form

Exclusion Criteria:

* Patients with a history of allergy or contraindications to local anesthetics or corticosteroids
* Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases
* Patients with a history of neck surgery or cervical spine disease
* Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of Stellate Ganglion Block treatment
* Pregnant or lactating women
* Patients who have participated in other clinical trials within the past 3 months

Primary outcomes:
measure: Epworth Sleepiness Scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Xinzhu
country: Taiwan
facility: Xinzhu Rehabilitation Hospital
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT02977390: Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM
Official title: Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM to Guide Fluid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Volume
Cardiovascular System
Fluid Therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to investigate whether patients at advanced age are fluid responders via a reversible fluid challenge, the passive leg raise test. This will be measured with a non-invasive cardiac output monitor, the LiDCO (LiDCO Hemodynamic monitoring) .

Detailed description: The intervention is as simple as a passive leg raise with measurement of effect on Stroke volume.

Eligibility criteria: Inclusion Criteria:

* patients ≥80 years of age, undergoing elective urologic surgical procedure

Exclusion Criteria:

* age \<80 years, severe aortic insufficiency, first case of the day on the operation program, unavailability of research personnel and contraindication to Lithium.

Primary outcomes:
measure: Assess passive leg raise responsiveness in spontaneously breathing aged patients.
timeFrame: Within 1 minute of the intervention
Secondary outcomes:
measure: Investigate whether there is an association between a positive response to passive leg raise on stroke volume and post spinal anesthesia.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Sigridur Kalman, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123590: Characteristics of Patients With Thymoma in Chulalongkorn Hospital
Official title: Characteristics of Patients With Thymoma Undergone Thymectomy in Chulalongkorn Hospital Between 2003-2007
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thymoma Staging
Clinical Presentations
Associated Disorders
Laboratory Findings
Keywords: Thymoma
Autoimmune diseases
Immunodeficiency
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007

Brief summary: The purpose of this study is to study characteristics of patients with thymoma in Chulalongkorn hospital between 2003-2007.

Detailed description: To study characteristics of patients with thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007 in terms of clinical manifestations, associated diseases, and laboratory findings.

Eligibility criteria: Inclusion Criteria:

* Patients with histocytological proved thymoma undergone thymectomy in Chulalongkorn hospital between 2003-2007

Exclusion Criteria:

* None

Primary outcomes:
measure: Thymoma staging and clinical manifestations
timeFrame: 5 years
Secondary outcomes:
measure: Associated diseases and laboratory findings Immunological data
timeFrame: 4 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thongprayoon C, Tantrachoti P, Phatharacharukul P, Buranapraditkun S, Klaewsongkram J. Associated immunological disorders and cellular immune dysfunction in thymoma: a study of 87 cases from Thailand. Arch Immunol Ther Exp (Warsz). 2013 Feb;61(1):85-93. doi: 10.1007/s00005-012-0207-9. Epub 2012 Dec 11.
Clinical trial NCT00508690: Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Official title: Randomized Controlled Trial of Antibiotic Prophylaxis in Elective Laparoscopic Colorectal Surgery: Oral and Systemic Versus Systemic Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Neoplasms
Keywords: Antibiotic Prophylaxis
Colorectal Surgery
Laparoscopy
Lead sponsor: Japan Multinational Trial Organization
Sponsor class: OTHER
First posted: 2007-07-30
Enrollment: 584
Sex: ALL
Minimum age (years): 20
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 optimal prophylactic antibiotics administration method in elective laparoscopic colorectal surgery.

Detailed description: The use of antibiotic prophylaxis in patients who undergo elective colorectal surgery is now accepted universally. But the rout of administration should be systematic, oral, or both is controversial. Furthermore, although many trails have been performed, no trial limited to laparoscopic surgery is performed. We compare 2 approaches - oral and systemic versus systemic antibiotic prophylaxis - in limited to elective laparoscopic colorectal surgery.

Eligibility criteria: Inclusion Criteria:

* Colorectal tumor(cancer, adenoma and suspected cases) with planned elective laparoscopic colorectal resection

Exclusion Criteria:

* ECOG Performance Status \>=2
* Age\<20
* Any organ dysfunction
* Ileus
* Preoperative infectious disease
* Antibiotic administration before surgery
* Steroid administration before surgery
* Neo-adjuvant radiation and/or chemo therapy
* Severe diabetes mellitus
* Pregnancy/lactational woman
* Severe allergy

Primary outcomes:
measure: Incidence and classification of surgical site infection (SSI)
timeFrame: Within the first 30 days after surgery
Secondary outcomes:
measure: Incidence of colitis, other infectious diseases and other postoperative complications.
timeFrame: Within the first 30 days after surgery
Other outcomes:
Locations:
city: Tenri
country: Japan
facility: Tenriyorozu Hospital
state: Nara
city: Kyoto
country: Japan
facility: Kyoto Univercity Hospital
city: Kyoto
country: Japan
facility: National Hospital Organization, Kyoto Medical Center
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
Study officials:
affiliation: National Hospital Organization Kyoto Medical Center
name: Hiroaki Hata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00870103: Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
Official title: An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.


Eligibility criteria: Inclusion Criteria:

* ≧18 years of age
* able to sign an informed consent and complete all required visits
* intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
* Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

Exclusion Criteria:

* Uncontrolled glaucoma or IOP
* use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
* use of steroid during the study or within 14 days prior to enrollment

Primary outcomes:
measure: The Percentage of Patients With a Score of Zero for Anterior Chamber Cells.
timeFrame: Day 15 after cataract surgery
measure: The Percentage of Patients With no Ocular Pain
timeFrame: Day 15 after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT01880203: Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Official title: Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Node
Indeterminate Cytology
Surgery Indication
Keywords: thyroid
elastography SWE
indeterminate cytology
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Fondation avenir
name: laboratoire Genzyme
First posted: 2013-06-18
Enrollment: 140
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: The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised

  * vesicular lesion of undetermined significance
  * follicular neoplasm or Hurthle cells
  * lesion suspicious for malignancy
* Confirmation of indeterminate cytology (IC) replay centralized
* Patient affiliated to a social security scheme
* Informed consent and signed

Exclusion Criteria:

* Thyroid node \<15 mm
* Nodules coalescing preventing proper individualization of targeted nodule
* Indeterminate cytology older than six months
* Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology
* Major subject to a measure of legal protection or unable to consent
* Refusal to participate

Primary outcomes:
measure: Evaluate the diagnostic performance of the AMC and SWE elastography
timeFrame: at inclusion, before surgery
Secondary outcomes:
measure: evaluate the diagnostic performance of elastography SWE
timeFrame: at inclusion, before surgery
measure: Establish a combined diagnostic score results of elastography
timeFrame: at inclusion, before surgery
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François BACLESSE
state: Calvados
city: Caen
country: France
facility: CHU
state: Calvados
city: Neuilly sur seine
country: France
facility: Hôpital Américain de Paris
city: Paris
country: France
facility: Hôpital Pitié-salpétrière
Study officials:
References:
citation: Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Menegaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.