louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03977818: METASARC: Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa
Official title: Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Metastases
Chemotherapy
Keywords: outcome
time to next treatment
overall survival
patterns of care
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: French Sarcoma Group
First posted: 2019-06-06
Enrollment: 2165
Sex: ALL
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: advanced soft tissue sarcoma

Brief summary: Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.

The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug.

Outcome (time-to-next treatment \[TNT\] and overall survival \[OS\]) will be reported according to histological subtype, as well as the association between TNT and OS.

Prognostic factors of OS will be investigated.


Eligibility criteria: Inclusion Criteria:

* advanced soft tissue sarcoma
* age \> 18

Exclusion Criteria:

-

Primary outcomes:
measure: Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié, Comprehensive Cancer Center
city: Lyon
country: France
facility: Centre Léon Bérard, Comprehensive Cancer Center
city: Villejuif
country: France
facility: Institut Gustave Roussy, Comprehensive Cancer Center
Study officials:
affiliation: Institut Bergonié, Comprehensive Cancer Center
name: Antoine Italiano, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.
Clinical trial NCT05719818: Dental Care and Initiation of Anti-osteoporotic Therapy
Official title: Dental Care and Initiation of Anti-osteoporotic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Condition
Osteoporosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the rhumatologic department - Nice University hospital for osteoporotic fracture and for who the treatment, either bisphosphonate or denosumab, has justified a dental evaluation

Brief summary: The initiation of bisphosphonate therapy for osteoporosis requires an assessment of the oral status to prevent the risk of osteonecrosis of the jaw. This recommendation is sometimes a hindrance to the initiation of treatment or may be responsible for a delay in treatment or even the failure to initiate treatment. However, in the case of a severe osteoporotic fracture (femoral or humeral neck fracture, vertebral fracture or pelvic fracture), treatment must be rapid because of the major risk of refracture in the short term (multiplied by 5 in the 2 years following the fracture).

In the rheumatology department of the Nice University Hospital, the investigator team take care of patients with osteoporotic fractures either directly in hospital or referred by the orthopedics department as part of a care program. For these patients, the team perform an etiological assessment, bone densitometry and evaluation of the oral status with dental panoramic and tele-expertise to determine if there is an indication to perform surgical care before starting the treatment.

Therefore, the investigator aimed to describe the number of patients requiring dental surgery befor the initiation of bisphosphonate or denosumab treatment before to introduce treatment for osteoporosis


Eligibility criteria: Inclusion Criteria:

* osteoporotic fracture requiring treatment with bisphosphonate or denosumab

Exclusion Criteria:

* osteoporotic fracture requiring teriparatide treatment

Primary outcomes:
measure: Number of patients requiring surgical dental care
timeFrame: 15 months
Secondary outcomes:
measure: Impact of dental care on osteoporosis treatment
timeFrame: Change from baseline
measure: Impact of dental care on osteoporosis treatment
timeFrame: Change from baseline
measure: Impact of dental care on osteoporosis treatment
timeFrame: Change from baseline
Other outcomes:
Locations:
city: NICE Cedex 1
country: France
facility: CHU de NICE
state: Chun
Study officials:
References:
Clinical trial NCT05949918: Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction
Official title: Efficacy of a Stage-Matched Intervention Based on The Transtheoretical Model of Change in Dietary Fat Reduction Among Female High School Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Fat Reduction
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 144
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.

Detailed description: This study aims to examine the efficacy of a Stage-Matched Intervention based on The Transtheoretical Model of Change in dietary fat reduction among female high school students.

The study intervention will be designed based on each Stage of Change of the Transtheoretical Model of Change in that participants in each Stage of Change will receive the intervention that matches the Stage of Change they would be in.

A 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.

Eligibility criteria: Inclusion Criteria:

* High school male students who do not experience any psychiatric-mental disorder.

Exclusion Criteria:

* High school male students who experience any psychiatric-mental disorder.

Primary outcomes:
measure: Stages of Change Scale for Dietary Fat Reduction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad
Study officials:
References:
Clinical trial NCT00025818: Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Sjogren's Syndrome
Lupus Erythematosus, Systemic
Arthritis, Rheumatoid
Scleroderma, Systemic
Keywords: dry eyes
rheumatoid arthritis
Lupus
Sjogren's syndrome
myositis
scleroderma
autoimmune disorder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2001-10-29
Enrollment: 290
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: A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.


Eligibility criteria: * Eighteen years or older
* Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria:
* Diagnosis of autoimmune disorder
* Female 65 years of age or older

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Eyecare of La Jolla
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Waterbury
country: United States
facility: Opticare
state: Connecticut
city: Tampa
country: United States
facility: Brandon Eye Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: UIC Eye Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Overland Park
country: United States
facility: Hunkleler Eye Center
state: Kansas
city: Leominster
country: United States
facility: D'Ambrosio Eye Care
state: Massachusetts
city: Saginaw
country: United States
facility: Great Lakes Eye Institute
state: Michigan
city: Albany
country: United States
facility: Cornea Consultants of Albany
state: New York
city: Brooklyn
country: United States
facility: Dr. Freedman's Office
state: New York
city: Stony Brook
country: United States
facility: Dr. Wittpen's Office
state: New York
city: Cleveland
country: United States
facility: The Cole Eye Institute
state: Ohio
city: Portland
country: United States
facility: Northwest Cornea
state: Oregon
city: El Paso
country: United States
facility: Corona Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT03529318: Mucosal Innate Immune Activation in Chronic Intestinal Disorders
Official title: Mucosal Innate Immune Activation in Chronic Intestinal Disorders
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population includes patients with known Crohn's disease, ulcerative colitis and indeterminant colitis. Patients will be recruited after they check in to the endoscopy unit, and before their endoscopic procedure, prior to any pre-procedure sedation medications having been given. All participants are undergoing endoscopy with biopsy for surveillance, screening, , diagnosis , or assessment of treatment. If no biopsy specimens are taken from subjects for diagnosis, no biopsy samples are taken for research purposes. The subject enrollment goal is 60 separate subjects with Crohn's disease, ulcerative colitis and indeterminant colitis or Irritable bowel syndrome. The subjects' participation will be limited to in the endoscopy suite.

Brief summary: Crohn's disease and ulcerative colitis are types of chronic intestinal disorder called inflammatory bowel diseases (IBD) that can affect the small and large bowel causing symptoms of abdominal pain, diarrhea, blood in the stool, and weight loss. Irritable bowel syndrome (IBS) is a milder form of IBD, with symptoms of abdominal pain, bloating, diarrhea or constipation, and blood in the stool. It is not known what causes diseases such as IBD and IBS. This study will look at the events in the gut that leads to leaky gut and inflammation in patients with IBD and IBS. The study will also see if medications such as rifaximin and mesalamine may reduce the amount of leaky gut.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-years old and older
* Presenting at the University of Arkansas for Medical Sciences (UAMS) Endoscopy center to undergo endoscopy with biopsy for surveillance, screening or diagnosis.

Exclusion Criteria:

* Subjects classified in an anesthesia risk group , American Society of Anesthesiologists Class (ASA) ≥ 4,
* history of bleeding diathesis or coagulopathy
* stroke or transient neurological attack within the last 6 months
* pregnancy
* currently on blood thinners (excepting aspirin)
* subject is unable to consent themselves

Primary outcomes:
measure: The number of specimens showing elevated levels of mucosal innate immune activation
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Benjamin Tharian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Julia Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111018: Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients With Rhabdomyolysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Rhabdomyolysis
Lead sponsor: CytoSorbents, Inc
Sponsor class: INDUSTRY
Collaborators: name: San Antonio Military Medical Center (SAMMC), US Army Institute of Surgical Research-Burn Center
First posted: 2014-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized non-blinded, controlled study to assess the feasibility of the CytoSorb as an adjunct to the standard of care in patients with rhabdomyolysis requiring renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Subject is age 18-80
* Subjects present with rhabdomyolysis
* Subject requires renal replacement therapy and has undergone adequate volume resuscitation
* Subject is willing to comply with specified follow up requirements

Exclusion Criteria:

* Subject or their legal guardian either declines or cannot give informed consent
* Subject is pregnant
* Subject has been previously enrolled in this clinical study
* Comorbid condition that may limit survival to ≤14 days
* Comorbid condition that could confound study results
* Subjects who are receiving immunosuppressive therapy

Primary outcomes:
measure: Efficacy of device as measured by change in myoglobin
timeFrame: 30 days
measure: Assessment of serious device or procedure-related adverse events
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center- US Army Institute of Surgical Research- Burn Center
state: Texas
Study officials:
affiliation: San Antonio Military Medical Center-US Army Institute of Surgical Research-Burn Center
name: LTC Kevin Chung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Antonio Military Medical Center-US Army Institute of Surgical Research- Burn Center
name: MAJ Ian Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06570018: Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer
Official title: Short Term Outcome Following Post Operative Enhanced Recovery Implementation in Patients With Perforated Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergent Surgery
Perforated Peptic Ulcer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcome.

The current study anticipated better outcomes in the form of early functional recovery, reduced length of hospital stays, less thirty days post operative morbidity, and better gastrointestinal quality of life after implementing post operative enhanced recovery in patients with perforated peptic ulcer.

Detailed description: This study aimed to evaluate the effect of implementing post operative enhanced recovery on perforated peptic ulcer surgery outcomes.

Methods: Quasi- experimental research design was utilized. The study was conducted at Assiut University Hospital.

A purposive sample of thirty patients (study group) who received postoperative enhanced recovery after open surgical repair of perforated peptic ulcer compared with thirty patients (control group) who exposed to routine care.

patient assessment sheet and gastrointestinal quality of life index were the tools used for data collection.

Eligibility criteria: Inclusion Criteria:

* Age ranged from 18 to 65 years,
* Diagnosed with perforated peptic ulcer,
* Ulcer size less than 10 mm.
* Underwent emergent surgical intervention

Exclusion Criteria:

* Malignant ulcer.
* Other GIT diseases (corn's disease \& ulcerative colitis)
* Pregnant women
* Psychiatric or neurological illness.
* Who refused to participate in the study

Primary outcomes:
measure: Gastrointestinal functional recovery (first bowel movement)
timeFrame: Within the first 24 hours postoperative or more
measure: Gastrointestinal functional recovery(first flatus passage)
timeFrame: Within the first 24 hours postoperative or more
measure: Gastrointestinal functional recovery(first stool passage)
timeFrame: First stool passage within three days postoperative or more
measure: postoperative complications
timeFrame: Immediately post operative up to thirty days postoperative
measure: Legnth of hospital stay
timeFrame: seven days up to two weeks
Secondary outcomes:
measure: gastrointestinal quality of life
timeFrame: Before hospital dicharge and after thirty days postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Assiut University -Assiut city
name: Mahmoud Ayoub, Ass. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181518: Tamoxifen Pharmacogenetics in Asian Breast Cancer Women
Official title: Observational Study: Biomarker Research for Tamoxifen Pharmacogenetics Among Asian Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poisoning by, Adverse Effect of and Underdosing of Tamoxifen
Keywords: Tamoxifen
Pharmacogenomics
Breast cancer
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who underwent surgery at Busan Paik Hospital, Inje University

Brief summary: The clinical outcome of tamoxifen treatment in breast cancer patients may be influenced by the activity of cytochrome P450 enzymes involving in tamoxifen biotransformation.

Detailed description: The investigators investigated the prognostic and/or predictive value of genetic polymorphisms of enzymes involved in tamoxifen metabolism for the treatment outcome among Asian breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* incident breast cancer patients who underwent surgery

Exclusion Criteria:

* previous cancer history before breast cancer diagnosis

Primary outcomes:
measure: Association between genetic polymorphisms of CYP2D6, CYP2C19, and CYP3A5 and disease free survival among tamoxifen treated breast cancer patients
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University
Study officials:
affiliation: Inje University
name: JaeGook Shin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162318: A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Official title: A Phase I Study of Cetuximab in Combination With Gefitinib in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small-Cell Lung Carcinoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 30
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: The purpose of this study is to find a safe and effective dose of Erbitux and Iressa for subject with non small cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced or metastatic non small cell lung cancer.
* Subjects should have had at least one prior chemotherapy with a platinum based therapy.

Exclusion Criteria:

* Subjects are excluded from this study if they do not have non small cell lung cancer that is advanced or metastatic or have not had at least one prior platinum based chemotherapy.

Primary outcomes:
measure: Safe and effective dose of combination of Erbitux and Iressa therapy.
Secondary outcomes:
measure: Response will be measured by radiographic measurement of disease every 4 weeks.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03509818: Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population
Official title: Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Population
Keywords: Klotho
Exercise
Physical Fitness
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 85
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Description of the sample
Primary purpose: OTHER

Brief summary: Exercise program in serum Klotho levels

Detailed description: This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population

Eligibility criteria: Inclusion Criteria:

* healthy people between 20 and 45 years old

Exclusion Criteria:

* acute and chronic disease, people who take medication and supplements, smoker.

Primary outcomes:
measure: Change in serum Klotho levels
timeFrame: Baseline and one hour
Secondary outcomes:
measure: Change in Cardiorespiratory Fitness VO2max
timeFrame: Baseline
measure: Change in Body Composition
timeFrame: Baseline
measure: Change in Body Composition, Body muscle mass Index
timeFrame: Baseline
measure: Change in Body Composition, % of Fat Mass
timeFrame: Baseline
measure: Change in Body Composition, Total Muscle Mass
timeFrame: Baseline
measure: Change in Body Composition, Visceral Fat Index.
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Escuela de Doctorado e Invesitgacion, Universidad Europea
state: Villaviciosa De Odon
Study officials:
affiliation: Universidad Europea de Madrid
name: Valentin Fernandez Elias, Ph
role: PRINCIPAL_INVESTIGATOR
References: