louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03923400: Jejunoileal vs Gastric GIST in the Era of Imatinib.
Official title: Characteristics and Prognosis of Jejunoileal Gastrointestinal Stromal Tumors (GISTs) in the Era of Imatinib. A Comparative Retrospective Study With Gastric GISTs.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease-free Survival
Overall Survival
Recurrence
Keywords: GIST
small bowel
jejunum
ileum
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GIST diagnosis was established by an experienced board-certified pathologist who reviewed our database prospectively maintained. After revision, we included in the study any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST. The patients were divided into two groups: patients with GISTs located in the jejunum or ileum, comprising the JI-GIST group; and patients with gastric GISTs, comprising the G-GIST group.

Brief summary: Introduction: Gastrointestinal Stromal Tumors (GISTs) located in the jejunum or ileum (JI-GIST) are considered of worse prognosis compared to other locations. It has been suggested that this dogma should be revised. The aim of this study is to describe the characteristics of jejunoileal GISTs and its prognosis; and to compare them with gastric GISTs in the era of imatinib.

Patients and methods: We retrospectively reviewed the clinical histories of all the patients diagnosed with GISTs between January 2000 and November 2016. Clinical and pathological data, as well recurrence, metastatic, disease-free survival (DFS) as overall (OS) rates of patients with JI-GIST or gastric GIST (G-GIST) were collected and compared.


Eligibility criteria: Inclusion Criteria:

* Any kind of primary mesenchymal tumor of the gastrointestinal tract with a histomorphological and immunohistochemical (CD117 (+) and/or DOG1 (+)) profile consistent with GIST.

Exclusion Criteria:

-

Primary outcomes:
measure: KIT Gene mutation
timeFrame: 15 years
measure: PDGFRA Gene mutation
timeFrame: 15 years
measure: Expression of CD117
timeFrame: 15 years
measure: Expression of DOG1
timeFrame: 15 years
measure: Recurrence
timeFrame: 15 years
measure: Deceased
timeFrame: 15 years
measure: Location
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: David Ferreras
Study officials:
References:
Clinical trial NCT01108900: A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil
Official title: Non-Interventional, Prospective Study Of the Evaluation Of Patients Population With ED, Treated With Sildenafil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction udenafil sildenafil treatment satisfaction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients, aged \>18 years and having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks.

Brief summary: In the present study, it is planned to observe a population of 100 ED patients treated previously with udenafil and for whom their physician decided to switch them to sildenafil because of poor udenafil tolerance and/or poor efficacy.


Eligibility criteria: Inclusion Criteria:

* Male patients aged ≥ 18 years.
* Clinical diagnosis of erectile dysfunction supported by a total score of less than or equal to 21 according to Sexual Health Inventory-Male (SHI-M).
* Patients having a sexual partner throughout the study.
* Patients having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks.

Exclusion Criteria:

* The patients for whom sildenafil is contraindicated according to the Local Product Document (LPD). (See appendix D)
* The patients for whom sexual activity is not indicated.

Primary outcomes:
measure: To observe the treatment satisfaction of ED patients (sum of questions 13-14 IIEF) that were switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated.
timeFrame: 1 month
Secondary outcomes:
measure: To evaluate a change of scores of the IIEF (sum of questions 1-5 and 15) and the EHS.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT07005700: Rapid Diagnostics for Genetic Disorders in Neonates
Official title: Development of Rapid Diagnostics for Genetic Disorders in Neonates Using a Novel Targeted Genomic DNA Sequencing Analysis Panel.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acid Base Disorder
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: MedySapiens
First posted: 2025-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to test a prototype genomic blood analysis for identifying rare diseases in infants hospitalized in the neonatal intensive care unit (NICU).

The main question it aims to answer is: Does the prototype accurately identify genetic variation(s) associated with an infant's health condition?

Researchers will compare the prototype's gene identification to traditional genome sequencing methods of gene identification.

Participants will be asked to provide a very small (one-tenth of a teaspoon) sample of blood, one-time.


Eligibility criteria: Inclusion Criteria: neonates of any gestational age.

* Abnormality in routine neonatal screening test.
* Unexplained neonatal hypotonia or neonate-onset seizures.
* Unexplained and abnormal biochemical laboratory findings.
* Skeletal dysplasia or joint problems.

Exclusion Criteria:

* Parental refusal of consent to participate.
* Provider refusal.
* Any condition that, in the opinion of the investigator, would interfere with interpretation of study results.

Primary outcomes:
measure: Identification of genes associated with congenital diseases
timeFrame: birth through hospital discharge or up to 1 month of age
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
References:
citation: Kim MJ, Kim SY, Lee JS, Kang S, Park LJ, Choi W, Jung JY, Kim T, Park SS, Ko JM, Seong MW, Chae JH. Rapid Targeted Sequencing Using Dried Blood Spot Samples for Patients With Suspected Actionable Genetic Diseases. Ann Lab Med. 2023 May 1;43(3):280-289. doi: 10.3343/alm.2023.43.3.280. Epub 2022 Dec 22.
Clinical trial NCT04512300: Parental Attitude Toward Children Dental Treatment During COVID-19 Pandemic
Official title: Parental Attitude Toward Children Dental Treatment and Care During COVID-19 Pandemic (Cross -Sectional Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Diseases
Keywords: Covid -19
Dental treatment
Dental Care
parental attitude
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 267
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian parents living in Egypt having children less than 16 years old

Brief summary: The aim of this study is assessment of parental attitude toward children dental treatment and care during Covid 19- crisis

Detailed description: The recent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its associated coronavirus disease has gripped the entire international community and caused widespread public health concerns.

Many countries all over the world including Egypt, have followed guidelines of limiting dental treatment for emergency cases only. However, as social distancing guidelines are starting to relax across many countries nowadays , dental offices start to reopen for elective procedures , many parents may still have a great concern regarding their children dental treatment during this pandemic. so the aim was to assess their attitude regarding their children dental visit

Eligibility criteria: Inclusion Criteria:

* Egyptian parents living in Egypt having children less than 16 years old

Exclusion Criteria:

* incomplete questionnaire

Primary outcomes:
measure: Assessment of parental attitude toward children dental visit during Coronavirus crisis
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Cairo university , Egypt
Study officials:
affiliation: Cairo University
name: Yasmin Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489200: EH301 for the Treatment of ALS
Official title: EH301 for the Treatment of Amyotrophic Lateral Sclerosis: a Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
Collaborators: name: Fundación Universidad Católica de Valencia San Vicente Mártir
name: University of Valencia
First posted: 2018-04-05
Enrollment: 32
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 objective of this trial is to evaluate the efficacy and tolerability of EH301 in patients with amyotrophic lateral sclerosis. Patients with ALS are randomized to receive either EH301 or placebo daily and undergo active evaluation for 6 months.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosis of probable or definite (sporadic or familial) ALS by El Escorial criteria
* Onset of symptomatology for more than 6 months
* If female: not lactating; negative pregnancy test; agree to use an effective method of birth control throughout study

Exclusion Criteria:

* Tracheostomy, invasive ventilation, or non-invasive positive pressure ventilation
* Gastrostomy
* Evidence of major psychiatric disorder or clinically evident dementia
* Diagnosis of a neurodegenerative disease in addition to ALS
* Current medication apart from riluzole that in the opinion of the investigator would make the patient unsuitable for study participation
* Recent history (within the previous 6 months) or current evidence of alcohol or drug abuse
* Concurrent unstable disease involving any system (e.g. carcinoma other than basal cell carcinoma), any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of coronary artery disease, or any other condition that in the opinion of the investigator would make the patient unsuitable for study participation
* Baseline QTc (Bazett) \> 450 msec for males and \> 470 msec for females
* Known hepatitis B/C or HIV positive serology
* Renal impairment defined as blood creatinine \> 2x ULN
* Hepatic impairment and/or liver enzymes (ALT or AST) \> 3x ULN
* Hemostasis disorders or current treatment with oral anticoagulants
* Participated in any other investigational drug or therapy study with a non-approved medication, within the previous 3 months
* No medical insurance

Primary outcomes:
measure: ALSFRS-r
timeFrame: 6 months
Secondary outcomes:
measure: MRC
timeFrame: 6 months
measure: FVC
timeFrame: 6 months
measure: Electromyogram
timeFrame: 6 months
measure: Anthropometry
timeFrame: 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad Católica de Valencia San Vicente Màrtir
Study officials:
References:
Clinical trial NCT00457600: ParentLink: Better and Safer Emergency Care for Children
Official title: ParentLink: Better and Safer Emergency Care for Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media
Urinary Tract Infection
Asthma
Head Injury
Keywords: information technology
emergency department
medication error
quality of care
patient-centered care
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: South Shore Hospital
First posted: 2007-04-06
Enrollment: 3000
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The emergency department (ED) constitutes a high-risk environment for errors and poor quality of care. Pediatric patients are at increased risk of medical errors. We postulate that implementation of a patient-centered health information technology - ParentLink - can address system-level deficiencies and the unique "just-in-time" information needs of ED physicians and the parents of ill children. The proposed work delivers an innovative product - an electronic interface linked to a pediatric knowledge base that integrates parent-derived data with best practices for safe and effective emergency care across common pediatric disease conditions: otitis media, urinary tract infections, asthma, and head trauma. The study has two aims, the first of which addresses critical gaps in data capture: to evaluate the completeness and accuracy of information on symptoms, disease condition, medications and allergies generated by parents using ParentLink versus information documented by ED physicians and nurses, using structured telephone interviews as a gold standard. The second aim measures the ParentLink's impact on ED patient safety and quality, specifically: a) the error rate for ordering and prescribing of medications during ED care, and b) the percent of ED visits that adhere to national evidence-based guidelines. Parentlink will be rigorously evaluated in a clinical trial at two diverse ED sites and will use a sequential, non-randomized observational design with two intervention and two control periods to measure the effects of ParentLink on data capture and safety and quality of patient care.


Eligibility criteria: Inclusion Criteria:

* Age less than 12 years with head trauma
* Age less than 12 years with ear pain
* Ages less than 12 years with concern for UTI
* 1 year - 12 years with asthma history and respiratory chief complaint
* 3 months - 2 years with fever
* Parent speaks English or Spanish
* Triage status is non-emergent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Stephen C Porter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007500: Effect of Dexamethasone Combined With Ondansetron on Postoperative Nausea and Vomiting in Patients With Patient-controlled Analgesia After Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: Postoperative nausea and vomiting after video-assisted thoracoscopic surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to study the effect of dexamethasone combined with ondansetron on postoperative nausea and vomiting in patients with patient-controlled analgesia after video-assisted thoracoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing video-assisted thoracoscopic surgery
* Age 20-75
* American Society of Anesthesiologists physical status classification I or II

Exclusion Criteria:

* Antiemetic within 24 hrs
* Taking Steroids, Opioids within 1 week
* Active drug or alcohol abuse
* GI motility disorder, severe renal/ hepatic disease.

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: within 48 hrs after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01809600: Retrospective Analysis of Rituximab-containing Immunochemotherapy for Burkitt's or Burkitt-like Lymphoma in Adults
Official title: Rituximab-Containing Immunochemotherapy for Burkitt's Lymphoma (BL) and High-Grade B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and BL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burkitt's Lymphoma
High-grade B-cell Lymphoma
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 43
Sex: ALL
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: patients who were treated with Burkitt's or Burkitt-like high-grade B-cell lymphoma in Republic of Korea

Brief summary: This retrospective study is aimed at evaluating the safety and efficacy of rituximab-containing immunochemotherapy in adult patients with Burkitt's lymphoma (BL) or high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL.

Detailed description: Inclusion criteria

1. pathologically confirmed BL or BL-U by World Health Organization 2008 criteria
2. age \>20 yrs
3. received rituximab+chemotherapy as first-line treatment
4. with measurable or evaluable lesion
5. with complete set of clinical and laboratory data for the analysis

Eligibility criteria: Inclusion Criteria:

1. pathologically confirmed Burkitt's lymphoma (BL) or High grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and BL (BL-U) by WHO 2008 criteria
2. age \>20 yrs
3. received rituximab+chemotherapy as first-line treatment
4. with measurable or evaluable lesion

Exclusion Criteria:

1. patients with BL or BL-U previously treated with rituximab

Primary outcomes:
measure: Event-free survival
timeFrame: one year
Secondary outcomes:
measure: complete response rate
timeFrame: 1-year
measure: overall survival
timeFrame: 1-year
measure: Grade 4 hematologic toxicities
timeFrame: one year
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Suk Jin Kim, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01934400: Osteoporosis and Fall Prevention Education
Official title: Osteoporosis and Fall Prevention Education With High Risk Population Telephone Follow up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Osteoporosis
fall prevention
high risk population
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 127
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who attending the fall prevention educational programme.

Brief summary: Objective: The study is to increasing osteoporosis awareness with fracture risk assessments and management as well as fall prevention among elderly in northern region of Taiwan.

Method: Six community osteoporosis and fall prevention educational programme will be held at northern region of Taiwan. A questionnaires design including demographic variables , FRAX variables, nutritional variables and osteoporosis and fall knowledge variables as well.The pretest-posttest method was used to analyse the effect on education.

Expected outcomes : (1)Fall prevention educational programme will hold in northern region of Taiwan at different communities in order to increasing osteoporosis awareness with fracture risk assessment tool, establishing fall knowledges among elderly and some fall prevention skills.(2)Elderly with 10-year probability of major osteoporotic fracture risk who more than 20% and 10-year probability of hip fracture risk who more than 3% will identify as high risk of osteoporosis. (3) To estimate number of cases who identified as high risk will recommend for BMD measurement.


Eligibility criteria: Inclusion Criteria:

1. Adults between the ages of 40 to 90.
2. Adults who been fractures prior to assessment.
3. Adults who have ability, well conscious to complete the questionnaires.

Exclusion Criteria:

1.Adults who have treatment currently will not include in this study.

Primary outcomes:
measure: Measurement of effects of fall prevention education.
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ding-Cheng Chan, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: