louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05961852: COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
Official title: COmbiNing Cutting and Drug-Eluting Balloon for Resistant Arteriovenous Fistula sTenOsis (CONCERTO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arteriovenous Fistula Stenosis
Keywords: arteriovenous fistula
drug-coated balloon
cutting balloon
stenosis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
First posted: 2023-07-27
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the preliminary efficacy of combination of cutting and drug-coated balloon for the treatment of resistant AVF stenosis.

Detailed description: This is a single arm pilot study recruiting 19 participants with resistant AVF stenosis (defined as having \> 30% residual stenosis after optimal balloon angioplasty) to receive cutting and drug-coated balloon.

The outcome measure is target lesion primary patency at 6 months. Outcome will be clinically driven.

Eligibility criteria: Inclusion Criteria:

1. Failing mature upper limb AVF
2. Resistant stenosis (\>30% residual stenosis) after optimal conventional balloon angioplasty (appropriately sized balloon, inflated up to rated burst pressure, at least twice for at least a minute per inflation)
3. Patient is \>= 21 years of age
4. Ability to provide informed consent

Exclusion Criteria:

1. Thrombosed AVF
2. Target lesion has a sharp angle (\> 45 degrees)
3. Lesions requiring cutting balloon size \> 7 mm
4. Coagulopathy or thrombocytopaenia that cannot be adequately managed for the procedure
5. Contraindication to dual antiplatelet therapy
6. Severe allergy to contrast media that cannot be adequately managed for the procedure
7. Breast-feeding and/or pregnant females
8. Male patients who are planning to father children during the trial period
9. Unable to comply with follow up protocol (for instance, limited life expectancy)

Primary outcomes:
measure: Target lesion primary patency
timeFrame: 6 months after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Kun Da Zhuang, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CC, Lin MC, Pu SY, Tsai KC, Wen SC. Comparison of cutting balloon versus high-pressure balloon angioplasty for resistant venous stenoses of native hemodialysis fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):877-83. doi: 10.1016/j.jvir.2008.02.016. Epub 2008 May 2.
Clinical trial NCT00700752: A Comparison of Two Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.


Eligibility criteria: Inclusion Criteria:

1. They are of legal age (18 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
timeFrame: after 4 weeks of lens wear
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT02496052: The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions
Official title: The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesions
Keywords: amnion graft
New biological barrier system
Lead sponsor: Beijing Obstetrics and Gynecology Hospital
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.

Detailed description: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention

Eligibility criteria: Inclusion Criteria:

* age 20-40 years；
* previously diagnostic hysteroscopy confirmed adhesion score \>5， according to the American Fertility Society （AFS）classification of IUA；
* complains of menstruation disorder and reproductive dysfunction；
* informed consent.

Exclusion Criteria:

* premature menopause,
* presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
* presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
* adhesions limited to the lower uterine cavity or the cervical canal.

Primary outcomes:
measure: second diagnostic hysteroscopy
timeFrame: postoperation three to four months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital，Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Obstetrics and Gynecology Hospital
name: Duan Hua, Ph.D
role: STUDY_CHAIR
References:
citation: Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x.
citation: Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1.
Clinical trial NCT01366352: Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets
Official title: Pharmacokinetics and Bioavailability Comparison of Two Different Formulations of MNTX Tablets: A Double-Blind, Single Dose, Crossover, Phase 1 Study in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Normal Volunteers
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This was a single-center, double-blind, randomized, cross-over Phase 1 study in normal, healthy volunteers. Study treatment entailed single doses of two different formulations of MNTX tablets.


Eligibility criteria: Inclusion Criteria:

1. Weight between 55 and 85 kg
2. In good health, based on history, physical examination, and appropriate laboratory and diagnostic tests at screening, with no evidence of clinically significant chronic medical condition
3. Non-smokers.

Exclusion Criteria:

1. History of evidence of cardiovascular, gastrointestinal, hepatic, musculoskeletal, neurological, pulmonary, renal, or other significant chronic illness
2. History of asthma, allergic skin rash, significant allergy, or other immunologic disorder
3. Consumption of barbiturates or other inducers or inhibitors of CYP450
4. History or suspicion of alcohol or drug abuse.

Primary outcomes:
measure: Peak plasma concentration (Cmax) of MNTX administered as two different oral formulations
timeFrame: 7 days
Secondary outcomes:
measure: Half-life of MNTX administered as two different oral formulations
timeFrame: 7 days
measure: Time from a single dose to maximum concentration (Tmax) of MNTX administered as two different oral formulations
timeFrame: 7 days
measure: Area under the plasma concentration (AUC) of MNTX administered as two different oral formulations
timeFrame: 7 days
measure: Total body clearance over bioavailability (CL/F) of MNTX administered as two different oral formulations
timeFrame: 7 days
measure: Volume of distribution over bioavailability (V/F) of MNTX administered as two different oral formulations
timeFrame: 7 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00627952: A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients
Official title: Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
intraglomerular pressure
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2008-03-04
Enrollment: 100
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: Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.

Detailed description: The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.

Eligibility criteria: Inclusion Criteria:

* male or female patients aged 18 years or older
* mild to moderate hypertension (systolic blood pressure \> 139 mmHg or diastolic blood pressure \> 89 mmHg)

Exclusion Criteria:

* secondary form of arterial hypertension
* severe hypertension (systolic blood pressure \> 179 mmHg or diastolic blood pressure \> 109 mmHg)
* pregnant or lactating women

Primary outcomes:
measure: effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
timeFrame: 4 weeks
Secondary outcomes:
measure: effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg
state: Bavaria
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Roland E Schmieder, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.
Clinical trial NCT04881552: Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area
Official title: Incidence, Clinical Characteristics and Prognosis of Patients With ST-segment Elevation Myocardial Infarction (STEMI) and Spontaneous Coronary Reperfusion in the Modern Antithrombotic Strategy Area
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Syndrome
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nīmes
First posted: 2021-05-11
Enrollment: 302
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: All patients with ongoing (within 12 hours after onset of symptoms) STEMI admitted for coronary angiography and receiving preloading dose of aspirin, heparin and P2Y12 inhibitor

Brief summary: The rapid and complete restoration of coronary flow is a key issue in the management of STEMI. Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy associated with antithrombotic drugs.

In daily practice, it is not rare that some patients may achieve reopening of the culprit artery without undergoing any mechanical reperfusion therapy, which is called " spontaneous reperfusion ". The latter is associated with improved outcomes in several studies but none of these studies were done in the modern antithrombotic strategy area including new P2Y12 inhibitors. The aim of this study is to report the incidence, characteristics and outcomes of consecutive patients with STEMI admitted for coronary angiography with angiographic clinical evidence of spontaneous reperfusion in the modern medical antithrombotic strategy associated with primary PCI.


Eligibility criteria: Inclusion criteria:

* Older than 18 years old.
* patients with ongoing (within 12 hours after onset of symptoms) STEMI admitted for coronary angiography and receiving preloading dose of aspirin, heparin and P2Y12 inhibitor

Exclusion criteria:

* Patients with thrombolysis treatment before angiography
* Patients with cardiac arrest without ST-segment elevation on ECG after resuscitation
* Patients with myocardial infarction outside of acute phase (pain lasting more 12 hours)
* Patients with mental disease
* Patients not living in France

Primary outcomes:
measure: Incidence of initial spontaneous coronary TIMI flow grade III
timeFrame: At admission
Secondary outcomes:
measure: Biological parameters
timeFrame: at 6 months
measure: Biological parameters
timeFrame: at 12 months
measure: Clinical events
timeFrame: at 6 months
measure: Clinical events
timeFrame: at 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Leclercq, PU PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06927752: Retrospective Data Analysis PelviGYNious/EndoGYNious
Official title: Retrospective Data Analysis PelviGYNious/EndoGYNious (PMCF-4.2-004)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prolapse
Sacrocolpopexy
Pelvic Organ Prolapse (POP)
Keywords: Sacrocolpopexy
Sacrocervicopexy
surgical mesh
laparoscopic mesh
Lead sponsor: A.M.I. Agency for Medical Innovations GmbH
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The planned clinical investigation is a retrospective chart review of clinical data.

All patients who underwent surgery between January 2016 and December 2023 and met the inclusion criteria and no exclusion criteria were analyzed.

Brief summary: The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.


Eligibility criteria: Inclusion Criteria:

* Surgery for POP
* Implantation of either EndoGYNious or PelviGYNious
* Concomitant procedures are allowed
* Women minimum 18 years old
* Written informed consent for surgery

Exclusion Criteria:

Patients who rule out subsequent contact by the hospital will be excluded.

The use of the products is contraindicated in case of:

* pregnancy and/or patients who consider future pregnancies
* adolescent/ pubescent patients
* existence of a known sensitivity/ allergy against plastic materials such as polypropylene, polyester, etc.
* any pathology, including known or suspected uterine pathology, which would compromise placement of the implant/mesh (e.g. anatomical distortion or abnormalities)
* known anticoagulation disorder
* anticoagulant therapy
* autoimmune connective tissue disease
* renal insufficiency and upper urinary tract obstruction
* cancer illnesses of the vagina / cervix / rectum
* undergone radiation therapy on the vagina, cervix, rectum
* planned or emergency opening of the gastro-intestinal tract, as this could cause a risk of product contamination that could lead to infection that would require removal of the implant/device
* active or latent infection especially of the genital system and/or urinary tract

Primary outcomes:
measure: Patient subjective outcome
timeFrame: From baseline to the end of last follow-up [3 months, 12 months]
Secondary outcomes:
measure: Postoperative complications
timeFrame: From baseline to the end of last follow-up [average of minimum 3 months]
measure: Anatomical success (POP-Q)
timeFrame: From baseline to the end of last follow-up [average of minimum 3 months]
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Frauenklinik
Study officials:
References:
Clinical trial NCT00900952: Epidemiologic Study Evaluating Infections in Elderly Patients
Official title: Epidemiologic Study of Infections in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infected elderly patients treated at Internal Medicine wards in Spanish hospitals

Brief summary: The purpose of this observational study is to assess the prevalence and demographic and clinical characteristics of infections in elderly people admitted to Internal Medicine wards in Spain, as well as the etiology and resistance pattern for the main causal agents, and outcome.


Eligibility criteria: Inclusion criteria:

* Patients \> 65 years of age that are hospitalized in an Internal Medicine ward and have an active infection (skin and soft tissue, intra-abdominal, or respiratory infections) from the community that needs antibiotic treatment
* Patients must have at least one sample processed for microbiological diagnosis

Exclusion criteria:

* COPD exacerbation
* Urinary tract infections
* Hospital acquired infections
* Other infections not in inclusion criteria

Primary outcomes:
measure: Prevalence of each kind of infection will be measured from a descriptive point of view, using relative and absolute frequencies.
timeFrame: 5 months
Secondary outcomes:
measure: Study the etiology and resistance pattern for the main causal agents.
timeFrame: 5 months
measure: Describe the demographic features, co-morbidities, concomitant treatment and outcome of patients.
timeFrame: 5 months
Other outcomes:
Locations:
city: Mataró
country: Spain
state: Barcelona
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03655652: Preoperative Progression of Retinal Detachment
Official title: Preoperative Progression of fovea-on Retinal Detachment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Detachment
Keywords: positioning
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2018-08-31
Enrollment: 50
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: Patients with a fovea-on retinal detachment referred to Rigshospitalet - Glostrup Department of Ophthalmology.

Brief summary: Patients are required to position prior to retinal detachment surgery. We seek to see whether there is a correlation between the performed positioning and retinal detachment progression/regression in fovea-on retinal detachment patients.


Eligibility criteria: Inclusion Criteria:

* fovea-on retinal detachment
* informed consent

Exclusion Criteria:

* previous retinal detachment surgery
* \>14 days of retinal detachment symptoms
* split-fovea retinal detachment
* other retinal disease with influence on retinal biomechanics/elasticity (proliferative diabetic retinopathy, wet AMD)

Primary outcomes:
measure: Retinal detachment progression/regression
timeFrame: 1-72 hours
Secondary outcomes:
measure: Positioning
timeFrame: 1-72 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Rigshospitalet - Glostrup
Study officials:
References: