louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02072629: HCU: Can VHVs Trained in ICCM Improve Care for Children
Official title: Healthy Child Uganda: Can Village Health Volunteers Trained in Integrated Community Case Management of Childhood Illness Improve Access to Care for Africa's Most Vulnerable Children?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea
Pneumonia
Malaria
Keywords: Antimalarials
Antibiotics
ORS Zn
Village Health Volunteers
Integrated Community Case Management
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2014-02-26
Enrollment: 4071
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess how the current VHV (VHV=CHW, community health worker) scope can be expanded to include iCCM and if such group interventions can provide improved access to treatment for children.

In rural SW Uganda, can iCCM provided by lay volunteers, increase the proportion of children with diarrhoea receiving ORS/Zn, ARI receiving anti-biotics, and fever/malaria receiving anti-malarials?


Eligibility criteria: Inclusion Criteria:

* Women living in intervention and comparison villages
* Mother to at least one child under 59 months old

Exclusion Criteria:

-No living child

Primary outcomes:
measure: Absolute change pre/post intervention (VHV ICCM training) in proportion of U5s receiving (a) antimalarial for fever (b) ORS/Zn for diarrhea (c) Abx for pneumonia
timeFrame: pre- (Dec 2010) post- (Dec 2012) intervention (2 years)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mbarara University of Science and Technology
name: Samuel Maling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: jenn Brenner, MD
role: STUDY_DIRECTOR
References:
citation: Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.
Clinical trial NCT06392529: Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
Official title: Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients suffering from vulvovaginal candidiasis albicans

Brief summary: To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days.

Detailed description: The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups:

Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:

Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.

Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.

Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses

Eligibility criteria: Inclusion Criteria:

* Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species.

Exclusion Criteria:

* Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans.

Primary outcomes:
measure: efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms
timeFrame: 1Month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Beni-Suef University Teaching Hospital
Study officials:
References:
Clinical trial NCT01102829: Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design
Official title: Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Knee Joint
Arthroplasty
Replacement
Knee
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).


Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
* Patient is capable of giving informed consent and expressing a willingness to comply with this study
* Patient has no major deformities
* The ability to perform a lunge and step-up motion without the help of bars or a cane.
* No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)

Exclusion Criteria:

* The patient is unable or unwilling to sign the Informed Consent specific to this study
* The individual has a functional impairment of any other lower extremity joint besides the operated knee
* Patient has a flexion contracture of more than 15°
* Patient has a varus/valgus contracture of more than 15°
* Patients requiring revision arthroplasty
* The patient does not understand the Dutch or English language good enough to participate.
* The use of walking aids
* The inability to walk more than 500 meters

Primary outcomes:
measure: Migration
timeFrame: 24 months post-operatively
Secondary outcomes:
measure: anterior-posterior translation patterns
timeFrame: 6 months post-operatively
measure: Axial rotation patterns
timeFrame: 6 months post-operatively
measure: Muscle activity
timeFrame: 6 months post-operatively
measure: Shear forces
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Rob GH Nelissen, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01713829: Cranberry Consumption Improves γδ T Cell Function
Official title: Cranberry Consumption Improves γδ T Cell Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: cranberry
gamma delta T cell
improvement in immune cell function in healthy humans
proliferation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: The Cranberry Institute
First posted: 2012-10-25
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the extent to which consuming a cranberry beverage modifies immune function, specifically related to γδ T cells and other innate immune cells. It is hypothesized that cranberry components will interact with immune cells to activate signaling pathways that enhance cell function. Enhanced immune cell function should result in reduced number, duration, and severity of cold and flu symptoms.


Eligibility criteria: Inclusion Criteria:

* between 21 and 35 years of age and in good health
* have a BMI between 18.5 and 29.9
* willing to consume the study beverage for 12 weeks
* willing to have a small amount of blood drawn two times
* willing to stop consuming tea and immune-enhancing dietary supplements (e.g. antioxidant-, probiotic-, or flavonoid-containing supplements, fish oil, and Echinacea) before and during the 12 weeks of the study
* willing to consume no more than 7 servings of fruits and vegetables a day
* willing to limit your alcohol consumption to no more than 14 glasses a week
* willing to limit your yogurt consumption to no more than one 8oz. serving per day

Exclusion Criteria:

* have food allergies
* have hypertension
* taking non-steroidal anti-inflammatory drugs on a chronic basis, antibiotics, or immunosuppressive drugs
* sensitive to aspirin or prone to kidney stones
* current smoker
* pregnant, lactating, or on hormone therapy, except for birth control pills

Primary outcomes:
measure: Change in Immune Cell Function
timeFrame: Measured at baseline and 6 weeks
Secondary outcomes:
measure: Cold and Flu Symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: 449 Food Science and Human Nutrition Department, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Susan S Percival, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00866229: Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level
Official title: Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
High LDL Cholesterol Level
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2009-03-20
Enrollment: 140
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: Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.


Eligibility criteria: Inclusion Criteria:

* SLE patients that on prednisolone more than 30 mg/day
* Normal liver faction: AST and ALT \< 80 mg/dl
* Normal muscle enzyme : CPK \< 100 U/L
* LDL cholesterol level \> 100 mg/dl

Exclusion Criteria:

* Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone \> 1mg/kg/day at screening.
* Statin allergy
* On statin treatment before screening
* On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin
* Pregnancy
* Abnormal liver function: AST or ALT \> 80 mg/dl
* Abnormal muscle enzyme : CPK \> 300 U/L

Primary outcomes:
measure: Percentage reduction of LDL Cholesterol level
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Proportion of patients that have transminitis, myositis or active SLE
timeFrame: 6,12, 18 and 24 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Ramathibodi Hospital
name: Parawee Suwannalai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04224129: Characterization and Causative Factors of Negative Dysphotopsia
Official title: Defining and Quantifying Negative Dysphotopsia Characterization and Causative Factors of Negative Dysphotopsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pseudoaphakia
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 patients after cataract extraction, suffering from negative dysphotopsia

Brief summary: The present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon.


Eligibility criteria: Inclusion Criteria:

* Pseudophakic
* Recurrently and persistently reporting about negative dysphotopsia
* Age 21 and older
* written informed consent prior to entering the study

Exclusion Criteria:

* Relevant ophthalmic diseases such as: glaucoma, (previous) traumatic cataract, corneal scars, age-related macular degeneration and other pathologies resulting in visual field defects
* Pregnancy

Primary outcomes:
measure: Identification of factors or a combination thereof that may cause negative dysphotopsia
timeFrame: 2 hours
Secondary outcomes:
measure: Method to standardize characterization of negative dysphotopsia
timeFrame: 20 minutes
measure: Correlation between eye biometry, patient complaints and psychophysics
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00499629: Study Evaluating the Safety of FXR-450 in Healthy Subjects
Official title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary purpose of the study is to evaluate the safety of FXR-450 in healthy subjects. This study will also evaluate pharmacokinetics (PK) of FXR-450 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
* Healthy as determined by the investigator on the basis of screening evaluations.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

* Any significant medical disease.
* History of cholecystectomy (removal of gallbladder).
* Any clinically important finding in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.

Primary outcomes:
measure: Safety, tolerability
timeFrame: 4 days
Secondary outcomes:
measure: pharmacokinetics
timeFrame: 4 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Facility
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01300429: Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus
Official title: Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: core biopsy
Resistance to Crizotinib
Non-small Cell Lung Cancer
11-014
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients seen by the Thoracic Oncology Service who have been diagnosed with an ALK mutant NSCLC and treated with an ALK kinase inhibitor who have experienced objective regression by RECIST, WHO, or clinical criteria and who then progress will be screened for this protocol.

Brief summary: The purpose of this study is to try to learn more about how small molecule kinase inhibitor medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been shown to shrink tumors in some patients with lung cancer. While the investigators know how this drug works to stop the growth of tumors that depend on change in the gene named ALK (also called EML4-ALK), the investigators do not know why the drug stops working. The investigators would like to examine the tumor to help us better understand why crizotinib has stopped working as well as it once did. The tumor will be examined with multiple tests to look for the reason that crizotinib stopped working.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus
* Clinical response to treatment with crizotinib as defined by either:

Radiographic partial or complete response defined by RECIST or WHO

OR:

Radiographic stable disease for at least 8 weeks

* Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO
* Signed informed consent

Exclusion Criteria:

* Deemed by their treating physician to be medically unfit for biopsy
* Women who are pregnant or breast-feeding

Primary outcomes:
measure: the frequency of acquired mutations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gregory Riely, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02352129: Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
Official title: Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathy, Dilated
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: : Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.

Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.

Methods: 330 patients are planned to be included and followed for 2 years


Eligibility criteria: Inclusion Criteria:

* patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
* and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: \> 90ml / m2 ( modified Simpson biplane).

Exclusion Criteria:

* Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.

Primary outcomes:
measure: Prognostic value of the increased level of myocardial fibrosis
timeFrame: two years
Secondary outcomes:
measure: hemodynamic consequences of the increased level of myocardial fibrosis
timeFrame: txw years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Public Hôpitaux de marseille
name: alexis JACQUIER, MD
role: PRINCIPAL_INVESTIGATOR
References: