louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00149136: Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.
Official title: Evaluation of Imatinib (GLIVEC) After Induction Therapy in Patients Aged More Than 55 Years With Philadelphia Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) : a Non Randomised, Controlled, Open, Multicentric, International Phase II Clinical Study (CSTI 571 AFR09 Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Lymphocytic Leukemia
Keywords: Acute Lymphocytic Leukemia,
Ph+,
elderly patients,
Imatinib
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation.

Duration of therapy : 2 years.


Eligibility criteria: Inclusion Criteria:

* Ph+ ALL patients
* 55 years or older
* Signed written informed consent

Exclusion Criteria:

* CML in transformation
* Concomitant malignancy
* Previous treatment by Imatinib
* Severe organ condition

Primary outcomes:
measure: Impact of Imatinib on survival in elderly patients with Ph+ALL
Secondary outcomes:
measure: Tolerance of Imatinib
measure: Complete remission rate
measure: Minimal Residual Disease after Imatinib treatment
measure: Leukemia free survival
measure: Impact of steroids given before starting chemotherapy
measure: Study of potential resistance mechanisums to Imatinib
Other outcomes:
Locations:
city: Lyon
country: France
facility: Xavier THOMAS
Study officials:
affiliation: Hospices Civils de Lyon
name: Xavier THOMAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190136: Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity
Official title: Yoga Improves Aerobic Fitness, Glycemia and Mood State and Reduces Abdominal Obesity in Overweight Women: The PRISE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: obesity
protein-rich whole foods diet
aerobic fitness
resistance training
stretching/yoga training
glycemia
mood state
Lead sponsor: Skidmore College
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 39
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Stretching and flexibility exercise such as yoga and functional resistance exercise are two forms of exercise that are growing in popularity. However, they have not been scientifically tested to demonstrate their ability to improve body composition, fitness, heart and metabolic health, and mood state in overweight/obese women. The investigators hypothesize that during an 11 week intervention, both forms of exercise will improve body composition, heart and metabolic health and mood state.

Detailed description: This study was a 11 week protein-rich whole food diet and exercise training intervention in middle aged overweight/obese women. Subjects were randomized into 3 groups: Protein-rich whole food only consumed as 20-25 grams per serving 4-6 per day (P); protein and resistance exercise training (R); and protein and stretching/yoga exercise training (S). All outcomes, including the primary outcomes of body composition and cardiometabolic biomarkers were measured at baseline (week 0) and post-intervention (week 12) in all study subjects.

Eligibility criteria: Inclusion Criteria:

* obese or overweight women
* between ages 25-60 and
* otherwise healthy

Exclusion Criteria:

* smokers,
* habitual exercisers

Primary outcomes:
measure: Total and Regional Body Composition
timeFrame: baseline and 11 weeks
Secondary outcomes:
measure: Aerobic Fitness
timeFrame: baseline and 11 weeks
Other outcomes:
measure: Plasma Biomarkers
timeFrame: baseline and 11 weeks
Locations:
city: Saratoga Springs
country: United States
facility: Human Nutrition and Metabolism Laboratory
state: New York
Study officials:
affiliation: Skidmore College
name: Paul J Arciero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruby M, Repka CP, Arciero PJ. Comparison of Protein-Pacing Alone or With Yoga/Stretching and Resistance Training on Glycemia, Total and Regional Body Composition, and Aerobic Fitness in Overweight Women. J Phys Act Health. 2016 Jul;13(7):754-64. doi: 10.1123/jpah.2015-0493. Epub 2016 Feb 19.
Clinical trial NCT05408936: SGLT2 Inhibitors and Effects on Hematopoiesis, Inflammation and Metabolic Markers
Official title: Study of the Mechanisms Leading to Increased Hemoglobin Levels and of the Cardiorenal Response in Type 2 Diabetic Patients With Recent Initiation of SGLT2 Inhibitors.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: SGLT2 inhibitors, hemoglobin, NTproBNP, ketones
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients who visit the diabetes outpatient clinic in the University Hospital of Patras, Greece

Brief summary: Study of the response to SGLT2 inhibitors in type 2 diabetic patients with relevance to the erythropoesis and indexes of cardiorenal function.

The study enrolls type 2 diabetic patients in whom the introduction of a SGLT2 inhibitor is deemed necessary as part of their routine treatment during their visit to our outpatient diabetes unit.

A whole blood, a serum and a urine sample is obtained before and one month after the initiation of treatment with a SGLT2 inhibitor.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* Hba1C\>7% on their current treatment
* introduction of SGLT2 inhibitor as part of their routine care

Exclusion Criteria:

* eGFR\<60 ml/min

Primary outcomes:
measure: Hemoglobin
timeFrame: 0-1-3 months
measure: Erythropoetin
timeFrame: 0-1-3 months
measure: NT-proBNP
timeFrame: 0-1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: University Hospital of Patras
Study officials:
References:
Clinical trial NCT01128036: Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion
Official title: Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congestive Heart Failure
Cardiomyopathy
Keywords: Congestive Heart failure
Cardiomyopathy
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2010-05-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the CICU (Coronary Intensive Coronary Unit) with congestive heart failure or cardiomyopathy

Brief summary: The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.

Detailed description: A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.

Eligibility criteria: Inclusion Criteria:

* CICU patients with a new diagnosis or history of CHF or cardiomyopathy
* Patients with a medical order for pulse oximetry monitoring
* Age greater than or equal to 18 years of age
* English speaking
* Signs of hypoperfusion

Exclusion Criteria:

* CICU patients with an impediment to sensor application
* CICU patients with excessive facial edema
* CICU patients with mechanical ventilation
* CICU patients with intra-aortic balloon pump therapy
* CICU patients with intravenous vasopressor drug administration

Primary outcomes:
measure: Signal quality loss (dropout rate)
timeFrame: Every 2 seconds for one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
Study officials:
affiliation: Saint Luke's Hospital
name: Lisa Riggs, MSN
role: STUDY_DIRECTOR
affiliation: Saint Luke's Hospital
name: Marci Sportsman, BSN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906113: Intra-arterial Chemotherapy for Children With Retinoblastoma
Official title: Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Retinoblastoma
Keywords: Retinoblastoma
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye.

This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.


Eligibility criteria: Inclusion Criteria:

* Children with retinoblastoma in a single remaining eye with useful vision

Exclusion Criteria:

* None

Primary outcomes:
measure: Salvage of eye and vision
timeFrame: Three years from intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
References:
Clinical trial NCT00421213: Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Official title: Phase II Study of ZIO-101 in Advanced Blood and Bone Marrow Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematologic Neoplasms
Bone Marrow Neoplasms
Non-Hodgkin's Lymphoma
Keywords: APL
Lymphoma
T-cell Lymphoma
Peripheral T-cell Lymphoma
Lead sponsor: Alaunos Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 50
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 study of safety of a new organic arsenic compound in the treatment of hematological malignancies.


Eligibility criteria: Inclusion Criteria

1. Hodgkin's or non-Hodgkin's Lymphoma.
2. ≥ 1 prior therapy and currently requiring therapy.
3. Evaluable disease (defined by disease-specific criteria listed in Appendix 1)
4. ≥ 18 years of age.
5. ECOG performance score ≤ 2 (see Appendix 2).
6. Life-expectancy ≥ 2 months.
7. Written informed consent in compliance with ZIOPHARM policies and the Human Investigation Review Committee with jurisdiction over the site.
8. No anti-cancer therapy exception of hydroxyurea ≤ 3 weeks before Baseline (Day 1, Cycle 1).
9. The following clinical laboratory values \< 2 weeks before Baseline:

   * Creatinine ≤ 2X upper limit of normal (ULN).
   * Total bilirubin ≤ 2X ULN.
   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3X ULN.

Exclusion Criteria

1. New York Heart Association (NYHA) functional class ≥3 myocardial infarction (see Appendix ) within 6 months before Baseline or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a QTc ≥450 msec; or a ≥grade-2 atrioventricular (AV) block or left bundle branch block (LBBB).
2. Pregnant and/or lactating female. (Women of childbearing age must use effective contraception from Screening through the duration of study participation).
3. Uncontrolled infection.
4. Prior seizures ≥ grade-3 in CTC v.3 criteria.
5. Arsenic allergy.
6. Significant neuropathology, defined as grade \> 2 per CTCAE Version 3.0.
7. Confusion or dementia.
8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment.

Primary outcomes:
measure: Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: toxicities
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Bethesda
country: United States
state: Maryland
city: Fargo
country: United States
state: North Dakota
city: Sioux Falls
country: United States
state: South Dakota
city: Morgantown
country: United States
state: West Virginia
Study officials:
References:
Clinical trial NCT03744013: A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis
Official title: A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammoplasty
Lead sponsor: RTI Surgical
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: post market prospective, multi-center study
Primary purpose: TREATMENT

Brief summary: This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.


Eligibility criteria: Inclusion Criteria:

1. Female 18 years or older
2. A candidate for immediate breast reconstruction during post-skin sparing or nipple-sparing mastectomy (unilateral or bilateral)
3. Estimated life expectancy \> 2 years
4. Able and willing to return for all scheduled and required study visits
5. Able to provide written informed consent for study participation
6. Able to read, understand and complete study questionnaires

Exclusion Criteria:

1. Any of the conditions listed in the approved labeling as contraindicated
2. Currently enrolled or plans to enroll in another clinical study that would affect the validity of the study
3. Any patient that per the physician's judgement is not a good candidate for this study

Primary outcomes:
measure: Safety of Fortiva® tissue matrix
timeFrame: 24 months
measure: Performance of Fortiva® tissue matrix
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Frankfurt am Main
country: Germany
facility: Frankfurt University Hospital
city: München
country: Germany
facility: University Hospital Technical University, Munich
city: Ulm
country: Germany
facility: University Hospital, Ulm
city: London
country: United Kingdom
facility: Guy's Hospital
city: Manchester
country: United Kingdom
facility: Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital
Study officials:
References:
Clinical trial NCT05825313: The Effect of Podcast Use Student's Skills in Nursing Education
Official title: The Effect of Podcast Use in Nursing Education on Students' Speech Skill, Affective Awareness Towards Instruction and Success: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted to find out the effect of the use of podcasts in nursing education on nursing students' speaking skills, affective awareness towards instruction, and success in the course and to serve as a source for prospective studies on the topic.

Detailed description: Objectives This study was conducted to find out the effect of the use of podcasts in nursing education on nursing students' speaking skills, affective awareness towards instruction, and success in the course and to serve as a source for prospective studies on the topic.

Design Randomized controlled trial. Settings A nursing faculty Participants Fourth-year nursing students who were studying at the faculty of nursing and were taking the "Academic Presentation Techniques" were randomly assigned to the experimental group (n=20) and the control group (n=20).

Methods Every week during the semester, students in the experimental group could listen to podcast episodes any time they desired following the course. Both before the podcast intervention and at the end of the semester, the Effective Speech Scale and the Scale of Affective Awareness Towards Instruction were administered to experimental and control groups. Final examination grades were evaluated as the indicator of success in the course.

Eligibility criteria: Inclusion Criteria:

* Be over 18 years old,
* Volunteer to participate in research

Exclusion Criteria:

* be under 18 years old,
* not voluntarily to participate in research

Primary outcomes:
measure: Speech Skills
timeFrame: Four months
Secondary outcomes:
measure: Affective Awareness Towards Instruction
timeFrame: Four months
Other outcomes:
measure: Success
timeFrame: Four months
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
References:
citation: O'Connor S, Daly CS, MacArthur J, Borglin G, Booth RG. Podcasting in nursing and midwifery education: An integrative review. Nurse Educ Pract. 2020 Aug;47:102827. doi: 10.1016/j.nepr.2020.102827. Epub 2020 Jul 6.
Clinical trial NCT02302313: Study of the ANI Validity on Evaluation of Nociception in State of Hypnosis
Official title: Pilot Study of the ANI (Analgesia Nociception Index) Validity on the Nociception Assessment in Healthy Volunteers in State of Hypnosis, Compared to Painful Numerical Verbal Scale (EVN).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy volunteers
critical awareness
hypnosis
Analgesia Nociception Index
numerical verbal scale
Determine the validity of the index (ANI)
nociception in critical awareness
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli of variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its safety. ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will be made on subjects at rest and in a state of hypnosis using the technique of "remembering a pleasant memory" and the ideo-sensory technique of "protective glove".

The average value of the ANI will be compared to the value of the EVN of pain intensity.


Eligibility criteria: Inclusion Criteria:

* Knowledge of the state of hypnosis
* Healthy volunteers
* Capable adults
* Free and informed consent

Exclusion Criteria:

* Heart diseases
* Medication affecting the heart rate
* Medication affecting the skin sensitivity

Primary outcomes:
measure: EVN value of pain intensity versus average value of the ANI
timeFrame: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation
Secondary outcomes:
measure: EVN value of the arduousness of pain perception versus ANI value
timeFrame: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation
Other outcomes:
Locations:
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé Saint-Grégoire
Study officials:
affiliation: Saint-Gregoire Private Hospital Center
name: Hervé MUSELLEC
role: PRINCIPAL_INVESTIGATOR
References: