louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00017446: CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Official title: Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma
Keywords: stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-06-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

Detailed description: OBJECTIVES:

* Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma.
* Determine the clinical toxic effects of this drug in these patients.

OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed soft tissue sarcoma

  * Metastatic or locally advanced
  * Failed at least 1 prior therapy
* Measurable disease outside prior irradiation field
* No CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine less than 1.5 times ULN
* Calcium less than ULN
* Potassium normal

Other:

* No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic response modifier therapy allowed

Chemotherapy:

* No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy for malignancy

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior surgery and recovered

Other:

* No other concurrent cardiac glycosides

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Robert N. Taub, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05885646: Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes
Official title: Treatment of Epilepsy Syndromes of Childhood With Sleep Activation Using Sulthiame: an Exploratory Study of the Short Term Effect on EEG
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Importance of Interictal Epileptiform Activity on Sleep EEG
Epilepsy in Children
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-06-02
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: -Children with pharmaco-resistant epilepsy

Brief summary: The effect of sulthiame on EEG has been studied in epilepsy syndromes of childhood with sleep activation by comparing sleep EEG obtained at baseline and after 4 weeks of treatment. The aim of the study is to know if an effect is still identifiable after 2 weeks of treatment by performing sleep EEG recordings after 2 and 4 weeks of treatment, respectively.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy syndromes of childhood with sleep activation
* Failure of at least two anti-epileptic drugs (AED)
* Sleep EEG performed in the last 7 days before inclusion and showing interictal epileptiform discharges (baseline EEG)

Exclusion Criteria:

* Previous trial with sulthiame
* More than 2 AED at inclusion
* Use of corticosteroids at inclusion
* Change in the anti-epileptic treatment in the 7 days before baseline EEG

Primary outcomes:
measure: Percentage of patients showing improved sleep EEG at day 14 compared to baseline EEG
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital, Pediatric department
city: Strasbourg
country: France
facility: Strasbourg University Hospital, Pediatric department
city: Toulouse
country: France
facility: Toulouse University Hospital, Pediatric Neurology Department
Study officials:
affiliation: Angers University Hospital
name: Patrick Van Bogaert, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981446: A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
Official title: A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open Angle Glaucoma or Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 370
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 investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons

Primary outcomes:
measure: Mean Diurnal IOP at Month 3
timeFrame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
Secondary outcomes:
measure: IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
timeFrame: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
measure: Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
timeFrame: Week 1
Other outcomes:
Locations:
city: Singapore
country: Singapore
Study officials:
References:
Clinical trial NCT02295969: Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis
Official title: An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Keywords: Rhinitis
Conjunctivitis
Grass pollen
Sublingual tablet
Allergen immunotherapy
Safety
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
Collaborators: name: Venn Life Sciences
First posted: 2014-11-20
Enrollment: 307
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of grass-pollen-induced allergic rhinitis with or without conjunctivitis.

Brief summary: Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.

Detailed description: The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.

Patients are followed for safety and tolerability during the first 30 treatment days.

Eligibility criteria: Inclusion Criteria:

Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.

Exclusion Criteria:

Patients already participating in a clinical trial.

Primary outcomes:
measure: All adverse events that started on or after the day the first dose of Oralair
timeFrame: During 30 days after the date of the first dose
Secondary outcomes:
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Klinikum Augsburg, Klinik für Kinder und Jugendliche
state: Bavaria
Study officials:
References:
citation: Gerstlauer M, Szepfalusi Z, Golden D, Geng B, de Blic J. Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.
Clinical trial NCT06299969: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest
Official title: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest (FITT-OHCA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: OHCA
Out-of-hospital cardiac arrest
In-hospital cardiac arrest
Resuscitation
Cardiac arrest center
Feedback intervention
Acute care medicine
Lead sponsor: St.Bernward Hospital
Sponsor class: OTHER
Collaborators: name: University Medical Center Goettingen
First posted: 2024-03-08
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated after out-of-hospital cardiac arrest

Brief summary: The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA).

Detailed description: With around 70,000 cases per year, out-of-hospital cardiac arrest (OHCA) is one of the most common causes of death in Germany. Only less than 10% of patients with an OHCA can currently be discharged with a satisfactory neurological outcome. The FITT-OHCA trial is a quality management project and collects data from Cardiac Arrest Centres on pre-hospital care and early post-resuscitation treatment in a standardized manner. The aim is to optimize the treatment process in patients following successful prehospital resuscitation through systematic data collection and feedback to the members of the rescue and treatment chain. The study includes cluster randomization of the participating hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients after cardiac arrest

Exclusion Criteria:

* refused register participation by patient or legal representative

Primary outcomes:
measure: In-hospital mortality
timeFrame: 3 weeks
Secondary outcomes:
measure: CPC score
timeFrame: 3 weeks
measure: MRS
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hildesheim
country: Germany
facility: St Bernward Hospital
state: Niedersachsen
Study officials:
References:
Clinical trial NCT00196469: Impact of Heparin on the Need for Mechanical Ventilation in Neonates
Official title: Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Respiration, Artificial
Hemorrhage
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 270
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test an incidental finding of a previous trial in which post hoc analysis showed that the rate of intensive care newborns requiring mechanical ventilation was lower in the group receiving heparin with the continuous infusion as compared to the placebo group.

Detailed description: Title: Randomized double blind trial comparing heparin and placebo as additives to continuous infusion in intensive care neonates for prevention of mechanical ventilation

Primary endpoint: Percentage of neonates requiring mechanical ventilation in both groups

Secondary endpoints: Duration of dependency on mechanical ventilation; major bleedings, incidence of heparin-induced thrombocytopenia and of anti-platelet factor 4/heparin antibodies

Eligibility criteria: Inclusion Criteria:

* Newborns \< day 28 of life
* Necessity for intensive care treatment
* Necessity for parenteral drug or fluid application for at least five days
* Informed consent of parents

Exclusion Criteria:

* Body weight \< 500g
* Mechanical ventilation directly after birth
* Major malformations
* Absolute indication for heparin
* Inborn hemorrhagic disease (e.g. hemophilia, von Willebrand disease)
* Cerebral bleeding or other major bleeding
* Platelet count \< 50,000/µl

Primary outcomes:
measure: percentage of neonates requiring mechanical ventilation
Secondary outcomes:
measure: duration of dependency on mechanical ventilation
measure: major bleeding
measure: heparin induced thrombocytopenia
measure: anti PF4/heparin antibodies
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Hospital Department of Pediatrics/Institute for Immunology and Transfusion Medicine
Study officials:
affiliation: Institute for Immunology and Transfusion Medicine, Ernst-Moritz-Arndt-University Greifswald
name: Andreas Greinacher, MD
role: STUDY_CHAIR
affiliation: Pediatric Department, Ernst-Moritz-Arndt-University Greifswald
name: Christoph Fusch, MD
role: STUDY_DIRECTOR
affiliation: Medical Faculty, Ernst-Moritz-Arndt University Greifswald
name: Anne F Klenner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05209269: Work of Breathing in Term Infants
Official title: Comparing Oxygen Saturation Stability and Work of Breathing Between Normal Term Infants and Premature Infants Prior to Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Work of Breathing
Term Infant
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants born ≥37 weeks gestation admitted to the Mother-Baby Unit

Brief summary: This is a prospective observational cohort study conducted in the mother-baby unit at ChristianaCare. The study is designed to assess work of breathing indices and oxygen saturation stability at discharge in full-term infants. Data obtained will be used to perform a comparative analysis on work of breathing data for premature infants obtained from our previous study. We hypothesize full term (≥37 weeks gestation) infants have decreased work of breathing indices (i.e., phase angle) compared to premature infants (born 26-37 weeks gestation) at discharge.


Eligibility criteria: Inclusion Criteria:

* Infants born ≥37 weeks gestation
* Admitted to the Mother-Baby Unit
* Within 24 hours of expected discharge

Exclusion Criteria:

* Infants born between \< 37week gestation admitted to the Mother-Baby Unit at CCHS
* Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will also be excluded.

Primary outcomes:
measure: Work of breathing indices
timeFrame: 25 minutes
Secondary outcomes:
measure: Oxygen saturations
timeFrame: 25 minutes
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Kelley Z Kovatis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05969769: Effect of Thoracic Mobilization in Females With Coccydynia
Official title: Effects of Thoracic Manual Mobilization Techniques in Females of Coccydynia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coccyx Disorder
Keywords: Coccyx Disorder
thoracic
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and muscles stretches. There is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. This study will determine the effects of thoracic mobilization techniques on coccydynia.

Detailed description: Coccydynia, refers to pain in the coccyx region. it can be caused by various factor including trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard surface, or even idiopathic reasons. Treatment options for Coccydynia may include conservative measures, such as pain medication, using cushion or donut-shaped pillows to relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the pain. Physical therapy including exercises such as stretching, Muscle Energy Technique (MET) can also be beneficial in some cases. Thoracic manual therapy, which involves hands-on techniques applied to the thoracic spine, can indeed be beneficial for improving spine mobility. While it may not directly target the coccyx itself, improving overall spinal mobility can have indirect effects on coccyx pain and dysfunction.

Eligibility criteria: Inclusion Criteria:

* Diagnosed females coccydynia patients.

Exclusion Criteria:

* Pregnancy
* 6 Months past Surgery, fracture or dislocation of coccyx.
* Malignancy or cyst in the pelvic area.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 8th Week
measure: Modified OSWESTRY Low Back pain Index
timeFrame: 8th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Rahman Medical Hospital
state: KPK
Study officials:
affiliation: riphah internation university
name: summra andleeb, MS(OMPT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06743269: Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women Using Inspiratory Muscle Strength Training
Official title: Time-efficient Inspiratory Muscle Strength Training for Improving Sympathetic Activity, Hot Flashes, and Sleep in Midlife Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Hot Flashes
Blood Pressure Regulation
Keywords: menopause
blood pressure
inspiratory training
hot flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to understand how training the muscles used for breathing (inhalation) affects menopausal hot flashes, sympathetic nerve activity and sleep.


Eligibility criteria: Inclusion Criteria:

* Females aged 45-60 with hot flashes.
* Participants will be recruited from Rochester, MN and surrounding areas.
* Non-smokers.
* BMI \< 40kg/m\^2.
* No history of cardiovascular disease, except for hypertension.

Exclusion Criteria:

* Detailed medical and social histories will be collected. To allow for ecological validity, participants will not be excluded for use of menopausal hormone therapy or medications affecting cardiovascular function so long as they have been on a consistent regimen for ≥3 months and during the study period. This approach to medications is consistent with recent work in this area.
* Participants will be screened for contraindications to inspiratory muscle strength training including, a history of spontaneous pneumothorax, collapsed lung that has not healed fully, a perforated eardrum that has not healed fully, and/or any other condition of the eardrum.
* Additional exclusion criteria will include the use of sleep aids (i.e., prescription, melatonin, doxylamine, valerian root, etc.).

Primary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, 6 weeks
measure: Change in Muscle Sympathetic Nerve Activity (MSNA) burst frequency
timeFrame: Baseline, 6 weeks
measure: Change in Muscle Sympathetic Nerve Activity (MSNA) burst incidence
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change in Hot Flash Frequency
timeFrame: Baseline, 6 weeks
measure: Chang in sleep duration
timeFrame: Baseline, 6 weeks
measure: Change in wake after sleep onset
timeFrame: Baseline, 6 weeks
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sarah Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References: