louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02226926: Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
Official title: Mechanism of Dipyridamole Action in Platelets: in Vivo Study With Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of the mechanism of dipyridamole action in platelets in an in-vivo study with healthy volunteers treated Aggrenox in comparison with volunteers treated with Persantin Retard or Acetylsalicylic Acid using platelet Vasodilator-Stimulated-Phosphoprotein (VASP)-phosphorylation as indication for an action and measurements of dipyridamole plasma levels


Eligibility criteria: Inclusion Criteria:

* Healthy females/males
* Age range from 18 to 60
* Volunteers will have given their written informed consent in accordance with local ethics committee and local legislation

Exclusion Criteria:

* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* Known history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Drug intake with long half-life (\> 24 hours), \< 1 month prior to administration or during the trial
* Volunteers received any other drugs which might influence the results of the trial, \< 10 days prior to administration or during the trial
* Participation in another study with an investigational drug, \< 1 month prior to administration or during the trial
* Smoking more than 15 cigarettes or 4 cigars or 4 pipes/day
* Drinking more than 60 g of alcohol per day
* Unable to refrain from excessive consumption of methylxanthine containing drinks or food
* Drug addiction
* Blood donation (\> 400 ml), \< 4 weeks prior to administration or during the trial
* Participation in excessive physical activities, \< 5 days prior to administration or during the trial

For female volunteers:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (acceptable: oral contraceptives, condoms, etc.)
* Lactation period

Primary outcomes:
measure: VASP-Ser239 / VASP-Ser157-phosphorylation
timeFrame: up to day 10
Secondary outcomes:
measure: Change in Dipyridamole plasma levels
timeFrame: up to day 10
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05376826: Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance.
Official title: A Study to Assess the Effectiveness of Nurse-led Physical Therapy in Terms of Patient Competency, Patient Engagement and Physical Performance Among CLD Patients With Physical Frailty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Liver Disease and Cirrhosis
Keywords: Patient Competency
Patient engagement
Physical Performance
CLD
MELD
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-test - Post test Control group design
Primary purpose: OTHER

Brief summary: Due to Prolonged diseased Condition, Patients are not able to care for themselves and even avoid movement their range of motion is limited which may develop frailty among Liver disease Patients.

This Study aims at assessing Engagement, Competency and Physical Performance of Physical Frail Chronic Liver disease Patients before and after Nurse led Physical therapy.

Besides these Parameters effect of Intervention on Physical frailty will also be assessed.

Detailed description: Research Approach: Quantitative Study Research design: Quasi Experimental Research design ( Pre-test - Post test Control group design) Setting: Study is planned on OPD patients of ILBS, New Delhi. Sampling Technique: Random Allocation in Experiment and Control group after matching for age and gender Sample size: 80 Patients Variables: Independent variable- Nurse-led Physical therapy Dependent Variable- Patient Competency, Patient Engagement, Physical Performance.

Eligibility criteria: Inclusion Criteria:

* Prefrail and Frail CLD Patients (MELD \<24)
* Follow up of Prefrail and Frail CLD Patients (MELD\<24)
* Participants willing for Research

Exclusion Criteria:

* Frail Patients who are bedridden
* presence of hepatopulmonary disease
* Presence of neurological defects
* Previous history of Liver Transplantation
* Severe COPD, Heart Failure

Primary outcomes:
measure: Patient Competency by patient Competency Scale at 1 week
timeFrame: 1 week
Secondary outcomes:
measure: Patient Engagement by Patient Engagement Scale at 1 week
timeFrame: 1 week
measure: Physical Performance by six minute walk test at 1 week
timeFrame: 1 week
Other outcomes:
Locations:
city: New delhi
country: India
facility: Sonam Kumari
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Sonam Ms Kumari, Nursing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01352026: Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 0
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

Brief summary: Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents.

Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at the pulmonary arteries level.

According to these results, and knowing that metformin is a widely used drug, with a favorable safety profile, the investigators decided to set up a pilot study, in order to evaluate the activity of metformin in PAH treatment. In parallel, the investigators will focus on metformin mechanism of action.


Eligibility criteria: Inclusion Criteria:

* Men or women aged between 18 and 80
* Patients included will have pre-capillary PAH
* they have to be stable for more than 3 months
* Patient with a 6-minute walk test comparable over the last 3 months before inclusion
* Informed consent signed

Primary outcomes:
measure: The primary objective of this study will be to demonstrate the improvement of walk test distance in patients with pulmonary arterial hypertension (PAH) treated by metformin.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
References:
Clinical trial NCT04937426: Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori
Official title: Development of a Laboratory Test for the Detection of a Fluorescent-labeled Urease Inhibitor Marker Attached to Helicobacter Pylori Using Biopsies Taken During Gastroscopy in Patients in Which the Bacterium is Suspected
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-06-24
Enrollment: 200
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: The aim of this study is to compare the usual rapid urease test (RUT) to a new florescent-labeled urease inhibitor marker to diagnose Helicobacter Pylori.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing gastroendoscopy with suspected Helicobacter Pylori

Exclusion Criteria:

* Patients with active bleeding
* Patients treated with anti-coagulation medication

Primary outcomes:
measure: Efficacy of a Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori Infection
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Yael Kopelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00266526: Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
Official title: A Bicentre Open Label Randomised Pilot Study for Proof of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen Bet v 1-FV Versus a Depot Extract of Natural Birch Allergen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Birch Pollen Allergy
Keywords: Allergy
Birch pollen
Recombinant
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2005-12-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV


Eligibility criteria: Inclusion Criteria:

* Positive RAST result to birch pollen
* Positive Skin Prick Test reaction to birch pollen
* positive nasal provocation test result to birch pollen extract

Exclusion Criteria:

* serious chronic diseases
* other relevant seasonal allergies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reinbek
country: Germany
facility: Allergopharma GmbH & Co. KG
Study officials:
name: Annemie Narkus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klimek L, Bachert C, Lukat KF, Pfaar O, Meyer H, Narkus A. Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial. Clin Transl Allergy. 2015 Aug 3;5:28. doi: 10.1186/s13601-015-0071-x. eCollection 2015.
Clinical trial NCT00315926: Melatonin and Cardiac Outcome After Major Surgery
Official title: Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aortic Aneurysm
Keywords: Cardiac morbidity
Melatonin
Surgery
Postoperative
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2006-04-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.

Detailed description: Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.

Eligibility criteria: Inclusion Criteria:

* Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
* Patients between 18 and 80 years old

Exclusion Criteria:

* Patients with ASA class \> 3
* Anticoagulation therapy (marevan and marcoumar)
* Preoperative therapy with opioid, anxiolytic and hypnotic medication
* Renal insufficient (preoperative creatinin \> 200 mmol/l)
* Well-known liver insufficient
* Alcohol consumption (more than 5 drinks)
* Compliance (language difficulty, mental problems etc.)
* Pregnancy and breast-feeding
* Lack of written consent

Primary outcomes:
measure: Cardiac morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Oxidative and inflammatory stress response
timeFrame: 3 days
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Study officials:
affiliation: Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
name: Bülent Kücükakin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05060926: Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning
Official title: Intubation Prediction in Sars-CoV-2 Patients Treated With Awake Prone Positioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Hypoxemic Respiratory Failure
SARS-CoV-2 Virus
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sars-CoV-2 pneumonia patients with severe hypoxemia

Brief summary: Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.


Eligibility criteria: Inclusion Criteria:

* Sars-CoV-2 pneumonia
* ICU stay
* Severe hypoxemia but non intubated

Exclusion Criteria:

* Intubated before admission
* Denied consent for data analysis
* Do not intubate order at ICU admission

Primary outcomes:
measure: Intubation rate
timeFrame: Once between ICU admission and extubation
Secondary outcomes:
measure: Alveolo-arterial gradient change
timeFrame: Within 6 hours before and 6 hours after each pronation
measure: Blood gas analysis
timeFrame: Within 6 hours before and 6 hours after each pronation
measure: Respiratory pattern
timeFrame: Within 6 hours before and 6 hours after each pronation
measure: Mortality
timeFrame: Up to 28 days from ICU admission
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospitals
state: Vaud
Study officials:
References:
Clinical trial NCT02862626: Assessment of Psychological State of Mothers of Diabetic Children Aged 5 and Under (in Terms of Depression, Stress, Coping , Anxiety, Fear of Hypoglycemia) and Influencing Factors of This Psychological State
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Diabetic children
Mothers
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 24
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers of diabetic children aged 5 and under followed-up in Pediatrics Department of Besançon University Hospital.

Brief summary: The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. This study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.


Eligibility criteria: Inclusion Criteria:

* Mother of diabetic child aged 5 and under, followed-up in Pediatrics Department of Besançon University Hospital.

Exclusion Criteria:

* Mother of diabetic child older than 5 years old

Primary outcomes:
measure: Evaluation of depression among mothers of children aged 5 or under with type 1 diabetes
timeFrame: at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Brigitte Mignot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03435926: OCT and Microperimetry in Patients With Active Neovascular ARMD (CORFI)
Official title: Evaluating the Link Between Active Neovascularization Found on OCT and Eye Fixation Quality Measured With Microperimetry in ARMD Patients Treated With antiVEGF
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Choroidal Neovascularization, Visual Field, Visual Acuity
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active neovascular ARMD treated with antiVEGF

Brief summary: ARMD is the main cause of visual disability after 50 years old in France. Patients with active neovascular ARMD are treated with intravitreal injections of antiVEGF. Reinjections criteria are decrease of best corrected visual acuity or active neovascularization's signs (mostly found on macular OCT but also on angiography when necessary).

The aim of this study is to evaluate the link between active neovascularization found on OCT and eye fixation quality measured with microperimetry in ARMD patients treated with antiVEGF.

Quality of eye fixation and exudative signs presents or not present on OCT will be gathered at each consultation over the two-years follow-up for each patient. The mean central retinal sensitivity, the best corrected visual acuity and the bivariate contour ellipse area will also be gathered.

In case no link will be found, for instance bad fixation quality without exudative signs on OCT or good fixation stability despite exudative signs on OCT, microperimetry should have an interest to improve reinjections criteria with a treatment more suitable to the patient.


Eligibility criteria: Inclusion Criteria:

* patients \> 50 years old,
* With neovascular ARMD
* who need an induction treatment (de novo patients or patients who had their last intravitreal injection of antiVEGF more than 6 months ago)

Exclusion Criteria:

* Other maculopathies
* Severe glaucoma with central visual field defect
* Diabetic patients
* Corneal, lens or vitreous opacities interfering in OCT analysis
* Attention or comprehension deficit

Primary outcomes:
measure: fixation stability measured by microperimetry and exudative signs on OCT
timeFrame: 2 years
Secondary outcomes:
measure: Bivariate Contour Ellipse Area (BCEA) value
timeFrame: 2 years
measure: mean central retinal sensitivity
timeFrame: 2 years
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: 2 years
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT03123926: Spontaneous Preterm Birth Marker Test
Official title: Spontaneous Preterm Birth Marker Test (SPBMT): Preterm Prediction Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Delivery
Keywords: spontaneous preterm birth
lipids
biomarkers
Lead sponsor: Sprim Advanced Life Sciences
Sponsor class: OTHER
Collaborators: name: BABYNOSTICS
First posted: 2017-04-21
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Estimated 600 symptomatic women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.

Brief summary: The prediction of preterm birth is beneficial because it initiates early treatment to minimize risk. It defines a population at risk to provide particular treatment and may lead us to a better understanding the mechanisms of preterm birth. The understanding of the mechanisms and etiology consequently leads to the possibility of early intervention and effective management aiming at preventing preterm birth. Five most common interventions for preventing and treating preterm birth are antibiotics, cervical cerclage, bed rest, progesterone, and tocolytic therapy. However, there are insufficient evidence showing the efficacy of cerclage and bed rest; antibiotics may only delay but not prevent the preterm birth; the use of certain tocolytics needs to be considered against the possible adverse effects. The early detection of pregnant women with high risk for preterm delivery would be the ideal solution to prevent preterm birth. However, to date, there is inadequate literature and little knowledge of diagnosis, treatment, prevention and prediction of preterm birth.


Eligibility criteria: Inclusion Criteria:

* Pregnancy women aged ≥ 18 years with pregnancy at 24 to 28 weeks of gestation.

Exclusion Criteria:

* Subjects with any conditions or diseases that investigator considers it is not appropriate to enter the study.

Primary outcomes:
measure: Cervical length
timeFrame: 6-12 months
measure: Biomarkers (serum)
timeFrame: 6-12 months
measure: Lipid analysis (serum and DBS)
timeFrame: 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Quezon
country: Philippines
facility: The Perinatal Association of the Philippines
state: Brgy Malaya
Study officials:
affiliation: MD
name: Mariano Diosdado V., MD
role: PRINCIPAL_INVESTIGATOR
References: