louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01930162: Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood Transplant
Official title: A Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Infusing HSC835 in Patients With Hematological Malignancies Undergoing UCB Transplantation Using a Non-myeloablative Conditioning Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Single Umbilical Cord Blood Transplantation
Non-myeloablative Conditioning
Acute Lymphocytic Leukemia
Myelodysplastic Syndrome
Non-Hodgkin's Lymphoma
Multiple Myeloma
Chronic Lymphocytic Leukemia
Keywords: HSC835
single umbilical cord blood transplantation
non-myeloablative conditioning regimen
Umbilical cord blood
UCB transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-08-28
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study was designed to evaluate the safety and tolerability of HSC835 for clinical use as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis that qualifies them for UCBT
* Adequate organ function
* Availability of eligible donor material

Exclusion Criteria:

* Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used
* Human immunodeficiency virus (HIV) infection
* Active infection

Primary outcomes:
measure: Absence of Graft Failure at Day 42
timeFrame: 42 days
Secondary outcomes:
measure: Incidence of Neutrophil Recovery Within 42 Days
timeFrame: 42 days
measure: Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year
timeFrame: 1 year
measure: Incidence of Overall Survival Within One Year
timeFrame: 1 year
measure: Incidence of Relapse-free Survival Within One Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02885662: Study of CS-3150 in Patients With Primary Aldosteronism
Official title: A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Aldosteronism
Keywords: Primary aldosteronism
Hypertension
mineralocorticoid receptor antagonist
Developmental Phase III
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-08-31
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
* Patients satisfying following blood pressure;

  * sitting systolic blood pressure (SBP) ≥ 140 mmHg and \<180 mmHg
  * sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \<110 mmHg

Exclusion Criteria:

* Secondary hypertension except primary aldosteronism or hypertensive emergency
* Patients diagnosed diabetic nephropathy
* Patients with type 1 diabetes
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
* Serum potassium level \< 3.0 or ≥ 5.1 milliequivalent (mEq)/L

Primary outcomes:
measure: Change from baseline in sitting blood pressure
timeFrame: Baseline to end of Week 12
Secondary outcomes:
measure: Time course of sitting blood pressure
timeFrame: Baseline to end of Week 12
measure: Proportion of patients achieving sitting blood pressure goal
timeFrame: Baseline to end of Week 12
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
state: Kanagawa
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT01553162: Studying Dexamethasone and Prednisone Sensitivity in Samples From Younger Patients With High-Risk B-Cell Precursor Acute Lymphoblastic Leukemia
Official title: B-precursor Acute Lymphoblastic Leukemia (ALL): Studying the Mechanisms Behind Dexamethasone and Prednisone Sensitivity in High-Risk Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia

Brief summary: RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial is studying dexamethasone and prednisone sensitivity in samples from younger patients with high-risk B-cell precursor acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* Identify differences in the effect of dexamethasone (Dex) and prednisone (Pred) on glucocorticoid receptor (GR) occupancy and gene expression in high-risk (HR) B-cell precursor (BCP)-acute lymphoblastic leukemia (ALL) samples from patients aged 1-9.
* Identify differences in gene expression and GR occupancy of response elements in HR BCP-ALL patients \> 10 years old in response to both Dex and Pred.

OUTLINE: Archived samples are analyzed for gene expression analysis and genomic location of glucocorticoid receptor by ChIP sequencing (ChiPseq) and RNA sequencing. Data of gene expression and ChiPseq data sets are compared by luciferase reporter assay.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Patients diagnosed with high-risk B-cell precursor acute lymphoblastic leukemia
* Samples from patients treated and not treated with Dex and Pred

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Differentially expressed genes from both HR BCP-ALL patients aged 1-9 and patients over 10 years old
measure: Genes that are required for efficient apoptosis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Miles A. Pufall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00938262: A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Official title: An Open-label, Three-treatment, Three-period, One-sequence, Crossover Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.


Eligibility criteria: Inclusion Criteria:

* age: 20 - 45 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan, ketoconazole and rifampicin
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism
* history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study

Primary outcomes:
measure: Cmax, AUClast, AUCinf, CL/F, Tmax, t1/2
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, (48, 56) h
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03982862: Botulinum Toxins Intralesional Injection for Scar Pain
Official title: Intralesional Injection of Steroids and/or Botulinum Toxin Type A in Hypertrophic Scars and Keloids for Pain Improvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Scar Keloid
Hypertrophic Scar
Keywords: Botulinum toxin type A
Triamcinolone
scar pain
scar itch
Lead sponsor: Kaohsiung Medical University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Botulinum toxins has been approved by the FDA to treat chronic migraine. Botox had been shown to inhibiting the release of inflammatory mediators and peripheral neurotransmitters from sensory nerve to treat neuropathic pain. In the clinical practice, botox indeed effect in scar pain. However, investigators need well controlled study to prove this finding and assess the improvement of scar appearance.

Detailed description: After surgery or trauma, scar tissues would form during the healing process. However, hypertrophic scars and keloids might happen to some patients, both of which are often pruritic and erythematous. Besides, the markedly elevated tumor-like appearance usually brings much concern to patients. Moreover, significant pain or discomfort could happen to keloids. Various treatment strategies were mentioned but without a solid solution to all of the scars. Investigators hope to evaluate the differences of scar volume, appearance and symptoms (itching and pain) in participants receiving simultaneous intralesional injection of Botulinum toxin type A and/or steroids. Besides, side effects would also be recorded. Investigators hope to establish a more effective intralesional injection therapy for participatns suffering from hypertrophic scars and keloids.

Eligibility criteria: Inclusion Criteria:

1. Patients have visible hypertrophic scars or keloids over three months after trauma or surgery.
2. Patients have symptoms of pain, itching or erythema.

Exclusion Criteria:

1. Patients had either Botulinum toxin type A or Triamcinolone intralesional before in the same scar
2. The scar size is larger than 10 cm2
3. Immunocompromised status
4. Systemic infection status
5. Allergic to Botulinum toxin type A or steroids

Primary outcomes:
measure: Scar pain relief
timeFrame: Change from baseline scar pain during 16 weeks after drug injection
measure: scar appearance
timeFrame: Change from baseline scar appearance during 16 weeks after drug injection
measure: itch
timeFrame: Change from baseline itch sensation during 16 weeks after drug injection
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
affiliation: Kaohsiung Medical University
name: Shu Hung Huang, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00626262: Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv
Official title: An Open, Randomised Two Way Crossover Study Comparing the Effects of 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection on Basal and Pentagastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: Gastroesophageal reflux disease
Nexium
Esomeprazole
Administration methods.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).


Eligibility criteria: Inclusion Criteria:

* Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
* Body Mass Index within the limits specified in the protocol.

Exclusion Criteria:

* History of esophageal, duodenal or gastric surgery
* History of severe liver disease.
* Any other significant disease or pathology judged to be clinically significant by the investigator.

Primary outcomes:
measure: To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
timeFrame: Every 10 days
Secondary outcomes:
measure: To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.
timeFrame: Post Day 10
measure: To compare maximum acid output when switching between Oral and IV adminstration of Nexium
timeFrame: Post Day 10
measure: Safety assessment via adverse event recording.
timeFrame: At each visit
Other outcomes:
Locations:
Study officials:
affiliation: Nexium Global Product Director, AstraZeneca
name: Paula Fernstrom
role: STUDY_DIRECTOR
References:
Clinical trial NCT01291862: Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
Official title: Obstructive Sleep Apnea, Retinal Vein Occlusion, Retinal Artery Occlusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Vascular Occlusion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Obstructive sleep apnea is a common disorder linked to serious long-term adverse health consequences; such as hypertension, metabolic dysfunction, cardiovascular disease. Retinal vascular occlusion is related to many systemic illnesses especially hypertension. Obstructive sleep apnea is also related to vascular endothelial dysfunction and vascular endothelial growth factor elevation which causes vision threatening complications of retinal vascular occlusion. Therefore the relationship between obstructive sleep apnea and retinal vascular occlusion should be studied.


Eligibility criteria: Inclusion Criteria:

* Any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months

Exclusion Criteria:

* Any ocular disease other than retinal vascular occlusion (for example: floppy eyelid syndrome, uveitis, glaucoma, other retinal diseases)
* Patient who has difficulty answering the questionnaires or portable sleep monitoring
* Patient who refuses the study enroll

Primary outcomes:
measure: Watchpat-100(noninvasive portable sleep monitoring device)
timeFrame: after finishing the tests with Watchpat-100
measure: Berlin questionnaire
timeFrame: after finishing the Berlin questionnaire
measure: Epworth sleepiness scale
timeFrame: after finishing the Epworth sleepiness sclae
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Kwon HJ, Kang EC, Lee J, Han J, Song WK. Obstructive Sleep Apnea in Patients with Branch Retinal Vein Occlusion: A Preliminary Study. Korean J Ophthalmol. 2016 Apr;30(2):121-6. doi: 10.3341/kjo.2016.30.2.121. Epub 2016 Mar 25.
Clinical trial NCT06500962: Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
Official title: SUPeRFOOD: Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Nutrition, Healthy
Nutrition Poor
Keywords: food insecurity
nutrition insecurity
food is medicine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Project Open Hand
First posted: 2024-07-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 Factorial Randomization
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to see if offering more navigation and text-message support will help increase participation and engagement in a Food is Medicine program. The study will recruit people currently participating in cardiac rehabilitation. People will be randomly assigned to 1 of 4 study groups: navigation, text-messaging, both, or neither. People will complete surveys at the start of the study and after 3 months. After 3 months, we will compare how many Food is Medicine meals or groceries people in each group received.


Eligibility criteria: Inclusion Criteria

1. Age 18 or older
2. Participating in UCSF Cardiac Rehabilitation
3. Able to communicate in English or Spanish
4. Resident of San Francisco County

Exclusion Criteria

1. Enrolled in hospice
2. Unable to consent for self

Primary outcomes:
measure: Participant reported satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Number of food is medicine meal or grocery distributions received
timeFrame: 3 months
measure: Proportion of participants initiating the food is medicine program
timeFrame: 3 months
measure: Proportion of participants engaged in the food is medicine program
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT06931262: Expanded Access Treatment Protocol With DCA for Patients With PDCD
Official title: Expanded Access Treatment Protocol With Dichloroacetate Sodium for Patients With Pyruvate Dehydrogenase Complex Deficiency
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Pyruvate Dehydrogenase Complex Deficiency
Keywords: PDCD
Lead sponsor: Saol Therapeutics Inc
Sponsor class: INDUSTRY
Collaborators: name: AnovoRx
First posted: 2025-04-17
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD

Brief summary: Expanded Access (EA) will provide a transition to continue therapy for those patients who are currently in the open label extension of the Phase III study, SL 1009-01, while also allowing new patients diagnosed with PDCD who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable.

Detailed description: Expanded Access (EA) will provide a transition to continue therapy for those patients who are currently in the open label extension of the Phase III study, SL 1009-01, while also allowing new patients diagnosed with PDCD who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable. The Expanded Access program (EAP) will also allow the sponsor to extend the collection of long term safety data for the current open label patients, while also expanding to an additional population of patients beyond those currently in the SL 1009-01 study.

Eligibility criteria: Inclusion Criteria:

1. Ages 0 through adulthood
2. Presence of characteristic clinical or metabolic features of PDCD and
3. Presence of a known pathogenic mutation of a gene that is specifically associated with PDC (PDHA1, PDHB, DLAT, PDHX, DLD).
4. Females of reproductive age must be willing to use an effective method of barrier contraception for the duration of the study.-

Exclusion Criteria:

1. A genetic mitochondrial disease other than those stipulated under inclusion criteria
2. Primary, defined organic acidurias other than lactic acidosis (e.g., propionic aciduria)
3. Primary disorders of amino acid metabolism
4. Primary disorders of fatty acid oxidation
5. Secondary lactic acidosis due to impaired oxygenation or circulation (e.g., due to severe cardiomyopathy or congenital heart defects)
6. Malabsorption syndromes associated with D-lactic acidosis
7. Renal insufficiency, defined as 1) a requirement for chronic dialysis or 2) serum creatinine ≥ 1.2 mg/dl or creatinine clearance \<60 ml/min
8. Primary hepatic disease unrelated to PDCD
9. Pregnancy or breast feeding -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Saol Therapeutics Inc
name: Kiki Diorgu, M.D.
role: STUDY_CHAIR
References: