louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01565317: Evaluating the Effect of Diabetes Control Through Intensive Lifestyle Modifications on Diabetic Peripheral Neuropathy
Official title: Evaluation of the Effect of Intensive Diabetes Control Through Non-Surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Weight Loss
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: NeuroMetrix, Inc.
First posted: 2012-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to find out the impact of improving diabetes control through weight reduction and lifestyle changes on a common diabetes complication called peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

Inclusion of Intervention group:

1. Men and Women with established Diabetes.
2. BMI between 30-45 Kg/m2
3. Age: 18-75 years old.
4. Enrolled in the Why WAIT program
5. Diabetes duration of at least 5 years
6. Hb A1C of 6.5% or higher

Inclusion of controls:

1. Men and Women with established Diabetes.
2. BMI between 30-45 Kg/m2
3. Age: 18-75 years old.
4. Diabetes duration of at least 5 years
5. Hb A1C of 6.5% or higher

Exclusion Criteria:

1. Anatomic changes that preclude the measurement of the nerve conduction: foot deformities, open skin injuries/ulcers, amputations and placement of surgical plates and screws in the ankle and lower leg (tibial) area.
2. Severe diabetic peripheral neuropathy as defined clinically.
3. Severe peripheral vascular disease e.g absent dorsalis pedis pulsation.
4. Recent weight loss/gain (10 pounds) during the past six months.
5. Neuropathy due to other causes other than diabetes: Alcohol abuse, Liver/Renal disease, Toxic exposure, Inflammatory Disease, Nutritional and Vitamin deficiencies.
6. Individuals with cardiac pacemakers.
7. Women who are Pregnant or who think they might be pregnant.

Primary outcomes:
measure: Change in Sural nerve conduction velocity
timeFrame: Baseline, at 3 months, at 6 months, at 12 months
Secondary outcomes:
measure: Change in Sural Nerve Amplitude potential
timeFrame: Baseline, at 3 months, at 6 months, at 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Osama M Hamdy, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05692817: Evaluation of Maxillary Canine Retraction Assisted With Two Different Methods of Low-Intensity Pulsed Ultrasound
Official title: Evaluation of Maxillary Canine Retraction Assisted With Two Different Methods of Low-Intensity Pulsed Ultrasound: A Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current clinical study will be done for evaluation of maxillary canine retraction assisted with application of two different methods of low-intensity pulsed ultrasound.


Eligibility criteria: Inclusion Criteria:

-

All patients should satisfy the following criteria:

1. An age ranges from 15-22 years.
2. Severe crowding or protrusion requiring 1st premolar extractions followed by symmetrical canine retraction.
3. All permanent teeth present, 3rd molars are excluded.
4. Good oral hygiene.
5. No systemic disease/medication that could interfere with orthodontic tooth Movement (OTM).
6. No previous orthodontic treatment.

Exclusion Criteria:

* 1. Patient diagnosed to have an indication for non-extraction approach. 2. Poor oral hygiene or periodontally compromised patient. 5 3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions. 4. Previous orthodontic treatment. 5. Any implanted assistive devices (e.g., pacemakers, cochlear implants, etc.) 6. Pregnant females.

Primary outcomes:
measure: Rate of canine retraction
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alazhar University
Study officials:
References:
Clinical trial NCT06810817: Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
Official title: The Effects of Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.

Detailed description: This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.

Eligibility criteria: Inclusion Criteria:

* diagnosed with stroke at least 6 months ago
* Fatigue Assessment Scale score ≥20
* cognitively intact

Exclusion Criteria:

* Unstable medical conditions leading to fatigue
* Under any clinical trials
* with any other neurological diseases
* history of transient ischemic attack
* Contraindications to tDCS

Primary outcomes:
measure: Fatigue Assessment Scale
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
measure: Geriatric Depression Scale
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
measure: Reintegration to Normal Living Index
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
measure: Cardio-ankle vascular index
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
measure: performance fatigue index
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
measure: psychomotor vigilance task
timeFrame: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT03384017: The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
Official title: The Impact of Transcutaneous Spinal Cord Stimulation (TSCS) and Gait Training on Walking Function in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim 1: Determine the neurophysiologic impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. The investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with TSCS. This will be assessed by surface EMG and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (MVC) and measurement of gait speed. Subjects will be tested in both TSCS and sham conditions.

Aim 2: Determine the impact of TSCS and gait training on walking function. The investigators hypothesize that concurrent TSCS and gait training will augment walking function in subjects with iSCI, as compared to gait training alone. Subjects will participate in an eight-week program of gait training with TSCS and be assessed with clinically relevant outcome measures, to include the Timed Up and Go, 10-Meter Walk Test, Walking Index for Spinal Cord Injury II, and 6-Minute Walk Test.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* \>1 year post SCI
* Non-progressive SCI
* Neurological level above T10
* Tolerates upright position for \>30 minutes
* Medically stable (no hospitalizations in last 3 months)
* Able to comply with procedures and follow up
* Are legally able to make their own health care decisions

Exclusion Criteria:

* Progressive SCI/D (MS, ALS, ADEM, etc.)
* Open wounds at stimulation site
* Pregnant women
* ROM limitations impacting gait training
* Cardiac pacemaker/defibrillator
* Active cancer diagnosis
* Currently receiving TSCS
* Evidence of uncontrolled autonomic dysreflexia
* Non-English speaking subjects will not be targeted

Primary outcomes:
measure: Change in walking speed
timeFrame: at the start, week 4, and week 8
Secondary outcomes:
measure: Change in walking capacity
timeFrame: at the start, week 4, and week 8
measure: Change in level of assistance and assistive device for walking
timeFrame: at the start, week 4, and week 8
measure: Change in walking endurance
timeFrame: at the start, week 4, and week 8
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Rebecca Martin, OTR/L, OTD, CPAM
state: Maryland
Study officials:
References:
Clinical trial NCT01261117: Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants
Official title: Oral Versus Intravenous Ibuprofen Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: Patent ductus arteriosis
İbuprofen
Extremely Low Birth Weigh infant
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

Detailed description: To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.

Eligibility criteria: Inclusion Criteria:

* Birth weight below 1000 gram
* Diagnosed patent ductus arteriosis by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* Severe thrombocytopenia \< 60.000
* Severe intracranial bleeding (Grade 3-4)
* Intestinal abnormality and necrotising enterocolitis

Primary outcomes:
measure: Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy and Safety of Oral Versus Intravenous Ibuprofen
timeFrame: Results will be identified in 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Omer Erdeve
role: STUDY_DIRECTOR
References:
Clinical trial NCT01239017: A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Single Dose Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2010-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).

Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
2. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion Criteria:

1. Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
2. Patients with joint replacement in the affected knee.
3. Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
4. Women who are pregnant or breast-feeding.

Primary outcomes:
measure: The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.
timeFrame: 16 weeks
Secondary outcomes:
measure: Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
timeFrame: 8 weeks
measure: Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).
timeFrame: 8 weeks
measure: Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: 8 weeks
measure: Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)
timeFrame: 8 weeks
measure: Patient assessment of response to treatment over time using the Patient Global Impression of Change.
timeFrame: 16 weeks
measure: Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Paul J Tiseo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04785417: Effect of Touch Screen Tablet on Fine Motor Functions
Official title: Effect of Touch Screen Tablet on Fine Motor Function un Children With Hemiparetic Cerebral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the objective of this study to asses the effect of touch screen tablet on fine motor functions


Eligibility criteria: Inclusion Criteria:

* hemiplegia
* mid spasticity of upper limb
* able to follow instructions

Exclusion Criteria:

* fixed deformities visual or respiratory problem

Primary outcomes:
measure: pinch gauge
timeFrame: pre and post three month of intervention increase score indicate improvement
measure: QUEST
timeFrame: pre and post three month of intervention increase score indicate improvement
measure: nine hole pegboard test
timeFrame: pre and post three month of intervention increase score indicate improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa Mohsen
Study officials:
affiliation: lecturer ,faculty of physical therapy, Badr universality in Cairo
name: hanaa mohsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381117: Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
Official title: A Phase 2b, Open-label Long-term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edematous Fibrosclerotic Panniculopathy
Keywords: EFP
Cellulite
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-05-08
Enrollment: 7
Sex: FEMALE
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 Durability Population, defined as all subjects in the Safety Population who have both CR-PCSS and PR-PCSS assessments at Visit 1 (Month 48).

Brief summary: This study will evaluate the long-term safety and duration of efficacy of CCH in the treatment of women with cellulite. This study will be a single day evaluation, approximately 48 months after the first dose of study drug was received in the EN3835-201.


Eligibility criteria: Inclusion Criteria:

1. Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
2. Be willing and able to cooperate with the requirements of the study.

Exclusion Criteria:

1. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
2. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
3. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
4. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
5. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.

Primary outcomes:
measure: CR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study
timeFrame: Approximately 4 weeks
measure: PR-PCSS change from baseline (Day 1) and reference time point (Day 71) from the EN3835-201 study
timeFrame: Approximately 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Clinical Trial Site #4
state: Florida
city: Coral Gables
country: United States
facility: Endo Clinical Trial Site #2
state: Florida
city: Washington
country: United States
facility: Endo Clinical Trial Site #3
state: Missouri
city: New York
country: United States
facility: Endo Clinical Trial Site #1
state: New York
Study officials:
affiliation: Endo Pharmaceuticals
name: Karen Chajko
role: STUDY_DIRECTOR
References:
Clinical trial NCT00855517: A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma
Official title: A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 0
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: The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Over 18 yrs of age with ocular hypertension or open-angle glaucoma
* Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Subjects who wear contact lenses.
* Uncontrolled medical conditions
* Subjects requiring chronic topical artifical tears, lubricants and/or requiring any other chronic topical medications
* Subjects who have a history of chronic or recurrent inflammatory eye disease

Primary outcomes:
measure: IOP change from baseline
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: QLT Inc.
name: Oscar Cuzzani, MD
role: STUDY_DIRECTOR
References: