louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01773785: Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer
Official title: Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line Treatment for Patients With Advanced Biliary Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Biliary Cancer
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the effectiveness of SPI-1620 in combination with docetaxel in patients with advanced biliary cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed biliary tract or gallbladder cancer that have relapsed or are refractory after one prior gemcitabine-based chemotherapy regimen for advanced biliary cancer
* Evaluable disease
* ECOG PS ≤ 2
* Adequate bone marrow, liver and renal function

Exclusion Criteria:

* Treatment with more than one prior chemotherapy regimen
* Known, uncontrolled CNS metastases
* Baseline peripheral neuropathy ≥ grade 2.
* Significant circulatory disorders in the past 6 months
* Concomitant use of phosphodiesterase inhibitors

Primary outcomes:
measure: Progression free survival
timeFrame: 18 months
Secondary outcomes:
measure: Overall response rate
timeFrame: 18 months
measure: Overall survival
timeFrame: 18 months
measure: Duration of Response
timeFrame: 12 months
measure: Safety of SPI-1620 when administered in combination with docetaxel
timeFrame: 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Chattanooga
country: United States
facility: Associates in Oncology and Hematology
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
References:
Clinical trial NCT06726785: Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment
Official title: Gene Expression Changes on Extended Use of Dopamine Agonists in Restless Legs Syndrome (RLS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Restless Leg Syndrome (RLS)
Keywords: restless leg syndrome
RLS
neurological
Lead sponsor: HBC Immunology Inc
Sponsor class: INDUSTRY
First posted: 2024-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with RLS and on Dopamine Agonist treatments.

Brief summary: The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS). Similar studies in Parkinson's disease have shown changes in alpha-synuclein expression, which might offer insights into the dopaminergic gene regulation seen in RLS. The dopamine agonist drugs to be included in this study are: Pramipexole (Mirapex), Ropinirole (Requip), Rotigotine (Neupro), Apomorphine (Apokyn), Bromocriptine (Parlodel). Specifically, the study will collect nasal swabs of participants partitioned into two groups, those who have not used a dopamine agonist or been on a dopamine agonist for less than 1 month compared to those who have been on the medication for 6 or more months. This research could provide insight into changes in dopaminergic gene expression associated with Augmentation Syndrome (AS) which occurs after long term dopamine agonist treatment in RLS patients.


Eligibility criteria: Inclusion Criteria:

* Able to provide Informed Consent
* Clinical diagnosis of Restless Legs Syndrome (RLS)
* On-going Treatment with a dopamine agonist

Exclusion Criteria:

\* Use of any medication that might affect nasal epithelial cell collection with a nasal swab

Primary outcomes:
measure: To analyze the effect of duration of dopamine agonist treatments for changes in dopaminergic genes expression using nasal epithelial cells.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Alethios Inc
state: California
Study officials:
References:
Clinical trial NCT03897556: Effect of High-Dose Guarana And Cancer-Related Fatigue
Official title: The Effect of High-Dose Guaraná on Cancer-Related Fatigue in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Fatigue
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a three-arm study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will examine the effectiveness of a guaraná nutrition energy bar supplement on cancer-related fatigue based on scores from fatigue questionnaires. Participants will be randomized to one of three study arms: 1) two guaraná energy bars/day, 2) one guaraná energy bar/day 3) usual-care only/ no guaraná energy bars during study in cancer patients who have completed cancer treatment. We would also like to find out if this energy bar supplement improves physical performance, mood and reduces plasma glutamine and inflammation.


Eligibility criteria: Inclusion Criteria:

* Have a confirmed diagnosis of a malignant solid tumor between 4 and 36 months post-treatment (pathology report or MD documentation).
* Completed all forms of standard treatment (surgery, chemotherapy, radiation therapy, and/or immunotherapy) between 4 and 36 months prior to enrollment in the study.
* Be 18 years of age or older.
* Have cancer-related fatigue, as indicated by a response of a 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0": = 'no fatigue' and "10" = 'as bad as you can imagine' as taken from a single item question on the Symptom Inventory Questionnaire.
* Be able to read English (since the assessment materials are in printed format).

Exclusion Criteria:

* Participants must not: Have used guaraná supplements within the previous two months.
* Self-report that they are very sensitive to caffeine.
* Uncontrolled hypertension
* Have an allergy to walnuts, seaweed, soybeans and/or chocolate.
* Use medications for which caffeine intake is contraindicated including: β-adrenergic agonists, and/or medications that contain pseudoephedrine.

Primary outcomes:
measure: The change in mean level of cancer-related fatigue based on the Brief Fatigue Inventory survey
timeFrame: Baseline to final visit (six weeks)
Secondary outcomes:
measure: The adherence to taking guarana energy bars: participant ate ≥ 80% of the guaraná energy bars assigned to them over the course of the study.
timeFrame: Baseline to final visit (six weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Wilmot Cancer Center
state: New York
Study officials:
References:
Clinical trial NCT01530256: Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
Official title: An Exploratory Phase 1/2 Clinical Trial Evaluating ALD518 in Subjects With Glucocorticoid-Refractory Acute Graft vs. Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Acute GvHD
Keywords: allograph
steroid refractory
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: 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 safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.


Eligibility criteria: Inclusion Criteria:

* Glucocorticosteroid refractory acute GVHD Grade 2-4
* Prior corticosteroid therapy at \> 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
* Karnofsky Performance Satus Scale ≥ 50%
* Adequate laboratory testing at screening

Exclusion Criteria:

* Subjects having Stage 1 skin acute GVHD
* Subjects with Stage 3 or 4 liver GVHD
* Prior EBV associated malignancy
* Prior or current Hepatitis B or C
* Prior or active tuberculosis

Primary outcomes:
measure: Number of Participants With Adverse Events, Including Infections and Loss of Engraftment
timeFrame: Through Week 24
measure: Number of Participants With Acute GVHD Response at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Number of Participants With Relapse of Underlying Malignant Disease
timeFrame: Through Week 24
measure: Number of Participants With Overall Survival
timeFrame: Through Week 24
measure: Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Maywood
country: United States
facility: Loyola Medical Center
state: Illinois
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Alder Biopharmaceuticals, Inc.
name: Javier San Martin, MD FRCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT04518956: Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
Official title: Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures

Detailed description: The mandible is the commonest facial bone to fracture. Mandibular fractures represent more than 74% of all maxillofacial fractures.

To compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures.

A total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. In this study all patients were subjected to closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as study group. Seven patients will receive neither and will constitute the control group.

Eligibility criteria: Inclusion Criteria -Patients selected for this study will have fresh fracture mandible which is indicated for closed reduction.

Exclusion Criteria

-Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area

Primary outcomes:
measure: Change in pain scale
timeFrame: after 24 hours and 1 week
measure: Change in bone density
timeFrame: after 6 Weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01049256: The Cyclocapnic Method for Measurement of Chemosensitivity
Official title: Developing an Improved Measure of Chemosensitivity for the Study of Periodic Breathing in Heart Failure: the Cyclocapnic Method
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Periodic Breathing
Heart Failure
Keywords: Periodic breathing
Heart Failure
Chemoreflex
Chemosensitivity
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We aim to test our method for measuring chemosensitivity (the ventilatory response to a change in carbon dioxide), which uses sinusoidal carbon dioxide stimuli.

Hypotheses:

* Carbon dioxide sensitivity is dependent on the cycle time over which we administer the gas (frequency).
* Chemoreflex gain decreases as deadspace increases.

Detailed description: We will apply a new method for the measurement of chemosensitivity (how sensitive a person is to changes in carbon dioxide), which is one of the principle determinants of whether people with heart failure develop abnormal breathing patterns We have shown in a pilot study that administering sinusoidal patterns of inspired carbon dioxide produces similar sinusoidal responses in ventilation. We aim to test our method for measuring chemosensitivity, which uses sinusoidal carbon dioxide stimuli (similar to those that drive the oscillations in ventilation found in periodic breathing). We aim to show that how the cycle time of carbon dioxide administered affects the resulting ventilatory oscillations and therefore that when measuring the chemoreflex clinically, it is important to deliver carbon dioxide stimuli that replicate the cycle time of oscillations in carbon dioxide seen in periodic breathing (typically approximately one minute).

Eligibility criteria: Inclusion Criteria:

* Heart failure subjects with stable cardiorespiratory control to be recruited from our institution's specialist heart failure clinic.
* Normal healthy volunteers, with normal systolic function.

Exclusion Criteria:

* We will exclude patients with chronic respiratory disease (every patient will have formal lung function testing on entrance into the study) or unstable coronary artery disease (myocardial infarction or unstable angina within the past 3 months).
* In addition any subjects receiving treatment with morphine and derivatives, theophylline, oxygen, benzodiazepines or acetazolamide will be excluded as these affect chemosensitivity.

Primary outcomes:
measure: Chemoreflex gain as measured by cyclocapnic method
timeFrame: every minute
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Imperial College London
name: Darrel P Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00678756: Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
Official title: Investigation of Antipsoriatic Effects of UVB-induced Synthesis of 1alpha, 25-Dihydroxyvitamin D3 (1alpha, 25(OH)2D3, Calcitriol)in Keratinocytes of Psoriatic Skin, Using Cytochrom-P(CYP)Inhibitor Ketokonazol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis vulgaris,
vitamin D, UVB-phototherapy, ketokonazol,
Optical Coherence Tomography,
local PASI, Nizoral
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2008-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Exploration of antipsoriatic effects of UVB-therapy +/- CYP-inhibitor Ketokonazol on affected psoriatic skin


Eligibility criteria: Inclusion Criteria:

* age: 18- 80
* diagnosis of psoriasis vulgaris (mild- middle)
* no other current antipsoriatic therapy (systemic/topical)
* at least 5 psoriatic areas of 5x5 cm

Exclusion Criteria:

* pregnancy/nursing mothers
* women in reproductive age without adequate contraception
* severe and acute forms of psoriasis vulgaris
* patients receiving systemic or topical antipsoroatic treatment in past 3 month
* UV-therapy in past 3 month
* patients having a positive anamnesis for squamous cell carcinoma, malignant melanoma, basalioma
* epilepsy

Primary outcomes:
measure: PASI, PGA
timeFrame: 4 weeks
Secondary outcomes:
measure: OCT/ultrasound- thickness of epidermis/ dermis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Dermatology, Medical Faculty, TU Dresden
Study officials:
affiliation: Department of Dermatology, Medical Faculty, Technical University Dresden, Germany
name: Gottfried Wozel, Prof. Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00238056: Effect of Domperidone on QT Interval in Premature Infants
Official title: Effect of Domperidone on QT Interval in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prematurity and Feeding Intolerance
Keywords: Domperidone, QT, prematurity
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2005-10-13
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 30 premature infants treated by domperidone upon decision of the attending neonatologist will have a daily recording of electrocardiogram for the first 7 seven days of treatment, and pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature infants, matched for gestational age, postnatal age and sex.


Eligibility criteria: Inclusion Criteria:

Gestational age less than 36 weeksPostnatal age greater than 10 days Treated / not treated by domperidone (case/control)Signed parental informed consent

Exclusion Criteria:

Severe cardiac arrhythmia Congenital heart disease (persistent ductus arteriosus excluded)Familial history of congenital long QT syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Centre Hospitalier de Nantes
Study officials:
affiliation: Service de Cardiologie et Service de Réanimation Néonatale CHU de Nantes
name: Véronique Gournay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00860756: Sleep Disturbance in Deployed Soldiers
Official title: Sleep Disturbance in Deployed Soldiers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Sleep Disturbance
Keywords: sleep
disturbance
deployment
intervention
actigraph
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2009-03-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Hypotheses:

* Hypothesis 1 - Sleep can be measured in Theater using actigraph technology.
* Hypothesis 2 - Standard sleep measures in Soldiers randomized to a sleep intervention group will more closely approximate normal as compared to sleep measures of Soldiers randomized to the control group.


Eligibility criteria: Inclusion Criteria:

* All study participants must be on Active Duty, or be Reserve or National Guard Service Members notified of impending deployment.
* Recruited prior to deployment in order to obtain baseline measures before deployment.
* Have been stateside at least one full year.
* Able to read and speak English and consent themselves.

Exclusion Criteria:

* Subjects with self-identified sleep disorder (for example restless leg syndrome or sleep apnea)
* Pregnancy. Pregnant women will be excluded from the study since pregnancy places women in a non-deployable status and pregnant Soldiers will not be deploying.

Primary outcomes:
measure: Actigraph and self report questionnaires
timeFrame: baseline, 6 months, 18 months
Secondary outcomes:
measure: Self report questionnaires
timeFrame: baseline, 6 months, 18 months
Other outcomes:
Locations:
city: Fort Carson
country: United States
facility: Evans Army Community Hospital
state: Colorado
city: Fort Hood
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: LTC, Chief Nursing Research Services
name: Mona O. Bingham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06578156: Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD
Official title: Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Thoracic Society
First posted: 2024-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.


Eligibility criteria: Inclusion Criteria:

* Able to consent
* Age 18 years or older
* Diagnosis of COPD
* Ability to ambulate without assistance
* Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all

Exclusion Criteria:

* Pregnancy
* Being on bedrest
* Inability to consent or cooperate with the study
* Using of \> 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime
* Hemodynamic instability (resting heart rate \> 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)
* Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)

Primary outcomes:
measure: 6-minute walk test
timeFrame: 30 minutes
Secondary outcomes:
measure: Breathing measured by the Borg dyspnea scale
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Saramaria Afanador Castiblanco, M.D.
role: PRINCIPAL_INVESTIGATOR
References: