louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04428424: Study To Evaluate The Response To Enbrel And The Impact Of Rheumatoid Factor(RF) And Anti-Cyclic Citrullinated Peptide(Anti-CCP) In Rheumatoid Arthritis(RA) Patients
Official title: The Impact of RF, and Anti-CCP on RA Patients in Response to Etanercept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 1493
Sex: ALL
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: Patients data from the local registry at the Baghdad Teaching Hospital registry.

Brief summary: This study is to evaluate available local data in Iraqi patients with rheumatoid arthritis on Enbrel treatment with regards to the impact of Rheumatoid factor and Anti-cyclic citrullinated peptide using data from the Baghdad Teaching Hospital registry.


Eligibility criteria: Inclusion Criteria:

* Diagnosed RA patients.

  -≥18 years of age
* Did not receive previous another biological treatment

Exclusion Criteria:

* Had previous biological treatment
* Use of etanercept for less than 1 year

Primary outcomes:
measure: Disease Activity Score 28 (DAS28) in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
timeFrame: Month 12 visit during retrospective data collection period of approximately 7 years
measure: Clinical Disease Activity Index (CDAI) Score in Participants With Positive Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
timeFrame: Month 12 visit during retrospective data collection period of approximately 7 years
measure: Disease Activity Score 28 (DAS28) in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
timeFrame: Month 12 visit during retrospective data collection period of approximately 7 years
measure: Clinical Disease Activity Index (CDAI) Score in Participants With Negative Rheumatoid Factor (RF) and Anti-Cyclic Citrullinated Peptide (ACCP) at Last Follow-up Visit (Month 12)
timeFrame: Month 12 visit during retrospective data collection period of approximately 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05568524: Resistance Training with Blood Flow Restriction in Hemophilia
Official title: The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients with Moderate/severe Hemophilia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemophilia
Keywords: Hemophilia
Electromyography
Muscle Activity
Resistance Training
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 20
Sex: MALE
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: The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.


Eligibility criteria: Inclusion Criteria:

* diagnosis of hemophilia A or B and undergoing prophylaxis;
* willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
* approval by their hematologist to participate in the exercise program;
* age between 18 and 60 years;
* informed consent signed.

Exclusion Criteria:

* the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
* non adherence to instruction on proper exercise technique;
* surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
* changes in medication during the study;
* a major bleeding episode that posed a risk or prevented exercise;
* another hemostatic defect;
* need for major surgery;
* withdrawal of informed consent.

Primary outcomes:
measure: HDsEMG
timeFrame: Baseline and week 8.
measure: Hand-held dynamometry (isometric elbow flexion/extension, knee extension)
timeFrame: Baseline and week 8.
measure: Muscle ultrasound (muscle mass, assessment of possible bleedings)
timeFrame: Baseline and week 8.
measure: Digital goniometry for active elbow and knee ROM
timeFrame: Baseline and week 8.
Secondary outcomes:
measure: Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)
timeFrame: Baseline and week 8.
measure: Pressure pain thresholds (digital algometry)
timeFrame: Baseline and week 8.
measure: Haemophilia Activities List (HAL) questionnaire
timeFrame: Baseline and week 8.
measure: A36 haemophilia quality of life (Hemofilia-QoL) questionnaire
timeFrame: Baseline and week 8.
measure: Patient Global Impression of Change Scale (PGICS)
timeFrame: Baseline and week 8.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Facultat de Fisioteràpia
Study officials:
affiliation: University of Valencia
name: Sofía Pérez Alenda
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Joaquín Calatayud
role: STUDY_CHAIR
References:
Clinical trial NCT04258124: Cervical Motor Control Exercises in Strength and Perception of Effort in Electronic Sports Players
Official title: Effectiveness of a Physical Therapy Intervention Through Cervical Motor Control Exercises in the Improvement of Strength and Perception of Effort in Electronic Sports Players. A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Physiotherapy
Motor Control
Cervical
Stabilizer
Esports
Lead sponsor: Investigación en Hemofilia y Fisioterapia
Sponsor class: NETWORK
First posted: 2020-02-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction. One of the most common injuries in competitive esports professionals is dorsolumbar and neck pain, due to the effort caused by the maintenance of the site for long periods of time. Cervical motor control exercises recruit the deep musculature by increasing its strength and reducing muscle fatigue.

Aim. Evaluate the effectiveness of motor control exercises in cervical muscle fatigue and strength, in electronic athletes from 18 to 25 years.

Study design. Randomized clinical trial, simple blind. Methods. 30 electronic athletes will be randomly assigned in two groups: experimental (which will perform 3 sessions of 3 motor control exercises) and control (which will not perform any type of intervention). The intervention will last 6 weeks, with 3 weekly sessions of 10 minutes each. The study variables are the muscle strength of the deep cervical muscle (measured by a stabilizer pressure gauge) and the subjective perception of the effort (Borg scale).

Expected results. The aim is an improvement in the muscular strength of deep cervical muscles, together with a decrease in subjective perception of exertion.


Eligibility criteria: Inclusion Criteria:

* Electronic sportsmen
* Male sex
* From 18 to 25 years
* That at the time of the study participate in national competitions
* That they have not suffered a musculoskeletal pathology in the last 4 months.

Exclusion Criteria:

* Athletes taking anti-inflammatory drugs that may influence the intervention
* Players who are allergic to nylon (main component of the evaluation device)
* That they have not signed the informed consent document.

Primary outcomes:
measure: Change from baseline strength of the deep cervical musculature after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes:
measure: Change from baseline subjective perception of effort after treatment and at 1 month
timeFrame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: European University of Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03313024: Berlin-Brandenburg Pregnancy Cohort
Official title: Characterization of Immune Cell-trophoblast-interaction in Pregnancy Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Pregnancy Complications
Diabetes Mellitus in Pregnancy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 1580
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 18 and 45 years of age without infections, severe or chronic diseases

Brief summary: This study will investigate the interplay of different immune cells and placental cells as well as their potential for the development of pregnancy complications. In particular, the translation of the uteroplacental syndrome into a maternal syndrome, considered in the multifactorial pregnancy disorder preeclampsia, will be investigated. Immune cell subtypes are causally involved in the formation and translation of preeclampsia by inducing an endothelial dysfunction which leads to cardiovascular damage.


Eligibility criteria: Inclusion Criteria:

* healthy pregnant women after giving informed consent
* pregnant with diagnosis of preeclampsia, gestational hypertension or gestational diabetes

Exclusion Criteria:

* infections
* alcohol and drug abuse
* manifest and chronic diseases

Primary outcomes:
measure: T cell population content at the time of preeclampsia diagnosis compared to controls and verified by flow cytometry
timeFrame: at the time of preeclampsia diagnosis compared to controls at the same time point in pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental and Clinical Research Center (ECRC)
Study officials:
References:
Clinical trial NCT04528524: Validation of the German Quality of Recovery-15 Questionnaire
Official title: Quality of Recovery After General Anesthesia for Elective Non-cardiac Surgery - Validation of the German Translation of the Quality of Recovery-15 Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Quality of Recovery
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective non-cardiac surgery under general anesthesia in a tertiary care hospital.

Brief summary: The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.


Eligibility criteria: Inclusion Criteria:

* elective non-cardiac surgery
* fluency in German
* general anesthesia

Exclusion Criteria:

* postoperative intensive care unit admission

Primary outcomes:
measure: the German version of the QoR-15 questionnaire
timeFrame: first postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT01668524: ATS907 Ph2a Open-Label Dose-ranging Safety and Tolerability in Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) Subjects
Official title: A Phase 2a Open-Label, Dose-ranging Study of the Safety and Tolerability of ATS907 in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Altheos, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 12
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: This single-site, dose-escalation study will evaluate safety and tolerability of increasing concentrations of ATS907 in 12 subjects with Primary Open Angle Glaucoma and/or Ocular Hypertension


Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* Diagnosis of open angle glaucoma or ocular hypertension in both eyes
* Corrected visual acuity in each eye +1.0 logMAR or better by Early Treatment Diabetic Retinopathy Study (EDTRS) in each eye (equivalent to 20/200)
* Must be willing to discontinue the use of all ocular hypotensive medications in both eyes prior to and during the entire course of the study

Exclusion Criteria:

Ophthalmic (in either eye):

* Glaucoma: pseudoexfoliation, steroid induced, pigment dispersion glaucoma, and or history of angle closure. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s). Refractive surgery in study eye
* Cataract surgery and or other intraocular surgery within one month prior to Screening in either eye
* History within 3 months prior to Screening of clinically significant moderate or severe chronic or active ocular infection, inflammation, blepharitis, dermatitis, uveitis or conjunctivitis
* Clinically significant corneal dystrophy, epithelial and or endothelial disease, corneal irregularities and or scarring such that reliable applanation tonometry would prevented
* Contact lens wear during the duration of the study
* Clinically significant ocular disease (e.g., diabetic retinopathy, macular degeneration, or uveitis) which might interfere or progress during the study

Primary outcomes:
measure: Evaluate local ocular safety and tolerability: change from baseline in ocular tolerability signs and symptoms (hyperemia, irritation, pain, tearing) using ocular tolerability and hyperemia grading scales; and change from baseline for vital signs
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
Study officials:
References:
Clinical trial NCT04167124: Evaluation of a Spatio-behavioral Application
Official title: Enhancing Physical Activity Levels in Youth at Risk for Cardiovascular Disease: Evaluating a Spatio-behavioral Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 115
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The CIRCUIT program (Centre pédiatrique d'interventions en prévention et en réadaptation cardiovasculaire) of the CHU Sainte-Justine is a multidisciplinary, personalized intervention for children with cardiovascular risk. This program includes an evaluation of the physical activity pattern using wearable sensors (accelerometer, heart rate monitor and GPS), to replace the physical activity practice of the patients in their respective real life context. The accelerometer will measure physical activity and heart rate, while the GPS will serve to obtain precise information about places visited and travels in the neighborhood. The data obtained with these tools will serve to develop indicators of the "environmental diagnosis". This information will help to personalize the intervention for each patient.


Eligibility criteria: Inclusion Criteria:

- Children at risk of cardiovascular disease, including children with diabetes mellitus, overweight/obesity, hypertension, dyslipidemia

Exclusion Criteria:

- Patients with physical or psychological problems that impair their ability to participate in physical activity

Primary outcomes:
measure: Physical activity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Sainte-Justine Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT02153424: Early Post-marketing Study of Eliquis (Apixaban)
Official title: Early Post-marketing Study of Eliquis (Apixaban)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-valvular Atrial Fibrillation (NVAF)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sentinel site for the CNFV in Mexico

Brief summary: The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* All patients with NVAF at the sentinel site for the CNFV in Mexico who received at least 1 dose of Apixaban to reduce the risk of stroke or systemic embolism during the specified 24-month study period

Exclusion Criteria:

* Subjects who received Apixaban as part of a clinical trial
* Subjects who received Apixaban for any indication other than local approval (ie, to reduce the risk of stroke and systemic embolism in patients with NVAF)

Primary outcomes:
measure: Determine the reporting rate of on-treatment adverse events (AEs) by the treating physicians
timeFrame: Up to 24 month study period
measure: Identify, describe, and report any suspected AEs that occur while on treatment with Apixaban or preventing stroke and systemic embolism in patients with NVAF
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Puebla
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05628324: EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
Official title: EMG-Controlled Game to Retrain Upper Extremity Muscle Activation Patterns Following Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: upper limb
rehabilitation
EMG muscle activation pattern
serious game
virtual reality
biofeedback
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-11-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

Detailed description: The purpose of this study is to develop and test if upper limb task practice and muscle activity training improve upper limb function in stroke survivors. Participants will be asked to come to the laboratory 23 times (approximately 3 times a week) over 2.5 months to receive upper limb task practice, muscle activity training, and/or upper extremity functional assessments.

Eligibility criteria: Inclusion Criteria:

* 18+ years old
* Stroke more than 6 months ago
* Moderate unilateral upper limb impairment
* Cognitive ability to participate in the study procedure
* Ability to see the full computer screen

Exclusion Criteria:

* Concurrent upper limb rehabilitation
* Inability to voluntarily contract muscles of at least 2 upper limb muscle groups, prohibiting participation in training
* Change in spasticity medication or botulinum toxin injection in the upper limb within 3 months prior to or during enrollment
* Total sensory loss
* Comorbidity (e.g., orthopaedic or premorbid neurologic condition) that limit upper limb movement and/or participation in the intervention
* Language barrier or cognitive impairment that precludes providing consent

Primary outcomes:
measure: Wolf Motor Function Test
timeFrame: Within 1 week from intervention completion
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Na Jin Seo, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02616224: A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrolment.

Brief summary: This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer (mBC), up to 6 months prior to registry enrolment. These participants will be prospectively followed for at least 5 years after study enrolment to evaluate their anti-cancer treatments. Data on participants' previous anti-cancer treatments for breast cancer will be collected retrospectively at study entry.


Eligibility criteria: Inclusion Criteria:

- Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrolment, although they can have received anti-cancer treatment during that time

Exclusion Criteria:

There are no exclusion criteria for entry into this study.

Primary outcomes:
measure: Progression-Free Survival (PFS) For Each Anti-Cancer Treatment Regimen
timeFrame: Up to approximately 8 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 8 years
measure: Objective Response Rate (ORR) For Each Anti-Cancer Treatment Regimen
timeFrame: Up to approximately 8 years
measure: Number and Percentage of Participants Receiving Each Unique Treatment Regimen Overall and as First-Line Therapy Versus Second-Line Therapy Versus Subsequent-Line Therapy
timeFrame: Up to approximately 8 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: