louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03388112: Shanghai Infants Gut Microbiome Associated Study
Official title: Effects of Probiotics on the Gut Microbiome of Infants Treated With Antibiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Microbiome
Keywords: Probiotics,Gut Microbiome,Antibiotics,Infants
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.

Detailed description: This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.

Eligibility criteria: Inclusion Criteria:

* Newborns with infectious diseases treated with antibiotic

Exclusion Criteria:

* Gestational weeks \<37
* Birth weight \<2500g or ≥4000g
* History of asphyxia anoxia at birth
* With congenital metabolic diseases or hereditary diseases
* With gastrointestinal diseases

Primary outcomes:
measure: change from birth,7 days,14 days(or 21 days) on gut mcrobiome at 42 days
timeFrame: 42 days
Secondary outcomes:
measure: change from birth on gut mcrobiome at 7 days
timeFrame: 7 days
measure: change from birth and 7 days on gut mcrobiome at 14 days(or 21 days)
timeFrame: 14 days（or 21days）
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Huanlong Qin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02211612: Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation
Official title: Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overfeeding
Muscle Mass
Body Composition
Ectopic Fat
Keywords: Overfeeding
Weight gain
Liver fat
Pancreatic fat
Ectopic fat
Skeletal muscle
Adipose tissue
Gene expression
DNA methylation
Palmitate
Linoleic acid
Saturated fat
Polyunsaturated fat
Metabolism
Insulin sensitivity
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2014-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity


Eligibility criteria: Inclusion Criteria:

* Body mass index 25-32

Exclusion Criteria:

* Type 2 diabetes
* Type 1 diabetes
* Kidney disease
* Liver disease
* Abnormal clinical chemistry at screening
* Intense physical exercise \> 2 hours per week
* Use of statins or drugs affecting energy metabolism
* Use of extreme diets

Primary outcomes:
measure: Change in lean tissue mass
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in hepatic fat content
timeFrame: 10 weeks
measure: Change in visceral adipose tissue (VAT)
timeFrame: 10 weeks
measure: Change in total adipose tissue
timeFrame: 10 weeks
measure: Change in pancreatic fat
timeFrame: 10 weeks
measure: Change in insulin sensitivity
timeFrame: 10 weeks
measure: Change in plasma lipids
timeFrame: 10 weeks
measure: Change in circulating inflammation and coagulation markers
timeFrame: 10 weeks
Other outcomes:
measure: Circulating hormones and molecular analyses in muscle and fat tissue
timeFrame: 10 weeks
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences
state: Please Select
Study officials:
affiliation: Uppsala University
name: Ulf Riserus
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.
citation: Rosqvist F, Kullberg J, Stahlman M, Cedernaes J, Heurling K, Johansson HE, Iggman D, Wilking H, Larsson A, Eriksson O, Johansson L, Straniero S, Rudling M, Antoni G, Lubberink M, Orho-Melander M, Boren J, Ahlstrom H, Riserus U. Overeating Saturated Fat Promotes Fatty Liver and Ceramides Compared With Polyunsaturated Fat: A Randomized Trial. J Clin Endocrinol Metab. 2019 Dec 1;104(12):6207-6219. doi: 10.1210/jc.2019-00160.
Clinical trial NCT00933712: Dermacyd Silver Floral (Lactic Acid) - Compatibility.
Official title: Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Floral (Lactic Acid).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral


Eligibility criteria: Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion

Exclusion criteria:

* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Disease which can cause immunosuppresion, such as diabetes, HIV
* Use of Antihistamines 30 days before selection
* Personnel history of atopy
* History of sensitivity or irritation for topic products
* Cutaneous active disease (local and/or general) which can modify the study results
* Use of new drugs and/or cosmetics during the study
* Cutaneous reaction
* Previous participation in studies using the same product in test
* Volunteer which has immunodeficiency congenital or acquired
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale
timeFrame: from the treatment start to the end of the study (treatment period 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT00786812: Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Official title: An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Myeloid Leukemia
Keywords: Leukemia
adult chronic myeloid leukemia
imatinib
nilotinib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the \[CAMN107A2109\] study


Eligibility criteria: Inclusion Criteria:

1. patients currrently participating in Novartis study CAMN107A2109
2. imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
3. males or females ≥18 years of age
4. WHO Performance Status of ≤ 2
5. patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor

Exclusion Criteria:

1. Impaired cardiac function; use of therapeutic coumarin derivatives
2. patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days
3. patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
4. patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
5. ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy

Primary outcomes:
measure: Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
timeFrame: 3 - 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Novartis Investigative Site
state: MG
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Campinas
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Jaú
country: Brazil
facility: Novartis Investigative Site
state: SP
city: Ribeirao Preto
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
state: SP
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00097812: Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid
Official title: A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: osteoporosis, osteopenia, post-menopausal, zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-01
Enrollment: 220
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women between 45 and 79 years of age
* Must be osteopenic/osteoporotic
* Treatment with oral bisphosphonate for at least 1 year

Exclusion Criteria:

* Any woman of child bearing potential
* Treatment with other bone active agents

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations
Secondary outcomes:
measure: To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
measure: To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
measure: To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: The Permanente Medical Group
state: California
city: Lakewood
country: United States
facility: Colorado Center for Bone Research
state: Colorado
city: Gainsville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: Kansas City
country: United States
facility: University of Kansas School of Medicine/ Division of Endocrinology
state: Kansas
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Lincoln
country: United States
facility: Arthritis Center of Nebraska
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Osteoporosis Research Center
state: Nebraska
city: Portland
country: United States
facility: Oregon Osteoporosis Center
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Wyomissing
country: United States
facility: Radiant Research
state: Pennsylvania
city: Seattle
country: United States
facility: Puget Sound Osteoporosis Center
state: Washington
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
References:
Clinical trial NCT06700512: Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO
Official title: Standard PMCF Study WSA @ HZO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Keywords: Hearing aid
Freiburger
Matrix Test
SSQ
IOI-HA
Lead sponsor: WSAUD A/S
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities

Detailed description: This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).

Eligibility criteria: Inclusion Criteria:

* Hearing loss should fall within fitting range of study hearing aid
* They should be experienced hearing aid users
* Air-Bone-Gap should be less or equal to 20 dB Hearing Loss (HL).
* Sensorineural HL, mild-to-moderate
* HL corresponding to the fitting range of the hearing aid
* Healthy (outer) ear
* Older than 18 years
* German is mother tongue
* Able to understand the instructions
* Willing to participate in laboratory tests and to wear the hearing aids at home for 2 weeks
* Informed consent

Exclusion Criteria:

* Contraindication for hearing aid treatment
* Fluctuating or rapidly progressing hearing loss
* "Central" hearing problems
* Limited mobility
* Limited dexterity (in handling the hearing aid)
* Known psychological problems

Primary outcomes:
measure: Oldenburg Sentence Test
timeFrame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
Secondary outcomes:
measure: Freiburger Monosyllabic Speech Test
timeFrame: Estimated Time Frame 2 weeks (Test conducted at second lab session).
measure: Match-to-Target
timeFrame: 1 day (Fitting procedure with real-ear measurements is done at first lab session)
measure: Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
timeFrame: 2 weeks
measure: International Outcome Inventory for Hearing Aids (IOI-HA)
timeFrame: 2 weeks
measure: Satisfaction Questionnaire
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Hörzentrum Oldenburg gGmbH
Study officials:
References:
Clinical trial NCT03996512: Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study
Official title: Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scaphoid Fixation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Performance Health
First posted: 2019-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is poor research supporting the benefits of Early Active Controlled Motion (EACM) protocols post operative scaphoid fixation. Advances in surgical fixation technique for scaphoid fractures should allow for start of earlier mobilization, however there is little evidence in the literature that supports the use of these protocols within the early phases of healing. The study uses a pre-experimental design with purposeful sample population recruitment.


Eligibility criteria: Inclusion Criteria:

* Date of injury and diagnosis: scaphoid fracture less than 3 weeks old
* Waist fractures in the middle 1/3 and distal pole 1/3 of scaphoid bone.
* Surgical procedure includes ORIF with screw fixation and/or percutaneous pin with screw fixation.
* To be included in the study the patient needs to have started rehab within the first 10 days after surgery date.

Exclusion Criteria:

* Proximal pole scaphoid fracture
* Past medical history of diabetes and other peripheral vascular disorders.
* History of osteopenia and osteoporosis.
* Previously failed ORIF of scaphoid
* Neurovascular or nerve lesion to the involved upper extremity
* Cognitive deficits related to memory, attention span, judgment as documented in the EMR or need for a legal guardian to be a medical proxy

Primary outcomes:
measure: functional outcome range of motion
timeFrame: at entry and up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Sarah Mersch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01889212: Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC
Official title: Imaging With 11C-erlotinib PET/CT to Identify Responders to Erlotinib Treatment in NSCLC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2013-06-28
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: New treatment strategies have been developed in lung cancer targeting the Epidermal Growth Factor Receptor (EGFR). Patients with an activating mutation in the EGFR have high responds rates to the treatment and should be treated with a EGFR inhibitor as first line of treatment. Some wild type patients do as well respond but selection of these patients is more difficult.

Erlotinib has been labeling with 11C and used as a new PET tracer. Accumulation of the tracer (11C-erlotinib) in tumors has showed promising results for selection of responders.

The investigators now want to conduct a larger clinical study to evaluate if accumulation of tracer on a pre-treatment 11C-erlotinib PET/CT can predict responds to erlotinib.


Eligibility criteria: Inclusion Criteria:

* Lung Cancer patients with non-small cell histology and stage IV disease who are candidate for erlotinib treatment as first/ second/ third line of treatment

Exclusion Criteria:

* pregnancy
* severe dyspnoea

Primary outcomes:
measure: Accumulation of 11c-erlotinib in tumors before and after treatment with erlotinib
timeFrame: From date of inclusion until the date of first documented progression on the erlotinib treatment or date of death, whichever came first, assessed up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Deparment of oncology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Peter Meldgaard, Ph.D MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01215812: Analysis of Cases of Sexual Assault in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Assault
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sexual assault

Brief summary: The aim of this study was to analyze victims, assailants, assaults, evidentiary examinations and treatment characteristics of cases of sexual assault sought emergency care at Far Eastern Memorial Hospital、National Cheng Kung University Hospital、Taoyuan General Hospital, Department of Health, Executive Tuan, R.O.C.、National Taiwan University Hospital Yun-Lin Branch、Hospital and National Taiwan University Hospital.


Eligibility criteria: Inclusion Criteria:

* all cases

Exclusion Criteria:

* nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pan-Chiao
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References: