louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03397056: How Participants Perceive Biomedical Research in Pulmonology
Official title: How Participants Perceive Biomedical Research in Pulmonology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biomedical Research
Keywords: Patient willingness
Participation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 500
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: The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.

Brief summary: The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

Detailed description: Over time, clinical research has become a challenge both in terms of public health and in terms of scientific progress. Additionally, it has also become a financial challenge for institutions, especially in France where a significant part of their government funding is provided according to their ability to conduct quality clinical research. Pulmonology is a sector where clinical research is well established with strong incentives from several pharmaceutical companies and numerous academic research projects. Nevertheless, it is important to put the patient back at the centre of biomedical research.

A better knowledge of patient expectations, questions and misunderstandings would considerably improve treatment observance, clinical trial data quality, doctor-patient trust/relationship, and ultimately, the patient's health.

The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

The secondary objectives are to determine:

* how biomedical research is experienced / felt;
* if the information delivered to the patient (orally - information note) is clearly perceived.

Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.

Eligibility criteria: Inclusion Criteria:

* The patient presents with at least one of the following: (1) asthma, (2) chronic obstructive pulmonary disease, (3) bronchiectasis, (4) idiopathic pulmonary fibrosis, (5) pulmonary arterial hypertension, (6) sleep apnoea syndrome
* The patient is participating in a biomedical research protocol.

Exclusion Criteria:

* Patient under 18 years of age
* Patient judged incapable of filling out the questionnaire for linguistic or other reasons.
* The patient has already participated in the present study.

Primary outcomes:
measure: The PROTOACCEPT2 questionnaire.
timeFrame: day 0 (transversal study)
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Montpellier
country: France
facility: CHRU Montpellier - Hôpital Arnaud de Villeneuve
Study officials:
affiliation: University Hospitals of Montpellier
name: Arnaud Bourdin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01292356: Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colon Cancer
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 28
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: Colon cancer is one of the most common cancers in France with more than 36,000 new cases per year. Despite significant advances in therapeutic care, the prognosis of colon cancers with metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor Receptor), which allowed a significant increase in patient survival. They are responsible for skin toxicity in the form of an acneiform rash which can be debilitating for patients and require discontinuation of treatment. However, this toxicity is strongly correlated with treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is therefore a major challenge to treat and better understand the association with treatment efficacy.

The objective of this study is to investigate a link between cutaneous inflammatory response in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will be conducted systematic consultations dermatology, skin biopsies and blood samples in patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of inflammatory cells and expression of genes involved in skin inflammation.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Patient with histologically proven metastatic colorectal cancer with KRAS wild-type
* Treatment with cetuximab in first line chemotherapy combined with FOLFOX or FOLFIRI
* Patient has signed informed consent
* Patient affiliated to the Social Security
* Prescription of cetuximab in agreement with the Summary of Product Characteristics

Exclusion Criteria:

* Patients aged under 18
* Patients taking immunosuppressive therapy
* Patient having a severe skin disease
* No measurable metastasis
* Patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients
* Severe alteration of respiratory or cardiac function or severe coronary disease
* Patients with contra-indication to chemotherapy FOLFOX and FOLFIRI
* Participation in another research protocol
* Patients not affiliated to the Social Security
* Hospitalized patients without consent
* Pregnant or nursing women, women of childbearing age with no effective contraception

Primary outcomes:
measure: Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
References:
Clinical trial NCT01660256: Confirmatory Study of OPC-12759 Ophthalmic Solution
Official title: Confirmatory Study of OPC-12759 Ophthalmic Solution in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 209
Sex: ALL
Minimum age (years): 20
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 verify whether OPC-12759 ophthalmic solution is effective compared with placebo in dry eye patients. OPC-12759 ophthalmic suspension will be used as a reference drug.


Eligibility criteria: Inclusion Criteria:

1. Out patient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with dry eye
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant,possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months.

Primary outcomes:
measure: Change in Fluorescein Corneal Staining (FCS) Score From Baseline
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Kansai Region
country: Japan
facility: Kansai Region
city: Kanto Region
country: Japan
facility: Kanto region
city: Kyushu Region
country: Japan
facility: Kyushu region
city: Tokai Region
country: Japan
facility: Tokai region
Study officials:
affiliation: Director of Division Dermatilogicals and Ophtalmolgicals, Otsuka Pharmaceutical Co., Ltd.
name: Eiji Murakami
role: STUDY_DIRECTOR
References:
Clinical trial NCT01288456: Study to Evaluate Novel Gastric Space Occupying Device
Official title: A Single Centre 30-day Observational Non-randomised Study to Evaluate Preliminary Safety and Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: medical device, space-occupying device
Lead sponsor: Obalon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from a community sample that satisfy the inclusion/exclusion criteria.

Brief summary: This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.


Eligibility criteria: Inclusion Criteria:

1. Age between 21-64 years
2. BMI 27-40 Kg/m2
3. No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion Criteria:

1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
5. History or symptoms of thyroid disease which is not controlled by medication;
6. Have severe renal, hepatic, pulmonary disease or cancer;
7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
8. Have a history of adhesive peritonitis;
9. History or symptoms of esophageal and/or gastric varices;
10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
13. Have gastroparesis;
14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
15. Currently using pharmaceutical agents for weight loss;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Obesity Control Center
state: Baja California
Study officials:
affiliation: Obesity Control Center
name: Ariel Ortiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03679156: Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
Official title: Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 18
Sex: ALL
Minimum age (years): 66
Maximum age (years): 98
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Initially 55 Participants were included in the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) trial \[16\]. These patients received a loading dose of 3 intravitreal injections of anti-VEGF and were subsequently treated as-needed \[pro re nata (PRN)\] \[16\]. From that study population we recruited for another long term follow up visit. Of these patients 9 (16%) were excluded due to missed visits, another 14 patients (25%) died before the last study visit and 14 former participants (25%) did not approve further study participation.

Brief summary: Purpose:

To assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis.

Methods:

18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated as-needed \[pro re nata (PRN)\]. Functional and morphological changes were assessed using spectral domain optical coherence tomography (SD-OCT).


Eligibility criteria: Inclusion Criteria:

* Inclusion and exclusion criteria corresponded to the criteria of the MANTA study

Exclusion Criteria:

* Inclusion and exclusion criteria corresponded to the criteria of the MANTA study

Primary outcomes:
measure: visual acuity
timeFrame: 93 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03826056: Neurology Inpatient Clinical Education Trial
Official title: Neurology Inpatient Clinical Education Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myasthenia Gravis
Guillain-Barre Syndrome
Multiple Sclerosis
Seizures
Parkinsonism
Meningitis
Encephalitis
Headache
Vestibular Disorder
Spondylosis
Normal Pressure Hydrocephalus
Keywords: clinical education
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study team members will randomize patients to receive either the current standard hospital education material or the new personalized education material. Investigators will use a stratified randomization process to allocate the patients from different categories including age range, gender, and discharge diagnosis into each group. Thereby the investigators will achieve equal distribution of diagnoses and other demographics among groups in real time. They will review the two groups when performing statistical analysis near the end of the study to ensure heterogeneity of distribution.

A study team member who has also been a member of the care team will use the either the current hospital standard or the new personalized education materials to explain the discharge diagnosis to the patient, the treatment, and the follow up needed. The study team member will also give a survey with a preaddressed envelope to each participant to complete at his or her convenience.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to compare the effectiveness of a personalized patient education program to the current hospital education and evaluate its impact using patient satisfaction scores.

The investigators hypothesize that a personalized patient education intervention will increase patient's understanding of their diagnosis and satisfaction with the care as reflected in the survey results.


Eligibility criteria: Inclusion Criteria:

* Over the age of 18
* Must have the capacity to consent and understand the study related activities and education materials.

Exclusion Criteria:

* Under the age of 18
* Have a condition that impairs the ability to understand the study, its risks, and appropriately consent for the study

Primary outcomes:
measure: Patient satisfaction scores
timeFrame: Subjects will be expected to mail the feedback forms within 2 weeks of discharge. Investigators will mail a single reminder prepaid return mail with a copy of the questionnaire to patients who do not respond within this time allowing 1 month total time.
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth- Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Vijay Renga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05602909: Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible
Official title: Evaluation of the Efficiency of Guided Biaxial Alveolar Distraction Device in Posterior Atrophic Mandible (A Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandible; Deformity
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 7
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Atrophic alveolar bone presents a unique difficulty, preventing correct implant placement and affecting long-term results. There are different techniques that are recommended to restore the proper length of the posterior ridge of the mandible and thus achieve proper form and function, one of those is distraction osteogenesis. Refinements in the technique of distraction can improve the treatment outcome and decrease postoperative complications.


Eligibility criteria: Inclusion Criteria:

* Patients with the posterior atrophic mandible.
* The distance from the alveolar crest to the upper border of the canal is not less than 5 mm.
* Adult patients from 30-60 years old with no gender predilection who agreed to present for follow-up visits for a minimum postoperative period of 4 months.
* Patientswithanadequateoralhygiene.
* The patient should be psychologically accepting of the involved procedures.

Exclusion Criteria:

* Medically compromised patients contradicting operation (ASA III, IV \& V).
* Patients receiving radiotherapy or chemotherapy or bisphosphonate.
* Bonediseases(Osteoporosis,Osteopetrosis,Osteomalacia...etc.)
* Any habits that might retard healing such as heavy smoking and alcoholism.
* A history of any grafting procedure at the designated area.

Primary outcomes:
measure: Change in Pain scorre
timeFrame: at 1, 7 and 14 days
measure: change in wound healing
timeFrame: at 1, 7 and 14 days
measure: Change in mental nerve reflex
timeFrame: Baseline, after 2 weeks and 1 month
measure: Change in bone density
timeFrame: Baseline,1 month, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT01886456: IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients
Official title: Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Angle Glaucoma,
Ocular Hypertension
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 210
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 investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.

Values for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.

* Trial with medical device


Eligibility criteria: Inclusion criteria:

* Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) \> 21 mm Hg
* visible angle structures over 360° on gonioscopy
* age = 18 years

Exclusion criteria:

* Intraocular Inflammation
* patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)
* monocle situation
* anterior chamber lenses (incl. iris claw)
* secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)

Primary outcomes:
measure: Intraocular pressure 6 months after Intervention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmology Clinic
state: ZH
Study officials:
affiliation: University Hospital Zurich, Ophthalmology Clinic
name: Christoph Kniestedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Clinical trial NCT00982956: Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthritis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2009-09-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the subjects who had been scheduled for simultaneous bilateral TKA,

Brief summary: Objective:

The purpose of this study is to evaluate the application of computer-assisted navigation in Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA.

Methods:

Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and the conventional TKA were separately performed on two knee joints. The operative method and order of the operations were decided on a randomized basis. All the patients and doctors conducting follow-up study and performing imaging measurement were blind to selection of the operation. Student t test was used for statistical analysis.

hypothesis: computer-assisted navigation system can significantly improve the accuracy of tibial and femoral cuts on coronal and sagittal planes.


Eligibility criteria: Inclusion Criteria:

* plan for simultaneous bilateral TKA.

Exclusion Criteria:

* plan for unilateral TKA.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: