louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01891526: Single Dose of 9-cis-retinoic Acid in Hepatic Patients
Official title: The Pharmacokinetics of a Single Dose of 9-cis-retinoic Acid (Alitretinoin, Toctino®) in Patients With Moderate to Severe Hepatic Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Insufficiency
Keywords: Metabolisation of 9-cis-retinoic acid
hepatic patients
investigation of urine and blood samples
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients with hepatic disease and 10 controls

Brief summary: To test whether patients with hepatic insufficiency can tolerate one oral dose of 9-cis-retinoic acid and to test whether the metabolism of retinoic acid is altered.


Eligibility criteria: Inclusion Criteria:

1. Have biopsy verified hepatic insufficiency
2. Medically stable.
3. Ultra sonic examination of lever within the past 3 months
4. No pregnancy documented in women. use of anticonception during study and 1 month after

Exclusion criteria:

1. Odd blood counts and samples not related to hepatic disease
2. encephalopathy (\> grad II)
3. concomitant treatment with pharmaca that is metabolized by CYP3A4 in the liver.
4. Cardiac disease
5. Kidney disease
6. Epilepsia
7. Stroke
8. Esophagal bleeding
9. Severe ascites
10. HIV-positivity
11. Psychiatric disorder
12. Cancer
13. pregnancy or lactating women.

Primary outcomes:
measure: A comparison of the metabolisation of retinoic acid in patients with hepatic insufficiency and controls
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte Hospital
Study officials:
References:
Clinical trial NCT00001926: The Connection Between Areas in the Brain of Blind Patients
Official title: Connectivity of Occipital and Somatosensory Cortical Areas in Blind Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blindness
Brain Mapping
Healthy
Keywords: Plasticity
Magnetic Stimulation
PET
Blind
Braille
Transcranial Magnetic Stimulation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to test the belief that specific areas of the brain are connected differently in blind patients than patients with sight. In addition, the study will examine the different anatomical connections between brain areas of patients who became blind early in life versus patients who became blind later.

Detailed description: The purpose of this protocol is to test the hypothesis that the anatomical connectivity of occipital and somatosensory areas in early blind subjects differs from that in subjects who became blind later in life and from that in sighted volunteers.

Eligibility criteria: INCLUSION CRITERIA:

Subjects with late blindness.

Subjects with early blindness.

Sighted volunteers.

Age between 18 and 65 years.

EXCLUSION CRITERIA:

Subjects with personal or family history of seizures or other neurological or demyelinating disorders.

Pregnant women tested after urine pregnancy test.

Subjects with metal in the cranium except mouth.

Subjects with intracardiac lines and implanted medication pumps.

Subjects with increased intracranial pressure as evaluated by clinical means.

Subjects with cardiac pacemakers.

Intake or neuroleptics.

Subjects with blindness secondary to degenerative CNS diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Cohen LG, Bandinelli S, Findley TW, Hallett M. Motor reorganization after upper limb amputation in man. A study with focal magnetic stimulation. Brain. 1991 Feb;114 ( Pt 1B):615-27. doi: 10.1093/brain/114.1.615.
citation: Fuhr P, Cohen LG, Dang N, Findley TW, Haghighi S, Oro J, Hallett M. Physiological analysis of motor reorganization following lower limb amputation. Electroencephalogr Clin Neurophysiol. 1992 Feb;85(1):53-60. doi: 10.1016/0168-5597(92)90102-h.
citation: Kew JJ, Ridding MC, Rothwell JC, Passingham RE, Leigh PN, Sooriakumaran S, Frackowiak RS, Brooks DJ. Reorganization of cortical blood flow and transcranial magnetic stimulation maps in human subjects after upper limb amputation. J Neurophysiol. 1994 Nov;72(5):2517-24. doi: 10.1152/jn.1994.72.5.2517.
Clinical trial NCT00646126: Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission
Official title: Validation of the Use of Istope-Based Molecular Techniques for Malaria Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasmodium Falciparum
Asymptomatic Parataemia
Sub Patent Parasitaemia
Lead sponsor: Tropical Medicine Research Institute
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: International Atomic Energy Agency
First posted: 2008-03-28
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The malaria parasite Plasmodium falciparum remains at sub-patent level throughout the dry season in areas of seasonal malaria transmission. Targeting this parasite reservoir before the transmission season could be a good strategy for malaria control. We are conducting a randomized double blind placebo controlled mass drug administration trial in eight village to clear the dry season low level parasitaemia with an ultimate aim of controlling malaria in eastern Sudan.


Eligibility criteria: Inclusion Criteria:

* All residents of the 8 villages

Exclusion Criteria:

* Pregnancy
* History of allergy to sulfa drugs

Primary outcomes:
measure: Parsitaemia detected during the transmission season among dry season PCR negative persons in the intervention and control villages
timeFrame: October to December 2006
Secondary outcomes:
measure: 1. Malaria prevalence during the transmission season 2. Frequency of mutation in drug resistance genes
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Tropical Medicine Research Institute
Study officials:
affiliation: Tropical Medicine Research Institute
name: Badria B El Sayed, PhD,MSc,BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah MP, Hwang J, Choi L, Lindblade KA, Kachur SP, Desai M. Mass drug administration for malaria. Cochrane Database Syst Rev. 2021 Sep 29;9(9):CD008846. doi: 10.1002/14651858.CD008846.pub3.
Clinical trial NCT01335126: Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
Official title: Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dry Eye
Keywords: Artificial tears
Lead sponsor: Hom, Milton M., OD, FAAO
Sponsor class: INDIV
Collaborators: name: Allergan
First posted: 2011-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and over inclusive.
* Males or females
* Patient is in generally good \& stable overall health.
* Patient likely to comply with study guidelines \& study visits.
* Informed consent signed.
* OSDI score \>18 OR
* TBUT \<10 seconds

Exclusion Criteria:

* Corneal refractive surgery or contact lens wear within 6 months of this study.
* Current use of Restasis
* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
* Pregnant or lactating women.
* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Primary outcomes:
measure: Tolerability Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Acceptability Questionnaire
timeFrame: 8 weeks
measure: Tear Break Up Time
timeFrame: 2-3 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Private Practice
name: Milton M Hom, OD FAAO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410626: The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original
Official title: Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original in Child With Attention-deficit-hyperactive Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhd
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 78
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: This study is a cross-over trial, design to determine the efficacy and safety of generic and original prolong-release methylphenidate (PR-MPH) in children with ADHD who had received immediate-release methylphenidate treatment

Detailed description: This 4 weeks cross-over study will recruit 78 children, aged 6 to 12 years, with ADHD. They will be randomized to receive generic or original PR-MPH for 4 weeks and then switch to another brand for 4 weeks. Swanson, Nolan and Pelham parent rating scale is used to measure the primary outcome.

Eligibility criteria: Inclusion Criteria:

* Ages 6 to 12 years
* Diagnosis of ADHD according to DSM-5 of ICD-10
* Patient who receiving a stable dose of IR-MPH for at least 4 weeks before screening
* Patient who has a stable clinical symptoms.
* Patients or their legal representatives provide informed consent prior to enrollment

Exclusion Criteria:

* Patients who present of a serious obstructive gastrointestinal disease
* Patients cannot swallow the whole tablet
* Patients with depression, schizophrenia, bipolar disorder, and 1-month substance use prior to study
* Patients who present of an unstable co-morbidity: anxiety, seizure, conduct disorder and oppositional defiant disorder
* Patients or patients' family have a history of poor compliance
* Patients who receiving monoamine oxidase inhibitors antidepressant or stop taking not more than 14 days
* Patients who receiving PR-MPH except stop taking more than 7 days
* Patients' parent has a family problem and currently treatment with family therapy or adjust medication

Primary outcomes:
measure: The change from baseline in parent Swansan, Nolan and Pelham version IV (SNAP-IV) parent rating score
timeFrame: baseline, 4 and 8 week
Secondary outcomes:
measure: The change from baseline in Clinical Global Impression-Severity (CGI-S) scale
timeFrame: baseline, 4 and 8 week
measure: The difference in discontinuation rate between two groups of treatment
timeFrame: 4 and 8 week
measure: The difference in adverse events rate between two groups of treatment
timeFrame: baseline, 4 and 8 week
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Chanatthida Muangkum
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03526926: A Post-Marketing Observational Study of VYXEOS™
Official title: A Post-Marketing Observational Study of VYXEOS™ to Assess the Incidence of Infusion-Related Reactions in Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia With Myelodysplasia-Related Changes
Therapy-Related Acute Myeloid Leukemia
Keywords: newly-diagnosed t-AML or AML-MRC
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A minimum of 50 patients who have received at least one infusion of prescribed VYXEOS at a dose of 44 mg/m2 daunorubicin and 100 mg/m2 cytarabine are planned for this study.

Brief summary: The purpose of this observational study is to provide data on the incidence and severity of infusion-related reactions during and immediately following each infusion of VYXEOS during the first induction.


Eligibility criteria: Inclusion Criteria:

1. The decision to prescribe VYXEOS must have been made prior to enrollment in this study and based upon approved US indications and dosing: 44mg/m2 daunorubicin and cytarabine 100 mg/2 on Days 1, 3, and 5.
2. Ability to understand and voluntarily give informed consent and understand the requirements of the registry.
3. Age ≥ 18 years.
4. Initiating VYXEOS therapy for the first time according to the current prescribing information.
5. Initiating VYXEOS therapy for the first time according to standard institutional practice.

Exclusion Criteria:

1. Prior treatment with VYXEOS.
2. Patients receiving any investigational agent other than VYXEOS (e.g., any drug or biologic agent or medical device that has not received approval in the US) or receiving VYXEOS for any indication not currently approved in the US.

Primary outcomes:
measure: Infusion-Related Reactions on Day 1
timeFrame: Day 1
Secondary outcomes:
measure: Incidence of Infusion-Related Reactions Occurring until One Day after the Last Infusion
timeFrame: 1 day after the last infusion
measure: Changes in Vital Signs
timeFrame: Up to 180 minutes after the start of infusion
measure: Incidence of Treatment-emergent Adverse Events (TEAEs)
timeFrame: 1 day after the last infusion
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Franciscan Physician Network Oncology and Hematology Specialists
state: Indiana
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Hospital & Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
References:
Clinical trial NCT00531726: Berlin Deep Brain Stimulation Depression Study
Official title: Investigation of Efficacy and Safety of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression in a Multicenter, Double-blind, Prospectivly-designed Delayed-onset Study (Tiefe Hirnstimulation Zur Behandlung Therapieresistenter Depressionen-eine Multizentrische, Doppelblinde, Prospektive Studie Mit Einem Delayed-onset Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Depression
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Hospital Carl Gustav Carus
name: Ludwig-Maximilians - University of Munich
name: Hannover Medical School
First posted: 2007-09-19
Enrollment: 11
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.


Eligibility criteria: Inclusion Criteria:

* patient is diagnosed with a severe major depressive episode
* patient is in a chronic current MDE and/or has had a history of recurrent MDEs
* patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode.
* patient has a score \> 20 on the HAMD24
* patient is stable on current psychotropic medication for at least 6 weeks
* patient is \>25 and \<80 years
* Global Assessment of Function (GAF) score of \< 45

Exclusion Criteria:

* Atypical Depression (according to DSM IV)
* Other relevant psychiatric axis I or axis II diseases
* Relevant neurological diseases
* Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score \> 3)
* Patient is currently enrolled in another investigational study not associated with the current study
* Patient has a history of, or evidence of, significant brain malformation or significant head injury
* Patient is likely to require a whole body MRI after implantation

Primary outcomes:
measure: HAMD/MARS score reduction
timeFrame: 4 weeks
Secondary outcomes:
measure: neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitaetsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Malek Bajbouj
role: STUDY_DIRECTOR
References:
Clinical trial NCT04695626: Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small to Medium Rotator Cuff Tear
Official title: Prospective Randomized Controled Study on the Outcome of Greenhouse Tec in the Arthroscopic Treatment of Small and Medium Rotator Cuff Tear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Stimulating
Modified Suture Bridge
Keywords: Rotator Cuff Repair
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the inclusion and exclusion criteria, 40 patients with small to middle rotator cuff injury treated by this technique（Greenhouse tec） in our hospital from September 2020 to December 2021 were included.

Brief summary: This study is aprospective cohort study on the outcome of a combination of bone marrow stimulation and modified suture bridge in the arthroscopic treatment of small and medium rotator cuff tear. The patients with small to medium rotator cuff injuries (less than 3cm in diameter) requiring arthroscopic surgery were collected. The patients were followed up before and 6 weeks, 3 months, 6 months and 12 months after surgery, including pain, functional score, joint range of motion, MRI and CT findings, complications and other quantitative and qualitative indicators. The self-control and intra group analysis were performed to evaluate the treatment effect; and the correlation analysis was performed on the treatment results To determine the important factors affecting the therapeutic effect.


Eligibility criteria: Inclusion Criteria:

* Arthroscopy confirmed small to medium rotator cuff injury
* The data of preoperative functional examination were complete
* Unilateral rotator cuff injury
* Clinical follow-up can be completed

Exclusion Criteria:

* Anterior superior rotator cuff injury with simple subscapular injury or combined subscapular injury
* Previous shoulder surgery (incision or arthroscopy)
* Combined with diseases of other parts of the same limb
* Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
* Bilateral onset
* Unable or unwilling to receive clinical follow-up

Primary outcomes:
measure: American Shoulder and Elbow Surgeons'Form，ASES score
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Integrity of the tendon in MRI
timeFrame: 1 year postoperatively
Other outcomes:
measure: the condition of bone healing in CT
timeFrame: 1 year postoperatively
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan hospital
state: Beijing
Study officials:
affiliation: Sports Medicine Service, Beijing Jishuitan hospital
name: Yi Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01463826: Respiratory Problems and Caries in Children With Bruxism
Official title: Association Between Respiratory Problem and Dental Caries in Children With Bruxism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bruxism
Dental Caries
Keywords: bruxism
children
oral breathing
dental caries
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with either the complete primary or mixed dentition who were not in dental treatment were included in the study and divided into two groups: those with bruxism and those without bruxism. For the diagnosis of bruxism, a questionnaire was administered to determine the occurrence of teeth clenching/grinding and a physical exam was performed for the determination of dental wear based on the criteria of the American Academy of Sleep Medicine. Dental caries were determined based on the criteria of the World Health Organization

Brief summary: The aim of the present study are to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.

Detailed description: Objectives: The aim of the present study was to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.

Method: Patient histories were taken and clinical exams were performed on 90 children for selection and allocation to one of two groups. For the determination of bruxism, a questionnaire was administered to parents/guardians and an oral clinical exam was performed based on the criteria of the American Academy of Sleep Medicine. Thirty-three male and female children between four and seven years of age participated in the present study - 14 children with bruxism and 19 children without bruxism. The data were statistically analyzed using the chi-square test, with level of significance set at 5% (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* Children with either the complete primary or mixed dentition who were not in dental treatment

Exclusion Criteria:

* Children in dental treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nove de Julho University
name: Lara Motta, PhD
role: PRINCIPAL_INVESTIGATOR
References: