louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01683123: Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning Regimen For HLA Identical Sibling Donor HSCT
Official title: Phase 2 Study With Intravenous Busulfan And Fludarabine Myeloablative Conditioning For HLA Identical Sibling Allogeneic HSCT In Myeloid Malignancies. Retrospective Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorders
Chronic Myeloid Leukemia
Keywords: Allogeneic HSCT
Busulfan
Fludarabina
Lead sponsor: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 143
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with myeloid malignancies submitted to allogeneic HSCT with an HLA identical sibling donor

Brief summary: Analyze the results of conditioning with once-daily dose intravenous busulfan and fludarabine in patients undergoing HLA identical sibling Allogeneic HSCT for myeloid malignancies.

Detailed description: In this study the investigators evaluate a conditioning regimen consisting in Fludarabine 40 mg/m2 once daily i.v in 60 min. on days -6 to -3 (total dose 160 mg/m2), followed by Busulfan 3,2 mg/kg once daily i.v. in 180 min. in the same days (total dose 12,8 mg/kg). No busulfan pharmacokinetic monitoring is performed. Graft versus host disease prophylaxis consists in the combination of cyclosporine and methotrexate. Graft products obtained from bone marrow or peripheral blood of HLA identical sibling donors are not manipulated in their cellular content before transplantation. Blood products were leukocyte depleted and irradiated before transfusion. Supportive care, including seizure prophylaxis, isolation measures, antiemetics, antimicrobial agents and growth factors use are followed according to standard procedures.

The main objectives are to record data regarding engraftment, regimen related toxicity and outcome in different patient populations according to age, disease type, disease status at HSCT and comorbidities.

Eligibility criteria: Inclusion Criteria:

* Acute Myeloid Leukemia
* Myelodysplastic Syndrome
* Myeloproliferative Disorders
* Chronic Myeloid Leukemia

Exclusion Criteria:

* Performance status ECOG\>2
* Cardiomyopathy (LVEF \<39%)
* Pulmonary dysfunction (DLCO\<39%)
* Hepatic dysfunction Grade \>1
* Renal dysfunction Grade \>1 (Creatinine \> 1.6 mg/dl)
* HIV infection
* Other active neoplasm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
name: Javier De la Serna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grupo Espanol de trasplantes hematopoyeticos y terapia celular
name: Guillermo Sanz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01029223: The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
Official title: The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Blood Pressure
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2009-12-09
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).


Eligibility criteria: Inclusion Criteria:

* Aged 18 - 25 years OR
* Aged \> 60 years

Exclusion Criteria

* Chronic disease
* Unable to give informed consent
* Treated or untreated systemic arterial hypertension (SBP \> 160 mmHg and/or DBP \> 90 mmHg)
* Resting bradycardia (heart rate \< 60 beats/minute)
* Pregnancy or active lactation

Primary outcomes:
measure: central and peripheral arterial and pulse wave velocity
timeFrame: baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.
Secondary outcomes:
measure: Central pulse pressure
timeFrame: Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, metoprolol or ivabradine.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04713423: Oral and Perioral Herpes Simplex Virus Infection Type I in a Five-month-old Infant: A Case Report
Official title: Oral and Perioral Herpes Simplex Virus Infection Type I in a Five-month-old Infant: A Case Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Simplex Virus Infection
Keywords: Herpetic gingivostomatitis
Herpes simplex virus
Perioral lesions
Infants
Case report
Herpes simplex virus type 1
Oral lesions
Lead sponsor: Princess Nourah Bint Abdulrahman University
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a case report study

Brief summary: A five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles.

Detailed description: The investigators present the case of a five-month-old healthy girl who presented with painful herpetic gingivostomatitis and perioral vesicles. The investigators discuss the pathophysiology of primary herpes simplex virus infection and the effect of maternal antibodies on the infant's immune system. In addition, the investigators explain the diagnosis, management, and prognosis of herpes simplex virus infection in young infants.

Eligibility criteria: Inclusion Criteria:

* Five-months-old infants or younger

Exclusion Criteria:

* Six-months-old infants or older

Primary outcomes:
measure: Health condition
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Princess Nourah Bint Abdulrahman University
Study officials:
affiliation: Princess Nourah Bint Abdulrahman University
name: Ashwag Y Aloyouny
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201123: Effects of Interferon-Gamma on Cavitary Pulmonary Tuberculosis in the Lungs
Official title: Host Response to Tuberculosis and Acquired Immune Deficiency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
AIDS-related Complex
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-20
Enrollment: 89
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: TREATMENT

Brief summary: This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Detailed description: BACKGROUND:

Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.

DESIGN NARRATIVE:

Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.

The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.

Eligibility criteria: Inclusion Criteria:

* Positive acid-fast bacillus (AFB) smear within 14 days prior to randomization
* Cluster of Differentiation 4 greater than 200 if HIV positive
* Ability to sign consent
* Bilateral, cavitary pulmonary TB

Exclusion Criteria:

* Multidrug-resistant (MDR) TB
* Extrapulmonary TB
* HIV positive with opportunistic infection within 30 days of study entry
* Cancer
* Asthma
* Pregnant or lactating women
* Chronic heart disease
* Chronic liver disease
* Chronic renal disease
* Seizure disorder
* Bleeding or clotting disorder
* Diabetes mellitus

Primary outcomes:
measure: Sputum Conversion
timeFrame: Measured at 16 Weeks
Secondary outcomes:
measure: Chest Cavity Size
timeFrame: 16 Weeks
measure: Bronchoalveolar Lavage (BAL) to Measure Flow of Cytometry and Cytokine Levels
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Cape Town
country: South Africa
facility: The Lung Institute at University of Cape Town
Study officials:
affiliation: NYU School of Medicine
name: William Rom, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dawson R, Condos R, Tse D, Huie ML, Ress S, Tseng CH, Brauns C, Weiden M, Hoshino Y, Bateman E, Rom WN. Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. PLoS One. 2009 Sep 15;4(9):e6984. doi: 10.1371/journal.pone.0006984.
Clinical trial NCT04548323: Hypoalgesic Effects of Walking and Running Imagined
Official title: Hypoalgesic Effects of Walking and Running Imagined in Sedentary Subjects and With High Levels of Physical Activity: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Analgesia
Keywords: Motor imagery
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2020-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects divided by their physical activity levels.

Brief summary: The main objective is to identify the hypoalgesic effect of the imagination of actions in sedentary subjects with high levels of physical activity.


Eligibility criteria: Inclusion Criteria:

* asymptomatic participants
* men and women aged 18 to 65 years

Exclusion Criteria:

* insomnia
* nausea
* headache
* pregnancy
* use of painkillers in the last 24 hours
* presence of metal inside the head
* pacemaker
* wound on the area of electrodes' application
* drug consumption; (j) recent application of tDCS
* psychiatric disease impeding understanding of the study.

Primary outcomes:
measure: Pain pressure threshold
timeFrame: Change from baseline and immediately post-intervention
measure: Temporal sumation
timeFrame: Change from baseline and immediately post-intervention
measure: Electrodermal activity
timeFrame: Change from baseline and immediately post-intervention
measure: Respiration Rate
timeFrame: Change from baseline and immediately post-intervention
measure: Heart rate
timeFrame: Change from baseline and immediately post-intervention.
measure: Salivary stress
timeFrame: Change from baseline and immediately post-intervention.
Secondary outcomes:
measure: Visual and Kinesthetic Motor Imagery Ability
timeFrame: Change from baseline and immediately post-intervention
measure: The degree of physical activity
timeFrame: Immediately before the intervention.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT01073423: Improving Sleep and Quality of Life in Adults With HIV Disease
Official title: Improving Sleep and Quality of Life in Adults With HIV Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: HIV
sleep
insomnia
yoga
music
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 20
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 purpose of this study is to see if yoga or music therapy can improve the sleep of adults with HIV.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* HIV seropositive
* current sleep disturbance
* able to speak, read, and write in English
* a phone number to maintain contact with research team
* willing to provide copy of most recent CD4 and viral load values
* willing to wear actigraph for 1 week per month for 3 months
* willing to participate in group intervention sessions 3 times per week for 8 weeks

Exclusion Criteria:

* pregnancy
* psychiatric diagnosis, such as schizophrenia, dementia, bipolar disorder (depression not excluded)
* sleep disorder diagnosis, such as apnea or narcolepsy (insomnia not excluded)
* current yoga practice

Primary outcomes:
measure: self-reported sleep disturbance
timeFrame: 8 weeks
Secondary outcomes:
measure: actigraphic estimates of sleep quality and quantity
timeFrame: 8 weeks
measure: self-reported well-being
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Kathryn A. Lee, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130023: The Relationship Between Oxygen Reserve Index and PaO2
Official title: The Relationship Between Oxygen Reserve Index and PaO2 in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Congenital Heart Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 98
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve using oximetry sensor. In this study, the investigators evaluate the correlation between ORI and the partial pressure of arterial blood oxygen (PaO2) in children.


Eligibility criteria: Inclusion Criteria:

* Age below 7 years
* Written informed consent
* Undergoing cardiac surgery

Exclusion Criteria:

* Presence of cyanotic heart disease

Primary outcomes:
measure: correlation coefficient between ORI and PaO2
timeFrame: through study completion, an average of 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566523: TeleRehabilitation for Patients With Chronic Respiratory Failure.
Official title: Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Respiratory Disease
Exercise
Lead sponsor: SOS Oxygene Mediterranee
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients from medical consultation

Brief summary: It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.


Eligibility criteria: Inclusion Criteria:

* chronic respiratory disease patients
* Patients with dyspnea or exercise intolerance.
* Stable patients at home.
* Patients who can use a computer (after explanations) and have adequate hearing and vision.
* Collection of the patient's non-objection

Exclusion Criteria:

* Life expectancy \<3 months.
* Absolute contraindication to performing physical activity
* Hospitalization for exacerbation in the two months prior to inclusion.

Primary outcomes:
measure: exercise tolerance
timeFrame: 3 month after inclusion
Secondary outcomes:
measure: exercise tolerance
timeFrame: 6 month and one year after inclusion
measure: VQ-11
timeFrame: 3, 6 month and 1 year after inclusion
measure: physical activity quantity
timeFrame: 3, 6 month and 1 year after inclusion
Other outcomes:
Locations:
city: Cornebarrieu
country: France
facility: Cabinet de pneumologie Clinique des Cèdres
Study officials:
affiliation: clinique des Cèdres
name: william Heurtaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154023: Behavioral Intervention for Insomnia in Older Adults
Official title: Behavioral Intervention for Insomnia in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Sleep Initiation and Maintenance Disorders
Behavior Therapy
Lead sponsor: Carl T. Hayden VA Medical Center
Sponsor class: FED
First posted: 2010-06-30
Enrollment: 179
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate and compare the efficacy of single interventions (stimulus control instructions, sleep restriction therapy) and multi-component intervention (stimulus control instructions and sleep restriction therapy) for chronic insomnia in community dwelling older adults. The subjects were randomly assigned to one of four conditions: stimulus control instructions, sleep restriction therapy, multi-component treatment (stimulus control instructions and sleep restriction therapy), or measurement control.


Eligibility criteria: Inclusion Criteria:

* 55 years or older
* Sleep onset or maintenance insomnia of 45 minutes or more per night for at least 3 nights per week as ascertained through 14 days of sleep diaries
* Insomnia duration of at least 6 months
* Impaired daytime functioning as a consequence of insomnia

Exclusion Criteria:

* Psychopathology evidenced by the Brief Symptom Inventory Global Severity Index T score \>60
* Cognitive impairment as ascertained by the Mini-Mental State Exam score \< 27
* Current psychotherapy or medical treatment for major depression or other psychopathology
* Current and regular use of over-the-counter medication or prescription medication for sleep (verified through urinalysis), or any medication affecting sleep
* Major physical or mental illness directly related to the onset and course of insomnia
* Substance abuse problem ascertained per interview
* Suspicion of sleep apnea as determined by an Epworth Sleepiness Scale score of 11 or greater, a respiratory disturbance index of \> 15 as established through in-home overnight use of the EdenTec Model 3711 Digital Recorder, and interview with a significant other, if available
* Restless leg syndrome, periodic limb movement disorder, or circadian rhythm sleep disorders as determined through the participant interview and an interview with a significant other, if available.

Primary outcomes:
measure: subjective sleep
timeFrame: 1 year
Secondary outcomes:
measure: insomnia severity
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Carl T. Hayden VA
name: Dana R Epstein, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein DR, Sidani S, Bootzin RR, Belyea MJ. Dismantling multicomponent behavioral treatment for insomnia in older adults: a randomized controlled trial. Sleep. 2012 Jun 1;35(6):797-805. doi: 10.5665/sleep.1878.
Clinical trial NCT05305950: Barriers and Facilitators in Access to OT/PT in Pediatric Cancer Survivors
Official title: Exploring Barriers and Facilitators to Mitigate Disparities in Access to OT/PT in Pediatric Cancer Survivors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pediatric Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: This study aims to identify the modifiable facilitators and barriers to occupational and physical therapy care for children during and after cancer treatment that may be contributing to disparities in health outcomes. The investigators will identify these facilitators and barriers by surveying and interviewing healthcare administrators at MD Anderson Cancer center. The investigators will also survey and interview physicians, advanced practice providers, and occupational and physical therapists to obtain their feedback on these issues.


Eligibility criteria: Aim 1 Inclusion Criteria:

* Employed as an administrator at MD Anderson Cancer Center and the sister institutions and working in the areas of pediatrics, survivorship, cancer control, health policy, and rehabilitation services.

Aim 2 Inclusion Criteria:

* Employed as a referring provider (e.g., oncologist, surgeon, advanced care practitioner), or an OT/PT therapist at MD Anderson Cancer Center and the sister institutions.

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Identify modifiable barriers to occupational and physical therapy care for children during cancer treatment that may be contributing to disparities in health outcomes.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Moody, MD
role: PRINCIPAL_INVESTIGATOR
References: