louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01151904: Study of Brimonidine and Timolol Ophthalmic Solution With Latanoprost Compared With Latanoprost in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma, Angle-Closure
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of patients switched from latanoprost monotherapy to a combination therapy of latanoprost with COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) for chronic angle closure glaucoma.


Eligibility criteria: Inclusion Criteria:

* Patient has been administering latanoprost eye drops in affected eye(s) for at least 12 weeks prior to study
* Patient must have at least partially responded to latanoprost and requiring further IOP lowering eye drops
* Diagnosis of chronic angle-closure glaucoma
* Patients using COMBIGAN® in the past must not have been discontinued due to adverse events or lack of efficacy.

Exclusion Criteria:

* Known allergy or hypersensitivity to COMBIGAN®
* Corneal abnormalities that would preclude accurate IOP readings
* Any other active ocular disease other than glaucoma or ocular hypertension
* Ocular surgery within the past 3 months.

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in IOP
timeFrame: Baseline, Week 2, Week 6
measure: Percentage of Responders With an IOP Reduction ≥20% From Baseline
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06327204: Efficacy of Different Low Level Laser Therapy Sessions
Official title: Efficacy of Different Low Level Laser Therapy Sessions in Management of Masseter Muscle Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Trigger Point Pain, Myofascial, Laser therapy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 90
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: Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function.

Detailed description: Low-level laser therapy has been a research focus in past few years as it provides effective and conservative treatment modality with minimal patient discomfort. LLLT promotes the release of endogenous opioids, enhance tissue repair and cellular respiration, increase vasodilatation and pain relief Recent systematic review and meta-analysis had reported that the available evidence didn't allow clinicians to draw firm conclusions on effective dosage. This study aimed to investigate the effect of different LLLT sessions' number on pain, maximum mouth opening and quality of life in patients with masseter muscle trigger points.

Eligibility criteria: Inclusion Criteria:

1. definite diagnosis of myofascial pain based on the DC/TMD criteria with a referral
2. presence of one or more trigger points in the masseter muscle
3. no history of any invasive procedures of the related masseter muscle.

Exclusion Criteria:

1. any painful conditions affecting the orofacial region
2. any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy)
3. pregnancy and lactation.

Primary outcomes:
measure: pain score
timeFrame: 8 weeks
Secondary outcomes:
measure: maximum mouth opening
timeFrame: 8 weeks
measure: quality of life questioner
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, October 6 University
Study officials:
affiliation: faculty of dentistry, October 6 University, Egypt
name: amany Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.
citation: Maia ML, Bonjardim LR, Quintans Jde S, Ribeiro MA, Maia LG, Conti PC. Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci. 2012 Nov-Dec;20(6):594-602. doi: 10.1590/s1678-77572012000600002.
Clinical trial NCT05408104: Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients
Official title: Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Heart Assist Device
Hyponatremic
Keywords: Tolvaptan
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients at University of Chicago Medical Center (UCMC) being followed by the advanced heart failure group that are planned to undergo LVAD implantation.

Brief summary: This research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with Left Ventricular Assist Device (LVAD). The study will compare the outcomes of LVAD patients with low sodium levels who take Tolvaptan to those who do not take Tolvaptan. Tolvaptan is FDA approved for use in the study population and is commonly used to treat low sodium levels in heart failure and LVAD patients. It is not known if taking Tolvaptan or not taking Tolvaptan is better at improving outcomes in newly implanted LVAD patients with low sodium levels. By doing this study, the Principal Investigator (PI) hopes to learn which is better at improving outcomes.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with American College of Cardiology (ACC) and the American Heart Association (AHA) Stage D heart failure and plan to undergo LVAD implantation
* Age greater than or equal to 18 years old

Exclusion Criteria:

* No plan for LVAD implantation
* Age less than 18 years old

Primary outcomes:
measure: Increase in Na level from the first post-operative day of hyponatremia, defined as Na < 135 mEq/L, to one-month follow-up.
timeFrame: one month
measure: Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Gene Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01878604: Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia
Official title: The Study of Gene Analysis and Treatment Optimization in Chinese Homozygous Familial Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Homozygous Familial Hypercholesterolemia

Brief summary: Identify new or novel genes which may impact on cholesterol level, and establish the relationship between those gene mutations with atherosclerosis, as well as responses to lipid-lowering drugs.

Detailed description: To better understand the genetics basis for LDL-C elevation and develop an optimized lipid-lowering strategy, we propose to do the following studies:

1. To establish a China HoFH registry, and collect DNA and blood samples from all available family members of each proband (pedigrees);
2. To detect gene mutations known to cause FH and identify family suitable for future whole genome sequencing aimed to identify novel genes controlling cholesterol levels.

3.To establish the relationship between types of gene mutations and lipid and atherosclerosis profile, as well as responses to lipid-lowering agents.

Eligibility criteria: Inclusion criteria:

Patients of any age and sex who meet clinical or genetic criteria for hoFH as follows:

* Cutaneous xanthomata before the age of ten years
* LDLC \> 13 mmol/L before treatment or \> 7.76 mmol/L despite treatment
* Phenotypic features in keeping with HeFH in both parents

Exclusion criteria:

Inability of patient, or, if less than 18, a parent, to sign informed consent.

Primary outcomes:
measure: Number of LDLR Gene Mutations
timeFrame: 1 year
Secondary outcomes:
measure: LDL-C Reduction Percentage
timeFrame: pre-treatment and 6-13 years post treatment
Other outcomes:
Locations:
city: Changsha
country: China
facility: Cardiology department of 2nd Xiangya Hospital
state: Hunan
Study officials:
affiliation: Central South University
name: Shuiping Zhao, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02211404: Children's Sleep in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Admitted to the Intensive Care Unit
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 11
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children admitted to the Intensive Care Unit

Brief summary: Prospective evaluation of sleep in children admitted to the Intensive Care Unit at Nationwide Children's Hospital to determine how children sleep while admitted to the Intensive Care Unit


Eligibility criteria: Inclusion Criteria:

* Any patient admitted to the Intensive Care Unit, or soon to be admitted to the ICU
* Age from 0 days to 17 years 364 days at the time of enrollment
* Any patient with anticipated ICU stay of at least overnight with a minimum of 12 hours duration

Exclusion Criteria:

* Any patient with Admitted with Traumatic Brain Injury, Admitted with an Active Seizure Disorder, Severe Developmental Delay that might impair normal sleep architecture, Known abnormal EEG, any patient actively receiving Mechanical Ventilation

Primary outcomes:
measure: Total Sleep Time
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01575704: Physical Exercise Therapy in Pediatric Stem Cell Transplantation
Official title: Physical Exercise Therapy in Pediatric Stem Cell Transplantation (BISON- Bewegungstherapie in Der Pädiatrischen Stammzelltransplantation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoetic Stem Cell Transplantation
Keywords: Exercise
Hematopoetic cell transplantation
Children
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Institut für Sportwissenschaften, Frankfurt
name: Fresenius University of Applied Science
First posted: 2012-04-11
Enrollment: 68
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this randomized controlled two-part study examines the effects of a structured sports intervention before, during and after hematopoetic stem cell transplantation (hsct) in children and adolescents.

The main aspects in the sports groups are resistance, endurance and flexibility training. The control group performs a mental training as well as relaxation exercises.


Eligibility criteria: Inclusion Criteria:

* Indication for hsct
* Informed consent signed

Exclusion Criteria:

* Contraindication for exercise
* Age \< 5 years
* Insuperable language barrier
* Orthopeadical, cardiological or neurological indication for physical therapy

Primary outcomes:
measure: Muscle strength
timeFrame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Secondary outcomes:
measure: Fatigue
timeFrame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
measure: Biomarker in blood
timeFrame: daily
measure: Body composition
timeFrame: one time per week and change between 3 months and 6 months after transplantation
measure: Endurance performance
timeFrame: change between hospital admission and discharge (approximately 4-6 weeks) and 3 months and 6 months after transplantation
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Children's Hospital
state: Hessen
Study officials:
References:
citation: Senn-Malashonak A, Wallek S, Schmidt K, Rosenhagen A, Vogt L, Bader P, Banzer W. Psychophysical effects of an exercise therapy during pediatric stem cell transplantation: a randomized controlled trial. Bone Marrow Transplant. 2019 Nov;54(11):1827-1835. doi: 10.1038/s41409-019-0535-z. Epub 2019 May 14.
Clinical trial NCT00928304: Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
Official title: An Open-Label, Non-Randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection of Cerebral ß-Amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Down Syndrome
Amyloid Beta-protein
Keywords: Amyloid beta-protein
Down Syndrome
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.


Eligibility criteria: Inclusion Criteria:

Study participants were individuals with DS and healthy volunteers (HVs).

* Main inclusion criteria for individuals without DS

  * \>=21 and \<= 40 years of age
  * Mini-Mental State Examination (MMSE) \>= 28
  * Clinical Dementia Rating (CDR) of 0
* Main inclusion criteria for individuals with DS

  * \>= 40 years of age

Exclusion Criteria:

* Main exclusion criteria for both groups

  * Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time

Primary outcomes:
measure: Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome
timeFrame: 100-120 min
Secondary outcomes:
measure: Sensitivity Results in the Down Syndrome Age Subgroups
timeFrame: 100 - 120 min
measure: Quantitative Parameters Standard Uptake Value Ratio
timeFrame: 100 - 120 min p.i.
measure: Consistency Between Visual and Quantitative Efficacy
timeFrame: 100 - 120 min
Other outcomes:
Locations:
city: Sun City
country: United States
state: Arizona
city: New Haven
country: United States
state: Connecticut
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6.
Clinical trial NCT02266004: Transcranial Direct Current Stimulation for Freezing of Gait
Official title: Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson's Disease
Keywords: transcranial direct current stimulation
neuromodulation
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).


Eligibility criteria: Inclusion Criteria:

1. age 18- 80
2. Parkinson's disease stages 2-3 Hoehn and Yahr.
3. Presence of Freezing of Gait
4. Stable medication regimen
5. Time to complete TUG \>12 seconds

Exclusion Criteria:

1. medical condition that would interfere with walking and training for 30 minutes
2. unable to perform timed up and go in the off condition
3. history of seizures
4. implanted deep brain stimulator, pacemaker or any other electronic device.
5. dementia
6. Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation

Primary outcomes:
measure: Change in Walking Speed
timeFrame: baseline, 3 weeks
Secondary outcomes:
measure: Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: baseline, 3 weeks
measure: Change in Stride Length
timeFrame: baseline, 3 weeks
measure: Change in Postural Sway
timeFrame: baseline, 3 weeks
measure: Change in Timed Up-and-Go (TUG) Time
timeFrame: baseline, 3 weeks
measure: Change in Motor Threshold
timeFrame: baseline, 3 weeks
measure: Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
timeFrame: baseline, 3 weeks
measure: Change in Backward Digit Span
timeFrame: baseline, 3 weeks
measure: Change in the Trail Making Test Time
timeFrame: baseline, 3 weeks
measure: Change in the Montreal Cognitive Assessment (MOCA)
timeFrame: baseline, 3 weeks
measure: Change in the Auditory Consonant Trigrams Test (ACT)
timeFrame: baseline, 3 weeks
measure: Change in the Freezing of Gait Questionnaire (FOG-Q)
timeFrame: baseline, 3 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Corneliu Luca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03848104: Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections
Official title: Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibiotic Reaction
Bone and Joint Infection
Keywords: cefoxitin
Bone and Joint Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration managed at the Croix-Rousse Hospital

Brief summary: Cephamycin related to 2nd generation cephalosporins, the use of cefoxitin has long been limited to antibiotic prophylaxis. Because of its spectrum (sensitive staphylococci, enterobacteria including ESBL, streptococci, anaerobes), its stability and its low cost, it could be useful in curative bone and joint infections, especially in case of infection polymicrobial disease in patients for whom antibiotic alternative per os is limited.


Eligibility criteria: Inclusion Criteria:

* patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration

Exclusion Criteria:

-

Primary outcomes:
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: Rate of use of this strategy
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Tristan Ferry, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03428204: Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment
Official title: Effect of Different Inflation Times on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoropopliteal Arterial Stenosis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The effect of two balloon inflation times will be evaluated in peripheral balloon angioplasty
Primary purpose: TREATMENT

Brief summary: Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30 sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a time consuming and expensive stent placement or balloon redilatation. The effect of different balloon inflation times has only been assessed ones in peripheral balloon angioplasty with better outcomes after prolonged balloon inflation.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic atherosclerotic stenotic lesions of the femoropopliteal artery suitable for angioplasty in the adult population

Exclusion Criteria:

* Artery lesions shorter than 1 cm and longer than 10 cm length, total occlusions, severe calcification, previous angioplasty with current restenosis, previous stenting with current insistent restenosis and subintimal recanalization of the lesion
* No pregnant and nursing women will be included.

Primary outcomes:
measure: Number of residual stenosis between both groups
timeFrame: at 3 or 5 minutes
Secondary outcomes:
measure: Number of redilatation or additional stenting between both groups
timeFrame: at 3 or 5 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Parla Astarci, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: