louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00919100: Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief
Official title: Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pediatric
venipuncture
pain
vibration
vapocoolant
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Mayday Fund
First posted: 2009-06-12
Enrollment: 81
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.

Detailed description: Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done yearly with no pain intervention. An inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain.

This study will evaluate pain self report and parent report using the Faces Pain Scale revised, and video-coded OSBD-R scores for patients undergoing emergency department venous access or cannulation procedures. Demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.

Eligibility criteria: Inclusion Criteria:

* Patients requiring venipuncture in a pediatric emergency department
* Informed consent
* Patient assent

Exclusion criteria:

* Patients with sickle cell or other sensitivity to cold
* Nerve damage in the area
* Abrasion or break in skin where device would be placed
* Critically ill

Primary outcomes:
measure: Faces Pain Scale-Revised (FPS-R)
timeFrame: 5 minute
Secondary outcomes:
measure: OSBD-R Observational Pain/Distress Scale
timeFrame: 5 minute
measure: Number of Participants With Venipuncture Success in One Attempt
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta, Scottish Rite
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Amy L Baxter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University
name: Lindsey L Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.
Clinical trial NCT02164500: JAK-inhibition in Recurrent Classical Hodgkin Lymphoma
Official title: A Phase II, Open-label, Prospective, Non-randomized, Multicenter Clinical Trial With the JAK-inhibitor Ruxolitinib in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Classical Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Purpose of this trial is:

* to determine the overall response rate (ORR, complete response \[CR\] + partial response \[PR\]) in patients with relapsed or refractory HL
* to determine the safety profile of ruxolitinib in patients with relapsed or refractory HL


Eligibility criteria: Inclusion Criteria:

* relapsed or refractory HL
* ECOG \<= 2,
* no major organ dysfunction
* written informed consent

Exclusion Criteria:

* history of another primary malignancy ≤ 2 years
* female patients who are pregnant or breast feeding
* patients with a known history of HIV seropositivity
* chronic active hepatitis

Primary outcomes:
measure: overall response rate
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: 1st Dept. of Medicine, Cologne University Hospital
Study officials:
References:
Clinical trial NCT03595800: Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
Official title: Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Leukemia
Non Hodgkin Lymphoma
Multiple Myeloma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.


Eligibility criteria: Inclusion Criteria:

* Patients with hematological malignancy
* Age\<55 years
* HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
* Patients without a matched related donor
* Patients eligible for an allogeneic HSCT from an alternative donor
* Able to comply with the protocol
* Written informed consent
* Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen

Exclusion Criteria:

* Clinical or biological contraindication to allogeneic HSCT
* Pregnant or breast-feeding women.
* Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
* Severe concomitant disease

Primary outcomes:
measure: Event-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Samia Harbi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Paoli-Calmettes
name: Didier Blaise
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01909700: Single Incision Pelvic Floor Mesh Implants
Official title: Single Incision Pelvic Floor Mesh Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Intra-operative Complications
Post Operative Complications
Keywords: Single Incision, Mesh, Complications
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2013-07-26
Enrollment: 157
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse.

Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure.

Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.

Detailed description: Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates

Eligibility criteria: Inclusion Criteria:

\* Patients with Gr 2-3 Pelvic Organ Prolapse

Exclusion Criteria:

\*Previous Pelvic irradiation

Primary outcomes:
measure: Operative mesh related complications
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta MC
Study officials:
affiliation: Western Galilee MC Nahariya
name: Menahem Neuman, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167400: Cybercycling for Cognitive Health
Official title: Cybercycling for Older Adults: Neuropsychological, Physiological and Behavioral Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Ability, General
Keywords: exercise
executive function
older adults
Lead sponsor: Union College, New York
Sponsor class: OTHER
Collaborators: name: Skidmore College
First posted: 2010-07-22
Enrollment: 63
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Exercise has been linked to cognitive health, but few older adults exercise at recommended levels. Cybercycling may provide additional cognitive benefits due to increased motivation to ride the interactive 3D tours. Participants will be randomly assigned to three months of either cybercycling or traditional stationary biking; and they will complete comprehensive evaluations before and after exercise. Older adults are expected to show significant neuropsychological, physiological and behavioral gains.

Detailed description: The purpose of this study is to test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercyle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase.

Eligibility criteria: Inclusion Criteria:

* age 50+
* able to participate in cycling
* physician permission

Exclusion Criteria:

* unstable heart condition
* physician denial
* neurological condition

Primary outcomes:
measure: Change in cognitive function after three months of exercise.
timeFrame: 3 months
Secondary outcomes:
measure: Weight
timeFrame: 3 months
Other outcomes:
Locations:
city: Colonie
country: United States
facility: Beltrone Living Center
state: New York
city: Malta
country: United States
facility: Highpointe Apartments
state: New York
city: Niskayuna
country: United States
facility: Glen Eddy
state: New York
city: Saratoga Springs
country: United States
facility: Prestwick Chase
state: New York
city: Saratoga Springs
country: United States
facility: Wesley Health Care (Woodlawn and Embury)
state: New York
city: Saratoga Springs
country: United States
facility: Westview Apartments
state: New York
city: Schenectady
country: United States
facility: Kingsway Village
state: New York
city: Schenectady
country: United States
facility: Schaffer Heights
state: New York
Study officials:
affiliation: Union College
name: Cay Anderson-Hanley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skidmore College
name: Paul Arciero, DPE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016.
Clinical trial NCT00195000: Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS
Official title: Phase II Evaluation of Gemtuzumab Ozogamicin in Combination With Cytarabine in Untreated Patients Above the Age of 60 Years With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Keywords: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out how safe and effective the combination of Mylotarg in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and advanced Myelodysplastic Syndrome over the age of 60 years.

Detailed description: To evaluate the safety and efficacy of gemtuzumab ozogamicin in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.

Patients eligible for treatment will receive the following:

Mylotarg at 6 mg/m2 on day 1 as a 2 hour intravenous infusion

Cytarabine at 100 mg/m2/day as a continuous intravenous infusion daily for 7 days

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of AML or advanced MDS
* No prior cytotoxic treatment for AML. (patients may have been treated with prior biologic therapy) Patients with MDS or AML that has evolved from MDS, could have received prior low-dose cytotoxic therapy (i.e. azacytidine or low-dose ara-C).

Exclusion Criteria:

* Uncontrolled or severe cardiovascular disease or pulmonary disease

Primary outcomes:
measure: To evaluate the safety and efficacy of gemtuzumab ozogamicin (Mylotarg) in combination with cytarabine in inducing complete remission in patients with AML and advanced MDS over the age of 60 years.
timeFrame: From entry until 30 days post treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medcial College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Eric Feldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02468700: OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Bilateral, Double-Masked, Vehicle Controlled Feasibility Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2015-06-11
Enrollment: 43
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 objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease


Eligibility criteria: Inclusion Criteria:

* Had a known history of dry eye disease
* Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

Exclusion Criteria:

* History of intraocular inflammation in either eye
* Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
* Uncontrolled glaucoma or is on medications to treat glaucoma
* History of IOP spikes in either eye
* Active epiphora

Primary outcomes:
measure: Total Corneal Fluorescein Staining
timeFrame: Day 15
measure: Total Corneal Fluorescein Staining
timeFrame: Day 30
measure: Total Conjunctival Lissamine Green Staining
timeFrame: Day 15
measure: Total Conjunctival Lissamine Green Staining
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06583200: Fluid Responsiveness in Post Cardiac Surgery Patients
Official title: End Expiratory Occlusion Test for Evaluation of Fluid Responsiveness in Comparison to Passive Leg Raising Test in Mechanically Ventilated Post Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiac Complication
Keywords: Cardiac surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.

Detailed description: Circulatory hypervolemia and hypovolemia are both associated with worse outcomes.Intravenous fluids are similar to drugs, with serious adverse effects and changeful efficacy. Fluids should be administered only if indicated. Passive leg raising test transiently increase venous return which can be used to evaluate fluid responsiveness.There is growing evidence that the End expiratory occlusion (EEO) test reliably detects fluid responsiveness. In patients under mechanical ventilation, the inspiration increases intra-thoracic pressure and decreases venous return. The expiratory hold augments the cardiac preload which, in case of preload responsiveness, leads to a significant increase of cardiac output (CO).EEO prevents any variation in intra-thoracic pressure leading to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. There're no studies comparing EEO with passive leg raising test in cardiac surgery patients. So, this is the target of the study.

Eligibility criteria: Inclusion Criteria:

* Age group: 21-60years old
* Sex: eligible both sexes
* Post cardiac surgery
* Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)

Exclusion Criteria:

* Patients refusal
* Pregnancy or any medical condition that may affect the intra abdominal pressure.
* Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (\<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation

Primary outcomes:
measure: Predictive value of EEO and passive leg raising
timeFrame: One year
Secondary outcomes:
measure: Arterial blood pressure
timeFrame: One year
measure: Heart rate
timeFrame: One year
Other outcomes:
measure: Central venous pressure
timeFrame: One year
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Marwa Khairy, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00132600: Clinical Evaluation of Bacitracin
Official title: Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Contact Dermatitis
Keywords: Allergic contact dermatitis
Patch testing
bacitracin
Lead sponsor: Mekos Laboratories AS
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.

Detailed description: Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. Test®) is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis.

The standard panel consists of two tape strips, panel 1, with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. T.R.U.E. TestTM panels 1 and 2 contain 23 of the most frequent contact allergens. With the 23 allergens the test currently consists of, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in T.R.U.E.Test in order to detect more contact allergic reactions. Bacitracin is one of these allergens, and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series.

Eligibility criteria: Inclusion Criteria:

* Positive bacitracin patch test within the latest 5 years.
* Age greater than or equal to 18 years.
* Signed informed consent.

Exclusion Criteria:

* Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
* Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
* Treatment with ultraviolet (UV)-light during the latest 3 weeks.
* Widespread active dermatitis or dermatitis on test area.
* Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study.
* Subjects not able to cooperate.

Primary outcomes:
measure: Skin reaction to the patch test after 72-96 hours and after 7 days
Secondary outcomes:
measure: Evaluation of safety including late and persistent responses
measure: Evaluation day 3/4, day 7 and day 21
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatological Clinic (Joseph Fowler MD)
state: Kentucky
Study officials:
affiliation: Mekos Laboratories AS
name: Joseph Fowler, Prof.
role: PRINCIPAL_INVESTIGATOR
References: