louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00466791: Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
Official title: A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Optimization, Analog Classroom, Crossover Study Designed to Assess the Time Course of Treatment Effect, Tolerability and Safety of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Noven Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-04-27
Enrollment: 93
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD

Detailed description: Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis ADHD
* Total score of greater than or equal to 26 on ADHD-RS-IV
* IQ of greater than or equal to 80
* Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline

Exclusion Criteria:

* Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
* Known nonresponder to psychostimulant treatment
* BMI for age greater than 90th percentile
* History of seizures during last 2 years
* Conduct Disorder

Primary outcomes:
measure: Score on SKAMP rating scale at 2,3,4.5,6,7.5,9,10.5 and 12 hours post application of MTS
timeFrame: 2,3,4.5,6,7.5,9,10.5 and 12 hours
Secondary outcomes:
measure: PERMP scores
timeFrame: pre-dose, 2.0, 3.0, 4.5, 6.0, 7.5, 9.0, 10.5 and 12.0 hours post application
measure: Clinician-rated ADHD-RS-IV score
timeFrame: 2,3,4.5,6,7.5,9,10.5 and 12 hours
measure: CGI-I score
timeFrame: Weeks 1-9
measure: PGA
timeFrame: Weeks 1-9
measure: CPRS-R score
timeFrame: Weeks 1-9
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Child Development Center
state: California
Study officials:
References:
citation: McGough JJ, Wigal SB, Abikoff H, Turnbow JM, Posner K, Moon E. A randomized, double-blind, placebo-controlled, laboratory classroom assessment of methylphenidate transdermal system in children with ADHD. J Atten Disord. 2006 Feb;9(3):476-85. doi: 10.1177/1087054705284089.
Clinical trial NCT00972491: The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia
Official title: The Optimal Time of Insertion of Laryngeal Mask Airway With Propofol Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2009-09-07
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without having to put a breathing tube in the throat. Previous studies have focused on the effect of different anesthesia medicines on optimal condition for LMA use. The objective of the present study is to find the optimal time for LMA insertion.

Detailed description: This is a randomized, controlled, blinded trial. Midazolam, 2 mg and fentanyl 1.0 µg/kg, would be given prior to induction with propofol, 2.5 mg/kg.

The investigator who does the induction of general anesthesia will also be responsible for the timekeeping. For this reason, it is not possible for this investigator to be blinded to randomization. The induction would conclude after loss of eyelash reflex (LER). At that point insertion of the LMA (#4 for females, #5 for males) will occur 0, 60 and 90 seconds after LER. The LMA will be lubricated with a water soluble gel and will be inserted with a deflated cuff according to the technique described by Brain.

The investigator who inserts the LMA (Inv1) will be in the operating room and blinded to randomization groups by not seeing the induction of general anesthesia. This investigator will insert the LMA only when called by the investigator who induces general anesthesia (Inv2). Inv1 will also grade ease of LMA insertion.

The primary outcome is Jaw opening at the time of LMA insertion, defined as full 1, partial 2, and nil 3.

Secondary outcomes include:

1. Insertion of LMA (easy, difficult, impossible)
2. Coughing or gagging (none, some, significant)
3. Head or body movement (none, some, significant)
4. Laryngospasm or airway obstruction (none, partial, total)

Eligibility criteria: Inclusion Criteria:

* subjects 18 years or older
* ASA status 1-3

Exclusion Criteria:

* high risk of aspiration
* anticipated difficult airway
* use of sedative drugs
* patient refusal

Primary outcomes:
measure: Ease of Mouth opening
timeFrame: From Induction of general anesthesia to satisfactory LMA insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Pei-shan Zhao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02024191: The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy
Official title: The Role of Glutamine for Preventing Oxaliplatin-Induced Peripheral Neuropathy in Colorectal Cancer Patients. Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Neuropathy
Keywords: glutamine
oxaliplatin
peripheral neuropathy
Lead sponsor: Ankara Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oxaliplatin is a chemotherapeutic agent, which is generally used in treatment of colorectal cancer. The dose limiting side effect of oxaliplatin is neurotoxicity. In this study we aimed to determine whether glutamine has role in prevention of oxaliplatin induced neuropathy.

Detailed description: Our study population includes the colorectal cancer patient who is going to have mFOLFOX6 (modified, Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil l 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours) regimen. We randomly assigned the patients into two groups. We administered glutamine at dose of 3x10 gr/day to one patient group concomitantly with mFOLFOX6 regimen and other group had no additional intervention. We performed questionnaire, neurological examination and EMG (Electromyography) before and after 4th cycle of mFOLFOX6 regimen in both patient groups. We planned to compare the neurological signs, symptoms and EMG action potentials between mFOLFOX6+Glutamine and only mFOLFOX6 group. We aimed to search the role of glutamine as a prophylactic agent against oxaliplatin induced neuropathy.

Eligibility criteria: Inclusion Criteria:

* Age between 20 - 65 years
* Operated and non operated colorectal cancer patients
* Patient administering mFOLFOX 6 ( Folinic acid 400 mg/m2 1 day, oxaliplatin 85 mg/m2 1 day, 5-fluorouracil 400 mg/m2 bolus 2400 mg/m2 continuous infusion 48 hours)

Exclusion Criteria:

* Patients who had chemotherapy in last 6 months
* Diabetes Mellitus
* Sensorimotor polyneuropathy
* Anemia

Primary outcomes:
measure: Electromyography parameters
timeFrame: 4 months interval
Secondary outcomes:
measure: Neurological signs and symptoms
timeFrame: 4 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Numune Education and Research Hospital
Study officials:
References:
Clinical trial NCT01172691: Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts
Official title: Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Transplant
Keywords: Liver transplant
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2010-07-30
Enrollment: 2
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).


Eligibility criteria: Inclusion Criteria:

* Liver Transplant

Exclusion Criteria:

* Living donor transplants

Primary outcomes:
measure: Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation.
timeFrame: 24 hours to 1 month
Secondary outcomes:
measure: iNO group will show accelerated restoration of liver allograft function following liver transplantation and this may translate to better clinical outcomes. Marginal grafts may function better in the treated group
timeFrame: 1 month to 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Univsersity Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Michael A Ramsay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960191: Functional Neuroimaging and Genetic Vulnerability to Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicidal Behavior
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 95
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.


Eligibility criteria: Inclusion Criteria:

* right-handed
* arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt
* arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide
* arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide

Exclusion Criteria:

* Cons-indications to the use of MRI
* Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture.

Primary outcomes:
measure: MRI variations
timeFrame: at day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
References:
Clinical trial NCT01467791: Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)
Official title: Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoidosis
Pulmonary Hypertension
Keywords: ambrisentan
Bosentan
Iloprost
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2011-11-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sarcoidosis associated pulmonary hypertension

Brief summary: Registry to follow patients with sarcoidosis associated pulmonary hypertension

Detailed description: This is a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. The investigators will also compare these features to non-US sites.

Eligibility criteria: Inclusion Criteria:

* Patients with sarcoidosis as defined by the ATS/WASOG statement
* Patients with pulmonary hypertension as confirmed by right heart catheterization
* Patients willing to provide written informed consent

Exclusion Criteria:

* Unwillingness to provide assurance that they will complete the follow up visits for the study

Primary outcomes:
measure: Survival
timeFrame: 4 years
Secondary outcomes:
measure: Disease management
timeFrame: 4 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert P Baughman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02019394: Absolute Bioavailability of Lu AE58054 in Healthy Subjects
Official title: Interventional, Open-label Study Investigating the Absolute Bioavailability of Lu AE58054 After Multiple Oral Dosing and a Single Radio-labelled Intravenous Micro-dose as Well as the Contribution of Cytochrome P450 2D6 to the Exposure of Lu AE58054 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2013-12-24
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady state


Eligibility criteria: Inclusion Criteria:

* Healthy men and women aged between 21-55 years (inclusive) and with an BMI in the range 18.5 to 32 kg/m2 (minimum weight 60 kg for men and 55 kg for women).
* The subjects CYP2D6 genotype must be determined before inclusion into the study.
* Women must not be pregnant or lactating.

Exclusion Criteria:

* The subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Absolute bioavailability: (AUC0-24) Dose oral/(AUC0-inf) Dose IV
timeFrame: Day 10
measure: Ratio of (AUC0-24(PM)/AUC0-24(EM))
timeFrame: Day 10
Secondary outcomes:
measure: Number and frequency of adverse events
timeFrame: Up to Day 16
measure: Number of subjects with adverse events
timeFrame: Up to Day 16
measure: Risk of Suicidality
timeFrame: Up to Day 16
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: GB803
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT06233994: A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib or Bevacizumab in Patients With Advanced Hepatocellular Carcinoma
Official title: A Study Evaluating the Efficacy and Safety of ZG005 in Combination With Donafenib Tosilate Tablets or Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Changsha Taihe Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-31
Enrollment: 30
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: This is a randomized, open-label study to evaluate the safety and efficacy of ZG005 in combination with Donafenib or Bevacizumab in patients with advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 years of age.
* Fully understand the study and voluntarily sign the informed consent form.
* Histologically or cytologically confirmed diagnosis of metastatic or unresectable hepatocellular carcinoma (HCC).
* Life expectancy \>= 3 months.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

* Fibrolamellar or sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
* Patients were deemed unsuitable for participating in the studyl by the investigator for any reasons.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: up to approximately 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Changsha Taihe Hospital
state: Hunan
Study officials:
affiliation: Changsha Taihe Hospital
name: Xiaoli Chai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294294: Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
Official title: A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix Hexa®) in Children at 2, 3, 4 and 11-14 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccines, Pneumococcal
Infant
Fever, Chemically Induced
Drug Therapy, Combination
Keywords: vaccine
infant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 300
Sex: ALL
Minimum age (years): 56
Maximum age (years): 112
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.


Eligibility criteria: Inclusion Criteria:

* Healthy infants age 55 to 112 days
* Subject's parents/legal guardians provide written informed consent

Exclusion Criteria:

* Prematurely born subjects \< 37 weeks gestation
* Known or suspected disease of immune system
* Known or suspected hypersensitivity to any vaccine or vaccine component

Primary outcomes:
measure: Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4
Secondary outcomes:
measure: Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine. BMC Pediatr. 2013 Jun 21;13:98. doi: 10.1186/1471-2431-13-98.
Clinical trial NCT01509794: Psychophysiological Indicators of Performance in Computer-Based Simulation
Official title: Psychophysiological Indicators of Performance in Computer-Based Simulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: CME
Simulation
Affective engagement
Cognitive performance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: As simulation is now used in many post-graduate education and assessment domains, the investigators want to learn about how autonomically engaged healthcare providers are with the investigators computer simulation paradigm. The investigators are interested in the relationship between autonomic arousal (as measured by heart rate variability and galvanic skin response), self-report of engagement, and performance in the simulation and cognitive debriefing.


Eligibility criteria: Inclusion Criteria:

* Healthcare provider
* Right-handed

Exclusion Criteria:

* Has a medical condition associated with cardiac arrhythmia
* Taking medications (such as antiarrhythmic or beta-blocker) that has an effect on heart rate or autonomic function

Primary outcomes:
measure: Engagement with simulation
timeFrame: All data will be collected during the one hour when participants engage in the simulation activities and debriefing.
Secondary outcomes:
measure: Cognitive performance
timeFrame: All data will be collected during the one hour when participants engage in the simulation activities and debriefing.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Division of Postgraduate Medical Education
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Tristan Gorrindo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorrindo T, Baer L, Sanders KM, Birnbaum RJ, Fromson JA, Sutton-Skinner KM, Romeo SA, Beresin EV. Web-based simulation in psychiatry residency training: a pilot study. Acad Psychiatry. 2011 Jul-Aug;35(4):232-237. doi: 10.1176/appi.ap.35.4.232.