louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01942200: A Non Interventional Study With Oxaliplatin Onkovis (Oxaliplatin) Utilized for the Treatment of Cancer
Official title: Open, Multicenter Observational Study of Oxaliplatin Utilized in Combination Therapy for Adjuvant Treatment of Colon Carcinoma of Stage III After Complete Removal of the Primary Tumor and for Treatment of Metastasizing Colorectal Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma
Keywords: carcinoma
colon cancer
colorectal cancer
ambulant chemotherapy
treatment cycles
Oxaliplatin
Oxaliplatin onkovis
Quantity of Oxaliplatin
Packaging Sizes
Lead sponsor: Onkovis GmbH
Sponsor class: INDUSTRY
Collaborators: name: AKP Freiburg GmbH
First posted: 2013-09-13
Enrollment: 383
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in practices, clinics, hospitals

Brief summary: The main purpose of this observational study with Oxaliplatin onkovis is to determine the number of treatment cycles and the quantity of Oxaliplatin onkovis needed for this purpose under the special circumstances of ambulant chemotherapy.

Onkovis aims to contribute to an economical utilization of the chemotherapeutics. This includes provision of appropriate packaging sizes to decrease the excess quantity to be discarded, and thus also follows this objective.

Secondary objective is the assessment of the side effects of Oxaliplatin onkovis. To this end, data regarding co-medication and adverse events are also collected.


Eligibility criteria: Inclusion Criteria:

* Indication for Oxaliplatin according to the Summary of Product Characteristics (SmPC) and treating physician

Exclusion Criteria:

* According to the Oxaliplatin SmPC

Primary outcomes:
measure: The Quantity of Oxaliplatin onkovis needed per treatment cycle
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Adverse events during and after treatment
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Elstra
country: Germany
facility: Practice
city: Leipzig
country: Germany
facility: Practice
city: Naunhof
country: Germany
facility: Practice
Study officials:
References:
Clinical trial NCT02031900: High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undergoing Esophagogastroduodenoscopy (EGD)
Lead sponsor: NinePoint Medical
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females \>18 years of age undergoing esophagogastroduodenoscopy (EGD).

Brief summary: This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE Optical Probe to acquire an image of an area of the esophagus to identify and discriminate abnormal areas of tissue from normal.


Eligibility criteria: Inclusion Criteria:

* Males and females over the age of 18 years.
* Patients presenting for an EGD.
* Ability to provide written, informed consent.
* Females who are able to become pregnant, are willing to take a pregnancy test.

Exclusion Criteria:

* Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)\*.
* Patients with esophageal varices that preclude biopsies.
* Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE catheter.
* Patients with esophageal strictures that would prevent adequate expansion of the balloon from the NvisionVLE catheter.
* Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the NvisionVLE catheter.
* Patients with known eosinophilic esophagitis.
* Patients that are pregnant.
* Patients with a history of hemostasis disorders\*\*.

  * Patients on anticoagulation undergoing low risk procedures are not excluded. \*\* Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (\<100,000 plt/ul) and individuals with von Willibrand's disease or other known platelet malfunction disorders.

Primary outcomes:
measure: The primary endpoint will be the number of patients achieving a VLE (volumetric laser endomicroscopy) image that includes stomach, gastro esophageal junction (GEJ) and esophagus.
timeFrame: 1 day
Secondary outcomes:
measure: The evaluation of procedural workflow and physician interface to the NvisionVLE Imaging Console.
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Prashanthi Thota, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00237900: Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer
Official title: An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Subjects With Resectable Local or Locally Advanced, Non-Metastatic (T2-T4, N0-N3, M0; Stages II and III) and Histologically-Confirmed Intestinal GC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed intestinal GC (T2-T4)
* Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
* Lymph node positive or negative
* Metastasis negative
* Resection with curative intent (R0, D2)
* Chemo- and radiotherapy naïve
* Measurable lesion according RECIST
* Written informed consent

Exclusion Criteria:

* Aged below 45 or over 70
* Prior gastric surgery
* Active ILD

Primary outcomes:
measure: Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
measure: Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
Secondary outcomes:
measure: Parts 2 and 3:
measure: Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
measure: Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
measure: Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Reseach Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Oncology Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00217100: A Multivitamin Comparison Study in Kidney Transplant Recipients.
Official title: Folic Acid for Vascular Outcome Reduction in Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplant Recipients
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
name: University of California, San Francisco
name: University of Alabama at Birmingham
name: Ohio State University
First posted: 2005-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is being done to compare arteriosclerotic cardiovascular disease in kidney transplant recipient taking a standard multivitamin versus those taking a multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6.

Detailed description: This is a multicenter, randomized, double-blind controlled clinical trial. The trial has been designed to determine whether total homocysteine lowering treatment with a standard multivitamin augmented by a multivitamin containing no folic acid B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid, will reduce the pooled rate of recurrent or new cardiovascular disease outcomes or events. Participants will have a brief visit, at which the participant will have physical measurements, blood pressure and history taken. Urine and blood tests will be performed to determine the levels of homocysteine, vitamins and creatinine. Qualifying participants will be randomly assigned to receive multivitamins containing a high dose of folic acid, vitamin B6, and vitamin B12, or an identical multivitamin containing no folic acid, and estimated average requirement amounts of vitamin B6 and vitamin B12. The participant will be required to return annually throughout the next five years for physical exams, blood and urine tests.

Eligibility criteria: Participants with elevated homocysteine levels that are between the ages of 35-75 years old and have had a kidney transplant with stable renal graft function.

Primary outcomes:
measure: Estimated Average Requirement (EAR) amounts
timeFrame: basline to death or common end date 4.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT05193500: Study 3 Learning Verbs and Pronouns
Official title: Study 3 Learning Verbs and Pronouns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Emerson College
First posted: 2022-01-18
Enrollment: 179
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research is to explore abilities to learn word meanings from overheard speech in children with ASD (and, as a control, typically developing children).

Specific Aim 3 (Experiment 3): Determine whether children with ASD can learn verbs and pronouns by overhearing. Most prior work on learning from overheard speech has focused on learning nouns that label objects. This experiment extends this work to study other kinds of words.


Eligibility criteria: Inclusion Criteria:

\* children with or without a diagnosis of ASD between 24 to 71 months of age

Exclusion Criteria:

* native language is not English
* born premature (\< 36 weeks)
* has uncorrected hearing or vision impairments
* has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD)
* has a history of photosensitive epileptic seizures

Primary outcomes:
measure: Object Preference for Verbs
timeFrame: During test phase of the experimental session (within 3 seconds after the learning phase); 1.0-2.5 seconds after the test question
measure: Object Selection for Pronouns
timeFrame: During test phase of the experimental session (within approx. 5 seconds of being asked the test question)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Emerson College
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
Clinical trial NCT04940000: Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)
Official title: Evaluation of the Interest of a Video-assisted Remote Speech Therapy Consultation in Patients With ORL Cancer (TELE ORTHOPHONIE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ORL Cancer
Keywords: Video-Assisted Speech Therapy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 105
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: Interventional, prospective, single-centre study aimed to evaluate the impact of a video-assisted remote speech therapy consultation in relation to the complexity and specificity of the care of patients with ORL cancer. Three indications will be studied: phonation problems, swallowing problems and other problems.

The study will be conducted on a population of patients with T3, T4 ORL cancer requiring speech therapy.

Each patient included will have a video-assisted speech therapy consultation with a private speech therapist and an expert speech therapist. At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire.

At the follow-up visit following the video-assisted consultation, the patient will have completed participation in the study.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years at study entry.
2. Patient with carcinological pathology of the VADS, relevant to surgery and/or radiotherapy and/or chemotherapy.
3. Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).
4. Patient affiliated to a Social Security system in France.
5. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures foreseen in the study protocol.
3. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).

Primary outcomes:
measure: The rate of patients for whom tele-therapy will be considered successful.
timeFrame: 12 months for each patient
Secondary outcomes:
measure: The rate of patients with full or partial resolution of speech-language pathology at the end of the telecare consultation.
timeFrame: 12 months for each patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References:
Clinical trial NCT05778500: Algorithms to Improve the Accuracy of the Echocardiographic Report
Official title: IMPlementazione di algoRitmi di Assistenza Alla diagnOsi in un Software di Refertazione Computerizzato Che Valuta Anche l'Accuratezza Dell'Esame ECOcardiografico
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Echocardiography
Keywords: Transthoracic echocardiography
Transesophageal echocardiography
Report
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Medimatic S.R.L., Genova, Italy
First posted: 2023-03-21
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who consecutively undergo an echocardiographic examination

Brief summary: This observational study aims to improve the accuracy of the report of the echocardiographic study, making it more consistent with the current international guidelines and reducing the diagnostic mistakes in patients undergoing clinically -indicated echocardiography. The main questions it aims to answer are:

* can the addition of automated diagnostic algorithms help to improve the overall accuracy of the echocardiographic report?


Eligibility criteria: Inclusion Criteria:

* Having undergone a clinically-indicated echocardiographic study

Exclusion Criteria:

* Denial of the consensus to use individual clinical data for research purposes

Primary outcomes:
measure: Inconsistencies between quantitative and qualitative parameters in the report
timeFrame: During analysis of echocardiographic data
Secondary outcomes:
measure: Inconsistencies between the clinical diagnosis and clinical guidelines
timeFrame: During analysis of echocardiographic data
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
References:
Clinical trial NCT05872100: THE EFFECT OF MINDFULNESS-BASED PRACTICES GIVEN TO NURSING
Official title: THE EFFECT OF MINDFULNESS-BASED PRACTICES GIVEN TO NURSING STUDENTS ON COMPASSION, COMPASSION AND NURSING CARE
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nurse's Role
Keywords: mindfulness
nursing
awareness
nursing care
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In our research, it is expected that the 'conscious awareness-based psychoeducation program' will be made to the nursing students who go into clinical practice, to increase the level of mindfulness of the students, to increase their level of compassion and compassion, and to reflect this awareness while providing nursing care. It is thought that it is important to evaluate the effects of mindfulness-based psychoeducation program practices on nursing care and to evaluate mindfulness-based psychoeducation program practices.

This study was planned as a randomized control study with an intervention group to determine the effect of mindfulness-based practices given to nursing students on compassion, compassion and nursing care.


Eligibility criteria: Inclusion Criteria:

* be over 18 years old
* become a nursing student
* Having successfully passed the internal medicine nursing course

Exclusion Criteria:

* not attending 1 session of the study
* unwillingness to quit

Primary outcomes:
measure: THE EFFECT OF MINDFULNESS-BASED PRACTICES GIVEN TO NURSING STUDENTS ON COMPASSION, COMPASSION AND NURSING CARE Compassion and Compassion
timeFrame: 1 month
measure: THE EFFECT OF MINDFULNESS-BASED PRACTICES GIVEN TO NURSING STUDENTS ON COMPASSION, COMPASSION AND NURSING CARE Caring Behaviors
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Tuğba Bilgehan
state: Ankara
Study officials:
References:
Clinical trial NCT01504100: Efficiency of Patellar Taping in Treatment of Patellofemoral Pain Syndrome
Official title: The Effects of Distal Femoral Rotation on Patellofemoral Pain Syndrome Treated With Patella Taping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients

Brief summary: Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been reported good outcomes in most patients. However, some studies reported less effective in patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q angle. The investigators hypothesized that femoral internal rotation is a negative factor to the patellar taping. The investigators enroll consecutive 100 patients with anterior knee pain and radiographic evidence of patellar subluxation. The investigators determine femoral rotation via physical examination. The visual analogue scale was evaluate to compare the result between the those with and without femoral internal rotation.

Detailed description: Consecutive 100 patients with anterior knee pain and compatible with inclusion criteria. Before treatment, an independent physiotherapist evaluates whether femoral internal rotation or not via physical therapy, and another studying nurse records the visual analog scale and measures Q angle. After evaluation, McConnell taping is applied to these patients. Two weeks later, outcomes are recorded including visual analog scale, satisfactory, and complication. The outcomes are compared between those with and without femoral internal rotation.

Eligibility criteria: Inclusion Criteria:

* anterior knee pain
* radiographic evidence of patellar subluxation

Exclusion Criteria:

* history of patellar dislocation
* osteoarthritis of ipsilateral knee
* pregnancy
* history of knee injury
* BMI \> 35
* allergy to taping

Primary outcomes:
measure: Knee pain
timeFrame: two weeks
Secondary outcomes:
measure: Satisfactory
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Orthopaedic Surgery, National Taiwan University Hospital
Study officials:
affiliation: Department of Orthopaedic Surgery, National Taiwan University Hospital, 7 Chungsan South Road, Taipei, Taiwan
name: Ching-Chuan Jiang, MD. PhD
role: STUDY_CHAIR
References: