louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004647: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Diabetic Neuropathies
Paresthesia
Keywords: diabetic neuropathy
disease-related problem/condition
neurologic and psychiatric disorders
pain
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Tennessee
First posted: 2000-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects.

The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.

Eligibility criteria: Patients with painful diabetic neuropathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Tennessee
name: Tulio Bertorini
role: STUDY_CHAIR
References:
citation: Bertorini TE, Alzagatiti BI, Horner LH, et al.: Electrophysiological effects of mexiletine in painful neuropathy. Nerve 21(11): 1576, 1998.
Clinical trial NCT04351347: The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment
Official title: Clinical Study Evaluating the Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: COVID
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of Ivermectin in larger doses in COVID-19 treatment

Detailed description: Clinical Study Evaluating the Efficacy of Ivermectin in higher doses in COVID-19 treatment

Eligibility criteria: Inclusion Criteria:

* Patients with covid 19

Exclusion Criteria:

* Allergy or side effects to treatment

Primary outcomes:
measure: Number of patients with improvement or died
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: sherief Abd-Elsalam, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734447: Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation
Official title: Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foetal Growth Problem
Small for Gestational Age
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.


Eligibility criteria: Inclusion Criteria:

* Patients born with IUGR enrolled in trial GHRETARD/F/1/F
* Bone age below 14 years in boys and 12 years in girls

Exclusion Criteria:

* Bone age above 14 years in boys and 12 years in girls

Primary outcomes:
measure: Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
Secondary outcomes:
measure: Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
measure: Pubertal development, assessed according to Tanner method
measure: Height velocity
measure: Final height
measure: Number of Adverse Events
Other outcomes:
Locations:
city: Paris
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06751147: Effects of Lateral Femoral Cutaneous Nerve Mobilization With and Without Muscle Energy Techniques in Pregnant Females
Official title: Effects of Lateral Femoral Cutaneous Nerve Mobilization With and Without Muscle Energy Techniques on Neuropathic Pain, Knee Range of Motion and Quality of Life in Pregnant Females
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meralgia Paresthetica
Keywords: femoral neuropathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 48
Sex: FEMALE
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: The rationale of this study is to provide empirical evidence regarding the efficacy and safety of neural mobilization in pregnant women with meralgia paresthetica. By investigating the potential benefits of this intervention, healthcare professionals can make informed decisions about incorporating neural mobilization into the management of this condition during pregnancy. Focusing on the impact of neural mobilization and muscle energy techniques on both neuropathic pain and quality of life aligns with a patient-centered approach to care. The goal is not only to reduce symptoms but also to enhance overall well-being and functional capacity

Detailed description: The literature gap of the study is that upto our knowledge, there is little or no evidence found in previous researches on the combined effects of lateral femoral cutaneous nerve mobilization in combination with MET in pregnant females. Secondly no quantitative measurement as range of motion with goniometer has been yet studied

Eligibility criteria: Inclusion Criteria:

* Age ranges from 18 to 40 years
* Body mass index ≥25kg/m2.
* Pregnant females in third trimester diagnosed with myalgia paraesthetica.
* Multigravida pregnant females
* Patients will be screened through Prone Knee Bend (PKB) test for femoral nerve compression.
* Positive pelvic compression test(1)

Exclusion Criteria:

* Those having other entrapment syndromes or radicular symptoms
* Motor weakness
* Having a history or ongoing cancerous proliferation
* Active infection

Primary outcomes:
measure: quality of life is assessed by QOL questioner
timeFrame: at base line pre intervention, at the end of 4th week post intervention
measure: Knee range of motion is used to measure ROM
timeFrame: at base line pre intervention, at the end of 4th week post intervention
measure: neuropathic pain
timeFrame: at base line pre intervention, at the end of 4th week post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurkhi Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: Ghurki Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Iqra abdul ghafoor, PPDPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06458647: The Effect of Video Streaming With Virtual Reality Before Coronary Angiography
Official title: The Effect of Video Streaming With Virtual Reality on Anxiety, Comfort and Patient Satisfaction Before Coronary Angiography
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Comfort
Patient Satisfaction
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form.

Detailed description: This study was planned as a randomized controlled experimental study to examine the effects of virtual reality video on anxiety, comfort and patient satisfaction before coronary angiography. Data will be collected using the Descriptive Characteristics Questionnaire, State-Trait Anxiety Inventory, Early Postoperative Comfort Scale, Visual Analog Scale (VAS) for patient satisfaction and pain, Vital Signs Follow-up Form and Complication Follow-up Form. In addition to the standard practices of the clinic, individuals in the intervention group will be shown a video with virtual reality glasses before entering the angiography procedure. Only standard practices of the clinic will be applied to the control group.

Eligibility criteria: Inclusion Criteria:

* Can speak and understand Turkish,
* Over 18 years of age,
* No previous angiography procedure,
* Oriented to place and time,
* No psychiatric illness,
* Not taking any sedative medication,
* No vision and hearing problems,
* Patients who volunteered to participate in the study will be included.

Exclusion Criteria:

* Patients with any pain or chronic pain prior to coronary angiography,
* Patients diagnosed with anxiety,
* Patients with pacemakers,
* Patients requiring emergency angiography,
* Patients taking antihistamines and psychiatric drugs,
* Patients who did not volunteer to participate in the study,
* Patients taking tranquilizers or pain medication up to 5 hours before the angiography procedure were excluded.

Primary outcomes:
measure: Anxiety
timeFrame: 30 minutes after angiography
measure: Comfort
timeFrame: 30 minutes after angiography
measure: Patient satisfaction
timeFrame: 30 minutes after angiography
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03726047: Exercise and Motor Learning After Stroke (Study #3)
Official title: Feedback and Cognition During Locomotor Learning Post Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects with chronic stroke (\> 6 months post-stroke) will learn a new walking pattern through distorted visual feedback. Retention of the pattern will be tested without visual feedback immediately after learning and 24 hours later. Subjects will be randomly assigned to the control group or the exercise group. The control group will simply complete the learning task. The exercise group will complete 5 minutes of exercise immediately following the first retention test to test for the effects of exercise on retention 24 hours later.

Detailed description: Despite significant time and money spent on post-stroke rehabilitation, stroke survivors are left with reduced walking capacity and significant disability. After stroke, individuals must relearn movements that have been disrupted due to damage to the brain, therefore, enhancing motor learning is critical to improving the rehabilitation of walking after stroke. In this project investigators will examine how individual factors influence motor learning after stroke and use this information to personalize post-stroke rehabilitation.

Eligibility criteria: Inclusion Criteria:

Age 18-85 Single, unilateral, chronic stroke (\>6 months post-stroke), confirmed by MRI or CT scan Score \>1 on question 1b and \>0 on question 1c of the NIH Stroke Scale Able to walk at self-selected speed without assistance from another person Resting heart rate between 40-100 beats per minute Resting blood pressure between 90/60 to 185/100

Exclusion Criteria:

Evidence of cerebellar stroke on clinical MRI or CT scan, because of role of cerebellum in learning Other neurologic conditions in addition to stroke Inability to walk outside the home prior to the stroke Coronary artery bypass graft or myocardial infarction within past 3 months, Musculoskeletal pain that limits walking Inability to communicate with investigators Visual field cut Neglect Unexplained dizziness in last 6 months

Primary outcomes:
measure: 24 hour retention
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Darcy Reisman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01594047: Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Official title: Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Hyperalgesia
Keywords: hyperalgesia
Patient controlled analgesia
morphine
methadone
ketamine
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 113
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: Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.

Detailed description: not desired

Eligibility criteria: Inclusion Criteria:

* patients undergoing open colo-rectal surgery

Exclusion Criteria:

* ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.

Primary outcomes:
measure: the Extent of Hyperalgesia Area Proximal to Surgical Wound
timeFrame: 24 and 48 hours after surgery
Secondary outcomes:
measure: Pain Intensity Measured by a Numeric Rating Scale (NRS)
timeFrame: 24 and 48 hours after surgery
measure: Opioid Consumption
timeFrame: 48 hours
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Emiliano Tognoli
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tognoli E, Proto PL, Motta G, Galeone C, Mariani L, Valenza F. Methadone for postoperative analgesia: contribution of N-methyl-D-aspartate receptor antagonism: A randomised controlled trial. Eur J Anaesthesiol. 2020 Oct;37(10):934-943. doi: 10.1097/EJA.0000000000001217.
Clinical trial NCT04681547: Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty.
Official title: Ultrasound-guided Genicular Nerve Block: An Analgesic Alternative to LIA for Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain
Analgesia
LIA
Ultrasound
Genicular Nerve Block
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hypothesis is to demonstrate the analgesic non-inferiority of the ultrasound-guided geniculate nerve block when compared to the local infiltration analgesia (LIA). It is expected to maintain the quality of analgesia with a selective blockade of the nerves responsible for the sensitive innervation of the knee, reducing the total dose of local anesthetic and adrenaline very markedly.

Detailed description: The main objective is to demonstrate that the ultrasound-guided geniculate nerve block provides not-inferior analgesia to LIA in patients undergoing primary total knee arthroplasty (TKA) in the first 24 hours postoperatively, and during the first mobilization using the numerical evaluation of the pain (NRS).

The secondary objectives are to demonstrate that the consumption of opioids and the range of joint mobility are not inferior in those patients who receive geniculate nerve blocks compared to those who receive LIA.

Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for primary elective total knee arthroplasty
* American Society of Anesthesiologists Physical Status I-III
* BMI 18-40 kg/m2

Exclusion Criteria:

* Inability to cooperate with protocol
* Allergy to any medication of protocol
* Contraindication to peripheral nerve block (e.g. local or systemic infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
* Revision or prothesis replacement knee surgery
* Chronic opioid consumption (daily morphine equivalent of \>30 mg for at least four weeks prior to surgery)
* Bleeding diathesis or non-pharmacological coagulopathy

Primary outcomes:
measure: NRS at PACU
timeFrame: 1 hour after surgery
measure: NRS at 12 hours after surgery
timeFrame: 12 hours
measure: NRS at 24 hours after surgery
timeFrame: 24 hours
measure: NRS after physiotherapy
timeFrame: 24 hours
Secondary outcomes:
measure: Opioid consumption in the postoperative period
timeFrame: until 24 hours
measure: Knee mobility range
timeFrame: 24 hours
measure: Quality of sleep
timeFrame: 24 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Tomás López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Xavier Sala-Blanch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06289647: Azithromycin Reduction to Reach Elimination of Trachoma B
Official title: Azithromycin Reduction to Reach Elimination of Trachoma B
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Trachoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: National Eye Institute (NEI)
First posted: 2024-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.


Eligibility criteria: Inclusion Criteria:

* Provision of appropriate informed consent
* Stated willingness to comply with all study procedures
* Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial

Exclusion Criteria:

* Does not consent to participation
* Unwilling to comply with all study procedures
* Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial

Primary outcomes:
measure: Ocular chlamydia measured in a population-based sample of 0-9 year-old children
timeFrame: 36 months
Secondary outcomes:
measure: Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia
timeFrame: 36 months
measure: Conjunctival inflammation
timeFrame: 36 months
Other outcomes:
Locations:
city: Kindu
country: Congo, The Democratic Republic of the
facility: University of California, San Francisco
state: Maniema
Study officials:
affiliation: University of California, San Francisco
name: Catherine Oldenburg, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Thomas Lietman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Elodie Lebas, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02606747: The Balance Control Mechanism of DPN Patients
Official title: The Balance Control Mechanism of Diabetic Peripheral Neuropathy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Neuropathy
Keywords: DPN
fall
fMRI
balance
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetics

Brief summary: This study will evaluate the balance ability of DPN (diabetic peripheral neuropathy)patients, which will help us to understand the relationship between peripheral and central nervous system, in order to early diagnosis and prevent the fall in DPN patients.

Detailed description: DPN is one of the most common complications of diabetes. The clinical manifestation of DPN contains sensory reduction, pain, muscle wastage and so on. Sensory and motor nervous are one of the most important factors in balance control, the reduction of balance ability will result in high risk of fall.

Most studies about DPN are focus on peripheral nervous, however, the central nervous system may also be involved in DPN patients. In this study, force platform, proprioception test and fMRI will be used to evaluate balance ability, proprioception and the brain function information of DPN patients, which will help to understand the relationship between peripheral and central nervous system.

Eligibility criteria: Inclusion Criteria:

* diabetics
* normal cognitive ability
* walk normally
* normal vision

Exclusion Criteria:

* other nervous system disease, foot ulcer

Primary outcomes:
measure: Berg Balance Scale
timeFrame: through study completion, an average of 6 months; Berg Balance Scale assessment
measure: Brain complexity and connectivity
timeFrame: through study completion, an average of 6 months; brain complexity and connectivity assessment
measure: Timed up and go
timeFrame: through study completion, an average of 6 months; timed up and go assessment
measure: Foot sole tactile threshold
timeFrame: through study completion, an average of 6 months; foot sole tactile threshold assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: PKU
name: Jue Zhang, Ph. D
role: STUDY_CHAIR
References: