louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01711853: Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
Official title: An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.


Eligibility criteria: Inclusion criteria:

1. Male and female patients aged 18 years and older
2. Impaired renal function defined as a stable Cockcroft-Gault and/or actual creatinine clearance between 15-30 ml/min over the last 3 months before study participation.
3. The single use of either aspirin or Vitamin K Antagonists
4. Provision of informed consent.

Exclusion criteria:

1. Unstable renal function and Creatinin Clearance \<15mL/min
2. Patients treated with two or more platelet aggregation inhibitors
3. Use of or indication for therapeutic heparin
4. Patients with prosthetic heart valves
5. Haemorrhagic disorder or bleeding diathesis
6. Platelet count \<100 109/L) at screening or during the last 30 days before screening.
7. Participation in another drug trial in the last 30 days before screening.

Primary outcomes:
measure: Cmax,ss
timeFrame: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h
measure: AUCtau,ss
timeFrame: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: 1160.166.31001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT05602753: Smoking Cessation Study
Official title: Carbon Monoxide Breath Testing Prior to Total Joint Arthroplasty to Ascertain Smoking and Aid in Encouraging Smoking Cessation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking Cessation
Arthropathy
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been referred to our outpatient orthopaedic clinic for a potential hip and knee joint replacement and have been placed on our surgical waitlist for surgery.

Brief summary: The primary outcome of this study is to determine the true incidence of smokers among patients undergoing joint replacement and secondly, what percent are able to quit smoking before surgery under a structured cessation program with carbon monoxide breath testing. The investigators hypothesize that self-reported smoking status is underreported and that routine carbon monoxide breath testing will improve abstinence rates at the time of surgery.

Detailed description: This study looks at patients who have been referred to our clinic for a potential hip and knee joint replacement surgery. Once it has been determined that the patient requires surgical replacement of either their hip or knee and is placed on our surgical waitlist, the patient will be asked if he or she would like to participate in the study. The investigators would ask all patients, both self-declared smokers and non-smokers, to participate. This study would include completing a smoking history questionnaire and a noninvasive carbon monoxide breath test. While smoking status is already assessed in the McGill University Health Centre preoperative questionnaire, the investigators intend on expanding these questions in study participants to better quantify their nicotine exposure.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18-85 who require a primary total hip or knee replacement
* Any gender
* Smokers and non-smokers
* Osteoarthritis, rheumatoid arthritis, avascular necrosis

Exclusion Criteria:

* Patients who require revision surgery
* Previous fracture to affected area
* Emergency surgery
* Patients who do not understand, read or communicate in either French or English

Primary outcomes:
measure: True incidence of smokers among patients undergoing joint replacement
timeFrame: 15 minutes
Secondary outcomes:
measure: To determine the incidence of patients who successfully quit smoking prior to surgery.
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Dr, Adam Hart
state: Quebec
Study officials:
References:
Clinical trial NCT04957953: Pregnant Women Vaccinated Against Covid-19.
Official title: Prospective Cohort of Pregnant Women Vaccinated Against Covid-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women Vaccinated Against Covid-19
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 1393
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pregnant woman who has received at least one Covid-19 vaccine during her pregnancy, regardless of the trimester of pregnancy.

Brief summary: Establish a cohort of pregnant women exposed to a COVID19 vaccine, whether or not they have experienced an adverse event, to assess the potential effects of vaccines on the course of pregnancy, on the fetus or newborn and on the mother.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years and over,
* Pregnant,
* Vaccinated against COVID-19,
* Not having expressed any objection to inclusion in the cohort

Exclusion Criteria:

* No agreement at inclusion,
* Age under 18 years

Primary outcomes:
measure: To assess the potential effects of vaccines on the course of pregnancy.
timeFrame: One month after injection
measure: To assess the potential effects of vaccines on the fetus or newborn
timeFrame: One month after injection
measure: To assess the potential effects of vaccines on the mother.
timeFrame: One month after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service Hospitalo-Universitaire de Pharmacotoxicologie
Study officials:
affiliation: Service Hospitalo-Universitaire de Pharmacotoxicologie
name: Judith COTTIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06480253: Cerebral Blood Flow: Helmet vs Oronasal Mask During Continuous Positive Airway Pressure Ventilation
Official title: Variation of Cerebral Blood Flow Depending on the Interface Chosen During Continuous Positive Airway Pressure Ventilation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventilation Therapy
Keywords: Continuous Positive Airway Pressure
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open Label, randomized, controlled with crossover
Primary purpose: TREATMENT

Brief summary: In this trial the investigators will evaluate blood flow in common carotid artery of healthy subjects treated with Continuous Positive Airway Pressure (CPAP) Ventilation, comparing two different devices: oronasal mask versus Helmet. The hypothesis is that Helmet CPAP reduces carotid flow compared to oronasal mask.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years,
* Ability to give informed consent

Exclusion Criteria:

* known cardiac pathologies
* known pulmonary pathologies
* known vascular pathologies
* history of concussion
* history of headache

Primary outcomes:
measure: Common carotid artery flow
timeFrame: 4 consecutive heart beats at the end of the intervention
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: single measure, at the end of the intervention
measure: Peripheral vascular resistance
timeFrame: 4 consecutive heart beats at the end of the intervention
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
Study officials:
affiliation: Ospedale Papa Giovanni XXIII
name: Roberto Cosentini, MD
role: STUDY_DIRECTOR
References:
citation: Haring HP, Hormann C, Schalow S, Benzer A. Continuous positive airway pressure breathing increases cerebral blood flow velocity in humans. Anesth Analg. 1994 Nov;79(5):883-5. doi: 10.1213/00000539-199411000-00011.
citation: Scala R, Turkington PM, Wanklyn P, Bamford J, Elliott MW. Effects of incremental levels of continuous positive airway pressure on cerebral blood flow velocity in healthy adult humans. Clin Sci (Lond). 2003 Jun;104(6):633-9. doi: 10.1042/CS20020305.
citation: Kolbitsch C, Lorenz IH, Hormann C, Schocke M, Kremser C, Zschiegner F, Felber S, Benzer A. The impact of increased mean airway pressure on contrast-enhanced MRI measurement of regional cerebral blood flow (rCBF), regional cerebral blood volume (rCBV), regional mean transit time (rMTT), and regional cerebrovascular resistance (rCVR) in human volunteers. Hum Brain Mapp. 2000 Nov;11(3):214-22. doi: 10.1002/1097-0193(200011)11:3&#x0003c;214::AID-HBM70&#x0003e;3.0.CO;2-I.
citation: Yiallourou TI, Odier C, Heinzer R, Hirt L, Martin BA, Stergiopulos N, Haba-Rubio J. The effect of continuous positive airway pressure on total cerebral blood flow in healthy awake volunteers. Sleep Breath. 2013 Mar;17(1):289-96. doi: 10.1007/s11325-012-0688-0. Epub 2012 Mar 22.
Clinical trial NCT00515853: The Role of Biofeedback in Improving Continence After Anterior Resection
Official title: The Role of Biofeedback in Improving Continence After Anterior Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Neoplasms
Fecal Incontinence
Aged
Keywords: Rectal neoplasms
Biofeedback (Psychology)
Fecal Incontinence
Aged
Anterior resection
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Rectosigmoid or rectal cancer

Exclusion Criteria:

* Inoperable

Primary outcomes:
measure: Cleveland Clinic Incontinence (CCI) Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
Study officials:
affiliation: Southampton University
name: S A Pilkington
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02199353: Occupational Therapy Programme of Patients With Dementia Performing Activities of Daily Living
Official title: Effectiveness of A Therapy Programme Based On The Reestablishment of Cognitive Functions on The Independence of Patients With Dementia Performing Activities of Daily Living - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Activities of daily living, Occupational Therapy, Dementia
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness of the Stimulation of Activities of Daily Living (SADL) Occupational Therapy programme on the independence of ADL by persons with dementia who are institutionalized. This programme is based on the recovery of the cognitive functions.

Detailed description: This study is a longitudinal and prospective clinical trial approved by the bioethics Commission of the University of Extremadura. 58 senior citizens institutionalized with dementia in residential homes in Extremadura (Spain) received a treatment focusing on activities of daily living with the SADL programme and with conventional occupational therapy during 5 weeks. The studied variables were the cognitive level and the independence level performing ADL. The variables were measured by an occupational therapist independent to the study at baseline, after 5 weeks of experimental treatment and 6 weeks after the treatment was completed. The standardized tests used were Barthel Index, Lobo's Cognoscitive mini test, Lawton and Brody Scale and Global Deterioration Scale (GDS).

Eligibility criteria: Inclusion Criteria:

* Institutionalization in residential homes at least 6 months before the commencement of the study.
* Diagnosis of dementia for at least one year according to the Diagnostic and Statistical Manual of Mental Disorders (DMS IV) criteria.
* Over 60 years old.
* Barthel Index scores greater than or equal to 40%.
* Lobo´s Cognitive Mini Test scores greater than or equal to 15 points.
* To be included in the BADL intervention programme of Occupational therapy in the previous 6 months and to have the informed consent signed by the legal tutor.

Exclusion Criteria:

* To present psychological or behavior symptoms diagnosed by a doctor.
* Barthel Index scores less than 40%
* Not being included in the BADL intervention programme of Occupational therapy in the previous 6 months.

Primary outcomes:
measure: Dependency level
timeFrame: after 5 weeks of treatment and after 6 weeks of follow up
Secondary outcomes:
measure: Cognitive level.
timeFrame: After 5 weeks of treatment and after 6 weeks of follow up
Other outcomes:
Locations:
city: Cáceres
country: Spain
facility: 'CARE' elderly residential homes
Study officials:
affiliation: University of Extremadura
name: Maria Jimenez, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023853: Non Surgical Treatment of Periimplantitis
Official title: The Use of Erythritol Powder and Locally Derived Metronidazole for the Non-surgical Treatment of Peri-implant Mucositis and Peri-implantitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peri-Implantitis and Peri-implant Mucositis
Lead sponsor: Proed, Torino, Italy
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 20
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: 20 consecutive adult implant patients, presenting the signs of peri-implant mucositis (probing depth ≥4 mm combined with bleeding and/or pus on probing) or initial peri-implantitis (probing depth ≥4 mm, bleeding and suppuration plus radiographic loss of supporting bone ≤30% compared with the situation after implant placement) will be included.

Sites will be treated by ultrasonic debridement of the pocket, performed using a piezoceramic ultrasonic device. For the purpose, a Tip will be connected to the Handpiece Led (5 minutes/pocket) . Then, it will be followed by the subgingival use of erythritol powder applied by the use of Handpiece connected to an airflow unit 2x5 seconds/pocket. At this time the subgingival delivery of metronidazole gel will be provided. After instrumentation, patients will rinse with chlorhexidine 0.20% 3 times/day for 2 weeks.

At baseline, 1 month, 3 months and 6 months the following parameters will be evaluated: Probing Pocket depth (PPD), Bleeding on Probing (BoP), Clinical Attachment Level (CAL).


Eligibility criteria: Inclusion Criteria:

* adult patients suffering from peri-implant mucositis or peri-implantitis

Exclusion Criteria:

* Heavy smokers current pregnant history of malignancy long-term steroidal or antibiotic therapy

Primary outcomes:
measure: probing pocket depth change
timeFrame: baseline, 6 months
measure: bleeding on probing change
timeFrame: baseline, 6 months
measure: clinical attachment level change
timeFrame: baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: PROED, Institute for Professional Education in Dentistry
Study officials:
affiliation: Proed, Torino, Italy
name: Daniele Cardaropoli, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690153: Novel Approach of Hayman Uterine Compression Sutures for Management of Severe Atonic Postpartum Hemorrhage: Three Vertical Sutures
Official title: Novel Approach of Hayman Uterine Compression Sutures for Management of Severe Atonic Postpartum Hemorrhage: Three Vertical Sutures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Atony
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Ismail Ozdemir
First posted: 2020-12-30
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with abnormal uterine bleeding other than birth Patients with known metabolic diseases Patients with known bleeding and coagulation disorders

Brief summary: Maternal deaths due to uterine atony bleeding are the leading causes of maternal death in our country and all over the world. In this respect, our clinic is among the clinics with the highest number of experience in our country and aims to reduce maternal deaths and mothers who will need intensive care due to bleeding with a hemorrhage stopping technique that will have a serious contribution to both our country and the world literature.

Our primary goal, thanks to the bleeding-stopping technique, to reduce their deaths. Our secondary aim is, thanks to the bleeding-stopping technique we offer, To prevent and reduce the complications seen in mothers during the operative period.

Detailed description: Our research was carried out to our obstetrics clinic between 01 Agustus 2015 - 01 December 2020.

Patients transplanted due to postpartum bleeding and patients requiring surgery due to abnormal postpartum bleeding in our clinic will be included. Patients with a previously known bleeding disorder will not be included in the study. In our study, the parameters of the patients who had bleeding due to postpartum uterine atony and who needed uterine surgery previously underwent triple Hayman compression suture to stop bleeding will be included in the study. Patients with a triple Hayman suture covering the upper 2/3 of the uterus to stop uterine bleeding will be evaluated in the study.

Eligibility criteria: Inclusion Criteria:

* Postpartum bleeding after birth
* Patients referred to our clinic from an external center due to postpartum bleeding
* Patients who have given birth due to pregnancy older than 24 weeks and have atony bleeding

Exclusion Criteria:

-

Primary outcomes:
measure: Reduce maternal deaths due to bleeding
timeFrame: 5 years
Secondary outcomes:
measure: to prevent and reduce complications seen in mothers in the post-operative period due to bleeding,
timeFrame: 5 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Pinar Yalcin Bahat
state: İ̇stanbul
Study officials:
References:
Clinical trial NCT00233753: Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Official title: Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intracranial, Wide-Neck, Saccular Aneurysms
Keywords: Intracranial
Wide-neck
Saccular
Aneurysms
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel


Eligibility criteria: Inclusion Criteria:

* pts with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria:

* Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05503953: Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
Official title: A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Daehwa Pharmaceutical Co., Ltd.
First posted: 2022-08-17
Enrollment: 306
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients with Essential Hypertension Inadequately Controlled with AGLS


Eligibility criteria: Inclusion Criteria:

* Hypertension patient who satisfied below condition at Visit 1.

  * patient who takes antihypertensive drug

    * 140mmHg \<= MSSBP \< 200mmHg
    * 130mmHg \<= MSSBP \< 200mmHg at or before visit 1(In high-risk patients)
  * patient who doesn't take antihypertensive drug

    * 160mmHg \<= MSSBP \< 200mmHg
* Hypertension patient who satisfied below condition at Visit 2.

  * 140mmHg \<= MSSBP \< 200mmHg at Visit 2
  * 130mmHg \<= MSSBP \< 200mmHg at or before Visit 1(In high-risk patients)

Exclusion Criteria:

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg\>= of difference in MSSBP or 10mmHg\>= of difference in MSDBP between 2 times of BP measuring at Visit 1
* Patient with MSDBP \>= 120mmHg at Visit 1 or 2
* Patient with secondary hypertension(including past medical history)

Primary outcomes:
measure: Change of MSSBP(Mean Sitting Systolic Blood Pressure)
timeFrame: From Baseline(Visit 2) to Visit 5(For 10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: