louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03289845: Clinical Survey of Oticon Medical Ponto BHX Implant
Official title: Clinical Survey of Oticon Medical Ponto BHX Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impaired (Partially)
Hearing Impairment, Conductive
Deafness Unilateral
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2017-09-21
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: TREATMENT

Brief summary: Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for treatment with a bone anchored hearing aid
* 18 years or older

Exclusion Criteria:

* Inability to participate in follow-up
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

Primary outcomes:
measure: Implant stability quotient (ISQ) at surgery
timeFrame: At surgery
Secondary outcomes:
measure: Surgical torque setting measured in Ncm
timeFrame: At surgery
measure: Possibility to fit the sound processor, yes/no
timeFrame: 5-12 days post surgery
measure: Implant stability quotient (ISQ) after 12 months of follow up
timeFrame: 12 months post surgery
measure: Implant survivability measured as percentage successful implants after 12 months
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Dept. of Otolaryngology - Head & Neck Surgery and Audiology, Gentofte/Rigshospitalet,
state: Copenhagen
city: Aalborg
country: Denmark
facility: Department of Oto-Rhino-Laryngology & Audiology Aalborg University Hospital
Study officials:
References:
Clinical trial NCT03869645: CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
Official title: CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Observational Study
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with clinical symptoms of extremity swelling with ultrasound evidence of acute thrombosis in the peripheral vasculature.

Brief summary: A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.

Detailed description: A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.

Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).

Eligibility criteria: Inclusion Criteria:

* Patients who are greater than or equal to 18 years of age
* Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms \< 14 days
* Patients cleared medically for invasive endovenous procedures

Exclusion Criteria:

* Patients with IVC filter in area to be treated
* Patients who are \< 18 years of age.
* Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
* Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention
* Female who is pregnant or nursing
* Concurrent participation in another investigational drug or device treatment study

Primary outcomes:
measure: Restoration of blood flow
timeFrame: Day 0 - Intervention
Secondary outcomes:
measure: Device Success
timeFrame: Day 0
measure: Technical Success Rate
timeFrame: Day 0
measure: Thrombus removal rate
timeFrame: Day 0
measure: VEINES Survey
timeFrame: </= Day 0 and Day 30
measure: Safety Endpoint
timeFrame: 30 days
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: Memorial Health Services
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Unity Health Toronto
name: Tiffany Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05311345: Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.
Official title: Integration of Cryobiopsies for ILD Diagnoses- Experience Based on 250 Biopsy Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Keywords: Cryobiopsy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients under investigation for Interstitial lung diseases that were having cryobiopsies performed.

Brief summary: A retrospective study on safety and Diagnostic yield in using cryobiopsies as a Diagnostic tool in diagnosing patients under investigation for Interstitial lung diseases. This includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.


Eligibility criteria: Inclusion Criteria:

* \>18years of age
* suspected of Interstitial lung Disease
* cryobiopsies performed.

Exclusion Criteria:

* FVC below 50% of predicted
* DLCO below 35%
* Body Mass Index (BMI) above 35
* pulmonary hypertension with a tricuspidal gradient above 40 mmHg
* other cardiac or other comorbidities that would increase the risk of complications

Primary outcomes:
measure: Pneumothorax
timeFrame: 2 weeks
measure: Hemorrhage
timeFrame: 3 days
measure: Acute exacerbation
timeFrame: 100 days
measure: Mortality
timeFrame: 100 days
Secondary outcomes:
measure: Diagnostic yield
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05440045: A Clinical Study of 6MW3211 in Patients With Renal Cancer
Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Clear Cell Renal Cell Carcinoma
Lead sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

Detailed description: This study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer

Eligibility criteria: Inclusion Criteria:

* Voluntarily participate in the study and sign the informed consent.
* Advanced clear cell renal cancer.
* At least one measurable tumor target lesion.
* Life expectancy≥3 months.
* Suitable organ functions.
* Patients who had failed at least one line therapy.
* ECOG 0-1.
* The samples of tumor tissue should be provided

Exclusion Criteria:

* Patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks.
* History of other malignant tumors within 5 years.
* Patients with CNS metastasis.
* History of active autoimmune diseases.
* Patients with poor-controlled systemic diseases after treatment.
* Patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing.
* Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1
* Patients who had experienced immune-related adverse events (irAE) with grade 3 or above.
* Patients who were allergic to any composition of experimental drug.
* Subjects with poor treatment compliance.
* Pregnant or lactating woman.
* Live vaccination within 28 days before first dosing.
* History of drug abuse or addiction
* Patients with active HBV or HCV, or HIV antibody positive,or Tp-Ab positive.

Primary outcomes:
measure: ORR
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03261245: Relationship Between Multi-exposure to Noise and Air Pollution and the Onset of Hypertension Disorders During Pregnancy
Official title: Hypertension Disorders During Pregnancy and Multi-exposure to Environmental Noise and Atmospheric Pollution in an Urban Setting: Case-control Study in Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 2650
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who gave birth at Dijon and Besançon CHU between 2005 and 2009

Brief summary: This retrospective study aimed to analyse the relationship between multi-exposure to noise and air pollution the onset of hypertension disorders during pregnancy

It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and 2009 split into two groups:

* 530 cases (women who experienced hypertension disorders during pregnancy
* 2120 controls (women who did not experience a hypertension disorder during pregnancy)


Eligibility criteria: Inclusion Criteria:

* Women living in Besançon or one of the 15 communes of the Dijon conurbation
* Who gave birth at Dijon or Besançon CHU
* Between 1st January 2005 and 31st December 2009

Criterion for the inclusion of cases:

* Onset of a hypertension disorder during pregnancy defined according to expert recommendations

Criterion for the inclusion of controls:

* No hypertension disorder during pregnancy

Exclusion Criteria:

* Medical termination of pregnancy
* Opposition to the use of their data

Primary outcomes:
measure: Onset of a hypertension disorder during pregnancy
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de BESANCON
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04254445: Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap
Official title: The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion
Pleural Effusion, Malignant
Pleural Pleurisy Effusion
Keywords: Personalized video training
Thoracocentesis
Pleural tap
Lead sponsor: GistMed Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.

Detailed description: 100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. Questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
* Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
* Patients who can read and understand the questions
* Patients who were interested in participating in the clinical trial and signed an informed consent form

Exclusion Criteria:

* Minors \< 18 years of age
* Pregnant women
* Patients who cannot read and understand, at the discretion of the investigator
* Patients which their medical condition does not allow them to undergo the study procedure

Primary outcomes:
measure: Fulfillment of need for information gap
timeFrame: 30 minutes
measure: Assessment of Anxiety
timeFrame: 30 minutes
Secondary outcomes:
measure: The need of an active role
timeFrame: 30 Minutes
measure: Confidence and Knowledge to take actions
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: GistMed Ltd.
name: Orit Neudorfer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01790945: Diabetic Macular Edema and Diabetic Retinopathy Screening (TeleMed) With Automated Retinal Photography
Official title: Diabetic Macular Edema and Diabetic Retinopathy Identification by Screening (Telemed) With Verified Automated Retinal Photography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Nonproliferative Diabetic Retinopathy
Moderate Nonproliferative Diabetic Retinopathy
Severe Nonproliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy
Diabetic Macular Edema
Lead sponsor: Retina Institute of Hawaii
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: (n=500) A large population will need to be screened to find 100-150 patients with diabetic eye disease

Brief summary: The purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

Detailed description: Retina Institute of Hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest Primary Care Clinics, General Medical and or Endocrine practices which re our primary referrals for diabetes patients. Each Sub-site will receive a DRS Automated Retinal Camera and our staff will train the sub-site's staff on taking images. The submission of these images to our practice will be administered by an automated job scheduler in the DRS Automated Retinal Camera removing the requirement of the locations to send images. Images will be electronically uploaded and sent to the Retina Institute of Hawaii for detailed interpretation and report sent back to the patients, their diabetes care MD's and their nurse practitioners/diabetic educators.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with diabetes that have not seen an Ophthalmologist in the past 1 year

Exclusion Criteria:

* Patients with diabetes already under the care of an Ophthalmologist.
* Patient not willing to give Consent for participation in the study

Primary outcomes:
measure: % change in Diabetic Retinopahy/Diabetic Macular Edema diagnosis with pre-screening system compared to post-screening system
timeFrame: 6 months
Secondary outcomes:
measure: Change in HgA1C from Primary Care Physician referral to post retinal specialist visit
timeFrame: six months
Other outcomes:
measure: Time from PCP referral for patient to see an ophthalmologist and appointment with retinal specialist
timeFrame: 6 months
Locations:
city: Hilo
country: United States
facility: Craig Kadooka, MD
state: Hawaii
Study officials:
affiliation: Retina Institute of Hawaii
name: Michael D Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02598245: Comparison of TOT 8/4 Versus TOT 6/3
Official title: Comparison of the Distance Between the Transobturator Tape (TOT) and the Urethra According to Two Different Placement Techniques of the Tape (TOT 8/4 vs TOT 6/3)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence, CESA, VASA, TOT, TVT
Lead sponsor: Klinikum der Universität Köln
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Transobturator tapes (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final Fixation of the tapes and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

Detailed description: Retrospective studies demonstrated that the distance between urethra and suburethral sling can vary considerably between 1 mm and 10 mm. In order to standardize the placement of the suburethral sling we choose two different distances between urethra and sling.

Transobturator tape (TOT) are placed according to the surgical technique described by Delorme et al. in patients with a previous cervico-sacropexy (CESA) or vagino-sacropexy (VASA). Before final fixation of the sling and suturing the vaginal skin a Hegar dilator sound with either 8 mm or 6 mm diameter is placed in the urethra and a second Hegar dilator sound with either 4 mm or 3 mm diameter is placed between the tape and the urethra. After suturing the vaginal skin the Hegar sounds are removed.

According to the used Hegar dilator sounds two different techniques are used:

TOT 8/4 or TOT 6/3.

Eligibility criteria: Inclusion Criteria:

* urinary incontinence

Exclusion Criteria:

* previous TOT or TVT

Primary outcomes:
measure: Distance between urethra and transobturator sling
timeFrame: 2 weeks
Secondary outcomes:
measure: Distance between urethra and transobturator sling
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Department of Obstetrics and Gynecology, University of Cologne
state: NRW
Study officials:
affiliation: Head of the Department of Urogyne
name: Wolfram Jager, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04133545: Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation
Official title: Discontinuation for Oral Anticoagulants During the First Year of Use in Patients With Atrial Fibrillation Covered by a Medical Insurance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Auricular Fibrillation
Anticoagulant Drugs
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2019-10-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients belonging to a Health Management Organization suffering from atrial fibrillation

Brief summary: The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year

Detailed description: The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year of use after their initiation during hospitalization in patients covered by our health insurance plan.

Eligibility criteria: Inclusion Criteria:

1. Patient older than 18 years of age covered by our Health Care Insurance Plan.
2. Indication for oral anticoagulation with an expected duration of use of no less than 1 year.

Exclusion Criteria:

1. Refusal to take part.
2. Use of oral anticoagulants within 6 months prior to admission.
3. Presence of mechanical prosthetic valve.
4. Chronic renal failure with creatinine clearance \<30 mL/min (estimated using the MDRD formula).

Primary outcomes:
measure: Anticoagulant Discontinuation Rate
timeFrame: One year
Secondary outcomes:
measure: Discontinuation Predictors
timeFrame: One year
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Jose L Navarrro Estrada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03573245: Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
Official title: Tranexamic Acid in Major Orthopedic Surgery: Comparison of 3 Dosage Regimen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tranexamic Acid
Knee Osteoarthritis
Ankle Osteoarthritis
Bleeding
Lead sponsor: CUF Santarém Hospital
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • Patients of a median size private hospital in Portugal

Brief summary: Tranexamic acid has been shown to be effective in reducing blood loss and transfusion in orthopedic surgery. It remains unknown the ideal therapeutic regimen. The goal of this study is to compare 3 dosage regimen of tranexamic acid in patients submitted to major orthopedic surgery.

Detailed description: There is ongoing debate, however, around optimal perioperative tranexamic acid dosing, which varies widely.

A large number of studies comparing tranexamic acid to placebo, overall blood loss and transfusion requirements are both reduced by ≈30%. A well designed tranexamic acid trial will provide answers to the best regimen dosage for perioperative tranexamic acid use. It will benefit patients by reducing allogeneic transfusions and their associated risks and costs, thus adding value to the care delivered.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 anos
* Total ankle arthroplasty
* Total knee arthroplasty
* Weight \>50 kilogram

Exclusion Criteria:

* Allergy and Hypersensitivity to tranexamic acid
* Thromboembolic events history
* Epilepsy
* Acute kidney injury, Glomerular Filtration Rate \< 50 ml/min
* Coagulation disorders
* Surgical reintervention
* Blood transfusion refusal

Primary outcomes:
measure: Perioperative bleeding
timeFrame: postoperative day 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CUF Santarem Hospital
name: Angela Sa, MD
role: PRINCIPAL_INVESTIGATOR
References: