louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00041704: The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)
Official title: A Phase 2 Open-Label Study of the Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis
Keywords: Azole-Refractory Mucosal Candidiasis
Mucosal Candidiasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Vicuron Pharmaceuticals
First posted: 2002-07-16
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole)
* Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast

Exclusion Criteria:

* Pregnant female
* Hypersensitivity to anidulafungin or echinocandin therapy
* Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
* Abnormal blood chemistries: Bilirubin \>2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 4 times the upper limit of normal
* Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents
* Patients taking other systemic antifungal therapies while on this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: King of Prussia
country: United States
facility: Versicor, Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01736904: wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
Official title: A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: advanced colorectal cancer
FOLFIRI
XELIRI
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of wXELIRI is not less than FOLFIRI with tolerable toxicity.

Detailed description: The combination of irinotecan and fluorouracil drugs regimen is frequently used in patients with advanced colorectal cancer. According to the previous data, higher rate of diarrhea was observed in the combination of irinotecan and capecitabine (XELIRI) regimen, compared to the combination of irinotecan and 5-fluorouracil (FOLFIRI) regimen. However, the modified weekly XELIRI regimen, which was investigated in our previous single armed study, show tolerate toxicities compared with FOLFIRI, without compromising efficacy. It is supposed that wXELIRI regimen is no less less than FOLFIRI regimen in efficacy.

Eligibility criteria: Inclusion Criteria:

* Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
* Age range 18-70 years old
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* chronic inflammatory bowel disease or intestinal obstruction
* Serious uncontrolled diseases and intercurrent infection

Primary outcomes:
measure: Progression free survival which is calculated from the start of treatment to disease progression or death
timeFrame: eight weeks
Secondary outcomes:
measure: Objective response rate which includes complete response(CR) and partial response(PR) participants
timeFrame: eight weeks
Other outcomes:
measure: Overall survival which is calculated from the start to treatment to the death
timeFrame: eight months
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Lin, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04942704: Development of Protocols and Methods for Image Processing and Enhancement of Magnetic Resonance Imaging (MRI) Data.
Official title: Development of Protocols and Methods for Image Processing and Enhancement of Magnetic Resonance Imaging (MRI) Data.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MRI Image Enhancement
Lead sponsor: Medic Vision Imaging Solutions Ltd
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Total number of subjects expected to participate in this study is up to 100. The study population consists of patients who will go through their standard care MRI exam. Children, pregnant women and prisoners that are considered vulnerable population by federal regulation will not be included in this study. In addition, decisional incapacity subject will be excluded.

Brief summary: The purpose of the study is to develop new methods for image processing and enhancement of MRI data. Different setting of acquisition parameters used in conventional clinical MRI protocols will be defined, to create "New Protocols".

The specific aim of this study is to assess and to improve the performance of our image processing methods, by comparing diagnostic qualities of images obtained by conventional MRI protocols with those obtained by corresponding New Protocols' and processed by our image enhancement method.


Eligibility criteria: Inclusion Criteria:

* Volunteers for clinical MRI examination
* Patients undergoing clinical MRI examination
* Capable to provide an informed written consent form

Exclusion Criteria:

* Any contraindication to MRI scanning, such as pacemakers or heart rhythm disturbances, permanent cosmetics or certain metallic implants in the body (excluding dental implants).
* Age \<18 years old
* Pregnancy
* Claustrophobia
* Decisional incapacity, mentally disabled,
* MRI exam under sedation or monitoring equipment.

Primary outcomes:
measure: Image Signal to Noise Ratio (SNR)
timeFrame: Through study completion, an average of 2 months.
measure: Image Resolution
timeFrame: Through study completion, an average of 2 months.
measure: MRI contrast
timeFrame: Through study completion, an average of 2 months.
measure: Artifacts
timeFrame: Through study completion, an average of 2 months.
measure: Diagnostic quality
timeFrame: Through study completion, an average of 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Medical Imaging
state: Texas
Study officials:
References:
Clinical trial NCT02532504: Change Your Life With Seven Sheets of Paper
Official title: Change Your Life With Seven Sheets of Paper: A Pilot Randomized Controlled Trial for Postnatal Depression: A Pilot Randomized Controlled Trial for Postnatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postnatal Depression
Keywords: postnatal depression
Cognitive behaviour Therapy
Traditional Birth Attendants
low income country
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to deliver CBT based intervention called "Change your life with 7 Sheets of paper" to women with mild to moderate postnatal depression (PND) through trained traditional birth attendants (TBAs). Participants will be recruited from low income area in Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers having children between birth till 12 months. Group intervention will be delivered through trained TBAs.

Detailed description: The prevalence rate of PND in Pakistani women and its effect on the growth and development of young children and child mortality is very high. Despite availability of interventions to improve maternal health, the major issue in implementation of those interventions is because of limited availability of trained health professionals . Therefore the aim of this study is to train TBAs in delivering Cognitive Behaviour Therapy (CBT) based intervention called "Changing your life with seven sheets of paper". Participants will be recruited from low income area in Karachi. Total 36 participants will be recruited and randomized into 2 groups; intervention and Treatment As Usual (TAU) group. Total 8 sessions will be delivered by trained TBAs over the period of 3 months.

Eligibility criteria: Inclusion Criteria:

* Mothers with a child between 0-12 months
* Women who score 14 or above on Edinburgh Postnatal Depression scale (EPDS)
* Age range between 18 to 45 years
* Women able to provide written informed consent.

Exclusion Criteria:

* Severe depression or any other major psychiatric disorder
* Severe suicidal ideation
* Currently receiving any psychiatric or psychological treatment
* Intellectual disability in mother
* Chronic medical condition
* Having children with intellectual or physical disability

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Change in scores from baseline to 3rd month
Secondary outcomes:
measure: Patient health Questionnaire-9
timeFrame: Change in scores from baseline to 3rd month
measure: World Health Organization Quality of Life
timeFrame: Change in scoares from baseline to 3rd month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Orangi Town
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Batool Fatima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084304: Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Official title: Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: Pregnancy
Ovulation tests
stress
Wishing to become pregnant
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females aged 18 to 40 wishing to become pregnant

Brief summary: Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.

A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with \<5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent to participate in the study and agree to comply with study procedures.
* Has menstrual bleeds.
* Seeking to become pregnant.
* Living in UK

Exclusion Criteria:

* Used hormonal contraception within the last 3 months.
* Currently undergoing fertility treatment or investigation.
* Diagnosed as infertile following investigations.
* Drug or alcohol dependency.
* history of depression, anxiety or panic attacks

Primary outcomes:
measure: Cortisol Measurement
timeFrame: Twice monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd
state: Bedfordshire
Study officials:
name: Sarah Johnson, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones G, Carlton J, Weddell S, Johnson S, Ledger WL. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health. 2015 Dec 21;12:116. doi: 10.1186/s12978-015-0103-y.
citation: Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.
Clinical trial NCT03725904: Daytime Profile of Salivary Progesterone
Official title: Daytime Profile of Salivary Progesterone During the Mid-luteal Phase of IVF and FET Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: Progesterone
Saliva
IVF
Frozen embryo transfer
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
Collaborators: name: Boston IVF
First posted: 2018-10-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. If progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future ART patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.


Eligibility criteria: Inclusion Criteria:

* 18-45 years
* One or two good quality embryos for transfer on day 5.
* BMI \>18,5 \<30 kg/m²

Exclusion Criteria:

* No good quality embryos for transfer
* Uterine abnormalities
* One ovary
* Oocyte donation

Primary outcomes:
measure: Levels of free progesterone in saliva
timeFrame: 12 hours
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 8 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertility Clinic Regional Hospital Skive
Study officials:
References:
Clinical trial NCT03644004: Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)
Official title: Descriptive Study of the Diabetes Mellitus, Type 2 Diagnosis Methods During Postpartum Period in Patients With Medical History of Gestational Diabetes Whom Benefited an Educational Therapy Session.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 173
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who develop a gestational diabetes.

Brief summary: Diabetes mellitus, type 2, is a chronic disease which can be linked with many complications in connexion with impaired blood glucose balance.

It diagnosis in risky subjects such as in patients with medical history of gestational diabetes is therefore imperative to prevent its complications.

Actual guidelines recommend an oral tolerance glucose test, measuring glucose levels after oral glucose intake (75g), between 6 an 12 weeks after childbirth. But studies reveal a low diagnosis rate.

The study of the current practices of diagnosis methods seem to be essential in order to improve this diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients followed in endocrinology at the hospital of Vienne for gestational diabetes, whom benefited an educational therapy session between the 01/01/2016 and the 31/12/2016 inclusive.

Exclusion Criteria:

* Minor patients or under legal protection (guardianship)
* Patients who not speak french
* Patients who did not declared an attending physician
* Refusal to take part in the survey
* Patients lost to follow-up before childbirth
* Patients whose pregnancy ended by foetal death.
* Pre-existing diabet before pregnancy

Primary outcomes:
measure: Performing oral glucose tolerance test in order to detect type 2 diabetes
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Vienne
country: France
facility: Centre hospitalier Lucien Hussel
Study officials:
affiliation: Centre Hospitalier de Vienne
name: Laura BOGENMANN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02126904: Comparison of the Time to Recurrence Between Ranibizumab and Aflibercept
Official title: Comparison of the Time to Recurrence After Ranibizumab or Aflibercept Loading for Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Injection Burden
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2014-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients were treated at Yokohama City University Medical Center between January 2012 and October 2013.

Brief summary: The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.


Eligibility criteria: Inclusion Criteria:

* They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept.

Exclusion Criteria:

* patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.

Primary outcomes:
measure: Time to recurrence after induction phase
timeFrame: More than 3 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
Study officials:
References:
Clinical trial NCT03468504: Mirror Therapy and Treadmill Training for Patients With Chronic Stroke
Official title: Mirror Therapy and Treadmill Training for Patients With Chronic Stroke: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Institute of Technology, Sligo
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomised Placebo Controlled Trial
Primary purpose: TREATMENT

Brief summary: This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

Detailed description: The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.

Eligibility criteria: Inclusion Criteria:

* Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis.
* Ambulatory with/without walking aid.
* Discharged from formal rehabilitation.
* A Mini Mental State Examination \>/= 24.

Exclusion Criteria:

* Younger than 18 years
* Any additional illness that may prevent treadmill walking
* A Mini Mental State Examination \< 24.

Primary outcomes:
measure: Ten Metre Walk Test
timeFrame: 5 mins.
measure: Six Minute Walk Test
timeFrame: 10 mins
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: 10 minutes
measure: Fugl-Meyer Assessment-Lower extremity
timeFrame: 10 mins
Other outcomes:
Locations:
city: Sligo
country: Ireland
facility: Institute of Technology, Sligo
state: Co Sligo
Study officials:
affiliation: PhD researcher
name: Patrick Broderick, PhD
role: PRINCIPAL_INVESTIGATOR
References: