louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07008846: Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis
Official title: Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Rheumatoid Arthritis
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to assess the efficacy of upadacitinib, methotrexate combination therapy in comparison to tofacitinib, methotrexate combination therapy in moderate to severe RA patients. This study will guide us to treat RA patients with inadequate response to methotrexate more effectively


Eligibility criteria: Inclusion Criteria:

- 1.Patients of both gender (age ≥18 years). 2.Patients fulfill the ACR/EULAR 2010 classification criteria for rheumatoid arthritis.

3.Patients with DAS-28 CRP \>3.2 despite optimum dose and duration of methotrexate (20-25 mg/week for minimum one month).

Exclusion Criteria:

* 1.Recent or concurrent infection

  2.Active or latent tuberculosis

  3. Hemoglobin (Hb) \< 8 g/dl 4. White blood cell count \< 4000/ micro L, Neutrophil count \< 1000/ micro L, Platelet count \< 100000/mm3 5. Live vaccines (rota virus, varicella, yellow fever) within 3 months prior to the first dose 6. Child-Pugh Class -C 7. Pregnant or planned for pregnancy and breastfeeding females of child-bearing potential 8. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ 9. New York Heart Association Class III and IV congestive heart failure 10. Previous history of thromboembolism, deep venous thrombosis, stroke, IHD

Primary outcomes:
measure: DAS28-CRP
timeFrame: Outcome 1:"Disease Activity Score 28 CRP (DAS28-CRP) at week 4" Outcome 2:"Disease Activity Score 28 CRP (DAS28-CRP) at week 12" Outcome 3:"Disease Activity Score 28 CRP (DAS28-CRP) at week 24"
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University
state: Shahbag
Study officials:
References:
Clinical trial NCT02734446: To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Official title: Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Bronchial Inflammation
Asthma
Childhood Asthma Control Test (C-ACT)
Asthma Exacerbations
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .

Detailed description: To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).

Eligibility criteria: Inclusion Criteria:

* Patients aged between 6 and 14 years old, of both sexes
* Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
* Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
* Levels of vitamin 25 (OH) D \<30 ng / ml
* Signature of the informed consent of one parent or a legal representative

Exclusion Criteria:

* Cardiovascular disease or systemic
* anatomical abnormalities
* Other respiratory diseases
* Taking probiotics and / or prebiotics in the previous 2 weeks
* Taking vitamin D or systemic corticosteroids within 4 weeks
* Participation in other clinical trials

Primary outcomes:
measure: Reduction of allergic bronchial inflammation
timeFrame: Up to 3 months
measure: Reduction of allergic bronchial inflammation
timeFrame: Up to 3 months
Secondary outcomes:
measure: Improvement of asthma control by C-ACT
timeFrame: Up to 3 months
measure: Improvement of asthma control by reduction of bronchodilator
timeFrame: Up to 3 months
measure: Improvement of asthma control by improvement of FEV-1
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Second University of Naples
Study officials:
References:
citation: Miraglia Del Giudice M, Maiello N, Allegorico A, Iavarazzo L, Capasso M, Capristo C, Ciprandi G. Lactobacillus reuteri DSM 17938 plus vitamin D3 as ancillary treatment in allergic children with asthma. Ann Allergy Asthma Immunol. 2016 Dec;117(6):710-712. doi: 10.1016/j.anai.2016.09.004. Epub 2016 Oct 6. No abstract available.
Clinical trial NCT06358846: Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan.
Official title: Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan. A Randomize Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Educational Intervention
Foot Care
Foot Ulcer, Diabetic
Foot Cellulitis
Keywords: Type 2 Diabetes
slums population
vulnerable population
low-socioeconomic status
Diabetes foot care
Knowledge on foot care
Lead sponsor: SINA Health Education and Welfare Trust
Sponsor class: OTHER
Collaborators: name: Aga Khan University
First posted: 2024-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control arm =75 Interventional arm = 75
Primary purpose: PREVENTION

Brief summary: There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial.


Eligibility criteria: Inclusion Criteria:

* 1. Patients aged 18 years or older.
* Patients who are registered at designated SINA clinic and clinical and biochemical diagnosis of DM for at least six months
* Patients who are able to understand Urdu language will be included in the study
* Patients who are voluntarily participated the study will be included.

Exclusion Criteria:

* Patients come with recurrent foot ulcers or gangrene.
* History of amputation
* Patient live in other than designated slums location.

Primary outcomes:
measure: Improved Foot Care Knowledge
timeFrame: Time Frame: Three months after patient counselling towards foot care
measure: Behavior Change
timeFrame: Time Frame: Three months after patient counselling towards foot care
Secondary outcomes:
measure: Reduction in Foot Complications
timeFrame: 3 months
measure: Empowerment and Self-efficacy
timeFrame: Three months treatment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: SINA Mewasha & North Clinic
state: Sindh
Study officials:
References:
Clinical trial NCT00988546: Evaluation of Computerized Template Entry for Compensation and Pension (C&P) Examinations
Official title: Evaluation of Computerized Template Entry for C&P Examinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Diseases
Keywords: Disability Evaluation
Joint Diseases
Joint Disability
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-10-02
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare C\&P examination reports performed using a Compensation and Pension Examination Program (CPEP) computerized, templated documentation tool to a customary examination performed and then report dictated in quality, completeness, timeliness and veteran satisfaction.


Eligibility criteria: Inclusion Criteria:

* Subjects for the current study included veterans scheduled for C\&P examination of two or fewer joints at VA TVHS.
* No ethnic or racial group or gender was excluded.

Exclusion Criteria:

* Veterans were excluded if they were scheduled:

  1. for examination of more than two joints,
  2. with other requested exam protocols in addition to joints

Primary outcomes:
measure: disability exam report quality
timeFrame: upon completion of report, generally within 3 months
Secondary outcomes:
measure: disability exam report data entry time
timeFrame: upon creation of report
measure: disability exam encounter time
timeFrame: upon creation of report
measure: disability exam patient satisfaction
timeFrame: following exam
Other outcomes:
Locations:
city: Nashville
country: United States
facility: VA Medical Center
state: Tennessee
Study officials:
affiliation: VA Medical Center
name: Theodore Speroff, PhD MS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02486146: GI Biorepository of Tissue and Bodily Fluids
Official title: GI Biorepository of Tissue and Bodily Fluids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Diseases
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 789
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals to be included will be all consenting adults aged 18 years or older with an appointment with a healthcare professional in the Division of Gastroenterology or the Department of Surgery. During their routinely scheduled appointment or procedure, eligible individuals will be informed of the program by the attending physician and encouraged to participate in order to establish a diverse collection of samples of GI-related pathologies and matched controls. The investigators' exclusion criteria will include minors, pregnant women, prisoners, and all other vulnerable populations who are unable to consent.

Brief summary: The purpose of this study is to establish the working protocols for a general biorepository with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal tract from a diverse range of clinical patients at the UC Davis Medical Center. The establishment of a GI-specific biorepository will support future translational endeavors within the UC Davis campus by providing laboratories with readily available GI tissue and bodily fluid samples to test newly developed hypotheses with relative ease.

Detailed description: UC Davis is currently lacking a general use biorepository for GI tissues and bodily fluids. As with any translational research study, the procurement of human tissue samples can be a difficult and time- consuming process. The establishment of this biorepository will help streamline GI biospecimen collection and centralize these samples in a conveniently located space to facilitate the implementation of future unspecified translational studies.

Eligibility criteria: Inclusion Criteria:

* all consenting adults aged 18 years or older with an appointment with a healthcare professional in the Division of Gastroenterology or the Department of Surgery

Exclusion Criteria:

* minors, pregnant women, prisoners, and all other vulnerable populations who are unable to consent.

Primary outcomes:
measure: To build a model biorepository to streamline the biobanking process and provide centralized specimens and associated health information for translational research.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health System
state: California
Study officials:
affiliation: University of California, Davis
name: Yu-Jui Yvonne Wan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02120846: Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
Official title: Effects of Flywheel Resistance Training on Cognitive Function in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Flywheel resistance exercise
Muscle function
Cognitive function
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2014-04-23
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Forty patients will be assigned to either a training group (12 wk unilateral knee extension flywheel resistance exercise; 4 sets of 7 reps 2 days/week) or a control group. Patients will maintain daily routines and any prescribed rehabilitation program. Established methods to assess muscle and cognitive function will be employed before and after the intervention.

This project will disclose whether an exercise paradigm, known to improve muscle function and increase muscle volume in healthy populations, will induce similar adaptations in chronic stroke patients. More importantly, this study will elucidate if any impairment in cognitive function caused by stroke, can be reversed with this particular resistance exercise regimen.

The information gained from this project will have significant implications and aid in advancing rehabilitation programs and exercise prescriptions for men and women suffering from stroke. The overall objective of this research is to promote independence and hence quality of life in these patients.


Eligibility criteria: Inclusion Criteria:

* Mild-moderate hemiparetic gait
* \> 6 months post-stroke
* Able to perform flywheel leg-press exercise

Exclusion Criteria:

* Unstable angina
* Congestive heart failure
* Severe arterial disease
* Major depression
* Dementia
* Chronic pain
* Psychotic alterations

Primary outcomes:
measure: Change from baseline in Cognitive Function at 3 months
timeFrame: Baseline, Month 3
measure: Change from baseline in Functional Performance at 3 months
timeFrame: Baseline, Month 3
measure: Change from baseline in Muscle Function at 3 months
timeFrame: Baseline, Month 3
Secondary outcomes:
measure: Change from baseline in Spasticity at 3 months
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
Study officials:
affiliation: Karolinska Institutet
name: Rodrigo Fernandez-Gonzalo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez-Gonzalo R, Fernandez-Gonzalo S, Turon M, Prieto C, Tesch PA, Garcia-Carreira Mdel C. Muscle, functional and cognitive adaptations after flywheel resistance training in stroke patients: a pilot randomized controlled trial. J Neuroeng Rehabil. 2016 Apr 6;13:37. doi: 10.1186/s12984-016-0144-7.
Clinical trial NCT00831246: Prevention of Ileus After Gynecologic Surgery Using Chewing Gum
Official title: Prevention of Post-Op Ileus After Gynecologic Surgery Using Chewing Gum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileus
Keywords: Ileus,
Gynecologic surgery,
Post-operative,
Flatus
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
First posted: 2009-01-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will attempt to determine if the use of chewing gum can cause the early return of bowel function after gynecologic surgery.


Eligibility criteria: Inclusion Criteria:

* All female patients 18 years of age or older undergoing surgery for any gynecologic procedure which the peritoneum is entered and general anesthesia is administered.
* Disease State will not affect inclusion in the study. Women with previous surgeries or other medical conditions will be included as will those undergoing an initial operation.

Exclusion Criteria:

* Patient deemed legally incompetent to sign their own consent
* Women under the age of 18
* Patients lacking their own or a false set of teeth

Primary outcomes:
measure: Incidence of ileus
timeFrame: Until ileus formation or first flatus post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
Study officials:
affiliation: Aultman Health Foundation
name: Michael Hopkins, MD
role: STUDY_CHAIR
affiliation: Aultman Health Foundation
name: James M Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06959446: Perioperative Homocysteine and Postoperative Complications/All-Cause Mortality in Elderly Non-Cardiac Surgery Patients
Official title: Association Between Perioperative Homocysteine and Postoperative Complications/All-Cause Mortality in Elderly Patients Undergoing Non-Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly
Homocysteinemia
AKI - Acute Kidney Injury
Mortality
Postoperative
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 12955
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An observational study using data from the First Medical Center of Chinese PLA General Hospital, an electronic medical record-based data set of 12,955 older patients (≥ 65 years) who had surgery between January 2014 to August 2019

Brief summary: This study aims to explore the association between perioperative homocysteine (Hcy) levels and their pre-to-postoperative changes with postoperative complications and all-cause mortality in elderly patients undergoing non-cardiac surgery. Besides, the dynamic changes in Hcy levels may reflect metabolic shifts, highlighting their potential value in predicting adverse postoperative outcomes. These findings suggest that monitoring perioperative Hcy levels and their changes could help identify high-risk patients and inform postoperative management strategies.


Eligibility criteria: Inclusion Criteria:

* Hospitalized older (≥ 65 years) patients underwent non-cardiac surgery

Exclusion Criteria:

* 21227 patients without preoperative Hcy data
* 957 patients undergoing neurosurgery
* 3 patients call off the surgery for reasons
* 164 patients with chronic kidney disease

Primary outcomes:
measure: Acute kidney injury (AKI)
timeFrame: January 2014 - August 2019
Secondary outcomes:
measure: mortality
timeFrame: January 2014 - August 2020
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02379546: The Effect of Anaesthesia Depth on Oculo-cardiac Reflex
Official title: The Effect of Anaesthesia Depth on Oculo-cardiac Reflex in Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Strabismus
Anesthesia, General
Keywords: reflex, oculocardiac
monitoring, intraoperative
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.

Detailed description: The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.

Eligibility criteria: Inclusion Criteria:

* physical status ASA (American Society of Anesthesiologists) I
* scheduled for elective strabismus surgery under general anesthesia
* aged between 3-16 years

Exclusion Criteria:

* have a neurological or cardiovascular disease
* receiving antiepileptic or another medications known to affect EEG or ECG

Primary outcomes:
measure: The effect of the anaesthesia depth on the incidence of oculocardiac reflex
timeFrame: during the traction of the extra-ocular muscle in the strabismus surgery
Secondary outcomes:
measure: The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery
timeFrame: during the traction of the extra-ocular muscle in the strabismus surgery
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tuğba Karaman
state: Merkez
Study officials:
affiliation: GOU
name: Tuğba Karaman
role: PRINCIPAL_INVESTIGATOR
References: