louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03747081: Efficacy Comparison of Warfarin Versus Rivaroxaban CVT
Official title: Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cerebral Venous Thrombosis
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although Rivaroxaban(selective and direct Xa factor antagonist ) has no monitoring and no drug interaction. This study aim to focus on efficacy of Warfarin versus Rivaroxaban.


Eligibility criteria: IInclusion Criteria:

* Patients of both gender
* Age 18 years and higher
* proven CVT on neuro imaging ( MRI-MRV)

Exclusion Criteria:

* Patients suffering from renal failure(GFR\<30) Patients
* Patients with contraindications for oral anticoagulation
* Patient who having pregnancy
* Uncooperative patient for completing the course of treatment

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 3 months
Secondary outcomes:
measure: hemorrhagic rate
timeFrame: 3 months
measure: Stroke
timeFrame: 3 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra University Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Mohammad Saadatnia, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
Clinical trial NCT00601081: Human Milk Fortifier and Cytokine Profile
Official title: Alterations in the Cytokine Profile of Premature Infants After Human Milk Fortifier
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Very Low Birth Weight
Keywords: Very low birth weight infants
HMF
immune system function
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 24
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants hospitalized in the newborn intensive care unit.

Brief summary: This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

Detailed description: In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.

Eligibility criteria: Inclusion Criteria:

* Infants born weighing less than 1500 grams
* exclusive breast milk feedings with intention to fortify with human milk fortifier

Exclusion Criteria:

* positive blood culture
* history of necrotizing enterocolitis
* significant lung disease at the start of the study

Primary outcomes:
measure: Cytokine profile pre and post initiation of HMF
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Hospital
name: Robert G. Locke, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Hospital
name: Christopher T. Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00073281: Islet Transplantation for Patients With Type 1 Diabetes
Official title: Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: diabetes
autoimmunity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Detailed description: We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.

Eligibility criteria: * Patients with type 1 diabetes with stable renal allografts

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
Study officials:
affiliation: Columbia Presbyterian Hospital
name: Mark Hardy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00732381: Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)
Official title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-08-12
Enrollment: 351
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* A subject must be 12 years of age or older, of either sex, and of any race.
* A subject must have at least a 2-year history of SAR which exacerbates during the study season.
* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
* A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
* A subject who is participating in any other clinical study.
* A subject who is part of the staff personnel directly involved with this study.
* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject previously randomized into this study.
* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Primary outcomes:
measure: The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
timeFrame: 15 days of treatment
Secondary outcomes:
measure: The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
timeFrame: 15 days of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
Clinical trial NCT06809881: OLFACTION and BIPOLAR DISODER
Official title: OLFACTION and BIPOLAR DISODER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2025-02-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To compare olfactory performance between patients with BD and HC and correlate their performances to neuroimaging data


Eligibility criteria: Inclusion Criteria:

* Patients with BD and HC
* Fluent in french
* Having a public health insurance
* Not being on tutorship

Exclusion Criteria:

* Family history of bipolar disorder for controls
* Alcohol dependence

Primary outcomes:
measure: Olfactive performance
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Inserm U 955 Eq 15
state: Val de Marne
Study officials:
References:
Clinical trial NCT03467581: Five-year Outcome of Laparoscopic Gastric Sleeve
Official title: Five-year Outcome of Laparoscopic Gastric Sleeve, Resolution of Comorbidities and Risk for Cumulative Nutritional Deficiencies.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgeries
Metabolic Surgery
Keywords: gastric sleeve
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital.

Brief summary: The aim of this study is to evaluate the long-term (5-year follow-up) results of laparoscopic gastric sleeve (LGS) in terms of weight loss and obesity related comorbidities, as well as the risk factors associated with postoperative nutritional deficiencies.

Detailed description: The consecutive patients who undergo LGS for the treatment of morbid obesity at Tartu University Hospital are followed prospectively in cohort study. The outpatient hospital follow-up visits are conducted at 3 months, 1 year and 5 years postoperatively.

Eligibility criteria: Inclusion Criteria:

* The criteria for bariatric surgery: BMI of \>40, or \>35 with certain obesity related comorbidities

Exclusion Criteria:

* Patients who did not fill the inclusion criteria

Primary outcomes:
measure: Five-year outcome of laparoscopic gastric sleeve
timeFrame: 5-year follow-up
Secondary outcomes:
measure: Five-year outcome of laparoscopic gastric sleeve
timeFrame: 5-year follow-up
measure: Five-year outcome of laparoscopic gastric sleeve
timeFrame: 5-year follow-up
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
References:
Clinical trial NCT01197781: Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
Official title: An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers When Fostamatinib Disodium 150 mg is Administered Alone and in Combination With Verapamil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interactions
Healthy Volunteers
Keywords: Phase I
FosD
fostamatinib disodium
verapamil
healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This Study evaluates the possible drug interaction between FosD and verapamil when taken together.

Detailed description: An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with Verapamil.

Eligibility criteria: Inclusion Criteria:

* Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive.
* Females must be of non-childbearing potential

Exclusion Criteria:

* History of clinically significant disease or disorder or presence of GI, hepatic or renal disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the drug
* Any clinically significant abnormalities in lab safety tests or vital signs as results as judged by the Investigator
* Use of prescription or over-the-counter drugs within 2 weeks of first administration of investigational product
* Current smokers or use of nicotine products within 1 month prior to enrollment

Primary outcomes:
measure: To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
timeFrame: Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD
Secondary outcomes:
measure: To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
timeFrame: Screening, throughout both treatment periods, and follow-up.
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Recruiting Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Mark Layton, MD
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Carlos Prendes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04023981: Parafricta Bootees vs UK Standard Care to Prevent Heel Pressure Ulcers
Official title: Parafricta Bootees Compared to UK Standard Care to Prevent Heel Pressure Ulcers: a Multicentre Pragmatic Randomised Controlled Trial With Blinded Assessment at Three Days and at Fourteen Days.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Pressure Injury
Heel Ulcer
Keywords: Parafricta
Pressure ulcer
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: Welsh Wound Innovation Centre
First posted: 2019-07-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomised study will assess whether Parafricta bootees, when used in addition to normal standard care, can reduce the incidence of heel PUs in patients at very high risk of skin breakdown. The participant group will be hospital inpatients at high risk of PUs (Waterlow score of 20 or more) who are bedbound and do not have existing heel PUs. The participants will be randomised to an intervention arm using Parafricta plus standard care, or a control arm of standard care only. The primary outcome is incidence of heel PUs at day 3. Secondary outcomes are incidence of PUs at day 14, length of stay, severity of PUs, patient acceptability of device, cost-effectiveness.


Eligibility criteria: Inclusion Criteria:

The eligibility criteria for this study at the time of recruitment were:

* Adult of age 18 years or over
* Admitted to secondary care in an in-patient hospital (with no specified interval from admission to hospital to study recruitment)
* Bedbound or unable to walk independently and requiring assistance to transfer to a chair
* 'Very high' risk group for pressure ulceration (defined by a Waterlow Score of 20 or more)
* No existing heel pressure ulcers of EPUAP/NPUAP/PPPIA Category 1 or above or any other type of wound on the feet.
* Patient was not being treated with pressure offloading boots.
* Patient was not being treated with a heel cast.

Exclusion Criteria:

• Patients with a single or double lower limb amputation were not eligible to participate in the study.

Primary outcomes:
measure: Incidence of heel pressure ulcers of EPUAP NPUAP/PPPIA Category 1 or above
timeFrame: Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cedar, Cardiff & Vale University Health Board
Study officials:
affiliation: Cedar, Cardiff & Vale University Health Board
name: Grace Carolan-Rees, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02610881: Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children
Official title: Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: International Food Policy Research Institute
First posted: 2015-11-20
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study seeks to assess the acceptability, compliance, and preference for iron supplementation; micronutrient powders (MNP) versus iron syrup. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.

Detailed description: The specific aims of this study are to assess the acceptability of, compliance, and preference for two delivery vehicles for pediatric prophylaxis iron supplementation (micronutrient powders (MNP) that contain iron versus iron syrup) among rural households in Bihar India delivered through home visits by front line health workers. Additionally, this study seeks to assess front line health worker perceptions and experiences regarding ease of implementation of each strategy and delivery strategy preference.

Eligibility criteria: Inclusion Criteria:

* Singleton Children or one child per home

Exclusion Criteria:

* Currently taking iron supplements
* Mid upper arm circumference (MUAC) or less than 11.5 cm
* Suspected severe anemia
* Known case of haemoglobinopathy
* History of repeated blood transfusion
* Current pneumonia
* Current fever
* Acute diarrhea

Primary outcomes:
measure: Acceptability of iron and folic acid (IFA) syrup
timeFrame: Endline (Up to 5 months)
measure: Acceptability of micronutrient powders (MNP)
timeFrame: Endline (Up to 5 months)
measure: Preference for vitamin supplementation
timeFrame: Endline (Up to 5 months)
measure: Vitamin supplementation compliance
timeFrame: Baseline, Endline (Up to 5 months)
Secondary outcomes:
measure: Change in perceived barriers to vitamin supplementation
timeFrame: Baseline, Endline (Up to 5 months)
measure: Preferred method of distribution
timeFrame: Endline (Up to 5 months)
Other outcomes:
Locations:
city: Patna
country: India
facility: CARE-India
state: Bihar
Study officials:
affiliation: Emory University
name: Melissa Young, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young MF, Girard AW, Mehta R, Srikantiah S, Gosdin L, Menon P, Ramakrishnan U, Martorell R, Avula R. Acceptability of multiple micronutrient powders and iron syrup in Bihar, India. Matern Child Nutr. 2018 Apr;14(2):e12572. doi: 10.1111/mcn.12572. Epub 2017 Dec 6.
Clinical trial NCT06305481: Glaucoma Evaluation With the P200TE
Official title: Glaucoma Evaluation With the P200TE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 75
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Images captured on the P200TE device on glaucoma patients


Eligibility criteria: Inclusion Criteria

* Subjects were 22 years of age or older on the date of informed consent;
* Subjects were able to understand the written informed consent and willing to participate as evidenced by signing the informed consent;
* BCVA 20/40 or better in the study eye;
* History of visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:

On pattern deviation (PD), there existed a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; or Glaucoma hemi-field test "outside normal limits;"

-Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage; and Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.

Exclusion Criteria

* Subjects unable to tolerate ophthalmic imaging;
* Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
* Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* No reliable visual field test result within the past year of the study visit, defined as fixation losses \> 33% or false positives \>33%, or false negatives \>33% in the study eye;
* Presence of any ocular pathology except glaucoma in the study eye.

Primary outcomes:
measure: Number of images collected
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cajon
country: United States
facility: Werner Optometry
state: California
city: Bellevue
country: United States
facility: Specialty Eyecare Centre
state: Washington
Study officials:
References: