louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02598622: A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
Official title: A Phase II Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vincristine Induced Neuropathy
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent painful nerve damage and nerve pain which is caused by vincristine, a drug used in chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug available for purchase as a nutritional supplement but for the purpose of this study is experimental.


Eligibility criteria: Inclusion Criteria:

* Subjects must meet the following inclusion criteria.

  * The subject must have a confirmed diagnosis of acute lymphoblastic leukemia within 1 week of starting therapy
  * Currently being treated on a standard ALL induction regimen
  * Subjects must be greater than or equal to 5 and less than 18 years old
  * Signed informed consent

Exclusion Criteria:

* Subjects will be excluded for the following:

  * Preexisting neurologic disease, including grade II, III, or IV neurological status by NCI Common Toxicity Criteria v3.0 on clinical exam
  * History of hypersensitivity to vincristine
  * History of hypersensitivity to Acetyl-L-carnitine
  * Previous use of Acetyl-L-carnitine
  * Concurrent anti-convulsant use
  * Concurrent Gabapentin use
  * Concurrent Glutamine use
  * Liver Function: Total bilirubin greater than 1.3 mg/dL and serum glutamic-pyruvic transaminase (SGPT) (ALT) greater than 5 x upper limit of normal for age and serum albumin less than 2 g/dL
  * Patients who are pregnant

Primary outcomes:
measure: Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.
timeFrame: Days 1 - 21
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05389722: A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
Official title: A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: CC-92480
Healthy Volunteer
Pharmacokinetic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-05-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Must have a body mass index between 18 and 33 kg/m2 (inclusive)
* Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments

Exclusion Criteria:

* Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion
* Any major surgery within 4 weeks of the first dose administration
* History of drug abuse within 2 years of the first dose administration

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 2 months
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 2 months
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 2 months
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 3 months
measure: Number of participants with physical examination findings
timeFrame: Up to 3 months
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 3 months
measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities
timeFrame: Up to 3 months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit - Dallas
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04543422: Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy
Official title: Green Tea Extracts for Mild-to-moderate Diabetic Peripheral Neuropathy A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2020-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the present randomized placebo-controlled study aimed to evaluate the effect of green tea extract administration on the clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with peripheral neuropathy

Exclusion Criteria:

* Patients under treatment of diabetic peripheral neuropathy.
* Patients with other causes of peripheral neuropathy.

Primary outcomes:
measure: Toronto Clinical Scoring System
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University Faculty of Medicine
Study officials:
References:
Clinical trial NCT03000322: Cooling Vest in Men With Hot Flashes
Official title: Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 8
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to determine the efficacy of the Cooling Vest in reducing the frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy treatment for prostate cancer.

Detailed description: The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.

This study attempts to collect data on the effects of the Cooling Vest in men with hot flashes and night sweats due to the side effects of chemotherapy. Participants will use the vest for 4 weeks and questionnaires will be used to determine effect.

Eligibility criteria: Inclusion Criteria:

* Males, who are at least 18 years old.
* Self-reports having at least two (2) daily hot flashes associated with prostate cancer chemotherapy-induced hot flashes and night sweats.

Exclusion Criteria:

* Has another existing medical condition that would prevent study compliance.

Primary outcomes:
measure: change in number of daily hot flashes
timeFrame: 4 weeks
measure: change in the intensity of daily hot flashes
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Urology Center Research Institute
state: New Jersey
Study officials:
affiliation: Englewood Hospital and Medical Center
name: Eric Margolis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03403322: Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
Official title: Imediate Effects of Kinesio Tapin in Muscle Activity and Time to Perform Sit to Stand Movement in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: intervention
children
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children with Cerebral Palsy (CP) present limited performance of functional activities and activities of daily life. Kinesio taping has been definied as a promising technique for children with CP ans has been extensively used in clinical practice. However, several studies have found a low level of evidence of its effectiveness in healthy individuals. We aim to evaluate the effects of the immediate application of Kinesio taping on the activation of the rectus femoris and anterior tibialis muscles and on the duration of sit-to-stand movement in children with CP.


Eligibility criteria: Inclusion Criteria:

* diagnosed with spastic CP
* aged from 5 to 18 years
* Gross Motor Function Classification System levels I and II
* able to understand simple commands
* able to perform the sit-to-stand movement without support

Exclusion Criteria:

* muscle shortening in hamstring, gastrocnemius and hip flexors
* deformities in the lower limbs such as fixed hip and knee flexion that could compromise the sit-to-stand movement
* surgical procedures in the lower limbs and trunk in the previous 12 months
* botulinum toxin injection in the previous 6 months

Primary outcomes:
measure: Muscle activity
timeFrame: on the day of evaluation
measure: Time to perform sit to stand
timeFrame: on the day of evaluation
measure: Time to perform five time sit-to-stand test
timeFrame: on the day of evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Araranguá
country: Brazil
facility: Universidade Federal de Santa Catarina
state: Santa Catarina
Study officials:
References:
Clinical trial NCT03660722: Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
Official title: Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects Commencing Antiretroviral Therapy: the BIGgeR Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV Positive
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation. Initiation of ART reduces inflammation and immune activation and is associated with changes in bone and renal biomarkers and gut microbiota. Investigators hypothesise that changes in gut microbiome when starting antiretroviral therapy correlate to changes in bone and renal biomarkers and wish to explore possible mechanisms linking these by investigating changes in markers of inflammation and immune activation.


Eligibility criteria: Inclusion Criteria:

* HIV-1 positive
* Age 18-64 years
* Able to give informed consent
* Not previously treated for chronic HIV-1 infection, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago
* Due to commence antiretroviral therapy by treating clinician

Exclusion Criteria:

* - Previous major intestinal surgery/inflammatory bowel conditions
* Infective diarrhoea in the last 3 months
* BMI\<18.5
* Currently pregnant OR planning to conceive during the study period
* Previous use of antiretroviral therapy, except for pre- or post- exposure prophylaxis exposure or treatment for mother to child transmission \>12 months ago
* Use of antibiotics (except for prophylactic co-trimoxazole) within the last 2 months

Primary outcomes:
measure: faecal microbial alpha-diversity
timeFrame: At 12 weeks
Secondary outcomes:
measure: markers of gut epithelium integrity
timeFrame: At 12 weeks
measure: inflammatory marker
timeFrame: at 12 weeks
measure: circulating markers of monocyte activation
timeFrame: at 12 weeks
measure: renal glomerular biomarkers
timeFrame: at 12 weeks
measure: bone biomarkers
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Amandine GAGNEUX-BRUNON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03702322: Improving Voice Production for Adults With Age-related Dysphonia
Official title: Improving Voice Production for Adults With Age-related Dysphonia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Presbylarynx
Age-Related Dysphonia
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2018-10-11
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants receive every intervention in randomized order
Primary purpose: TREATMENT

Brief summary: The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. The central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.


Eligibility criteria: Inclusion Criteria:

* Adults in age range who volunteer
* Can understand and complete directions presented in English
* People with voice disorder associated with advancing age will be included, including bowing, incomplete closure, mild edema, erythema, signs of laryngopharyngeal reflux.

Exclusion Criteria:

* Laryngeal differences not related to aging (e.g., vocal fold paralysis, moderate-severe edema, lesions, leukoplakia, dysplasia, Parkinson disease)
* Known history of stroke, brain injury, or other neurological disorder

Primary outcomes:
measure: Relative glottal gap from laryngeal high-speed videoendoscopy
timeFrame: End of year 3
measure: Perceived voice quality
timeFrame: End of year 3
measure: Acoustic measure of voice quality (Cepstral Peak Prominence)
timeFrame: End of year 3
Secondary outcomes:
measure: Open quotient from laryngeal high-speed videoendoscopy
timeFrame: End of year 3
measure: Speed index from laryngeal high-speed videoendoscopy
timeFrame: End of year 3
measure: Maximum area declination ratefrom laryngeal high-speed videoendoscopy
timeFrame: End of year 3
measure: Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy
timeFrame: End of year 3
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: Robin A Samlan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04894422: Microbiome Analysis of Skin and Airway Samples and Effect of Face Masks
Official title: Effect of Face Masks on the Microbial Communities of the Skin and Upper Airways and the Optimalisation of Microbiome Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: skin microbiome
16S amplicon sequencing
face masks
upper airway microbiome
shotgun sequencing
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2021-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy, adult volunteers

Brief summary: The goal of this study is to optimize two methods for microbiome analysis of skin and upper airway samples (16S amplicon sequencing and Shotgun sequencing). In addition, the researchers will investigate whether there is an effect of wearing a face mask on the microbial communities of the skin and upper airways. The volunteers will self-collect swabs of the skin and upper airways (nose and/or throat). Bacterial DNA and/or total RNA will be isolated and the microbial communities will be investigated with 16S amplicon sequencing and shotgun metagenomic sequencing.


Eligibility criteria: Inclusion Criteria:

* Adult age 18 at the start of the study

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Change from baseline in microbiome composition of the skin and upper airways after wearing a face mask
timeFrame: Start, 4 hours
measure: Optimalization of microbiome analysis of skin and upper airway samples
timeFrame: Start
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University of Antwerp and University Hospital Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Sarah Lebeer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02369822: Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
Official title: Trial of Vitamin C as Add on Therapy for Children With Idiopathic Epilepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Idiopathic Epilepsy
Keywords: Vitamin C
convulsions status
EEG
children
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: There are no solid treatment guidelines for idiopathic intractable epilepsy in children. The investigators propose that vitamin C being an antioxidant will improve seizure frequency and EEG in children with idiopathic intractable epilepsy.

Detailed description: Is vitamin C; being an antioxidant based on the hypothesis of oxidative stress as a provocation factor for idiopathic epilepsy low in those with idiopathic epilepsy, and is it lower in those with refractory than those with newly diagnosed? Will vitamin C supplementation for 1 month be efficient to raise the vitamin C level and will it improve seizures and EEG findings in those with idiopathic epilepsy?

Eligibility criteria: Inclusion Criteria:

* Normal neuroimaging

Exclusion Criteria:

* Developmental delay.
* Suspected metabolic problems.

Primary outcomes:
measure: Seizure severity and frequency, EEG findings
timeFrame: up to 30 days
Secondary outcomes:
measure: vitamin C level in children with epilepsy
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Shaymaa Maher Deifalla
state: Nasr City
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Iman A Elagouza, A Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01367522: Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function
Official title: A Phase 1, Open-Label, Study to Evaluate Single Dose Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Volunteers With Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Dysfunction
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, non-randomized, single-dose, parallel-group study. Each subject will receive a subcutaneous dose of MNTX. Eight subjects with normal hepatic function and eight subjects from each classification of hepatic impairment will be enrolled. Plasma samples will be collected before and at specified intervals after dosing and the concentration of MNTX will be analyzed.


Eligibility criteria: Inclusion Criteria:

1. Males and females between the ages of 18-80 years
2. Body weight greater than 100 lbs and BMI between 18-38
3. Liver values that are abnormal must not be clinically relevant as judged by the investigator. Liver enzyme and bilirubin must be less than 5 times the upper normal of reference range and may be repeated under fed conditions if abnormal. Stable hepatitis patients as well as cirrhosis patients of either etiology.

Exclusion Criteria:

1. History of current alcohol abuse with less than 1 year abstinence
2. Conditions possibly affecting drug absorption, e.g. gastrectomy or clinically significant diabetic gastroenteropathy.
3. Currently pregnant or nursing
4. Methadone use.

Primary outcomes:
measure: Plasma Concentration of SC MNTX
timeFrame: 20 days
Secondary outcomes:
measure: Time of Maximum Plasma Concentration of SC MNTX
timeFrame: 20 days
measure: Area Under the Plasma Concentration versus Time Curve (AUC) of SC MNTX
timeFrame: 20 days
measure: Percentage of SC MNTX Excreted in Urine
timeFrame: 20 days
measure: Urinary Clearance of SC MNTX
timeFrame: 20 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References: