louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02386332: A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies
Official title: A Randomized Multicenter Study Comparing Unrelated Umbilical-cord Blood Transplant Versus Human Leukocyte Antigen (HLA)-Haploidentical Related Hematopoietic Stem Cell Transplant for Adult Patients With Hematologic Malignancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematologic Malignancies
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2015-03-11
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option

Brief summary: This is an open-label, prospective, observational, multicenter, randomized study to compare the efficacy between unrelated umbilical cord blood transplantation (UCBT) and HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative conditioning for adult patients with hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

1. Age: subjects ≥ 18 and ≤ 55 years old.
2. Patients without suitable matched related donor
3. Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option.
4. Written consent form signed.

Exclusion Criteria:

* Performance status: Eastern Cooperative Oncology Group(ECOG) score \>2
* Prior allogenic hematopoietic stem cell transplant
* Left-ventricular ejection fraction at rest \< 45%, uncontrolled arrhythmias or symptomatic heart failure.
* Diffusing capacity (DLCO) and/or forced vital capacity (FVC) \< 39% of predicted values or symptomatic pulmonary disease
* Altered liver function tests (total bilirubin \> 2 mg/dL and/or alanine aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis.
* Serum creatinine \> 2 mg/dL or estimated creatinine clearance \< 50 mL/min
* Evidence of uncontrolled bacterial, viral or fungal infection prior to the conditioning regimen
* Serious diseases that prevent patients from receiving chemotherapy treatments.
* Concomitant neoplasms.
* Pregnancy or breast-feeding.
* Any other medical, surgical or psychiatric condition that is considered by the attending and/or medical team as a contraindication for intensive treatment

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital La Fe, Valencia
name: Miguel A Sanz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01224132: Effect of Probiotics in the Atopic Dermatitis
Official title: Effect of Probiotics in the Treatment of Children With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis, Probiotics
Keywords: Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.

Detailed description: Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has rapidly increased as a result of industrialization. Thus, a new wave of quests for the treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and placebo-controlled study this study was designed to evaluate the efficacy of probiotics in the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic group of patients after treatment and skin prick tests were higher than that of the control group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate, the skin prick test, the serum total and specific of the probiotic group showed no difference from those of the control group. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.

Eligibility criteria: Inclusion Criteria:SCORAD (SCORing Atopic Dermatitis) index is based on medium-heavy (Carr 2006). Age range is 1-13 with no patient showing evidence of any other disease except the existent disease -

Exclusion Criteria:No drug was used for 14 (fourteen) days prior to study, including antihistamines and steroids. Also, no occurrence of malabsorption, such as gastrointestinal disease, was detected.

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03270332: Effect of Inhaled Albuterol in Pulmonary Hypertension
Official title: Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.


Eligibility criteria: Inclusion Criteria:

* A Mean Pulmonary Artery Pressure \>25mmHg, Pulmonary Vascular Resistance \>3 wood/units and pulmonary arterial wedge pressure \<15mmHg, as documented by right heart catheterization within the last 3 years
* Regular use of oral pulmonary vasodilators

Exclusion Criteria:

* Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography)
* women of childbearing potential who do not use accepted birth- control measures
* pregnant and breast-feeding women
* respiratory infection within 4 weeks of testing
* A systemic systolic arterial BP\> 150 and/or diastolic arterial BP\>100 on the experiment day
* A resting O2 saturation of \< 90%
* Current smoking
* BMI \>35 kg/m2 and/or a diagnosis of obstructive sleep apnea
* Use of inhaled or intravenous pulmonary vasodilators

Primary outcomes:
measure: Change in Mean Pulmonary Artery Pressure (MPAP)
timeFrame: Baseline, up to 30 minutes after inhalation
Secondary outcomes:
measure: Change in Pulmonary Vascular Resistance (PVR)
timeFrame: Baseline, up to 30 minutes after inhalation
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Adam Wanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06481332: Diagnostic Characterization and Evolution of "Triple Negative" Thrombocytosis (CASTETTE)
Official title: Diagnostic Characterization and Evolution of "Triple Negative" Thrombocytosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myeloproliferative Neoplasm
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed by hematologists of the French Intergroup of MPN

Brief summary: Evaluation of Event free survival in patients with triple-negative thrombocytosis

Detailed description: Patients with non-reactive thrombocytosis, explored at least by bone marrow biopsy and NGS panel will be included. Clinical and biological characteristics as well as evolution will be recorded retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients with non reactive thrombocytosis for at least 6 months
* availability of bone marrow biopsy and NGS panel

Exclusion Criteria:

* Unable to consent

Primary outcomes:
measure: Event-free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT05200832: Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
Official title: Impact of Long COVID-19 on the Health and Quality of Life of Military Personnel (Active or Retired) and Their Families
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: quality of life
long COVID
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of people affiliated to the French military health insurance, i.e., military Personnel (active or retired) and their families.

Brief summary: Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%).

These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care.

The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years-old
* Be affiliated to the French military health insurance

Exclusion Criteria:

* Age \< 18 years-old

Primary outcomes:
measure: Prevalence of mental health events
timeFrame: Until the end of the study (12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Centre d'Epidémiologie et de Santé Publique des Armées
Study officials:
References:
Clinical trial NCT00789932: Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Official title: Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Organization for Autism Research
First posted: 2008-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating core autism symptoms, social and emotional problems, and adaptive behavior deficits in children with autism spectrum disorders.


Eligibility criteria: Inclusion criteria:

* 7 - 11 years of age
* meet research criteria for a diagnosis of autism, Asperger Syndrome, or PDD-NOS
* meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder
* If taking medication, have maintained a stable dose for 1 month prior to baseline assessment

Exclusion Criteria:

* child has an IQ of less than 80
* begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period
* for any reason the child or parents appear unable to participate in the treatment program

Primary outcomes:
measure: ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)
timeFrame: 8 months (post-treatment)
Secondary outcomes:
measure: Behavioral observations of social responsiveness
timeFrame: 8 months (post-treatment)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jeffrey Wood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767832: Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.
Official title: Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy pregnant patients undergoing elective cesarean delivery with spinal anesthesia.

Brief summary: The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

Detailed description: The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.

Eligibility criteria: Inclusion Criteria:

* All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Hospital who undergo elective Cesarean delivery.
* We will select 100 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective Cesarean delivery, with no anticipated risk of obstetric hemorrhage.

Exclusion Criteria:

* Patients with underlying coagulation disorders.
* Patients with thrombocytopenia.
* Patients with pregnancy-induced hypertension, pre-eclampsia.
* Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.
* Patients requiring non-elective Cesarean delivery.
* Patients with significant obstetric or medical disease.
* No patients \<18 years of age will be recruited.

Primary outcomes:
measure: Estimated blood loss; Coagulation data (Thromboelastography, Laboratory)
timeFrame: pre and post cesarean delivery
Secondary outcomes:
measure: Hematologic indices
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alexander J Butwick
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7.
Clinical trial NCT05531032: HRQOL of Life After ECMO Due to COVID-19.
Official title: Health-related Quality of Life Following Extracorporeal Membrane Oxygenation Due to Coronavirus Disease 2019.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
COVID-19 Pneumonia
Extracorporeal Membrane Oxygenation
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phone Interview
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We intend to prospectively investigate physical and mental state (HRQOL) by means of quantitative telephone interviews after hospital discharge in patients surviving COVID-19 ARDS and ECMO therapy.


Eligibility criteria: Inclusion Criteria:

* patients surviving COVID-19 ARDS and ECMO therapy

Exclusion Criteria:

* no consent

Primary outcomes:
measure: HRQOL after COVID-19 ARDS and ECMO therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: MUW
name: Alexander Hermann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01137032: Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
Official title: An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Atopic Dermatitis
Keywords: Psoriasis
Atopic Dermatitis
Lead sponsor: Fougera Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 19
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psoriasis or atopic dermatitis involving more than 20% of body surface area
* Good health with the exception of psoriasis or atopic dermatitis

Exclusion Criteria:

* Any disease affecting the HPA-axis
* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period

Primary outcomes:
measure: Post-injection Serum Cortisol Level
timeFrame: 22 Days
Secondary outcomes:
measure: Pre-injection Serum Cortisol Levels
timeFrame: 22 Days
measure: and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
timeFrame: 22 days
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Christopher Huerter, MD
state: Nebraska
city: Hilton Head Island
country: United States
facility: Oswald Mikell, MD
state: South Carolina
city: Nashville
country: United States
facility: Michael Gold, MD
state: Tennessee
Study officials:
affiliation: Fougera Pharmaceuticals Inc.
name: Angela C Kaplan
role: STUDY_DIRECTOR
References:
Clinical trial NCT02269332: Vitamin D and Screening Colonoscopy or Polyp Surveillance
Official title: Association of 25-OH Vitamin D Status With Findings on Screening Colonoscopy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2014-10-21
Enrollment: 298
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: DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate.

Brief summary: The investigators will recruit DoD beneficiaries 18 years or older, that have been referred for a screening colonoscopy or polyp surveillance (or had one in the last 2 weeks), and have no previous diagnosis of colorectal cancer. They will have a 25 OH Vitamin D level drawn to determine if there is an association between the level obtained and findings on colonoscopy, or previous findings (if repeating).

Detailed description: DoD beneficiaries age 18 or older will be recruited from the clinics at the Mike O'Callaghan Federal Medical Center (MOFMC). Subjects meeting the inclusion/exclusion criteria will be offered an opportunity to participate:

Screening Visit:

* Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
* Record: Date of birth, age, gender, race, ethnicity, current email address, height (in inches), weight (in pounds), waist circumference (in inches) measurement, blood pressure, and whether subject is taking or has taken any vitamin D supplement or derivative, and if so, note the dosage, frequency, and duration of therapy.
* Subjects will be told to fast for at least 10 hours prior to Visit 1

Visit 1 (within two weeks of their screening colonoscopy):

-Subjects will have the following research-driven blood test drawn which include: Serum 25-OH vitamin D via 1 venipuncture (5-10 mls, approximately 1-2 teaspoons of blood will be drawn)

Eligibility criteria: THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion:

* DoD beneficiaries 18 years or older
* Referred for a screening colonoscopy or polyp surveillance or had one in the last 2 weeks

Exclusion:

* Previous diagnosis of colorectal cancer, adenomatous polyps, and/or cancer
* Military trainees
* Pregnant women

Primary outcomes:
measure: Serum Vitamin D
timeFrame: 2 weeks
measure: Adenomatous Polyps
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Federal Hospital/Nellis Air Force Base
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Federal Medical Center
name: Carl Bryce, MD
role: PRINCIPAL_INVESTIGATOR
References: