louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04920240: Application of Standardized Cleaning and Disinfection Mode of HFT Surface in Hospital Infection Prevention and Control
Official title: Application of Multi-center Unified High-frequency Contact Surface Standardized Cleaning and Disinfection Mode in Hospital Infection Prevention and Control in ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hospital Infection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Jiaxing University
name: Changxing People's Hospital
name: Yuhang Hospital
First posted: 2021-06-09
Enrollment: 432
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Multi-center unification, before-after study,
Primary purpose: PREVENTION

Brief summary: The scientific, feasible and effective mode of standardized cleaning and disinfection of ICU high-frequency contact surfaces is discussed and verified.

Detailed description: This study is a multi-center unified interventional study, using the front and rear control method, it is proposed to improve the ICU traditional cleaning and disinfection method on the basis of the ICU high-frequency contact surface status survey, explore the best frequency and disinfection method of ICU high-frequency contact surface cleaning and disinfection, establish a multi-center unified ICU high-frequency contact surface standardized cleaning and disinfection mode, in order to achieve the ideal cleaning and disinfection effect, effective prevention and control of ICU hospital infection occurrence and transmission.

Eligibility criteria: Inclusion Criteria:

* High-frequency contact with the surface of an object by ICU patients and their surroundings; informed consent.

Exclusion Criteria:

* Admission \< 24 hours; \< 18 years old; hospital infection prior to admission to the ICU.

Primary outcomes:
measure: Incidence of hospital infections
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jiangshuyuan Liang
role: STUDY_CHAIR
References:
Clinical trial NCT06052540: Probiotic Supplementation in Children Affected by Upper Respiratory Infections
Official title: Effetto Della Supplementazione di Una Miscela di Ceppi Probiotici (Bifidobacterium Breve M-16V, Bifidobacterium Lactis HN019, Lactobacillus Rhamnosus HN001) in Bambini Febbrili Con Infezioni Delle Alte Vie Respiratorie
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Upper Respiratory Tract Infection
Keywords: probiotic
children
respiratory infection
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 128
Sex: ALL
Minimum age (years): 29
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized non-pharmacological Intervention study is to evaluate the effects of probiotic supplements (Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, Lactobacillus rhamnosus HN001) on children affected by upper respiratory tract infections.

The main questions it aims to answer are:

* probiotic formulation can reduce intensity and duration of fever in children affected by upper respiratory tract infections
* probiotic formulation can influence the gut microbiota composition in children affected by upper respiratory tract infections

Participants will be asked to take probiotic supplements or placebo for 14 days and to collect three fecal samples: before probiotic supplementation (T0), 14 days after probiotic supplementation (T1), and 12 months after the enrollment (T2).


Eligibility criteria: Inclusion Criteria:

* Access to the Emergency room with fever and upper respiratory tract infection
* Age \> 28 days and ≤ 4 years
* Signature of informed consent by parents or guardian

Exclusion Criteria:

* Presence of pathologies associated with immunosuppression or ongoing immunosuppressant treatments
* Hospitalisation/hospitalisation
* Diarrhea at enrollment
* No signed informed consent

Primary outcomes:
measure: Mean duration of fever in days by measuring body temperature
timeFrame: Approximatively 7 days
Secondary outcomes:
measure: Mean change in gut microbial composition by measuring gut microbiota characterization in fecal samples
timeFrame: 1 year
measure: Gastrointestinal symptoms
timeFrame: Approximatively 7 days
measure: Adverse events
timeFrame: Approximatively 15 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Study officials:
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
name: Carlo V Agostoni, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02326740: An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Classic Pyoderma Gangrenosum
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2014-12-29
Enrollment: 9
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: The study will evaluate the efficacy and safety of gevokizumab in treating active ulcers of pyoderma gangrenosum (PG).


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of classic pyoderma gangrenosum
* An active pyoderma gangrenosum ulcer
* Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

* Clinical evidence of acutely infected pyoderma gangrenosum
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The proportion of subjects at Day 126 with complete closure of the PG target ulcer confirmed 2 weeks later (at Day 140) and without the need for rescue treatment
timeFrame: Day 126
Secondary outcomes:
measure: The proportions of subjects at Day 126 with a reduction in the target ulcer area of ≥ 75% or ≥ 90% from baseline.
timeFrame: Day 126
Other outcomes:
Locations:
city: Oceanside
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: St. Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Bronx
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Benowa
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Parkville
country: Australia
state: Victoria
city: Fremantle
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Westmead
country: Australia
city: Markham
country: Canada
state: Ontario
city: Richmond Hill
country: Canada
state: Ontario
Study officials:
References:
Clinical trial NCT02945540: Assessment of Patient Satisfaction Program "Gestational Diabetes"
Official title: Assessment of Patient Satisfaction Supported in the Patient Education Program "Gestational Diabetes" at the University Hospital of Caen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes
Keywords: Gestational diabetes
Patient education
Patient Satisfaction
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 350
Sex: FEMALE
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: Pregnant women with gestational diabetes and cared in therapeutic patient education

Brief summary: This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals.

This study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* Gestational diabetes diagnosis based on OGTT glucose 75g, performed after 24 weeks of gestation
* Women aged 18 and over
* After 24th week of gestation
* Before 36th week of gestation
* initial management in therapeutic education at the University Hospital of Caen

Exclusion Criteria:

* Another form of diabetes (existing before pregnancy or diagnosed before 24 weeks of gestation)
* women under 18 years
* Initial management of gestational diabetes by health professionals outside the University Hospital of Caen
* Poor understanding of the French language

Primary outcomes:
measure: Measuring patient satisfaction by a questionnaire on therapeutic education
timeFrame: 36th week of gestation
measure: Measuring patient satisfaction at childbirth by a questionnaire on satisfaction of hospital care
timeFrame: baseline
Secondary outcomes:
measure: Blood glucose self-monitoring
timeFrame: until birth (up to a maximum of 16 weeks)
measure: weight gain
timeFrame: during pregnancy until birth (up to a maximum of 16 weeks)
measure: type of birth
timeFrame: baseline
measure: Measure of abdominal diameter
timeFrame: before childbirth
measure: Measure of fetal weight
timeFrame: before childbirth
measure: Birth weight
timeFrame: at childbirth
measure: Apgar score
timeFrame: 1 minute and 5 minutes after birthchild
measure: Neonatal blood glucose measurement
timeFrame: during the first 48 hours after birth
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT00472940: Prevalence of Hypogonadism in Male Cancer Patients
Official title: Prevalence of Hypogonadism in Male Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Hypogonadism
Keywords: Cancer
Hypogonadism
testosterone
cachexia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Michael E. DeBakey VA Medical Center
name: Solvay Pharmaceuticals
First posted: 2007-05-14
Enrollment: 135
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male subjects with cancer and non-cancer controls

Brief summary: Cancer and its complications are common problems. In most cases, this condition has a profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. However, these symptoms also are seen in men with other conditions including those with low testosterone levels.

The objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.


Eligibility criteria: Inclusion Criteria:

1. Male subjects ≥ 18 years of age with histological diagnosis of cancer for cancer group.
2. Provide written informed consent prior to screening.
3. Histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups.

Exclusion Criteria:

1. Concomitant use of GH, Megestrol, Marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study.
2. Participation in a clinical trial with investigational agents within 1 month of enrollment.
3. Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine, Michael E. DeBakey VAMC
name: Jose M Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia JM, Li H, Mann D, Epner D, Hayes TG, Marcelli M, Cunningham GR. Hypogonadism in male patients with cancer. Cancer. 2006 Jun 15;106(12):2583-91. doi: 10.1002/cncr.21889.
citation: Burney BO, Hayes TG, Smiechowska J, Cardwell G, Papusha V, Bhargava P, Konda B, Auchus RJ, Garcia JM. Low testosterone levels and increased inflammatory markers in patients with cancer and relationship with cachexia. J Clin Endocrinol Metab. 2012 May;97(5):E700-9. doi: 10.1210/jc.2011-2387. Epub 2012 Mar 14.
Clinical trial NCT01429740: A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults
Official title: A Phase 1, Placebo-Controlled, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-05180999 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: PF 05180999
safety
pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
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 the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

male or female of non-childbearing potential,

Exclusion Criteria:

Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption

Primary outcomes:
measure: Composite (or profile) of Pharmacokinetics
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose on Day 1 and Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00311740: A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)
Official title: A Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension,
Valsartan,
Hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-06
Enrollment: 582
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.

This study is being conducted in Japan.


Eligibility criteria: Inclusion Criteria:

* Essential hypertension measured by mercury sphygmomanometer
* Outpatients

Exclusion Criteria:

* Secondary hypertension or suspected of having secondary hypertension.
* A history of malignant hypertension
* Severe hypertension
* Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
* Gout Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in systolic blood pressure after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks
measure: Change from baseline in standing diastolic blood pressure after 8 weeks
measure: Change from baseline in standing systolic blood pressure after 8 weeks
measure: Adverse events and serious adverse events at each study visit for 8 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novatis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04774640: Development of a NIPTT for Detecting Copy Number Variations
Official title: Noninvasive In Vitro Diagnostic Test For Fetal Chromosomal Abnormality: Assay Development and Optimization in Affected Pregnancies With Abnormal Microarray Findings
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Copy Number Variations
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
First posted: 2021-03-01
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with a fetus previously determined by microarray to have a chromosomal abnormality of interest..

Brief summary: To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal abnormalities of interest defined as microinsertions, microdeletions and other copy number variations (CNVs). The NIPT result will be compared to the test results obtained by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling.

Detailed description: This is a single center specimen collection study. Eligible subjects from across the USA will be referred to the single center for participation.

This study will evaluate whether the test methods being developed for the detection of fetal chromosomal abnormalities of interest in maternal whole blood samples can be used in clinical practice.

Enrollment of study subjects will be done in two phases - an initial pilot study phase to collect samples for research and development activities, followed by a larger single-blinded sample collection phase for NIPT evaluation. For both phases, study subjects will be enrolled in a prospective manner until the predetermined sample size is attained. Each study subject will be asked to provide one 20mL blood sample.

Eligibility criteria: Inclusion Criteria:

* Subject is female
* Subject is 18 years of age or older
* Subject is pregnant at no less than 10 weeks and no more than 36 weeks gestation
* Subject provides a signed and dated informed consent
* Subject has a current pregnancy in which the fetus is determined to have a chormosomal abnormality of interest (microinsertions, microdeletions and other CNVs) as determined by microarray analysis of fetal cellular material obtained by IP

Exclusion Criteria:

* Subject has experienced fetal demise in the current pregnancy

Primary outcomes:
measure: Development of non-invasive pregnancy test (NIPT)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
References:
Clinical trial NCT06529640: Periosteal Pedicle Flap Versus Subepithelial Connective Tissue Graft in Management of Gingival Recession
Official title: Can a Periosteal Pedicle Flap Replace the Subepithelial Connective Tissue Graft in the Management of Gingival Recession? Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 10
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: Gingival recession is defined as the apical shift of the marginal gingiva from its normal position on the crown of the tooth to levels on the root surface beyond the cemento-enamel junction (CEJ).Various surgical procedures including repositioned flaps as well as autogenous and other type grafts have been used in the treatment of gingival recession.The present gold standard technique is the bilaminar technique using the subepithelial connective tissue graft (SCTG) which provides for long-term stability but also increases tissue morbidity.Hence, a suitable alternative technique - the periosteal pedicle flap (PPF) - has been practiced, which is less invasive, does not require a second surgical site, and provides a graft of adequate dimensions.


Eligibility criteria: Inclusion Criteria:

* Patients with one or more Miller's Class 1 and Class II buccal recessions demonstrating ≤20% of plaque and bleeding scores, respectively, after Phase I therapy.
* age from 18 th 60 years.

Exclusion Criteria:

* Smokers
* patients with malposed or crowded teeth
* pregnant and lactating women
* patients using medications that could affect the periodontal status

Primary outcomes:
measure: the percentage of root coverage (%RC)
timeFrame: at base line, 1 month and 3 months after treatment
Secondary outcomes:
measure: recession depth
timeFrame: at base line, 1 month and 3 months after treatment
measure: recession width
timeFrame: at base line, 1 month and 3 months after treatment
measure: clinical attachment gain
timeFrame: at base line, 1 month and 3 months after treatment
measure: keratinized tissue gain
timeFrame: at base line, 1 month and 3 months after treatment
Other outcomes:
Locations:
Study officials:
References: