louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00989950: Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD
Official title: Open Label Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children 6-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
INSOMNIA
Keywords: daytrana
sleep latency
adhd rating scales
ADHD
Lead sponsor: Cox Health Systems
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 26
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: Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.

Detailed description: Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.

25 patients will be enrolled in order to obtain statistical significance.

Eligibility criteria: Inclusion Criteria:

* ADHD without significant comorbidity

Exclusion Criteria:

* Cardiac disorder
* Hypertension
* Thyroid disease
* Glaucoma
* History of sudden death, motor tics and/or Tourette's syndrome
* Hypersensitivity to methylphenidate

Primary outcomes:
measure: Sleep Latency
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Pediatric Neurology of the Ozarks
state: Missouri
Study officials:
affiliation: pediatric neurology of the ozarks
name: arie ashkenasi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashkenasi A. Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder. Pediatr Neurol. 2011 Dec;45(6):381-6. doi: 10.1016/j.pediatrneurol.2011.09.003.
Clinical trial NCT00191750: A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned
Official title: Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Small Cell
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 80
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: The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed


Eligibility criteria: Inclusion Criteria:

* Diagnosis of small cell lung cancer
* One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment
* At least 18 years of age
* Estimated life expectancy of at least 12 weeks
* Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours)

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication
* Less than 2 weeks from radiation therapy
* Other serious illness that would compromise the safety of the patient
* Most second primary malignancies treated less than 5 years previously

Primary outcomes:
measure: To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population
Secondary outcomes:
measure: To better understand any side effects of pemetrexed
Other outcomes:
Locations:
city: Aurora
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Colorado
city: Chapel Hill
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: North Carolina
city: Dallas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00547950: A Multiple-Centered, Prospective Cohort Study: the Second Prevention Trial for Ischemic Stroke With Deng Zhan Sheng Mai Capsule（SPIRIT-DZSM-2）
Official title: A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 12000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. From November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai capsule or not. The basic therapy included antiplatelet aggregation , stroke health education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the subjects are visited on the 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.


Eligibility criteria: Inclusion Criteria:

* 40-75 years old
* Ischemic stroke diagnosed by CT/MRI scan
* Patient presenting from 14 days to 6 months of first onset of Ischemic stroke.
* Presence of at least one risk factor of stroke (such as hypertension, Diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.)that can be interfered in.
* Informed consent.

Exclusion Criteria:

* Silent cerebral infarction;
* Patients after vasculoplasty with Intracranial Artery Stenosis.
* Watian drinking test≥grade 4.
* MRS=grade 5.
* Cerebral infarction due to other causes except arterial Sclerosis(i.e. cardiogenic embolism, arteritis, polycythemia vera, primary thrombocythemia, sickle-cell anemia,, thrombotic thrombocytopenia purpura, DIC, cerebral amyloid angiopathy, Moyamoya disease, intracranial vascular malformations etc);
* Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage;
* Patients with mental disorder.
* Patients that cannot take medicine due to other causes
* Females during pregnancy or lactation.
* Already attend other clinical trial.
* That unsuitable for clinical trial.

Primary outcomes:
measure: recurrence of stroke
timeFrame: 1 year
Secondary outcomes:
measure: Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Province Hospital of Tradtional Chinese Medicine
name: Yan Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02904850: Validation of a Kinetic Model of Erlotinib
Official title: Validation of a Kinetic Model of Erlotinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Non-small cell lung cancer
locally advanced or metastatic
erlotinib monotherapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated in the care departement of the hospital

Brief summary: Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.


Eligibility criteria: Inclusion Criteria:

* All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen
* Age\> 18 years
* Subject has signed an informed consent
* Treatment initiated for at least 7 days or dosage changed for at least 7 days

Exclusion Criteria:

* Contraindication to the use of drug
* Subject to exclusion period (as determined by a previous study or in progress)
* Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...)
* Subject under judicial protection
* Subject under tutorship or curatorship
* Pregnancy (and woman of childbearing age without contraception)
* Breastfeeding

Primary outcomes:
measure: Difference between plasma concentrations of erlotinib concentrations observed and predictive model
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)
timeFrame: 1 year
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pneumologie Nouvel Hôpital Civil
state: Alsace
Study officials:
affiliation: Service Pneumologie Hôpitaux Universitaires Strasbourg 67 091 STRASBOURG cedex
name: Anne Elisabeth QUOIX
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04641650: Pilot Study : FreeStyle Libre Pro Flash Continuous Glucose Monitoring System in Subjects With Diabetes on HemoDIALsis
Official title: FreeStyle Libre Pro Flash Continuous Glucose Monitoring (CGM) System in Subjects With Diabetes on HemoDIALsis (FSL-DIAL Pilot Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Diabetes
Keywords: glycemia
diabetes
kidney failure
dialysis
glucose sensor
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 29
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: Subjects with diabetes on hemodialysis

Brief summary: Continuous monitoring of glucose with a FreeStyle Libre pro sensor in diabetic and dialysis patients


Eligibility criteria: Inclusion Criteria:

* Diabetes without any change in treatment in the last 3 months
* Hemodialysis for \> 3 months
* Recent laboratory HbA1c (\< 15 days)

Exclusion Criteria:

* Patient does not show non-opposition
* Skin allergy to the sensor
* Sepsis / Acute anaemia

Primary outcomes:
measure: Difference between estimated Hba1c (or Glucose Management Index (GMI)) with FreeStyle Libre Pro sensor and laboratory Hba1c
timeFrame: At sensor removal (day 14)
Secondary outcomes:
measure: Time in glucose range
timeFrame: At sensor removal (day 14)
measure: Time with Glucose < 70mg/dL
timeFrame: At sensor removal (day 14)
measure: Time with Glucose > 180 mg/dL
timeFrame: At sensor removal (day 14)
measure: Glucose total coefficient of variation (CV)
timeFrame: At sensor removal (day 14)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
Study officials:
affiliation: Study Principal Investigator
name: Lucien Marchand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01563250: Improving the Management of Acute Coronary Syndromes in the Emergency Department
Official title: Improving the Management of Acute Coronary Syndromes in the Emergency Department Using a Rapid Acute Cardiac Evaluation Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Cardiac Biomarkers
point of care testing
Lead sponsor: Integrated Medical Research LLC
Sponsor class: OTHER
Collaborators: name: Alere San Diego
name: New York State Department of Health
First posted: 2012-03-26
Enrollment: 705
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: By using a Rapid Cardiac Evaluation (RACE) pathway in the Emergency Department (ED), the investigators can effectively reduce ED wait times and ED length of stay by decreasing overall hospital admissions and telemetry admissions. In addition, the investigators hypothesize a decrease in mortality of those patients admitted for cardiac evaluation by increasing the patient to health care provider ratio.


Eligibility criteria: Inclusion Criteria:

* Chief complaint of chest pain
* 35 years old or greater

Exclusion Criteria:

* ST elevation MI
* New Left Bundle Branch Block
* Admission regardless of test result
* Leaving ED against medical advice

Primary outcomes:
measure: ED length of stay
timeFrame: Average of 3 hours stay in the Emergency Department
Secondary outcomes:
measure: Mortality rate of admitted patients
timeFrame: During hospital admission and at 30 days
measure: Hospital Admission Rate
timeFrame: Baseline
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
Study officials:
affiliation: New York Presbyterian Brooklyn Methodist Hospital
name: Bethany A Byrd, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birkhahn RH, Haines E, Wen W, Reddy L, Briggs WM, Datillo PA. Estimating the clinical impact of bringing a multimarker cardiac panel to the bedside in the ED. Am J Emerg Med. 2011 Mar;29(3):304-8. doi: 10.1016/j.ajem.2009.12.007. Epub 2010 Apr 2.
Clinical trial NCT05530850: The Effect of Holistic Corrective Exercise Program
Official title: The Effect of Holistic Corrective Exercise Program on Kyphosis Degree, Balance and Quality of Life in Kyphotic Adolescent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kyphosis Thoracic
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 62
Sex: MALE
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study was planned to investigate the effect of holistic approach corrective exercise program on the degree of kyphosis, balance and quality of life in kyphotic adolescents. A holistic approach corrective exercise program including corrective exercises and postural perception training was applied to one group. Thoracic region focused exercise program was applied to the other group. The programs of the exercise groups were applied three days a week, for 12 weeks. The kyphosis angle of all individuals participating in the study was evaluated using the flexible ruler, the Romberg index measured with balance pedobarography, and the quality of life using the Scoliosis Research Society-22 Questionnaire (SRS-22). In our study, a decrease in the degree of kyphosis was detected in the holistic approach corrective exercise and thoracic region-focused exercise group after 12 weeks of exercise training (p\<0.001), while no change was observed in the control group (p\>0.05). Balance improved after exercise training in the holistic corrective exercise group (p=0.006). The quality of life increased in the holistic approach corrective exercise and thoracic region focused exercise groups after the training (p\<0.001). The use of postural perception training together with corrective exercise programs in applications for thoracic kyphosis reveals a holistic approach and may increase the effect of the intervention.


Eligibility criteria: Inclusion Criteria:

* Male individual between the ages of 10-18,
* Kyphosis degree ≥50°,

Exclusion Criteria:

* Rrigid thoracic kyphosis
* Scoliosis with a Cobb angle \>10°
* Congenital spine problem,
* Shoulder, pelvis and other spinal injuries

Primary outcomes:
measure: The Kyphosis angle by using flexible ruler
timeFrame: 12 weeks
Secondary outcomes:
measure: Balance assesment by using the romberg index
timeFrame: 12 weeks
Other outcomes:
measure: Quality of Life by using SRS-22
timeFrame: 12 weeks
Locations:
city: Şehi̇tkami̇l
country: Turkey
facility: Hasan Kalyoncu Üniversitesi
state: Gazi̇antep
Study officials:
affiliation: HKU
name: GÖNÜL ELPEZE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00194350: Factor V Leiden Mutation and Implantation Failure
Official title: Evaluation of the Role of Factor V Leiden Mutation in Implantation Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Infertility
Factor V Leiden
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 399
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing in-vitro fertilization with successful ovarian hyperstimulation, oocyte retrieval, and fertilization; and the transfer of at least 2 fresh embryos of Grade 2 (preembryo with blastomeres of equal size and \<=10% cytoplasmic fragmentation) or better

Brief summary: The purpose of this study is to determine whether inherited thrombophilias (tendency toward blood clotting) increase the risk of failure of the embryo to implant in IVF. The specific condition to be studied is the presence or absence of the Leiden mutation of the Factor V gene.


Eligibility criteria: Inclusion Criteria:

* Women undergoing in-vitro fertilization with successful ovarian hyperstimulation, oocyte retrieval, and fertilization
* Transfer of at least 2 fresh embryos of Grade 2 (preembryo with blastomeres of equal size and \<=10% cytoplasmic fragmentation) or better

Exclusion Criteria:

* Infertility due to uterine anatomic defect
* Current use of anticoagulant medication, such as heparin or aspirin
* Known presence of any other condition associated with increased risk of thrombosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kurt T Barnhart, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06655350: Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction
Official title: Is Harvesting the Peroneus Brevis an Alternative in Anatomic Ankle Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Disease
Ankle (Ligaments); Instability (Old Injury)
Keywords: Ankle instability
Graft
Peroneus brevis
Ankle ligament reconstruction
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Saint-Etienne University Hospital who underwent Haemi-Castaing-type ankle stabilisation surgery.

Brief summary: Severe ankle sprains are the most frequent reason for emergency trauma consultations. Between 30% and 80% of sprains result in sequelae such as pain, joint derangement or instability. Ankle instability can itself lead to osteoarthritis if left untreated (1st cause of post-traumatic ankle osteoarthritis). To treat instability, ligament reconstruction is performed by harvesting the tendon of the gracilis muscle (inserted at knee level) to replace the damaged ankle ligaments. This tendon is also used for other ligament reconstructions (anterior cruciate ligament), so is not always harvested. Moreover, it represents an invasive procedure at a distance from the site of interest (the ankle), and can cause sensory nerve damage (20-60% of cases). For a long time, half of the peroneus brevis tendon was harvested as part of a now-defunct ankle stabilization technique (Hemi-Castaing). This tendon does, however, play a role in stabilizing the ankle.

Detailed description: Before considering harvesting the peroneus brevis as an alternative to harvesting the gracilis, it is important to ensure that the peroneus brevis remains functional after harvesting. The aim of this study was to evaluate the potential for tendon regrowth after harvesting half of the peroneus brevis tendon after Hemi-Castaing-type ankle stabilization surgery.

Eligibility criteria: Inclusion Criteria:

* Adult one year after peroneus brevis harvesting (Hemi-Castaing)

Exclusion Criteria:

* No.

Primary outcomes:
measure: Peroneus brevis diameter of a native ankle and at one-year postoperative harvested ankle.
timeFrame: Year : 1
Secondary outcomes:
measure: Peroneus brevis MRI aspect of a native ankle and at one-year postoperative harvested ankle.
timeFrame: Year : 1
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Pierre-Henri Vermorel, MD
role: PRINCIPAL_INVESTIGATOR
References: