louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02358005: Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-Stroke Elbow Spasticity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥20 years
* inpatients
* Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii
* Modified Ashworth scale (MAS) ≥2,
* At least a 3-month period from stroke,
* Written informed consent has been obtained

Exclusion Criteria:

* Fixed contractures and/or deformities at the elbow,
* Previous fractures of the paretic upper limb,
* Peripheral nervous system disorders/myopathies,
* Previous BTX-A treatment and/or ESWT,
* Structural alterations in the soft tissue (e.g., fibrosis),
* Known allergy or sensitivity to the study medication or its components
* Presence of an unstable medical condition or uncontrolled systemic disease
* Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function.
* Bleeding tendency and/or anticoagulation therapy
* Presence of infection or skin disorder at injection sites
* Females were are pregnant, nursing, or are planning a pregnancy during the study
* Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception
* Participant who should be withdrawn from the study in the opinion of the investigator for any reason

Primary outcomes:
measure: Range of Motion (ROM) of elbow flexor
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Healthcare System, Severance Hospital
Study officials:
References:
Clinical trial NCT02389205: The Effect of Functional Activities and Balance Ability With Taping in Subjects of Hemophilia
Official title: Rehabilitation Department of Tri-Service General Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding, and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle articular joint disease will affect lower limbs activities, and the functional activities will impaired.

Review studies, in addition to physical therapy, Kinesio taping is a common intervention to improve other subjects' static balance, proprioception, functional ankle stability, correct poor posture.

The main intervention of this study is physical therapy and Kinesio taping, expect to improve the stability and muscular strength of lower extremities, and balance, correcting gait and lower extremity functional activities of subjects with hemophilia.

Detailed description: Methods:

This study is a randomized controlled trial, the subjects were randomly divided into two groups, the control group received physical therapy once a week for a period of three months; experimental group received the same physical therapy in addition to treatment, but each will be accepted Kinesio taping. Experiments group carried out before and after the relevant tests, including: muscle strength, balance, lower extremity functional activities. The participants will be followed for the duration of physical therapy , an expected average of 3 months.

Eligibility criteria: Inclusion Criteria:

* subject of Hemophilia
* 20-65 years old

Exclusion Criteria:

* Any history of surgery

Primary outcomes:
measure: standing balance ability (biodex balance system)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director of Rehabilitation department
name: Chen Liang-Cheng
role: STUDY_DIRECTOR
References:
citation: Rodriguez-Merchan EC. Orthopaedic problems about the ankle in hemophilia. J Foot Ankle Surg. 2012 Nov-Dec;51(6):772-6. doi: 10.1053/j.jfas.2012.06.005. Epub 2012 Jul 10.
Clinical trial NCT05341505: Outcomes of Emotion Regulation Therapy in Young Autistic Adults
Official title: Outcomes and Neural Mechanisms of Emotion Regulation Therapy in Young Adults With Autism: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Keywords: Emotion regulation
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.

Detailed description: Five young adults with ASD with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (ER) intervention administered twice weekly for a total of 16 sessions. Participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism Spectrum Disorder
* Ages 18-40
* Estimated full-scale IQ ≥ 80
* T score \> 60 on either the externalizing or internalizing symptoms scores of either the Adult Behavior Checklist (ABC-L) or the Adult Self Report (ASR)
* Participation in previous study at the Olin Center ("Social Emotional Study"; E-HHC- 2018-0241)

Exclusion Criteria:

* Intellectual disability (estimated full scale IQ\<80
* History of a significant head injury (severe concussion, hospitalization)
* History of neurosurgery
* History of epilepsy, stroke, MS, a neurodegenerative disorder, or any other neurological disorder
* A current major medical condition (e.g. cancer, heart failure)
* Current substance use (determined by urine screen done to all participants before each MRI scan)
* In-body metal implants (e.g. surgical clips, certain pacemakers) or history of exposure to metal shards or other MRI contraindications
* Pregnancy

Primary outcomes:
measure: Adult Self Report (ASR)
timeFrame: Baseline
measure: Adult Self Report (ASR)
timeFrame: 8 weeks
measure: Adult Self Report (ASR)
timeFrame: 2 months follow-up
measure: Adult Behavior Checklist (ABC-L)
timeFrame: Baseline
measure: Adult Behavior Checklist (ABC-L)
timeFrame: 8 weeks
measure: Adult Behavior Checklist (ABC-L)
timeFrame: 2 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living, Hartford Hospital
state: Connecticut
Study officials:
References:
Clinical trial NCT01246505: Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Official title: Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Total Occlusion
Lead sponsor: BridgePoint Medical
Sponsor class: INDUSTRY
First posted: 2010-11-23
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.


Eligibility criteria: Inclusion Criteria:

* suitable candidate for non-emergent, peripheral angioplasty
* documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
* limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery

Exclusion Criteria:

* intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
* appearance of thrombus or intraluminal filling defects
* peripheral intervention in the target limb within two weeks of the procedure
* renal insufficiency (serum creatinine of \> 2.3 mg/dl)
* contraindication to a peripheral artery intervention
* participation in another investigational protocol

Primary outcomes:
measure: Incidence of Patients with a Major Adverse Events (MAE)
timeFrame: 30 Day
measure: Incidence of Intraprocedural Technical Success
timeFrame: Intraprocedural (<24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Denver
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University Medical Center
state: Georgia
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants
state: Illinois
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Heart Center
state: North Carolina
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Bellingham
country: United States
facility: St. Joseph Hospital
state: Washington
Study officials:
affiliation: Columbia University
name: William A Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01444105: Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
Official title: A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open-angle Glaucoma
Keywords: Open angle glaucoma
Pseudoexfoliative glaucoma
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 80
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: Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Detailed description: Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.

Eligibility criteria: Inclusion Criteria:

* Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)
* Primary open-angle glaucoma (including pseudoexfoliative)

Exclusion Criteria:

* Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)
* Prior stent implantations (study eye)

Primary outcomes:
measure: Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayan Ophthalmological Center
Study officials:
affiliation: S.V. Malayan Ophthalmological Center, Yerevan, Armenia
name: Lilit A Voskanyan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Clinical trial NCT06221605: Composite Probiotics Stabilize Lipid Metabolism in Chronic Hepatitis B Patients:A Clinical Trial
Official title: Probiotic Supplementation With BLa80, BL21, and LRa05 Stabilizes Lipid Metabolism in Chronic Hepatitis B Patients Receiving Tenofovir Alafenamide: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this is to verify the clinical efficacy of compound probiotics in reducing HBV infection levels and regulating intestinal flora in patients with chronic hepatitis B.

The main question it aims to answer is:

• Conventional antiviral therapy combined with a 3-month probiotic intervention was used to evaluate the clinical efficacy of reducing HBV infection levels (HBeAg, HBsAg, and HBV DNA levels) and regulating gut microbiota.


Eligibility criteria: Inclusion Criteria:

1. Meet the hepatitis B clinical diagnostic criteria of the Chronic Hepatitis B Prevention and Treatment Guidelines (2022 edition), excluding patients infected with hepatitis C virus, hepatitis D virus and other hepatitis viruses;
2. Be aware of the content and purpose of this study, and voluntarily sign the treatment study consent.

Exclusion Criteria:

1. Patients infected within 3 months;
2. Received antibiotic treatment within 3 months;
3. Received probiotic and probiotic therapy within 3 months;
4. Complicated with hypertension or diabetes;
5. Obesity or significantly low weight;
6. Obvious atherosclerosis;
7. Chronic kidney disease;
8. Inflammatory bowel disease, irritable bowel syndrome, or a history of gastrointestinal surgery;
9. Malignant tumors;
10. Autoimmune diseases;
11. Mental illnesses such as Parkinson's disease, Alzheimer's disease and stroke;
12. Pregnant or lactating women;
13. Patients with cirrhosis or decompensated liver disease;
14. Subjects cannot participate in the experiment due to their reasons; Those who meet any of the above criteria will not be selected.

Primary outcomes:
measure: Test the level of HBV infection in chronic hepatitis B patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated with Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06037005: The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students
Official title: The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students in the COVID 19 Process: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma and Stressor Related Disorders
Keywords: Nurse
Therapy
Post-Traumatic Stress
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded study with parallel groups.
Primary purpose: OTHER

Brief summary: Objectives: This research was planned to examine the effect of cognitive behavioral therapy on the post-traumatic stress symptoms of nursing students during the COVID-19 pandemic.

Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants: 60 first-year students studying at the Faculty of Nursing were randomly assigned to the intervention (n=30) and control (n=30) groups.

Method: Data were collected using the Information Form prepared by the researcher and the Post Traumatic Stress Disorder Checklist for DSM-5. The intervention group was collected online three times, before the cognitive behavioral group therapy, at the end of the therapy and three months later. Group intervention program based on cognitive behavioral approach of ten sessions; face-to-face, the intervention group was divided into two separate groups and each group was completed in approximately one and a half months (May-June 2022), two days a week. Follow-up measurement was completed in September 2022. While group therapy was applied to the intervention group, no intervention was made to the control group.


Eligibility criteria: Inclusion Criteria:

* Being a first year nursing student

Exclusion Criteria:

* Being a foreign student
* Having a psychiatric diagnosis

Primary outcomes:
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: First assessment will be made at the baseline (pre-intervention)
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: The second assessment will take place 5 weeks after the first assessment (after the program is completed).
measure: Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Third assessment will take place average 12 weeks after the second assessment.
Other outcomes:
Locations:
city: Meram
country: Turkey
facility: Fatma Yener Özcan
state: Konya
city: Tekirdağ
country: Turkey
facility: Burcu CEYLAN
Study officials:
References:
Clinical trial NCT05969405: Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy
Official title: Comparison of Prognosis in Endometrial Cancer Treated With Different Surgical Methods: Laparoscopy, Robotic-assisted Laparoscopy and Laparotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: endometrial cancer patients

Brief summary: Objective：To compare the clinical outcomes of endometrial cancer patients who received surgerical treatments: Comparisons of robotic-assisted laparoscopic, laparoscopic and laparotomic methods

Detailed description: We will review the medical records of clinically uterine-confined endometrial cancer women who received robotic-assisted laparoscopic, laparoscopic or laparotomic methods; and compare their outcomes.

Eligibility criteria: Inclusion Criteria:

* womwn who received endometrial cancer surgical from January 01, 2008 to November 30, 2022 were be reviewed.

Exclusion Criteria:

* Endometrial cancer patients did not undergo surgery.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Progression free survival
timeFrame: 5 years
measure: length of hospital stay
timeFrame: 2 weeks
measure: surgical time
timeFrame: 1 day
measure: Estimate blood loss
timeFrame: 1 day
measure: lymph node number
timeFrame: 1 day
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01630005: Talk Therapy After Stroke
Official title: Talk Therapy After Stroke. PS-POST AVC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adams-Stokes Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Strokes are the first cause of acquired physical disability among adults. Some studies proved that depression is often an unrecognized complication from stroke, associated with a vital prognosis, functional and cognitive pejorative diagnosis. It led us to pose the hypothesis of the existence of a particular psychological state after stroke particularly favorable to a psychotherapeutic alliance. So, this longitudinal monocentric study aims to estimate the feasibility of a talk therapy and its impact on the anxio-depressive symptomatology after stroke.


Eligibility criteria: Inclusion Criteria:

* ischemic or aemoragic stroke minor 1 week, confirmed by cerebral imaging

Exclusion Criteria:

* severe aphasia (NIHSS criteria 9: sup or egal: 2)
* Chronic psychiatric preexistant desease.

Primary outcomes:
measure: acceptability
timeFrame: at 6 months
Secondary outcomes:
measure: Rates of anxiety and depression
timeFrame: at 3 and 6 months
measure: Evaluation of quality of life
timeFrame: at 3 and 6 months
measure: Evaluation of functional recovery
timeFrame: at 3 and 6 months
measure: Assessment of apathy
timeFrame: at 3 and 6 months
measure: Categorization of patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Hélène MAHAGNE, PH
role: STUDY_DIRECTOR
References: