louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01841710: Genetic Variability in Taste Perception
Official title: Genetic Variability in Taste Perception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Bitter Taste
Pediatric Medications
Lead sponsor: Monell Chemical Senses Center
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: University of Pennsylvania
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2013-04-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred women who were previously enrolled in the study entitled "Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations," Protocol #809789; will be recruited for the current study

Brief summary: This proposal describes a pilot study aimed at determining whether genetic variations in taste receptors determine differential taste tolerability of pediatric medications.

Detailed description: This is a cross-sectional call-back study of taste perception and the relationship between taste perception and taste receptor genotype.

Eligibility criteria: Inclusion Criteria:

* Adult females who were previously enrolled in Efficacy of Bitter Blockers on Taste Acceptance in Pediatric Populations Study (Protocol #809789)

Exclusion Criteria:

* Women who are pregnant
* Women on drugs with potential serious adverse effects that are mediated through cytochrome P450.

Primary outcomes:
measure: Psychophysical data for taste solutions
timeFrame: 1-2 hours
Secondary outcomes:
measure: Maternal practices and perceptions of medication use
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Monell Chemical Senses Center
state: Pennsylvania
Study officials:
affiliation: Monell Chemical Senses Center
name: Julie A. Mennella, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Elizabeth Lowenthal, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mennella JA, Mathew PS, Lowenthal ED. Use of Adult Sensory Panel to Study Individual Differences in the Palatability of a Pediatric HIV Treatment Drug. Clin Ther. 2017 Oct;39(10):2038-2048. doi: 10.1016/j.clinthera.2017.08.012. Epub 2017 Sep 18.
Clinical trial NCT01888510: CT in Diagnosing Patients With Lung Cancer
Official title: Comparison of Conventional Free Breathing CT, 4D CT, and Integrated Active Breath Hold CT Image Acquisition for Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.

II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.

III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.

OUTLINE:

Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Measurable disease on CT scan
* Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
* Patients must be able to perform ABC procedures

Exclusion Criteria:

* Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
* No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
* Women of childbearing potential will undergo a pregnancy test

Primary outcomes:
measure: Amount of inter- and intra-physician contouring variability on 4D CT, ABC CT, free breathing CT, and free breathing and ABC CBCT
timeFrame: up to 1 week
Secondary outcomes:
measure: Magnitude and distribution of target and organ at risk volume variations between the different imaging modalities
timeFrame: up to 1 week
measure: Dosimetric changes related to contouring variations for tumor and normal tissue
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Elizabeth Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04483310: Meditation-Relaxation (MR Therapy) for Sleep Paralysis.
Official title: Meditation-Relaxation (MR Therapy) for Sleep Paralysis: A Pilot Study in Patients With Narcolepsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Paralysis
Narcolepsy Type 1
Keywords: Behavioral Treatment
Sleep Paralysis
Narcolepsy Type 1
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2020-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate, with a small-scale pilot study, the efficacy of Meditation Relaxation therapy for Sleep Paralyses in patients with narcolepsy. The study involves two arms, with intervention with Meditation Relaxation therapy or sham over a period of three months.


Eligibility criteria: Inclusion Criteria:

* Narcolepsy (type 1 and 2) based on polysomnography, Multiple Sleep Latency Test \[MLST\] and CSF hypocretin level testing).
* Patients had to have experienced SP at least four times in the last month.

Exclusion Criteria:

* Psychiatric comorbidity.

Primary outcomes:
measure: Sleep Paralysis Experiences and Phenomenology Questionnaire (SP-EPQ)
timeFrame: Three months.
Secondary outcomes:
measure: Daily journal
timeFrame: Three months.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda USL di Bologna
Study officials:
References:
Clinical trial NCT04355910: Intermittent Fasting in Nonalcoholic Fatty Liver Disease
Official title: Effects of Intermittent and Continuous Calorie Restriction on Body Weight and Metabolism in Adults With Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Fasting
Non-Alcoholic Fatty Liver Disease
Insulin Resistance
Obesity
Gut Microbiota
Lead sponsor: Shaoguan University
Sponsor class: OTHER
Collaborators: name: Guangdong Medical University
name: Sun Yat-sen University
First posted: 2020-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.


Eligibility criteria: Inclusion Criteria:

* The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* Excessive alcohol consumption (ethanol \> 140 g/wk for men and \> 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline body weight at week 8
Secondary outcomes:
measure: Lipid profile
timeFrame: Change from baseline plasma TG, TC and LDL at week 8
measure: Insulin resistance
timeFrame: Change from baseline plasma glucose and insulin at week 8
measure: Gut microbiota
timeFrame: Change from baseline plasma bile acids and the gut microbiome at week 8
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Guangdong Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT01672112: Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Official title: Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postcraniotomy Pain
Keywords: analgesic efficacy
oral codeine
oral oxycodone
postcraniotomy
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2012-08-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The efficacy of codeine is dependent on its demethylation to morphine. This extent of demethylation has wide inter-individual variability, making codeine's efficacy as a analgesic variable. Oxycodone is a semi-synthetic opioid and is a weak agonist on mu opioid receptors.

Codeine has been the mainstay of analgesia for patients after craniotomy for many years. Traditionally, craniotomies were not thought to be very painful procedures, hence the use of codeine, a moderately potent opioid (when compared to morphine).

However, in recent years, it has been found that up to 70% of post-craniotomy patients have moderate to severe pain and codeine did not provide adequate analgesic relief. Many studies have compared codeine to other drugs such as PCA morphine, fentanyl and tramadol, and patients on these stronger opioids generally had lower pain scores and better satisfaction.

No study has been conducted to determine the efficacy of analgesia of oral oxycodone to oral codeine.

Hence, the hypothesis is that oxycodone is more effective than codeine in providing pain relief in post-craniotomy patients.


Eligibility criteria: Inclusion Criteria:

* Ages 21-70 years of age
* Planned elective craniotomy
* ASA 1-3
* GCS 15 pre and post-op
* Able to understand and use the visual analogue scale

Exclusion Criteria:

* Patients with GCS \< 15 pre and/or post-op.
* Patients who are unable to quantify pain according to VAS scale.
* Patients who will be left intubated post-op.
* Contraindications and/or allergies to any of the trial drugs.
* Patients with renal and/or hepatic impairment.
* Patients with decreased respiratory reserves.
* Patients with post-op cognitive dysfunction.

Primary outcomes:
measure: To determine the difference in the mean pain VAS scores in the oxycodone and codeine groups at 24hr.
timeFrame: 24hr post-op.
Secondary outcomes:
measure: To look at the incidence of adverse events in the oxycodone and codeine groups.
timeFrame: Up to 72hrs post-op.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References:
Clinical trial NCT00604812: Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Single-Dose Pharmacokinetics of MK0462 in Subjects With Migraines Aged 6 to 17 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine Disorders
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.

After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.


Eligibility criteria: Inclusion Criteria:

* Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
* Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
* Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration

Exclusion Criteria:

* Subject has no history of migraine headaches
* Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
* Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study

Primary outcomes:
measure: Safety and Tolerability of Single Doses of Rizatriptan in Pediatric Migraineurs
timeFrame: 24 Hours
Secondary outcomes:
measure: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))
timeFrame: 24 Hours
measure: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)
timeFrame: 24 Hours
measure: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)
timeFrame: 24 Hours
measure: Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)
timeFrame: 24 Hours
Other outcomes:
Locations:
Study officials:
References:
citation: Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P. Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study. Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.
Clinical trial NCT06450912: Strain Index Ratio as a Biomarker for Mechanical Complication of Hemorrhagic Myocardial Infarction
Official title: WSI Ratio as a Biomarker for Mechanical Complication of Hemorrhagic MI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Hemorrhagic Myocardial Infarction
Myocardial Stunning
Myocardial Hemorrhage
Myocardial Reperfusion Injury
Myocardial Rupture (Post Infarct)
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of individuals aged 18 to 80 who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).

Brief summary: Hemorrhagic Myocardial infarctions are at high risk for mechanical complications including cardiac rupture. Prediction of vulnerable myocardial segments is an important step for the stratification of hemorrhagic MI patients. Wall motion index ratio is an important parameter to determine regions of high vulnerability within the 17-segment LV model of hemorrhagic MI.


Eligibility criteria: Inclusion Criteria:

* Index STEMI
* Primary PCI
* Able to complete Cardiac MR - STRAIN Protocol

Exclusion Criteria:

* Contraindication to CMR (Contrast Hypersensitivity, Metallic Implants, Abnormal Rhythms, breathing difficulties)

Primary outcomes:
measure: Wall Strain Index for Potential Detection of Intramyocardial Hemorrhage
timeFrame: 48 hours Post-PCI
measure: Wall Strain Index in Detecting the Severity of Intramyocardial Hemorrhage
timeFrame: 48 hours Post-PCI
measure: Wall Strain Index Ratio in Identification of Vulnerable LV Segments for Cardiac Rupture
timeFrame: 48 hours Post-PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Krannert Cardiovascular Research Center, Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Rohan Dharmakumar, PhD
role: STUDY_DIRECTOR
affiliation: Indiana University School of Medicine
name: Keyur P Vora, MD FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06842212: Balance Training To Enhance Stability And Athletic Performance During The Menstrual Cycle
Official title: Targeted Balance Training During The Menstrual Cycle To Enhance Stability And Athletic Performance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Menstrual Cycle Phase
Athletic Performance
Balance Training
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was done to investigate the effect of balance training on improving balance and athletic performance during menstrual cycle in young athletic females Does balance training improve balance and athletic performance during the menstrual cycle? 60 athletic females will participate in the study. They will be randomly assigned into two groups. Group A will receive balance training on biodex, while group B will be the control group.


Eligibility criteria: Inclusion Criteria:

* Their age will be ranged from 18 to 22. Their BMI will be from 18.5 to 25 kg/cm2 - Athletes

Exclusion Criteria:

* free of musculoskeletal or neurological diseases that could affect balance/ taking any medications that affect sex hormones

Primary outcomes:
measure: Balance
timeFrame: 12 weeks
Secondary outcomes:
measure: atheletic performance
timeFrame: 12 weeks
measure: Athletic dynamic balance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: British University in Egypt
Study officials:
References:
Clinical trial NCT06839612: Evaluation of the Efficacy of the Two-point Method in Percutaneous Transhepatic Choledoscopy and the Influence of the Long-term Recurrence of Hepatolithiasis
Official title: Evaluation of the Efficacy of the Two-point Method in Percutaneous Transhepatic Choledoscopy and the Influence of the Long-term Recurrence of Hepatolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatolithiasis
Endoscopy, Digestive System
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are:

① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged.

② To analyze the probability of short-term complications of the two-point method during the operation and to judge its safety.

③ Patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications.

The researchers will compare the two-point method with conventional PTCS to evaluate its effectiveness.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* PTCS were only used for the treatment of hepatolithiasis
* patients receiving PTCS for the first time.

Exclusion Criteria:

* PTCD failure and withdrawal from treatment due to patients' subjective wishes were excluded.

Primary outcomes:
measure: Technical success rate
timeFrame: up to 1 week
measure: Clinical success rate
timeFrame: up to 1 week
measure: Stone recurrence rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Bleeding
timeFrame: up to 2 weeks
measure: Liver abscess
timeFrame: up to 2 weeks
measure: Cholangitis
timeFrame: up to 2 weeks
measure: Bile leakage
timeFrame: up to 2 weeks
measure: Pancreatitis
timeFrame: up to 2 weeks
measure: Thoracic complication
timeFrame: up to 2 weeks
measure: Iatrogenic injury
timeFrame: up to 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01158612: The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella
Official title: The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Hormone
Elderly
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2010-07-08
Enrollment: 12
Sex: MALE
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.

Detailed description: Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.

in order to investigate the collagen synthesis potential and the influence of growth hormone, 12 elderly males age \> 50 year, is enrolled in this study.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5 - 25.0

Exclusion Criteria:

* earlier knee injury

Primary outcomes:
measure: • Fraktionele collagen protein synthesis in human patella tendon
timeFrame: 01122010
Secondary outcomes:
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Århus universitetshospital nørrebrogade 44
Study officials:
name: Mette Hansen, PH.D.
role: PRINCIPAL_INVESTIGATOR
References: