louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01367535: Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
Official title: A Phase I, Randomized, Open-Label, Active- and Placebo-Controlled Parallel Group Study of the Effect of Subcutaneous and Intravenous Methylnaltrexone on CYP450 2D6 Activity in Healthy Extensive Metabolizers of Dextromethorphan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.


Eligibility criteria: Inclusion Criteria:

1. Healthy males between the ages of 18 and 55
2. Non-Smokers
3. Body weight range form 154-220 lbs
4. No history of clinically significant metabolic disorders.

Exclusion Criteria:

1. Any history of low CYP450 2D6 activity
2. History of alcohol abuse or recreational drugs
3. History of any clinically significant disease or condition affecting a major organ system
4. Donation or loss of blood, 60 days proceeding to screening visit.

Primary outcomes:
measure: Plasma Concentration of MNTX
timeFrame: 4 months
Secondary outcomes:
measure: Plasma Concentration of Paroxetine
timeFrame: 4 months
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01211535: Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Official title: Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Refractive Error
Keywords: Soft contact lenses
Multi-purpose Solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 104
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: The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Currently wearing silicone hydrogel contact lenses on a daily wear basis;
* Currently using OPTI-FREE RepleniSH contact lens solution;
* Generally healthy;
* Normal ocular health;
* Willing to follow study procedures and visit schedule;
* Sign Informed Consent and privacy document;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Use of additional lens cleaners;
* Known sensitivities to any ingredient in either test article;
* Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
* History of ocular surgery/trauma within the last 6 months;
* Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
* Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
timeFrame: Baseline (Day 0), Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Trial Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01342835: Postoperative Analgesia in Children After Propofol Anesthesia
Official title: Postoperative Analgesia in Children After Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain
Keywords: propofol
sevoflurane
postoperative pain
children
Lead sponsor: University Clinical Centre of Kosova
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.

Detailed description: In a randomize, prospective, double-blind study, the subjects are 100 premedicated children, aged 3 to 6 years, who undergo one type of surgical procedure, hernia repair surgery. Anesthesia is maintains with propofol anesthesia (group P, n=50) or with sevoflurane anesthesia (group S, n=50). and fentanyl administered during surgery. Faces Pain Scale (FPS) is use to assess pain severity.

Eligibility criteria: Inclusion Criteria:

* Patient is 3- 6 years old
* Patient is scheduled for hernia repair surgery at University Clinical center of Kosovo Patients is ASA I/II Patient meets criteria to receive either propofol or sevoflurane anesthesia Patient's parent/guardian provides written consent

Exclusion Criteria:

* allergy to any of the drugs
* preoperative anxiety
* postoperative agitation
* ASA physical status \>II

Primary outcomes:
measure: postoperative pain
timeFrame: 120 minutes
Secondary outcomes:
measure: recovery time
timeFrame: 120 minutes
measure: adverse effects
timeFrame: 0-120 minutes
Other outcomes:
Locations:
city: Pristina
country: Serbia
facility: University Clinical Center of Kosovo
state: Kosovo
Study officials:
affiliation: University Clinical Centre of Kosova
name: Antigona Hasani, MD,MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245635: Fluoxetine in Pediatric Body Dysmorphic Disorder
Official title: Fluoxetine in Pediatric Body Dysmorphic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Body Dysmorphic Disorder
Keywords: Body Dysmorphic Disorder
BDD
BDD treatment
delusionality variant
OCD
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2005-10-28
Enrollment: 43
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.

Detailed description: BDD usually begins in childhood or adolescence, but its treatment in pediatric populations has not been investigated. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs) such as fluoxetine (Prozac). Preliminary findings from case reports suggest that SRIs may also be effective in the treatment of BDD in children and adolescents. This study is the first large-scale, double-blind, placebo-controlled medication trial of fluoxetine for children and adolescents with BDD. Participants should be aged 16 or younger. Participation in this trial will last approximately 14 weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female children and adolescents aged 16 and younger
* BDD or its delusional variant present currently and for at least 6 months prior to the study
* Ability to communicate meaningfully with the investigators and competent to provide written assent

Exclusion Criteria:

* Presence of Schizophrenia or Bipolar Disorder
* Recent suicide attempt or suicidal ideations that warrant hospitalizations
* Previous allergic reaction to fluoxetine
* History of a seizure disorder

Primary outcomes:
measure: Change in Total Score on the BDD-Y-BOCS Scale
timeFrame: Baseline compared to the study endpoint (week 12) [two time points]
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Albert Einstein College of Medicine
state: New York
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Eric Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03182335: Vasopressor SAT Study
Official title: An Assessment of Vasoactive Medication Dose in Mechanically Ventilated Patients Undergoing Daily Sedation Awakening Trial (SAT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Low Blood Pressure
Delirium
Critical Illness
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients admitted to the intensive care unit

Brief summary: To assess the impact of daily awakening from sedation on the amount of vasoactive medication required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug required to maintain an adequate mean arterial blood pressure will be reduced during a daily awakening from sedation.

Detailed description: This observational study will compare mean arterial pressure and vasoactive drug dose recorded at two time points:

1. prior to awakening from sedation
2. during the awakening from sedation trial The vasoactive infusion will be titrated to a mean arterial pressure as determined by the medical team prior to study enrollment. Each enrolled patient will have measurements taken only on the first day of enrollment. Enrolled subjects will also have a delirium assessment using the CAM-ICU tool before the awakening from sedation trial and during the awakening from sedation trial.

Eligibility criteria: Inclusion Criteria:

* requiring Mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic agent for comfort
* requiring vasoactive drug via central venous catheter for the treatment of shock

Exclusion Criteria:

* patients receiving Dexmedetomidine as sedative

Primary outcomes:
measure: change in vasoactive drug dose
timeFrame: baseline thru study completion on average < 4 hrs
Secondary outcomes:
measure: change in mean arterial blood pressure
timeFrame: baseline thru study completion on average <4 hrs
measure: change in prevalence of ICU delirium
timeFrame: baseline thru study completion on average <4hrs
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: John Kress, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06212635: Hemostasis in Liver Cirrhosis and Hepatocellular Cancer
Official title: Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemostasis in Decompensated Liver Cirrhosis
Inflammation in Decompensated Liver Cirrhosis
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Sahlgrenska University Hospital
First posted: 2024-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 patients each with NAD, AD and ACF and 30 healthy volunteers.

Brief summary: Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

Detailed description: The rebalanced hemostasis in liver cirrhosis is vulnerable and patients are prone to both bleeding and thrombosis. There are today no gold standard for evaluating the hemostasis and we will evaluate novel methods for this.

Eligibility criteria: Inclusion Criteria:

* Patients with decompensated liver cirrhosis
* 18 years or older.
* Healthy individuals 18 years or older will serve as controls.

Exclusion Criteria:

* • Extrahepatic malignancy or recurrence of such within the last year.

  * Diagnosis of non-cirrhotic coagulopathy, coagulation disorder or thrombophilia prior to inclusion.
  * Diagnosis of hematological disease such as hematologic malignancies, non-cirrhotic thrombocytopenia or thrombocytosis, Polycytemia Vera, hemoglobinopathies
  * Previous liver transplantation.
  * Transfusions the last 7 days.
  * Treatment with platelet inhibitors or anticoagulant except for prophylactic dosage of LMWH. If a prophylactic dose of LMWH has been used study sampling with addition of antiFXa must be taken \>12 hours after the last injection.

Primary outcomes:
measure: Differences in laboratory values between groupstests
timeFrame: up to 5 years
measure: Correlation between systemic inflammation and hemostasis measured by novel assays
timeFrame: uo to 7 years
Secondary outcomes:
measure: Number of participant with bleeding
timeFrame: Up to 7 years
measure: Number of participants with Thrombosis
timeFrame: Up to 7 years
measure: Number of participants that die
timeFrame: Up to 7 years
measure: Number of participant going to transplant
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Huddinge
Study officials:
affiliation: Region Stockholm, Karolinska Institute
name: Maria Magnusson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06884735: Virtual Reality Exposure Therapy (VRET) in Psychomotor Disadaptation Syndrome
Official title: Virtual Reality Exposure Therapy (VRET) for Balance in Patients Suffering from Psychomotor Disadaptation Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychomotor Disadaptation Syndrome
Keywords: Virtual Reality Exposure Therapy
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling.

Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability.

Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with PMDS
* Ability to stand without human or technical assistance
* Falls Efficacy Scale International Short (FES-I short) \> 13
* Functional Reach Test (FRT) score \< 26 cm
* Mini-Mental State Examination (MMSE) score ≥ 20

Exclusion Criteria:

* Patients with disorders that may interfere with immersion in virtual reality (e.g. cerebellar syndromes, Parkinsonian syndromes, hallucinations, sensory or neurocognitive disorders)
* Cybermalaise or cyberkinetosis

Primary outcomes:
measure: Balance
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Trevenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT02737735: The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation


Eligibility criteria: Inclusion Criteria:

* Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age \> 18 ages
* Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.
* White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
* ALT, AST, normal or less than 2 times, bilirubin is normal
* Serum level in the normal range;Thr ecg is normal
* Expected survival time≥ 3 months or more;
* Agreed to the treatment combined traditional Chinese medicine with western medicine

Exclusion Criteria:

* Engaged in other clinical subjects
* Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
* Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
* Severe damage of heart, liver and kidney (cardiac function grade 3 \~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
* Mental illness, Refused to partner; Cannot obtain informed consent

Primary outcomes:
measure: Overall survival rate
timeFrame: 36months
measure: progression-free survival rate
timeFrame: 36months
Secondary outcomes:
Other outcomes:
measure: Quality of Life Questionnaire (EORTC QLQ C30)scores
timeFrame: 36months
measure: RECIST(Response Evaluation Criteria In Solid Tumors)
timeFrame: 36months
measure: KPS scores
timeFrame: 36months
measure: nutritional evaluation scores
timeFrame: 36months
measure: BMS(Bone marrow suppression) scores
timeFrame: 36months
measure: Gastrointestinal reactions scores
timeFrame: 36months
measure: hair loss level scores
timeFrame: 36months
measure: AST value
timeFrame: 36months
measure: ALT value
timeFrame: 36months
measure: creatinine value
timeFrame: 36months
Locations:
city: GuangZhou
country: China
facility: The First Affiliated Hospital of Sun-yat Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03942835: Psychometric Validation of the Competitive Attention Test
Official title: Psychometric Validation of the Competitive Attention Test (CAT) : Simultaneous and Separated Measures of Voluntary and Involuntary Attention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
attention
distraction
psychometric test
neuropsychological test validating procedure
psychostimulant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims at validating a new neuropsychological test to measure voluntary and involuntary attention for clinical use to diagnose attentional deficits.

This project proposes:

* a test-retest procedure in healthy subjects aged from 6 to 90 year-old;
* testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment;
* testing in attention deficit hyperactivity disorder (ADHD) patients before psychostimulant treatment.


Eligibility criteria: Inclusion Criteria:

healthy major participants:

* Age from 18 to 90 year-old
* Informed consent to participate in the study
* No neurological or psychiatric disorder
* No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, attention deficit disorder

healthy minor participants:

* Age from 6 to 17 year-old
* Informed consent of parents or guardians for the child's participation in the study
* No neurological or psychiatric disorder
* No history of neuro-psychiatric disorder or neurodevelopmental type dysphasia, dyslexia, dyspraxia, Attention deficit disorder

ADHD minor patients:

* Age from 6 to 17 year-old
* Informed consent of parents or guardians for the child's participation in the study
* ADHD Diagnosis with or without hyperactivity
* No psychiatric history other than ADHD.
* For Experience 3: treatment in progress.

Exclusion Criteria:

healthy major participants

* Age below 18 or above 90 year-old
* unaffiliated or non-beneficiaries of the social security scheme

healthy minor participants:

* Age below 6 or above 18 year-old
* unaffiliated or non-beneficiaries of the social security scheme

ADHD minor patients:

* Age below 6 or above 18 year-old
* unaffiliated or non-beneficiaries of the social security scheme

Primary outcomes:
measure: Reaction times in healthy subjects and patients with ADHD.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percentage of correct responses in healthy subjects and patients with ADHD.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de Recherche en Neurosciences de Lyon, INSERM U1028
Study officials:
References: