louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05750680: DOCE Study Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers
Official title: Interaction Between Direct Oral Anticoagulants and Drug-metabolizing Enzyme Inducers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Thromboembolism, Venous
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 23
Sex: ALL
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: For sample size calculation we used data from a pilot study on 10 patients and controls. A significant difference of subject frequency with DOAC plasma concentrations below the expected peak value, respectively 35% and 10% for patients using or not using EI/AED, was defined as the primary end-point. A sample size of 40 subjects in each group was estimated for 80% power and alfa = 0.05

Brief summary: Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism

Detailed description: Aim of the study is to investigate whether the influence of drugs inducing of CYP 3A4 isoenzyme of CYP450 and P-gp transporter significantly affect plasma levels of DOACs in patients with NVAF and venous thromboembolism. Also the difference between DOACs inducing both CYP3A4 and P-gp transporter (rivaroxaban and apixaban) and DOACs inducing the P-pg transporter only will be investigated. Thriomboembolic and bleeding events during the study duration will be registered and correlated to the measured DOAC plasma levels.

Eligibility criteria: Inclusion Criteria:

* patients with a diagnosis of nonvalvular atrial fibrillation or a diagnosis of venous thromboembolism who are taking direct oral anticoagulants according to current guidelines and concomitant enzyme inducers antiepileptic drugs; patients available for a 12 months follow up; patients who can sign informed consent

Exclusion Criteria:

* patients who stop antiepileptic drugs; age \<18 yo patients not willing to perform blood draw or not available for a 12 months follow up; patients who cannot sign informed consent

Primary outcomes:
measure: measurement of trough plasma levels of DOACs
timeFrame: 12 months
Secondary outcomes:
measure: measurement of peak plasma levels of DOACs in patients treated and not treated with EI-EAD
timeFrame: 12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A.Gemelli IRCCS Rome
name: Erica De Candia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04479280: Evaluation of Coagulopathy in Critically Ill COVID-19 Patients.
Official title: Evaluation of the Role of Sonoclot Signature in Assessment of Coagulopathy in Critically Ill COVID 19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are suspected to be COVID 19 infection

Brief summary: Novel coronavirus disease 19 (COVID-19) is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), this pneumonia was first emerged in December 2019 in Wuhan, China and rapidly spread around the world .

Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation


Eligibility criteria: Inclusion Criteria:

* COVID 19 critically ill patients

Exclusion Criteria:

* any critical illness not related to COVID 19

Primary outcomes:
measure: clot rate formation
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT02942680: Efficacy and Safety of Aspirin Therapy With CABG
Official title: A Prospective Randomized Study of the Efficacy and Safety of Aspirin Therapy With CABG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Heart Disease
Keywords: coronary artery bypass grafting
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2016-10-24
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation

Detailed description: The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe.

The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patient able to give informed consent

Exclusion Criteria:

* Missing consent
* Urgent or emergent surgery
* Off-pump CABG
* Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent)
* History of bleeding diathesis, significant GI bleed, ICH, or liver failure
* Allergy to or intolerance of aspirin

Primary outcomes:
measure: on discharge drains after surgery in milliliters
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: myocardial infarction
timeFrame: myocardial infarction by 30th day after procedure
measure: ischemic stroke
timeFrame: stroke by 30th day after procedure
measure: repeat revascularization
timeFrame: repeat revascularization within 30 days after surgery
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Meshalkin State Research Institute of Circulation Pathology
Study officials:
affiliation: Academician Ye. Meshalkin Novosibirsk Research Institute of Circulation Pathology Ministry of Health care of Russian Federation
name: Alexander M. Chernyavskiy, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02568280: Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-10-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

Primary outcomes:
measure: Mean change in plasma glucose concentration
timeFrame: From 0-1 hour after trial product administration
Secondary outcomes:
measure: Rate of endogenous glucose production
timeFrame: From 0-6 hours after trial product administration
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0-6 hours after trial product administration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Basu A, Pieber TR, Hansen AK, Sach-Friedl S, Erichsen L, Basu R, Haahr H. Greater early postprandial suppression of endogenous glucose production and higher initial glucose disappearance is achieved with fast-acting insulin aspart compared with insulin aspart. Diabetes Obes Metab. 2018 Jul;20(7):1615-1622. doi: 10.1111/dom.13270. Epub 2018 Mar 30.
citation: Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Clinical trial NCT06916780: Elhafez Technique Combined With Dynamic Scapulohumeral Mobilization in Shoulder Adhesive Capsulitis
Official title: Elhafez Technique Combined With Dynamic Scapulohumeral Mobilization in Patients With Shoulder Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Adhesive Capsulitis of the Shoulder
Keywords: Elhafez technique
Adhesive capsulitis
Dynamic scapulohumeral mobilization
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2025-04-08
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Elhafez Technique Combined with Dynamic Scapulohumeral Mobilization in Adhesive Capsulitis

Detailed description: Elhafez Technique is an emerging rehabilitation approach that integrates axillary ultrasound, axillary laser therapy, and post-isometric facilitation (PIF) to target capsular stiffness, inflammation, and neuromuscular dysfunction. These techniques aim to enhance tissue healing, improve joint mobility, and reduce pain. When combined with Dynamic Scapulohumeral Mobilization (DSM), which focuses on restoring scapular control and shoulder joint biomechanics, this comprehensive approach may offer superior outcomes compared to conventional treatments.

This study aims to evaluate the biomechanical and functional effects of combining Elhafez Technique with DSM in patients with shoulder adhesive capsulitis. By assessing pain levels, ROM, and functional recovery, this research seeks to determine whether this combined intervention provides faster and more effective relief for patients suffering from this condition.

Eligibility criteria: Inclusion Criteria

1. Adults aged 30-60 years diagnosed with Stage 2 (Frozen) or Stage 3 (Thawing) Shoulder Adhesive Capsulitis based on American Shoulder and Elbow Surgeons (ASES) guidelines.
2. Pain score ≥4/10 on the Visual Analog Scale (VAS) for at least 3 months.
3. Restricted external rotation of ≥25% compared to the unaffected shoulder.
4. No prior shoulder injections, surgery, or physiotherapy within the last 3 months.

Exclusion Criteria

1. History of shoulder fractures, rotator cuff tears, or labral injuries.
2. Systemic inflammatory conditions (e.g., Rheumatoid Arthritis, Uncontrolled Diabetes).
3. Neurological disorders affecting the shoulder (e.g., Stroke, Parkinson's Disease).
4. Current participation in another physiotherapy intervent

Primary outcomes:
measure: Range of motion
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Functional activities
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Dokki, Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Giza
Study officials:
References:
Clinical trial NCT02412280: Validity of Different Prognostic Models Assessing 1 Year Survival After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: liver failure

Brief summary: Validity of MELD vs MELD XI in assessing 1 year survival after living donor liver transplantation.


Eligibility criteria: Inclusion Criteria:

* liver transplantation recipients

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: 1 year survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00600080: A Comparison of Two Daily Disposable Contact Lenses
Official title: The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
First posted: 2008-01-24
Enrollment: 60
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 performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.


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: Visual Acuity
timeFrame: 2-week
measure: Subjective Lens Comfort
timeFrame: 2-week
Secondary outcomes:
measure: Subject-reported Overall Product Performance
timeFrame: 2-week
measure: Optimum Lens Fit
timeFrame: Baseline, 1-week, 2-week
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research, The University of Manchester Dpt. of Optometry & Neuroscience
Study officials:
References:
Clinical trial NCT06164080: The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes
Official title: The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes In Late Preterm Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Pregnancy
Antenatal Corticosteroid
Perinatal Problems
Keywords: Antenatal corticosteroids
Late preterm pregnancy
Late perinatal outcomes
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 459
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this study, the investigators aims to evaluate whether antenatal corticosteroid administration to women likely to give birth in the late preterm period will reduce early and late neonatal complications and contribute to the literature in this sense.

Detailed description: This study is a single-center prospective case-control study investigating the effect of antenatal corticosteroids administered in the late preterm period on early and late perinatal outcomes. 459 patients who gave birth between 34-37 weeks between June 1,2021 to October 1,2022 in the Obstetrics and Gynecology Clinic of the University of Health Sciences were included. Patient were divided into two groups antenatal corticosteroid administration (n:231) and non-administration (n:228). Postpartum early and late perinatal outcomes were compared between these two groups.

Eligibility criteria: Inclusion Criteria:

* All pregnant women who had normal vaginal delivery, cesarean section or operative delivery between 34-37 weeks
* Singleton pregnancies resulting in a live birth

Exclusion Criteria:

* Twin pregnancies
* All births before 34 weeks or after 37 weeks
* Pregnant women with intrauterine ex fetus
* Fetuses with major congenital and chromosomal abnormalities
* Pregnant women who administrated antenatal corticosteroids for any reason before 34 weeks

Primary outcomes:
measure: The results of antenatal corticosteroid effects
timeFrame: 16 months
Secondary outcomes:
measure: Other consequences of antenatal corticosteroid effects in late term pregnant women
timeFrame: 16 months
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Nefise Nazlı YENIGUL
Study officials:
References:
Clinical trial NCT04533880: The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction
Official title: The Effect of Bone-void Filler on Anterior Knee Pain Following ACL Reconstruction With Bone-Patellar Tendon Bone Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the common complaints after ACLR with BPTB autograft anterior knee pain. It is thought that this may be due to harvesting the patellar tendon for graft use. Specifically, this may be due to the bone defect that is left after graft harvesting. There is currently no consensus on a gold standard for treating the bone defect with surgeons using multiple commercially available bone void fillers as well as autologous bone graft in standard practice.

The purpose of the proposed study is to evaluate the effect bone-void filler on anterior knee pain following ACL reconstruction BPTB autograft.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing ACLR with BPTB autograft
* Skeletally mature (as defined by closed growth plates on plain radiograph)
* At least 18 years of age
* Willing and able to provide consent

Exclusion Criteria:

* knee with intact ACL
* skeletally immature (as defined by open physis on plain radiograph)
* pregnant
* less than 18 years of age
* previous ACL repair or reconstruction
* unable to speak english or perform informed consent
* multiligamentous knee injury (two or more ligaments requiring surgical attention)
* varus or valgus malalignment greater than 3 degrees

Primary outcomes:
measure: Score on Knee Injury and Osteoarthritis Outcome Score (KOOS) Survey
timeFrame: Month 12 Post-Op
measure: Score on Kujala Anterior Knee Pain Scale (AKPS)
timeFrame: Month 12 Post-Op
measure: Change in VAS Score for Anterior Knee Pain
timeFrame: Baseline, Month 12 Post-Op
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Orthopedic Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eric Strauss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05515380: 8-stage Model and Its Implications in National Pakistani Tennis Players
Official title: Performance Evaluation of the Tennis Serve Using 8-stage Model and Its Implications in National Pakistani Tennis Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: 8-Stage Model
Flexibility
Strength
Tennis Serve
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to determine the effectiveness of structured exercises for tennis serve performance by using 8-stage model.

Detailed description: Tennis serve stroke is the most crucial component of tennis. 8-stage model like other training programs has proven to be effective in improving performance. This exercise program has yet not been implemented in Pakistani tennis players and remain to be tested in local population.

This randomized controlled trial has been designed to assess the effectiveness of 8-stage model based exercise program in Pakistani national tennis players. The present study has hypothesized that there will be a significant difference between the effects of 8-stage model and conventional training program. There are two arms of intervention in this study: experimental and control group. Experimental group would follow the 8-stage model based exercise training program while control group would follow their conventional exercise training program. Outcome measurements (speed, flexibility, strength) has been carried out at baseline and after 12 weeks.

Eligibility criteria: Inclusion Criteria:

* National level tennis players
* Players who are playing tennis from last one year continuously

Exclusion Criteria:

* Players with any MSK injury
* Any systemic disease affecting players performance
* Any inflammatory conditions.

Primary outcomes:
measure: Serve speed
timeFrame: Change from Baseline at 12th week
measure: Upper limbs' flexibility
timeFrame: Change from Baseline at 12th week
measure: Upper limbs' strength
timeFrame: Change from Baseline at 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal
Study officials:
affiliation: Riphah International University, Islamabad.
name: Noman Sadiq, MS-SPT
role: PRINCIPAL_INVESTIGATOR
References: