louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06641518: Effectiveness of TENs Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
Official title: Effectiveness of Transcutaneous Electrical Nerve Stimulation Combined With Task-Related Training on Upper Limb Function in Subacute Hemiparetic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Function in Subacute Hemiparetic Stroke Patients
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 18
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: To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.

Detailed description: To study the effectiveness of transcutaneous electrical nerve stimulation (TENS) combined with occupational therapy on restoring the function of the weakened limb in subacute stroke patients.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a first-ever stroke, presenting with unilateral weakness and accompanying arm weakness, in the subacute phase (2 weeks - 6 months).
* Able to follow commands and cooperate in an active training program.
* Patients must consent to participate in the research project by signing a consent form.
* Aged between 18 and 80 years.
* Exhibiting mild to moderate muscle spasticity (Modified Ashworth Scale \< 3).

Exclusion Criteria:

* Patients with other neurological disorders, such as traumatic brain injury or spinal cord injury, or those experiencing severe complications from treatment.
* Unable to tolerate the use of TENS.
* Contraindications for using TENS, such as having a pacemaker or infected skin lesions.
* Unstable or uncontrolled vital signs or other comorbidities.
* Communication difficulties that prevent following commands or cooperating in training.
* Participants who refuse or withdraw from the research.

Primary outcomes:
measure: Fugl-Meyer Assessment of upper extremity scores (FMA-UE)
timeFrame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Secondary outcomes:
measure: Wolf motor function test (WMFT)
timeFrame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
measure: Box and block test (BBT)
timeFrame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
measure: Modified functional reach test (FRT)
timeFrame: baseline, 2 weeks, 4 weeks, and 8 weeks post-intervention.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical medicine and rehabilitation
Study officials:
References:
citation: Carrico C, Westgate PM, Salmon Powell E, Chelette KC, Nichols L, Pettigrew LC, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Am J Phys Med Rehabil. 2018 Nov;97(11):808-815. doi: 10.1097/PHM.0000000000000971.
Clinical trial NCT00599118: Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation
Official title: Identification of Genetic, Biochemical and Hormonal Factors Contributing to Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Genetics
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with atrial fibrillation

Brief summary: The purpose of this study is to establish a genebank repository of blood samples and data to generate information about the hereditary (genetic) basis of atrial fibrillation.

Detailed description: Blood samples and data will be collected from subjects with atrial fibrillation and normal controls. The primary aim of future research using these samples is to identify mechanisms and pathogenesis of atrial fibrillation. Through this information, we hope to identify targets for new therapies and improve knowledge and understanding of atrial fibrillation. Identification of disease genes could improve strategies that prevent progression of atrial fibrillation to more persistent disease.

Eligibility criteria: Inclusion Criteria for Atrial Fibrillation group:

* Male or female at least 18 years old
* Subjects with a history of or current Atrial Fibrillation
* Subjects able to give informed consent Exclusion Criteria for Atrial Fibrillation group: no history of atrial fibrillation

Inclusion Criteria for Controls:

* Male or female at least 18 years old
* Subjects with no history of Atrial Fibrillation
* Subjects able to give informed consent Exclusion Criteria for controls: History of atrial fibrillation

Primary outcomes:
measure: Genetic variants associated with atrial fibrillation
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinical Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mina K Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165018: Prospective Study FNB, Is It Time To Abandon Cytological Assessment
Official title: Prospective Study FNB, Is It Time To Abandon Cytological Assessment (FACET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Keywords: Pancreatic masses and lesions
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to EUS-FNB for pancreatic mass lesions

Brief summary: Endoscopic Ultrasound (EUS) is a minimally invasive procedure used by gastroenterologists to examine pancreatic masses and lesions. A fine needle is traversed through an endoscope and used to acquire tissue samples, which are then sent for pathology. The standard approach for diagnosing solid pancreatic lesions has been fine needle aspiration (FNA) (Han et al. 2016). However, the use of FNA comes with its limitations, some of which include multiple needle passes to acquire fluid, the need for on-site cytologists, and decreased diagnostic yield. Fine needle biopsy (FNB) is the latest approach being employed by endosonographers in lieu of FNA. FNB confers several advantages over FNB. First, FNB requires fewer needle passes than FNA to acquire tissue sample for immunohistochemical staining. In addition, FNB provides better tissues samples, greater sensitivity of the tissue core, and thus, improved diagnostic yields (Tian et al. 2018). Finally, FNB is more cost-effective than FNA and relies on pathologists, instead of on-site cytologists, and preserves the tissue core (Tian et al. 2018). The objective of this study is to establish a database of samples placed in formalin for patients who will undergo a fine-needle biopsy (FNB) for pathological evaluation without rapid on site cytological assessment.


Eligibility criteria: Inclusion Criteria:

* Patient is greater than or equal to 18 years of age
* Patient is referred to EUS-FNB for pancreatic mass lesions

Exclusion Criteria:

* Patient is younger than 18 years of age
* Patient refused and/or unable to provide consent
* Patient is a pregnant woman

Primary outcomes:
measure: Sensitivity and Specificity using FNB sampling pancreatic mass
timeFrame: 2 years
measure: Diagnostic yield between FNB samples placed in formalin for pathology evaluation from two different types of needle
timeFrame: 2 years
Secondary outcomes:
measure: Rate of adverse events of utilizing the FNB technique, including pancreatitis, bleeding, or perforation
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Baylor St. Lukes Medical Center (BSLMC)
state: Texas
Study officials:
References:
Clinical trial NCT02003118: A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Akron Molecules AG
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 266
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proof of concept study will be a placebo controlled, randomised, double blind, parallel study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of osteoarthritis (OA) pain in the knee.


Eligibility criteria: Inclusion Criteria:

Patient is between 40 and 75 years of age with a clinical diagnosis of OA of the knee for more than 6 months prior to Visit 1 based on clinical and radiographic criteria, and being of American Rheumatism Association (ARA) functional Class I, II, or III. Patients should have an average pain level of between 4 and 8 on a Numeric Rating Scale (NRS) for at least 5 of 7 days before the randomisation, when answering the question: Please, rate the average pain in your index knee during the last 24 hours. Prior to the study, patients should have been using pharmacological treatments, such as Non-Steroidal Anti-Inflammatory Drug (NSAIDs), acetaminophen or weak opioids for their OA pain on a regular basis (defined as having used NSAIDs, acetaminophen or weak opioids at least 10 days out of 30 days during the last month prior to the screening visit).

Exclusion Criteria:

Patient has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy.

Patients with impaired renal function, defined as an estimated creatinine clearance less than or equal to 50 ml/min, or patients taking medications that might impair renal function.

Patient has New York Heart Association (NYHA) Class III-IV congestive heart failure.

The patient has a history of uncontrolled hypertension or a current blood pressure that in the opinion of the Investigator makes the patient unsuitable for the study.

Patients with a trauma or surgery at the index knee within 3 months prior to screening.

Primary outcomes:
measure: WOMAC
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clinical study center
Study officials:
affiliation: Akron Molecules
name: Study Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05325918: HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers
Official title: HIF-1 Alpha, VEGF and MMP-8 Levels in Peri-implant Crevicular Fluid of Smokers Versus Non Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Keywords: gingival crevicular fluid
Smoking
inflammation
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smoker patients with restored implants

Brief summary: Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis

Detailed description: Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals.

The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8

Eligibility criteria: Inclusion Criteria:

* Medically free patients
* Individuals with restored implants placed one year or more before study enrollment
* Both genders
* Age range 20-50 years old

Exclusion Criteria:

* Pregnant Females
* Lactating females

Primary outcomes:
measure: Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of oral and dental medicine,FUE, Cairo,Egypt
Study officials:
affiliation: Lecturer of Oral Medicine and Periodontology
name: Sarah M Elkot, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02573818: Sedasys Post Approval Study Users Response to System Alarms
Official title: Open-Label Post Approval Study of the SEDASYS System User Response to System Alarms
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Conscious Sedation
Keywords: sedation for EGD and colonoscopy procedures
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2015-10-12
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects 18 years or older scheduled for colonoscopy or EGD

Brief summary: The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I and II
* male and female
* Scheduled for routine colonoscopy or EGD
* ≥18 years of age
* Able to read, speak, and understand English

Exclusion Criteria:

* Physical or psychological condition which would impair trial participation, at the discretion of the PI
* BMI ≥ 35
* Pregnancy or lactation
* Known or suspected hypersensitivity to propofol or fentanyl
* Use of a fentanyl patch
* Allergies to eggs, egg products soybeans or soy products
* Diagnosis of sleep apnea
* Gastroparesis
* Full stomach at the time of procedure
* Participation in any other investigational device or drug study within 30 days of enrollment

Primary outcomes:
measure: Percent of documented responses/actions taken in response to SEDASYS System alarms (oxygen desaturation, apnea, hypotension, and bradycardia alarms)
timeFrame: <24 hours, i.e., for duration of study procedure
Secondary outcomes:
measure: Fraction of users responses/actions to oxygen desaturation, apnea, hypotension, and/or bradycardia alarms deemed sufficient by Endpoint Adjudication Committee (EAC)
timeFrame: assessment of sufficient alarms will be reviewed by EAC after 100, 400, and 866 subjects completed the study
Other outcomes:
Locations:
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
Study officials:
affiliation: Ethicon Endo-Surgery, Inc.
name: James F Martin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05868018: EBP Confidence and Behavior Throughout PT Edu
Official title: Evidence-based Practice Confidence and Behavior Throughout the Curriculum of Four Physical Therapy Education Programs: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evidence Based Practice
Physical Therapy
Education
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Sacred Heart University
name: University of Toronto
name: Chatham University
First posted: 2023-05-22
Enrollment: 269
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled in masters (University of Toronto) or doctorate physical therapy programs (Rutgers, Sacred Heart and Chatham). Physical therapy students and recent graduates will be invited to participate. Ages for students may range from 21-65

Brief summary: This study aimed to describe changes in EBP confidence and behavior of students from four physical therapy education programs throughout their curriculum using the Evidence-Based Practice Confidence (EPIC) Scale and the Evidence-Based Practice Implementation Scale (EBPIS).

Detailed description: Introduction Evidence-based practice (EBP) is a foundational process taught in health professional education, yet it is unclear when EBP confidence and skills are obtained.

Review of Literature Increases in EBP confidence and behaviors from the start of physical therapy programs to post graduation have been reported in studies that evaluated a single program or used non-valid questionnaires. This study aimed to describe changes in EBP confidence and behavior of students from four physical therapy education programs throughout their curriculum.

Subjects Two hundred sixty-nine physical therapy students were recruited across 4 PT programs (3 in US and 1 in Canada).

Methods Students completed the Evidence-Based Practice Confidence (EPIC) Scale and the Evidence-Based Practice Implementation Scale (EBPIS) at 6 timepoints: start of the program, prior to first clinical experience, after first clinical experience, at the end of classroom instruction, graduation, and one year post. Medians (Mdn) and 25th and 75th percentiles (P25, P75) were calculated for 42 (23.2%) students with complete data across all timepoints. Change between timepoints was assessed using Friedman's test and Wilcoxon signed rank test with a Bonferroni correction for post hoc analysis.

Eligibility criteria: Inclusion Criteria:

* students enrolled in the 4 selected physical therapy programs

Exclusion Criteria:

-

Primary outcomes:
measure: Evidence Based Practice Confidence
timeFrame: 4 years
measure: Evidence Based Practice Behavior
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sacred Heart University
name: Wendy Romney, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03951818: Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
Official title: Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thalassemia Major
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20-85 years old thalassemia major patients treated in the OPD of NTUH

Brief summary: Patient with thalassemia major have many endocrine diseases, such as hypopituitarism, hypothyroidism, hypoparathyroidis, osteoporosis, and etc.. These problems may be due to anemia itself or related to iron deposition. This study aimed to investigate the endocrine aspect of thalassemia major patients in Taiwan in order to introduce early intervention or treatment in the future.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Thalassemia major
* Patients of 20-85 years old

Exclusion Criteria:

* Patients younger than 20 years old.
* Patients older than 85 years old.
* Patients who are pregnant

Primary outcomes:
measure: Abnormal bone mineral density rate
timeFrame: 10 years
Secondary outcomes:
measure: abnormal thyroid function rate
timeFrame: 10 years
measure: abnormal pituitary function rate
timeFrame: 10 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shyang-Rong Shih
Study officials:
affiliation: National Taiwan University Hospital
name: Shyang-Rong Shih, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Yang WP, Chang HH, Li HY, Lai YC, Huang TY, Tsai KS, Lin KH, Lin DT, Jou ST, Lu MY, Yang YL, Chou SW, Shih SR. Iron Overload Associated Endocrine Dysfunction Leading to Lower Bone Mineral Density in Thalassemia Major. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz309. doi: 10.1210/clinem/dgz309.
Clinical trial NCT01197118: Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
Official title: Phase 2 Study of Chemoradiotherapy for Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
sequence chemoradiotherapy
OLF regimen
survival rate
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric cancer is one of the most prevalent malignancies in China; the survival rate remains poor despite potentially curative resections. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, even after a complete resection with negative margins, many patients will experience recurrence. In recent years, the radiation therapy in the carcinoma of the stomach represents a new issue that should be addressed accompanying the development of radial physics and radial biology, the clinical application of computed tomographic (CT) simulation and digital reconstitution technique, especially the application of 3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus concurrent chemotherapy has been demonstrated to cause a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the investigators designed the trial to see whether a postoperative sequence chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival for advanced gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
2. Age of 18 to 75, Karnofsky score higher than 70.
3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, with or without positive incisal margin.
4. No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
5. No clinical findings of distant metastasis.
6. Predictive survival time longer than 6 months.

Primary outcomes:
measure: overall survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Cancer Center,Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Cancer Center
name: Shiying Yu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xiang-Lin Yuan, Qiang Fu ,Shi-Ying Yu .Postoperative sequence chemoradiotherapy for advanced gastric cancer:an analysis of 36 cases.World Chinese Journal of Digestology,2007(36):3856-3859.