louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00673140: Far Infrared Irradiation for Control, Management and Treatment of Amyotrophic Lateral Sclerosis (ALS)
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for the Control, Management and Treatment of Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS (Amyotrophic Lateral Sclerosis)
Amyotrophic Lateral Sclerosis With Dementia
Amyotrophic Lateral Sclerosis, Guam Form
Dementia With Amyotrophic Lateral Sclerosis
Gehrig's Disease
Guam Form of Amyotrophic Lateral Sclerosis
Lou Gehrig Disease
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Amyotrophic Lateral Sclerosis (ALS, sometimes called Lou Gehrig's s Disease, or Maladie de Charcot) is a progressive, usually fatal, neurodegenerative disease caused by the degeneration of motor neurons, the nerve cells in the central nervous system that control voluntary muscle movement.

This study will investigate the use of far infrared radiation for the control, management and treatment of ALS.

Detailed description: As a motor neuron disease, ALS causes muscle weakness and atrophy throughout the body as both the upper and lower motor neurons degenerate, ceasing to send messages to muscles. Unable to function, the muscles gradually weaken, develop fasciculations (twitches) because of denervation, and eventually atrophy due to that denervation. The patient may ultimately lose the ability to initiate and control all voluntary movement except of the eyes.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have ALS.

Eligibility criteria: Inclusion Criteria:

* Patients with ALS

Exclusion Criteria:

* None

Primary outcomes:
measure: Therapy for ALS
timeFrame: 2 years
Secondary outcomes:
measure: Rehabilitation of ALS patients
timeFrame: 2 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06803940: Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Clear Aligner Versus Fixed Appliances
Official title: Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Appliances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances
Spacing Between Anterior Teeth
Keywords: Clear aligner, anterior spacing, root parallelism
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: evaluate root parallelism in cases of anterior teeth spacing treated with clear aligner versus fixed orthodontic appliances


Eligibility criteria: Inclusion Criteria: 1. Patients with anterior spacing as less than 2mm for anterior 2. Age range from 14 to 22 years old with no sex discrimination. 3. Good oral hygiene. 4. Presence of all permanent teeth not including third molars. 5. Provide informed consent and willingness to cooperate with study protocol.

Exclusion Criteria:

1. Medical problems or craniofacial disorders known to affect bone remodeling.
2. Congenital defect or deformed anterior teeth.
3. Presence of chronic or acute periodontal disease.
4. Radiographic evidence of bone loss.
5. History of systemic disease.
6. Previous orthodontic treatment.

Primary outcomes:
measure: root parallelism
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dental Medicine
state: Naser City
Study officials:
References:
Clinical trial NCT03867240: Gabapentin and Chronic Post Surgical Pain
Official title: The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain, Postoperative
Scoliosis Idiopathic
Keywords: Gabapentin
Pain medication
Chronic postsurgical pain
Pediatric
Idiopathic scoliosis surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Detailed description: Pain after surgery can last for a long time. When it lasts for over two months, it is considered chronic postsurgical pain (CPSP). This is a problem in kids and adolescents that can impact many areas of the patient's life and their family. Many patients who undergo surgery for their scoliosis develop CPSP. The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Eligibility criteria: Inclusion Criteria:

* Be aged 10-18 years at the time of surgery
* Have a diagnosis of idiopathic scoliosis and/or kyphosis
* Be undergoing elective posterior spinal fusion
* Have only mild systemic disease

Exclusion Criteria:

* A diagnosis of neuromuscular scoliosis and/or kyphosis
* A diagnosis of chronic pain
* Used opioids in the past 6 months
* Developmental delay
* Liver or kidney disease
* Obstructive sleep apnea
* Body mass index \>40
* Be pregnant or breastfeeding

Primary outcomes:
measure: Change in NRS for pain intensity score comparing gabapentin and placebo groups
timeFrame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
measure: Change in FDI score comparing gabapentin and placebo groups
timeFrame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively
Secondary outcomes:
measure: Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo
timeFrame: Postoperative period up to 1 month
measure: Time to ambulation in patients receiving gabapentin versus placebo
timeFrame: Postoperative period up to 1 month
measure: First oral intake in patients receiving gabapentin versus placebo
timeFrame: Postoperative period up to 1 month
measure: Time to discharge in each group in patients receiving gabapentin versus standard of care
timeFrame: Postoperative period up to 1 month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Cheryl Hartzell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02662140: Mobile Health Solutions for Behavioral Skill Implementation Through Homework
Official title: Mobile Health Solutions for Behavioral Skill Implementation Through Homework
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Oppositional Defiant
Conduct Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this study is to develop a mobile health (mHealth) application that will both advance theory in and clinical practice of homework (HW) implementation. The mobile health application will enhance the existing evidence informed curriculum of a Multiple Family Group model (called 4 Rs and 2 Ss for Strengthening Families Model) for families with children who have disruptive behavior disorders. This mobile application consists of two primary components that will support engagement and integration of the model's core concepts in family life. The first component focuses on delivering homework via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the "Design" and "Do" process of homework.The second component focuses on targeting factors putatively related to poor HW implementation within the "Do" process.


Eligibility criteria: Inclusion Criteria:

* youth between the ages of 7 to 11 years and an accompanying adult primary caregiver available to participate in the research and intervention activities
* English speaking youth and adult caregiver and
* the child should meet criteria for a primary diagnosis of Oppositional Defiant or Conduct Disorder.

Exclusion Criteria:

* a significant cognitive impairment or emergent psychiatric needs of the caregiver or child that interferes with understanding of program content or informed consent process or requires a higher level of care.

Primary outcomes:
measure: Demographics
timeFrame: 4 Months
measure: Measure of Disruptive Behavior Disorder (DBD) Symptoms using DBD Rating Scale
timeFrame: 4 Months
measure: Measure of Child's Impairment using the Impairment Rating Scale
timeFrame: 4 Months
measure: Change in quantity and quality of homework measured using the Homework Rating Scale -II
timeFrame: 4 Months
measure: Change in Homework Adherence and Competence Scales
timeFrame: 4 Months
measure: Change in Attendance to sessions
timeFrame: 4 Months
measure: Change in Consumer Satisfaction and Feedback Measured by Weekly Interviews
timeFrame: 4 Months
measure: Change in behavior measured by the IOWA Conners Oppositional/Defiant Scale
timeFrame: 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Mary McKay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03325140: Platelet Transfusions in Critically Ill Patient
Official title: Platelet Transfusion Efficacy in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Transfusion
Critical Illness
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to intensive care and receiving platelet transfusion whatever the reason for it.

Brief summary: Between 10 and 15% of critically ill patients require platelet transfusion within their intensive care unit (ICU).

Platelets (PLT) are given to prevent bleeding in thrombocytopenic patients or to treat bleeding as part of massive transfusion or in bleeding thrombocytopenic patients.

International and local guidelines (American Association of Blood Banks-AABB) are mainly based on experts' opinion. The efficacy of PLT transfusion in the ICU setting remains poorly studied and unknown and the administration of PLT may be associated with adverse effects including an increased risk of hospital acquired infection. Finally, the short PLT shelve-life may be responsible for inventory issues. Altogether, this makes very important to improve the evidence that support PLT transfusion in ICU patients.

This is a multicentre prospective observational study that aims to first determine PLT transfusion efficacy and to identify the parameters associated with transfusion efficacy and to analyse the compliance with international (and local) guidelines of PLT transfusion in ICU patients.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to intensive care and receiving at least one platelet transfusion in intensive care unit

Exclusion Criteria:

* Age less than 18

Primary outcomes:
measure: platelet transfusion efficacy
timeFrame: between 18 hours and 28 days after transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CH des Pays de Morlaix
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU de Rennes
city: Tours
country: France
facility: CHU de Tours
city: Vannes
country: France
facility: Chba Site de Vannes
Study officials:
References:
Clinical trial NCT04721340: The Minnesota Manual Dexterity Test As A Measure Of Hand Function in Multiple Sclerosis
Official title: Upper Limb Assessment in Multiple Sclerosis: The Minnesota Manual Dexterity Test As A Measure Of Hand Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
upper limb
manual dexterity
assessment
minnesota manual dexterity test
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Test group: 80 people with multiple sclerosis will be evaluated. Inclusion and exlusion criteria listed above. Control group: 40 healthy volunteers with demographic characteristics similar to people with multiple sclerosis will be evaluated to compare people with multiple sclerosis.

Brief summary: The aim of the study is to report the results of manual dexterity using the Minnesota Manual Dexterity Test in people with Multiple Sclerosis.

Detailed description: Upper limb can be affected even in early stage in people with Multiple Sclerosis (pwMS). Manual dexterity is important to maintain upper limb function and 9-Hole Peg Test (9HPT) is used as gold standard to assess dexterity in pwMS. There are no studies evaluating manual dexterity with the Minnesota Manual Dexterity Test (MMDT) in pwMS. This study aims to:

1. reporting the results of manual dexterity using the Minnesota Manual Dexterity Test and comparing the test results with healthy volunteers,
2. examining the relationship between MMDT and 9HPT, ABILHAND, grip strength, pinch strength, fatigue.

Eligibility criteria: Inclusion Criteria:

* (1) age 18-65;
* (2) definitive diagnosis of MS according to McDonald criteria;
* (3) ability to read and write in Turkish.

Exclusion Criteria:

* (1) acute attacks of MS (within 3 months);
* (2) cognitive impairment (Mini Mental test result 24 points and below);
* (3) having spasticity (3 and above according to Modified Ashworth Scale)
* (4) any chronic disease other than MS;
* (5) being addicted to alcohol or drugs,

Primary outcomes:
measure: Minnesota Manual Dexterity Test
timeFrame: baseline (on the predetermined assessment day)
Secondary outcomes:
measure: 9-Hole Peg Test
timeFrame: baseline (on the predetermined assessment day)
measure: ABILHAND
timeFrame: baseline (on the predetermined assessment day)
measure: grip strength
timeFrame: baseline (on the predetermined assessment day)
measure: pinch strength
timeFrame: baseline (on the predetermined assessment day)
measure: Fatigue Severity Scale
timeFrame: baseline (on the predetermined assessment day)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
state: Küçükçekmece
Study officials:
References:
Clinical trial NCT00535340: An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder
Official title: An Eight-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Fixed Dose of SR58611A 350 mg Twice a Day in Elderly Patients With Generalized Anxiety Disorder With an Optional Twenty-Four Week Extension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anxiety Disorders
Keywords: Anxiety
Anti-Anxiety Agents
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 55
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).

Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module

Exclusion Criteria:

* Minimum total score of less than 22 on the 14-item HAM-A scale
* Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Mini-Mental State Examination (MMSE) score of 22 or less

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Change from baseline to visit 7 (Day 56) in the 14-item Hamilton Anxiety Rating Scale (HAM-A) total score
Secondary outcomes:
measure: Clinical Global Impression (CGI) Severity of Illness Score
measure: Adverse events
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Zagreb
country: Croatia
facility: Sanofi-Aventis Administrative Office
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Bratislava
country: Slovakia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06610240: Perioperative Treatment Outcomes of Early NSCLC
Official title: Perioperative Treatment Patterns and Clinical Outcomes in Early-Stage Non-Small Cell Lung Cancer: a Real-World Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: NSCLC
Keywords: NSCLC；
perioperative treatment
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage I-III NSCLC under different perioperative treatment

Brief summary: This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. According to the inclusion and exclusion criteria, perioperative NSCLC patients admitted to the study center from January 1, 2020, to one year after the study initiation will be retrospectively screened and collected.


Eligibility criteria: Inclusion Criteria:

* Stage I-III NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
* Patients who have undergone radical lung cancer surgery.
* Patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined.

Exclusion Criteria:

* Patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment.
* Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
* Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
* Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.

Primary outcomes:
measure: event-free survival
timeFrame: From date of diagnosis until the date of first documented progression, recurrence or date of death from any cause, whichever came first, assessed up to 36 months
measure: overall survival
timeFrame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes:
measure: R0 resection rate
timeFrame: usually 1 week after surgery
measure: major pathological response
timeFrame: usually 1 week after surgery
measure: p-CR
timeFrame: usually 1 week after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhong Hua
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Zhong Dr., MD
role: STUDY_CHAIR
References: