louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02277808: Which Apparatus for Inhaled Pentamidine?
Official title: Which Apparatus for Inhaled Pentamidine? A Comparison of Drug Delivery to the Lung Between Two Nebulizers: The Respirgard II and the Isoneb.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Pneumocystis
Nebulizer
Pentamidine
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.


Eligibility criteria: Inclusion Criteria:

* Be in good health

Exclusion Criteria:

* Known Tachycardia
* Renal Dysfunction
* Respiratory Diseases and history

Primary outcomes:
measure: Amikacine urinary dosage
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Clinique universitaire Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Grégory Reychler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oudyi M, Chaumuzeau JP, Diot P, Dubus JC; GAT (Groupe Aerosoltherapie de la SPLF). [Use of pentamidine nebulization in children]. Rev Mal Respir. 2012 May;29(5):656-63. doi: 10.1016/j.rmr.2012.02.003. Epub 2012 Mar 28. French.
citation: McIvor RA, Berger P, Pack LL, Rachlis A, Chan CK. An effectiveness community-based clinical trial of Respirgard II and Fisoneb nebulizers for Pneumocystis carinii prophylaxis with aerosol pentamidine in HIV-infected individuals. Toronto Aerosol Pentamidine Study (TAPS) Group. Chest. 1996 Jul;110(1):141-6. doi: 10.1378/chest.110.1.141.
citation: Kim CS, Garcia L, Wanner A. Actual pentamidine dose delivered by Respigard II nebulizer. Eur Respir J. 1995 Dec;8(12):2178-81. doi: 10.1183/09031936.95.08122178.
Clinical trial NCT01551108: Parent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)
Official title: Parent-targeted Mobile Phone Based Intervention to Increase Physical Activity in Children (P-Mobile)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Children
physical activity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: The Coca-Cola Company
First posted: 2012-03-12
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine if parents can deliver an intervention that will help increase physical activity in their children. The parents will be given the intervention through their mobile phones.

Detailed description: Most children engage in insufficient amounts of moderate-to-vigorous physical activity. These low levels of moderate-to-vigorous physical activity are associated with adverse health consequences including increased risk for obesity, and cardiovascular and diabetes risk factors. Therefore, there is a need for studies that can increase physical activity levels in children. Mobile phones are a way to deliver behavioral interventions. Mobile phones are portable, allow for real-time data collection, and can potentially reach large numbers of people. Text messages can also be utilized to promote behavior change. Few mobile phone based interventions have specifically targeted child physical activity.

The aims of this pilot study were to determine the feasibility and efficacy of a physical activity promotion program targeting 6-10 year old children that is delivered to parents through mobile phones.

Eligibility criteria: Inclusion Criteria:

* Parent must own a mobile phone.
* Parent must use the text (SMS)messaging service on their mobile phone.
* Parent can access the internet on their mobile phone.

Exclusion Criteria:

* Child is 6 through 10 years old.
* Child does not engage in regular physical activity.
* Chile is physically capable of exercising.

Primary outcomes:
measure: Step counts
timeFrame: 3 Months
Secondary outcomes:
measure: Waist circumference, body mass index, blood pressure
timeFrame: 3 Months
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Robert L. Newton, Jr., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pennington Biomedial Research Center
name: Timothy Church, MD,MPH,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newton RL Jr, Marker AM, Allen HR, Machtmes R, Han H, Johnson WD, Schuna JM Jr, Broyles ST, Tudor-Locke C, Church TS. Parent-targeted mobile phone intervention to increase physical activity in sedentary children: randomized pilot trial. JMIR Mhealth Uhealth. 2014 Nov 10;2(4):e48. doi: 10.2196/mhealth.3420.
Clinical trial NCT03512808: A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions
Official title: A Single-dose, Comparative Bioavailability Study of Two Formulations of Ursodiol 500mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-05-01
Enrollment: 77
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: A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions

Detailed description: A single-dose, comparative bioavailability study of two formulations of ursodiol 500mg tablets under fasting conditions: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, male and female subjects, 18 years of age or older
* BMI ≥ 19.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of chilbearing or non-childbearing potential

Exclusion Criteria:

• Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0-72 hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Pharma medica research Inc.
state: Ontario
Study officials:
References:
Clinical trial NCT00171938: Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Official title: Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Glioblastoma
Brain tumors
Imatinib
PDGFR
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label clinical trial of imatinib mesylate 800 mg po/day in a population of patients with unresectable, recurrent glioblastoma multiforme. Patients will be treated for up to 12 months


Eligibility criteria: Inclusion Criteria:

1. Histologically documented diagnosis of GBM.
2. Immunohistochemical documentation of expression of PDGFR.
3. Unresectable, recurrent disease by MRI and spectroscopy

Exclusion Criteria:

1. Treatment with any other investigational agents within 28 days of first day of study drug dosing.
2. Concurrent chemotherapy.
3. Concurrent radiotherapy.

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: PFS (progression free-survival), defined by the percentage of patients without evidence of progressive disease in 6 months
Secondary outcomes:
measure: Objective Tumoral Response defined by RECISt criteria performed by MRI
measure: OS (overall survival)
Other outcomes:
Locations:
city: Rio Grande
country: Brazil
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05700838: Refining Cough Skill Training in Parkinson's Disease and Dysphagia
Official title: Refining Cough Skill Training in Parkinson's Disease and Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Dysphagia
Lead sponsor: Teachers College, Columbia University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Airway protection deficits (cough and swallowing) are prevalent and pervasive in Parkinson's disease (PD), contributing to adverse health outcomes like pneumonia. This study aims to refine cough skill training by examining whether variable versus constant practice conditions improve cough outcomes in people with PD. In addition, this study will provide insight into optimal respiratory adaptations that occur during training to support cough effectiveness, resulting in immediately translatable treatments to improve airway protection-related health outcomes in people with neurodegenerative disease.


Eligibility criteria: Inclusion criteria:

* 40 years of age or older
* have dysphagia as documented by a penetration-aspiration score \> 2 on a flexible endoscopic evaluation of swallowing
* have cough disorder as defined as a maximal voluntary cough peak flow \< 5 L/s
* have no history of other neurological disorders, head and neck cancer, respiratory disease, smoking within 5 years, uncontrolled hypertension, or allergy to capsaicin (reflex cough stimulus)

Exclusion criteria:

* unable to participate due to neuropsychological dysfunction (i.e., dementia with a score of \< 19 on the Montreal Cognitive Assessment)
* actively participating in other cough or swallowing treatments

Primary outcomes:
measure: Change in Peak Expiratory Flow Rate
timeFrame: Before to after two sessions of cough variable practice training over two weeks
Secondary outcomes:
measure: Change in Respiratory Kinematics, specifically lung volume excursion
timeFrame: Before to after two sessions of cough variable practice training over two weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Teachers College, Columbia University
state: New York
Study officials:
References:
Clinical trial NCT01356238: Application of Two Different Synthetic Sequential Media for the Human IVF-Embryo Transfer (IVF-ET) Program
Official title: Application of Two Different Synthetic Sequential Media for the Human IVF-ET Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Maria Fertility Hospital
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 360
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Quality-controlled commercial media have been used in many in-vitro fertilization (IVF) laboratories. However, commercial media are costly and difficult to compare directly because their exact compositions are not clearly indicated. Although commercially available media have commonly been used in most IVF programs worldwide, there are several advantages to the use of in-house synthetic sequential media at IVF laboratories. First, the results of quality control should be reliable due to a stringent protocol setting-up. Second, any direct supplementations or deletions of specific components are feasible to obtain good quality embryos and high pregnancy rates since those components can be defined. Finally, dependence on commercially available media diminishes so that the laboratory can more easily accommodate unexpected situations or problems, such as a sudden increase in IVF patients. Therefore, the present study was conducted to compare the efficacy of in-house MRC media in the human IVF-embryo transfer (ET) program to that of commercially available media.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF treatment in our clinic during study period

Exclusion Criteria:

* Females older than 40 years
* Patients showed fertilization failure
* Patients with less than two 2PN embryos

Primary outcomes:
measure: Embryo Quality
timeFrame: 3 Days
Secondary outcomes:
measure: Pregnancy and Implantation rates
timeFrame: 2 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Maria Fertility Hospital
Study officials:
affiliation: Maria Fertility Hospital
name: Jeong Yoon, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577538: Prevalence of Lymphoma in IBD
Official title: Prevalence and Risk Factor for Lymphoproliferative Disease in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Inflammatory Bowel Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with both Inflammatory bowel disease and lymphoma over the last 30 years.

Brief summary: Patients with inflammatory bowel disease (IBD) may be at increased risk of lymphoma. The majority of lymphomas in patients with IBD occur in areas of active inflammation. The relationship between IBD and lymphoproliferative disease is however unclear, since both chronic inflammation as well as medications used to treat IBD (especially immunosuppressives - Azathioprine or 6-MP - and anti-TNF alpha agents) have been associated with increased risk of lymphoma. We plan to study the association between IBD and lymphoma in a large, mixed, community based and referral population from the IBD database at Indiana University.


Eligibility criteria: Inclusion Criteria:

* Inflammatory Bowel disease
* Lymphoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Michael V. Chiorean, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666938: Telephone Counselling to Promote Physical Activity in Diabetes Mellitus People
Official title: The Use of a Telephone Counselling as a Strategy to Promote Physical Activity in Diabetes Mellitus People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Telephone
Physical activity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effects of phone counselling support as a strategy to increase physical activity in people with diabetes.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus
* age between 18 and 80 years
* both sexes
* medical recommendation for physical activity
* ability to listen and answer questions
* have cell phone and/or residential
* be registered the Center for Family Health 03 in 2012
* People should also produce higher frequency than 75% stake in the proposed activities Diabetes Education Group and telephone counseling

Exclusion Criteria: People who do not attend the criteria for inclusion.

* did not have clinical diagnosis of type 2 diabetes mellitus
* did not have age between 18 and 80 years
* did not have medical recommendation for physical activity
* did not have ability to listen and answer questions
* did not have cell phone and/or residential
* do not be registered the Center for Family Health 03 in 2012
* People who did not participate in 75% of the activities of the Group proposed the Diabetes Education and telephone counseling

Primary outcomes:
measure: level of physical activity
timeFrame: four months
Secondary outcomes:
measure: Metabolic Control
timeFrame: Four Months
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Center for Family Health 03
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Gabriel Guidorizzi Zanetti, graduated
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220138: Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex
Official title: Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 53
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: With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.

Detailed description: Several surgical techniques have been used to alleviate the problem of poor lens visibility. fixed a chandelier illuminator on the sclera, turned off the microscope light source, and visualized the lens by illuminating the vitreous cavity. Furino improved anterior lens capsule visibility by staining it with triamcinolone acetonide. Although both techniques were effective, both had limitations. Vitreous chamber illumination reduces the visibility of the cornea and iris because of the need to turn off the microscope light. Staining the anterior lens capsule with triamcinolone acetonide allows for better anterior chamber visualization but the lenticular nucleus and cortex remain difficult to see.

This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.

Eligibility criteria: Inclusion Criteria:

* cataract with poor red reflex

Exclusion Criteria:

* Eyes that had previous intraocular surgery or trauma were excluded.

Primary outcomes:
measure: number of patients with completion of the capsulorhexis and in-the-bag implantation of an intraocular lens
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
References:
Clinical trial NCT03355638: Treatment of CNV With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3
Official title: Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macular Edema
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a prospective, randomized, pilot study in 60 patients with treatment-naïve choroidal neovascularization. Patients were randomized 1:1:1 into 3 groups: aflibercept monotherapy, aflibercept plus pranoprofen, or aflibercept plus nutraceutical tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.
Primary purpose: TREATMENT

Brief summary: To determine whether a combination of intravitreal aflibercept and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization in age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* provision of written informed consent and compliance with study assessments for the full duration of the study
* age \> 40 years
* presence of treatment-naïve neovascular AMD.

Exclusion Criteria:

* any previous intravitreal treatment
* previous laser treatment in the study eye
* myopia \> 7 diopters in the study eye
* concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
* concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
* known sensitivity to any component of the formulations being investigated.

Primary outcomes:
measure: Central Retinal Thickness (microns)
timeFrame: 12-month
measure: Visual Acuity (LogMAR)
timeFrame: 12-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: