louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02040350: Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning?
Official title: Study Effect of WHO Recommended Dose of Pralidoxime in the Treatment of Organophosphorus Poisoning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Deaths
Keywords: Pralidoxime, atropine, organophosphorous poisoning.
Lead sponsor: Sheri Kashmir Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of Pralidoxime, a drug used for treatment of pesticide poisoning (Organophosphorous poisonings)

Detailed description: The present study was designed to critically analyze the role of pralidoxime in patients with moderate to severe poisoning by dividing them into two comparable groups in all aspects and using WHO recommended dose of pralidoxime (30mg/kg bolus I.V over 20 min followed by 8mg/kg/hr continuous infusion). This dose and continuous infusion protocol is more likely to maintain adequate blood concentrations of pralidoxime throughout 24 hours and thus would avoid any failures in effectiveness of pralidoxime because of inconsistent blood levels.

Eligibility criteria: Inclusion Criteria:

history of alleged organophosphorus intake age \> 14 years \< 60 years clinical signs and symptoms of organophosphorus poisoning.

Exclusion Criteria:

\< 14 years or \> 60 years of age known pregnancy pralidoxime administration at the transferring hospital carbamate poisoning any chronic illnesses

≥ 12 hour interval from time of poisoning to initiation of treatment pre-hospital cardiac or respiratory arrest.

Primary outcomes:
measure: mortality rate
timeFrame: upto one year
Secondary outcomes:
measure: duration of ventilation
timeFrame: upto one year
Other outcomes:
measure: duration of ICU stay
timeFrame: upto one year
Locations:
city: Srinagar
country: India
facility: Sheri kashmir insititute of medical sciences
state: Srinagar Kashmir
Study officials:
affiliation: SKIMS
name: Showkat Gurcoo, MD
role: STUDY_DIRECTOR
References:
citation: Eddleston M, Buckley NA, Eyer P, Dawson AH. Management of acute organophosphorus pesticide poisoning. Lancet. 2008 Feb 16;371(9612):597-607. doi: 10.1016/S0140-6736(07)61202-1.
Clinical trial NCT03643250: Effects of Varying Portion Size and Palatability on Food Intake of Preschool Children
Official title: Lunch Feeding Study for Preschool Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feeding Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-08-22
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to determine the effect of varying both the portion size and the appeal (palatability and presentation) of foods served to preschool children at a meal on the outcomes of food and energy intake at the meal.


Eligibility criteria: Inclusion Criteria:

* Children who are enrolled in a scheduled classroom of the designated childcare centers

Exclusion Criteria:

* Children who are allergic to any of the foods served
* Children whose diets exclude any of the foods served
* Children who will not be present at the childcare center for all of the scheduled study days

Primary outcomes:
measure: Difference between interventions in meal energy intake
timeFrame: Study weeks 1, 2, 3, 4, and 5
Secondary outcomes:
measure: Difference between interventions in food intake
timeFrame: Study weeks 1, 2, 3, 4, and 5
measure: Difference between interventions in meal energy density
timeFrame: Study weeks 1, 2, 3, 4, and 5
Other outcomes:
measure: Liking of food served at the meal
timeFrame: Study week 6
measure: Preference of plate and vegetables served at the meal
timeFrame: Study week 6
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior, The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00716950: Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients
Official title: Evaluation of Antihypertensive Activity of Valsartan and Amlodipine Compared to Losartan and Amlodipine Through Ambulatory Blood Pressure Monitoring in Moderate Hypertensive Patients in a Randomized, Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 187
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.


Eligibility criteria: Inclusion Criteria:

* diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure \> 140 mmHg at the end of the selection period

Exclusion Criteria:

* type 2 diabetes mellitus
* heart failure
* AMI in the previous 6 months
* angina pectoris
* secondary hypertension
* malignant hypertension
* women child-bearing potential
* women who are pregnant and lactating
* suspected history of allergy to the sartans or calcium channels blockers

Primary outcomes:
measure: 24 hours mean, determinated through ABPM; diastolic mean after 4 weeks of losartan 100mg/amlodipine 5mg and valsartan 160mg/amlodipine 5mg treatment
timeFrame: after 4 weeks
Secondary outcomes:
measure: 24 hours systolic mean, determinated through ABPM; day systolic and diastolic mean determinated through ABPM; night systolic and diastolic mean determinated through ABPM
timeFrame: after 4 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Giuseppe Derosa
Study officials:
affiliation: University of Pavia
name: Roberto Fogari, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04973150: Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
Official title: Study on the Effect of Eye-covering Pretreatment on Acute Delirium After General Anesthesia in Pre-school Aged Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ophthalmology
Keywords: Pre-school Aged Children
Acute Delirium
Eye-covering Pretreatment
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 350
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Participants (preschool children), because their cognitive ability and anti pressure ability are obviously weaker than adults, most of the children who have this kind of operation and anesthesia stressors will have perioperative anxiety. After eye surgery, they need to bandage their eyes with gauze (single or double), so that the participants are in a state of complete or partial darkness for a certain period of time, which is easy to produce dark phobia. In clinical practice, investigators found that more than 80% of children with advanced ophthalmology were prone to leprosy, resistance, crying and other symptoms after general anesthesia, which brought greater difficulties to nursing. How to improve the cognitive ability of preschool children, reduce the anxiety level of children during the perioperative period, the incidence of postoperative detention and the difficulty of nursing are new topics worthy of exploration.


Eligibility criteria: Inclusion Criteria:

1. Ages 3-7;
2. Selective ophthalmological general anesthesia (static inhalation compound: propofol + fentanil intravenous administration; heptaflurane inhalation);
3. No mental disorders, stunting and low intelligence;
4. There is no other history of surgical hospitalization.

Exclusion Criteria:

1. Those who have completed the operation under local anesthesia;
2. People with visual impairment of both eyes;
3. Eyeball removal and/or eye socket implanter;
4. Hearing and language impairment cannot communicate normally;
5. Have a history of taking psychotropic drugs;
6. People with severe organs such as the heart, lungs, brains and kidneys.

Primary outcomes:
measure: Anxiety
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: peifang Dong
Study officials:
References:
citation: Dong PF, Qiao DN, Chen HL, Lu SH, Qu SH, Wu YT, Zhao D, Wan T. Effect of Different Durations of Eye-Covering Pretreatment on Emergence Delirium after Ophthalmic Surgery in Preschool-Aged Children: A Randomized Controlled Study. J Ophthalmol. 2022 Sep 16;2022:3656148. doi: 10.1155/2022/3656148. eCollection 2022.
Clinical trial NCT03144050: Optical Imaging For Assessment of Foot Perfusion
Official title: Optical Imaging For Assessment of Foot Perfusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcer Foot
Diabetes
Lead sponsor: Modulated Imaging Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2017-05-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person at risk for foot ulcer formation

Brief summary: This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.

Detailed description: This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Pregnant/lactating women
* Rheumatoid arthritis

Primary outcomes:
measure: Clinical risk category
timeFrame: immediate
Secondary outcomes:
measure: Ulcer incidence
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
Study officials:
References:
Clinical trial NCT00222950: Concentration of Plant Sterols in Serum and Aortic Valve Cusps
Official title: Concentrations of Plant Sterols in Serum and Aortic Valve Cusps: a Prospectiv Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: plant sterols, serum, aortic valve cusps
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This study investigates the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations of plant sterols. We assume that consumption of margarine supplemented with plant sterol esters increases serum and cardiovascular tissue concentrations of plant sterols (sitosterol; campesterol).

Detailed description: The role of plant sterols in cardiovascular diseases is controversially debated. There is an increasing body of evidence that indicates that increased plant sterol serum concentrations are correlated with an increased cardiovascular risk. Functional foods such as margarines supplemented with plant sterol esters are advertised to patients with hypercholesterolemia. Numerous studies show that margarines supplemented with plant sterol esters reduce serum cholesterol concentrations significantly. However, there are no studies available investigating relevant clinical endpoints. Nor are there any studies availabe investigating the effect of the consumption of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations. This study is done to investigate the effect of margarines supplemented with plant sterol esters on serum and cardiovascular tissue concentrations.

Eligibility criteria: Inclusion Criteria: aortic valve stenosis -

Exclusion Criteria:familial hypercholesterolemia.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University of the Saarland
state: Saarland
Study officials:
affiliation: University of the Saarland
name: Michael Bohm, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weingartner O, Lutjohann D, Ji S, Weisshoff N, List F, Sudhop T, von Bergmann K, Gertz K, Konig J, Schafers HJ, Endres M, Bohm M, Laufs U. Vascular effects of diet supplementation with plant sterols. J Am Coll Cardiol. 2008 Apr 22;51(16):1553-61. doi: 10.1016/j.jacc.2007.09.074.
Clinical trial NCT01196650: Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Official title: A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
Lead sponsor: Intec Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo


Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 18 and 65 years of age
* Subjects that meet DSM IV diagnostic criteria for Insomnia
* Subjects that report a time in bed NLT 6.5 and NMT 9 hours
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep \>1.0 hour
* Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
* On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
* On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
* On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights

Exclusion Criteria:

* Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
* Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
* Subject with a history (past year) of alcohol or substance abuse
* Subject that needs to smoke during the sleep period time
* Subject that reports habitual napping (more than 3 times per week)

Primary outcomes:
measure: Wake after sleep onset
Secondary outcomes:
measure: Objective and Subjective sleep parameters
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References:
Clinical trial NCT00846950: Effects of H1-Antagonist on Cognition
Official title: Effects of H1-Antagonist on Stages of Human Information Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Keywords: H1-antagonist
Event Related Potentials
Memory
Information processing
The effects of an H1 antagonist (dexchlorpheniramine) on human cognition
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.

Detailed description: The neurotransmitter histamine appears to be involved in human cognitive performance. However, the exact role is very unclear. The role it plays in memory performance is highly disputed, as animal studies show decreased performance when the H1-receptor is blocked in the central nervous system while such findings in humans is scarce. To clarify the role of histamine in human memory and different processes in cognition, the effects of an H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are measured. The study will be conducted according to a within subject cross-over design using healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy as determined by a physician

Exclusion Criteria:

* present or history of any neurological of psychiatric disease
* present or history of any substance abuse

Primary outcomes:
measure: P300 latency and LRP onset latency
timeFrame: 1.5 hours after treatment
Secondary outcomes:
measure: Words recalled
timeFrame: 1.5 hours after treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Faculty of Psychology and Neuroscience, Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University hospital
name: Annemiek Vermeeren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00183950: Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy
Official title: Phase I/II Study of Noscapine for Patients With Low Grade Non Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Refractory to Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 12
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 is for patients with non-hodgkin's lymphoma or chronic lymphocytic leukemia, which has failed to shrink or has returned after previous treatment with chemotherapy. The purpose of this study is to find out whether patients with these types of cancer will have their tumor shrunk after treatment with a drug called Noscapine. The second purpose is to see what are the side effects of this drug. This drug is being used as an over-the-counter cough suppressor in Europe and Japan, but has also shown to be effective against cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with low grade NHL (follicular lymphoma, small cell lymphocytic lymphoma, marginal cell lymphoma, monocytoid B-cell lymphoma, MALT lymphoma, plasmacytoid lymphocytic lymphoma) or chronic lymphocytic leukemia who have demonstrated chemotherapy resistance (have not achieved CR,CRu, PR)or who have relapsed at any time following a response (CR, CRu, PR) after at least one therapy regimen, including chemotherapy, Rituximab, or high dose chemotherapy with stem cell rescue.
* Karnofsky performance status 60 % or greater.
* Creatinine less or equal to 2.0 mg/dl, bilirubin less or equal to 2.0 mg/dl, SGPT/SGOT less or equal to 4 x upper normal range

Exclusion Criteria:

* Patients with unconfirmed complete response(CRu)after last treatment and who currently remain in CRu.
* Pregnant or lactating women.
* Disease-specific treatment less than 1 month prior to starting this study.
* CNS disease.
* HIV-positive patients.
* Other cancer, except basal cell or squamous cell cancer of the skin or carcinoma in-situ of cervix.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
Study officials:
References:
Clinical trial NCT01487850: Wind Instruments' Fungal Contamination
Official title: Study of Wind Reed Instruments' Fungal Contamination and Its Immunological and Clinical Consequences for Musicians.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunologically-induced Lung Disease
Hypersensitivity Pneumonitis
Keywords: wind instruments
molds
hypersensitivity pneumonitis
fungal contamination of wind instruments
specific antibodies against molds in musicians' sera
musicians
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2011-12-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the investigators supposed that wind reed instruments could be contaminated with molds. The investigators led a study on 40 musicians playing a wind reed instrument to analyze instruments' fungal contamination and its immunological and clinical consequences for musicians.


Eligibility criteria: Inclusion Criteria:

* must be 18 year old or more
* must play a wind reed instrument (saxophone, clarinet, bassoon or oboe) one hour per week or more

Exclusion Criteria:

* refuse to sign consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: Centre Hospitalier Universitaire Saint Jacques
state: Franche Comté
Study officials:
References:
citation: Lodha S, Sharma OP. Hypersensitivity pneumonitis in a saxophone player. Chest. 1988 Jun;93(6):1322. doi: 10.1378/chest.93.6.1322. No abstract available.
citation: Metzger F, Haccuria A, Reboux G, Nolard N, Dalphin JC, De Vuyst P. Hypersensitivity pneumonitis due to molds in a saxophone player. Chest. 2010 Sep;138(3):724-6. doi: 10.1378/chest.09-2991.