louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02116374: Physiopathology Study of the Microbiota Biodiversity of HIV Seropositive Patients
Official title: Correlation Between Microbiota Biodiversity of HIV Seropositive Patients With Their Clinical and Immunological Status (ANRS EP 55 MICROGUT).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infection
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2014-04-16
Enrollment: 80
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: HIV-1 seropositive patients

Brief summary: The bacterial diversity of HIV patients digestive microbiota seropositive is poorly understood, it remains to be defined.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 or more.
* Patients with a confirmed diagnosis of HIV infection 1.
* Patient who signed an informed consent form.
* Patient affiliated or beneficiary of a social security system.

Exclusion Criteria:

* Patient known to be suffering from inflammatory bowel disease (Crohn's disease or ulcerative colitis).
* Patient HIV-2 or HIV-1/HIV-2 co-infected
* Patient having received immunotherapy
* Patient participating in another research.
* Pregnant women, parturient or lactating person under guardianship, or deprived of liberty by a judicial or administrative decision.

Primary outcomes:
measure: Proportion and type of OTU (Operational Taxonomic Unit) assigned to the rank of phylum genus and species of bacteria in the intestinal microbiota of HIV-1 seropositive patients.
timeFrame: Baseline
Secondary outcomes:
measure: Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients compared to the general population
timeFrame: Baseline
measure: Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on CD4, viral load, the Elite controller status, antiretroviral and antibiotic treatment and the existence of invasive bacterial infections.
timeFrame: Baseline
measure: Proportion and OTU types in the gastrointestinal microbiota of HIV-1 seropositive patients based on inflammation parameters (IL-6, TNF-a, IP-10), CRPus, CD14 and integrity of the epithelial barrier (I-FABP).
timeFrame: Baseline
measure: Transcriptomic analysis in the groups that present differences in the microbiota and analysis of lymphocyte populations Th17 and Treg.
timeFrame: Baseline
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Henri Mondor
city: Le Kremlin Bicêtre
country: France
facility: Service de Médecine Interne et Immunologie Clinique
city: Marseille
country: France
facility: IHU Méditerranée Infection; Hôpital Nord, AP-HM
city: Marseille
country: France
facility: Service de maladies Infectieuses
Study officials:
affiliation: IHU Méditerranée infection
name: Didier Raoult, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03872674: A Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
Official title: A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: standard nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
Primary purpose: PREVENTION

Brief summary: Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.


Eligibility criteria: Inclusion Criteria:

* 1. patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation

Exclusion Criteria:

* 1. dementia or cognitive dysfunction
* 2. altered mental status
* 3. intubated patients or tracheostomy
* 4. pregnancy
* 5. recent history of nasal bleeding
* 6. illiteracy or foreigner

Primary outcomes:
measure: lowest SpO2 measured with pulse oximetry during the procedure
timeFrame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
Secondary outcomes:
measure: incidence of desaturation below 90% during the procedure
timeFrame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
citation: Kim SH, Bang S, Lee KY, Park SW, Park JY, Lee HS, Oh H, Oh YJ. Comparison of high flow nasal oxygen and conventional nasal cannula during gastrointestinal endoscopic sedation in the prone position: a randomized trial. Can J Anaesth. 2021 Apr;68(4):460-466. doi: 10.1007/s12630-020-01883-2. Epub 2021 Jan 6.
Clinical trial NCT03242174: Health Behaviors in Pregnancy
Official title: Health Behaviors in Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prenatal Care Late
Pregnancy Related
Lifestyle
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 143
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA will be offered the opportunity to participate in this study at the time of a prenatal appointment ≥ 28 weeks GA

Brief summary: To assess health and lifestyle behavior of pregnant women in Baton Rouge including women receiving traditional obstetrical prenatal care and delivering in a hospital and those receiving prenatal care from a midwife and delivering at the birth center.

Detailed description: It is of scientific interest to learn what the health and lifestyle behaviors are for women receiving prenatal care in a non-traditional birth center and the impact of these behaviors on pregnancy and birth outcomes.Participants will be offered a questionnaire packet to complete at a prenatal appointment in the third trimester of pregnancy by their obstetrical prenatal care provider. The questionnaire packet will take approximately 10-15 minutes to complete.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA

Exclusion Criteria:

* None

Primary outcomes:
measure: Eating Habits
timeFrame: 1 Day
measure: Eating Habits
timeFrame: 1 Day
measure: Mindful Eating
timeFrame: 1 Day
measure: Physical Activity
timeFrame: 1 Day
measure: Frequency of Weighing
timeFrame: 1 Day
measure: Sedentary Behavior
timeFrame: 1 Day
measure: Functional health and well-being
timeFrame: 1 Day
measure: Sleep Habits
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859274: Saline Challenge in Monitoring Asthma Control
Official title: Saline Challenge in Monitoring Asthma Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: It is generally accepted that symptoms and lung function are not sufficient ways to monitor asthma control. Therefore, several objective tests have been developed to help asthma control monitoring, each having their own shortcomings. We have developed a new test, the hypertonic saline cough challenge. In our previous publication this test has proven useful in diagnosing asthma. The present study is planned to investigate whether hypertonic saline cough challenge could be used to monitor asthma control. A group of steroid-naive asthmatics will be recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at regular intervals utilising a validated questionnaire. At the same time points, hypertonic saline cough challenges will be performed. We will analyse whether changes in the responsiveness to the cough challenge reflects the changes in asthma control


Eligibility criteria: Inclusion Criteria:

* symptomatic asthma

Exclusion Criteria:

* usage of inhaled or oral corticosteroids
* recent febrile respiratory infection
* severe, unstable asthma

Primary outcomes:
measure: Changes in responsiveness to hypertonic saline cough challenge
timeFrame: Before budesonide treatment, and after 1, 4, and 12 weeks' treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Department of Respiratory Medicine, Kuopio University Hospital
Study officials:
References:
citation: Koskela HO, Purokivi MK. Airway oxidative stress in chronic cough. Cough. 2013 Dec 2;9(1):26. doi: 10.1186/1745-9974-9-26.
citation: Koskela HO, Purokivi MK. Capability of hypertonic saline cough provocation test to predict the response to inhaled corticosteroids in chronic cough: a prospective, open-label study. Cough. 2013 May 20;9:15. doi: 10.1186/1745-9974-9-15. eCollection 2013.
Clinical trial NCT04825574: Study for Patients Previously Treated in Avapritinib Clinical Trials
Official title: Extension Protocol for Patients Previously Treated in Avapritinib Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Stromal Tumors
Lead sponsor: Blueprint Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 2
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 is an open-label extension study to provide long term safety data for GIST patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.


Eligibility criteria: Inclusion Criteria:

1. Patient has histologically confirmed metastatic or unresectable GIST as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials.
2. Patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator.
3. Patient or legal guardian, if permitted by local regulatory authorities, provides informed consent.

Exclusion Criteria:

1. Patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome P450 (CYP) 3A4
2. Patient has a history of intracranial bleeding either prior to or during avapritinib treatment
3. Patients who have poor organ function, defined as Adverse Events of NCI CTCAE version 5.0 Grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to Grade 2 or baseline, or the start of treatment has been approved by the Sponsor.
4. Patients who have ongoing cognitive or mood effects Adverse Events of NCI CTCAE version 5.0 higher than Grade 1 must delay start of treatment until symptoms return to Grade 1 or baseline.
5. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib.
6. Women who are pregnant.
7. Women who are breast feeding.

Primary outcomes:
measure: Number of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From date of first avapritinib dose through 30 days after the last avapritinib dose (up to approximately 31 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Cancer Campus Grand Paris Institut de Cancerologie Gustave-Roussy
state: Val-de-Marne
Study officials:
References:
Clinical trial NCT01660074: Glycemic Index and Glycemic Response of Food and Products
Official title: Glycemic Index and Glycemic Response of Food and Products That Produced in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: glycemic index, resistant starch, glycemic response
Lead sponsor: National Pingtung University Science and Technology
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of ths study was to evaluate the glycemic index and glycemic response of food and products that produced in Tiwan. The food and product are in includes local produced fruits, starchy food and bread made from resistant starch.

Detailed description: Low glycemic index (GI) diets have protective and therapeutic potential for diabetic patients and general public. With recent recognition of resistant starch (RS), an indigestible fraction which has postprandial glucose lowering effects, the addition of resistant starch in bread may alter its glycemic effects and thus glycemic index. Therefore, the objectives of this study were to investigate the glycemic index, glycemic reponse of Taiwan local food and effects of resistant starch in bread formulation.

Eligibility criteria: Inclusion Criteria:

* 1) healthy weight, stable for 6 months prior to the study, 2) not being on a diet, 3) not taking prescription medication, 4) not a smoker, 5) normotensive and 6) normal fasting glucose

Exclusion Criteria:

-

Primary outcomes:
measure: glycemic index
timeFrame: 2 hour postprandial blood glucose
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: Food Science Department
Study officials:
affiliation: NPUST
name: Lin Meng-Hsueh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04100174: Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Official title: Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 150
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL

Detailed description: In this Phase IIR trial investigators primarily seek to determine if fBT boost (15Gy) to SBRT (35Gy/5) can be shown to be superior to standard care (whole-gland BT boost 15Gy to RT 37.5Gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL as measured by ePRO (EPIC-26) at 12 and 24 months post completion of therapy.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland.
* ECOG 0-1
* Charlson Comorbidity Index ≤ 4
* Imaging visible disease encompassing \< 50% of the prostate gland and consistent with biopsy findings.

Exclusion - none

Primary outcomes:
measure: Urinary Quality of Life
timeFrame: 12-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Québec
country: Canada
facility: CHUQ
state: Quebec
Study officials:
References:
Clinical trial NCT02040974: Allergen Immunotherapy in Allergic Patients
Official title: Long Term Follow up in Patients Using Immunotherapy: Efficacy and Impact on Quality of Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Keywords: immunotherapy, house dust mites, pollens, allergic rhinitis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. Patients were separated in two groups according to sensitization patterns including pollens or house dust mites. All patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.

Brief summary: Our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the symptom scores (RSS), visual analog scale (VAS) and medication scores (MS) and the impact on quality of life with rhinoconjunctivitis quality of life questionnaire (RQLQ) in allergic rhinitis patients sensitized to different allergens. Also the development of new sensitizations and asthma during the immunotherapy were determined.

Detailed description: Allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. Patients were separated in two groups according to sensitization patterns including pollens or house dust mites. All patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.

Eligibility criteria: Inclusion Criteria:

* allergic rhinitis/asthma

Exclusion Criteria:

* pregnancy,
* malignity,
* autoimmunity

Primary outcomes:
measure: The improvent of quality of life
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul Faculty of Medicine
name: Mustafa Demirturk
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05589974: Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy
Official title: Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2022-10-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with acute or chronic CSC.

Brief summary: Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.

Detailed description: Acute CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. Such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity.

Chronic CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with PDT. The research of such changes will increase the understanding of the treatment response. This knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.

Eligibility criteria: Inclusion Criteria:-

* Able to sign informed consent
* Possible to obtain fundus imaging
* Acute CSC ˂4 months of duration in one eye, defined as:

  1. Subfoveal presence of SRF on OCT
  2. Present attack is 1st -3rd attack of CSC

  b) Patient history and examination consistent with acute CSC c) Characteristic appearance of acute CSC on fundus autofluorescence (FAF) and OCT
* Chronic CSC ≥4 months of duration in one eye, defined as:

  1. Subfoveal presence of SRF on OCT
  2. Subjective visual loss/symptoms
  3. Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT
  4. Patient history and examination consistent with chronic CSC

Exclusion Criteria:

* History of retinal disease other than CSC (e.g. retinal detachment)
* Contraindications for FA, ICGA or PDT (only for chronic CSC)

Primary outcomes:
measure: Change in mean blur rate
timeFrame: 6 months
measure: Change in pulse wave form analysis
timeFrame: 6 months
Secondary outcomes:
measure: Change in choroidal density
timeFrame: 6 months
measure: Change in choroidal thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Department of Ophthalmology
Study officials:
affiliation: Helse Stavanger HF
name: Vegard Forsaa, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: