louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00399971: Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia
Official title: Phase I/II Study of An Ex Vivo Immunotherapy for Treatment of Idiopathic Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Anemia, Aplastic
Keywords: Idiopathic Aplastic Anemia
Has Failed Conventional Immunosuppressive Therapy
Not Eligible For Bone Marrow Transplantation
C15.378.071.085
Lead sponsor: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The 12th Guangzhou Municipal Hospital
name: Liu Hua Qiao Hospital
First posted: 2006-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that ex vivo activated immune cells would produce multiple known and unknown potent hematopoietic cytokines, working in concert, these cytokines help stem cell growth and differentiation. Additionally, these cells travel and home to bone marrow as well as spleen and liver involved in hematopoietic activities, where direct cell-cell contact may be beneficial.

Detailed description: Patients will be required to stay in our hospitals to receive the immunotherapy. Allogeneic peripheral blood mononuclear cells from healthy donors and the autologous peripheral mononuclear cells will alternately used for the treatment. Patients are expected to spend at least 6 to 12 months in the hospital and won't be released until they have improved significantly.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Idiopathic Aplastic Anemia
* Not Eligible for Bone Marrow Transplantation
* Not Responsive to Conventional Immunosuppressive Therapy

Exclusion Criteria:

* Leukemia or MDS or PNH or Fanconi's Disease
* pregnancy
* Allergic to Blood Product
* Severe Hypertension or Heart Disease
* Liver or Kidney Disease

Primary outcomes:
measure: Survival
timeFrame: 2 years
Secondary outcomes:
measure: Hematological Parameters
timeFrame: 2 years
measure: Hematopoietic Activities in Bone Marrow
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology, Liu Hua Qiao Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Zhongxing Yangfan Biotech Co. Ltd.
name: Demao Yang, PhD
role: STUDY_CHAIR
References:
citation: Chen J, Liu W, Wang X, Chen H, Wu J, Yang Y, Wu L, Yang D. Ex vivo immunotherapy for patients with benzene-induced aplastic anemia. J Hematother Stem Cell Res. 2003 Oct;12(5):505-14. doi: 10.1089/152581603322448213.
citation: Li G, Wang X, Wu L, Zhang W, Chen H, Xie Y, Yang D. Ex vivo activated immune cells promote survival and stimulate multilineage hematopoietic recovery in myelosuppressed mice. J Immunother. 2005 Jul-Aug;28(4):420-5. doi: 10.1097/01.cji.0000170360.99714.3f.
Clinical trial NCT06586671: A Study to Compare Forms of Nemtabrutinib (MK-1026) in Healthy Adult Participants (MK-1026-007)
Official title: An Open-Label, Two-Part, Two-Period Crossover Study to Determine Bioequivalence Between Nemtabrutinib FFP and FMF2 Formulations & FMF1 and FMF2 Formulations at 65 mg Single Dose in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hematological Malignancy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to measure and compare the levels of nemtabrutinib in the blood after taking different forms of nemtabrutinib orally on an empty stomach (fasted) to see if they are the same or different.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer with pre-specified exceptions (adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, per protocol guidelines)

Primary outcomes:
measure: Parts 1 and 2: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 2 weeks)
measure: Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Nemtabrutinib
timeFrame: At designated time points (up to approximately 2 weeks)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 2 months
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 2 months
Other outcomes:
Locations:
city: South Miami
country: United States
facility: QPS-MRA, LLC-Early Phase (Site 0002)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01469871: Evaluation of Three Types of Dressings After Hip Surgery
Official title: Reduction of Tape Blisters After Hip Surgery. A Prospective Evaluation of Three Types of Dressings.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tape Blisters
Hip Surgery
Keywords: Dressing
Blisters
Silicone
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 150
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if one of the new types of dressings (MEPORE PRO and/or MEPILEX BORDER ) will reduce the blister rate compared to the currently used HYPAFIX.


Eligibility criteria: Inclusion Criteria:

* Male or Female 45 years old or older
* Hip surgery at Hopital de l'Enfant-Jesus between 02/2009 and 01/2010 (THR,rTHR, DHS, screw fixation, hemiarthroplasty, resurfacing)
* Signed consent form

Exclusion Criteria:

* Allergy to dressing
* Polytrauma / high energy trauma
* Wound at the surgical site prior to surgery
* Neurological deficit of operated side (hemiplegia, etc.)
* Bilateral fracture

Primary outcomes:
measure: The prevalence of tape blisters after hip fracture surgery
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: The correlation between risk factors and tape blisters
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: The possible link between the presence of tape blisters and hospital morbidity.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
measure: The costs related to a tape blister.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 8 days
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre hospitalier affilié universitaire de Quebec - Hopital l'Enfant-Jesus
Study officials:
affiliation: Hopital l'Enfant-Jésus
name: Stephane Pelet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04917471: Effect of Nitrate on Red Blood Cell Function in Type 2 Diabetes
Official title: The Effect of Dietary Nitrate Supplementation on Red Blood Cell Function in Patients with Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To investigate the effect of nitrate supplementation on red blood cell function in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

Type 2 diabetes

Exclusion Criteria:

Acute coronary syndrome Vegetarian diet Impaired renal function Absolute indication for proton pump inhibitor Ongoing treatment with organic nitrate Heart failure (ejection fraction \<35%) Any condition that interferes with the possibility to fulfill the study protocol

Primary outcomes:
measure: Percentage recovery of left ventricular function
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: John Pernow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04793971: Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
Official title: Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tendinopathy
Keywords: chronic midportion Achilles tendinopathy
percutaneous paratenon release
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy

Brief summary: To evaluate the outcome of percutaneous paratenon release for chronic midportion Achilles tendinopathy.

Detailed description: Since 2011 the percutaneous procedure took the place of the open release of the paratenon for the surgical treatment for chronic midportion Achilles tendinopathy in the investigators' center. In this study the investigators re-evaluate the patients undergoing percutaneous surgery since then in order to compare the outcome with the excellent results cited in literature. The patients will be contacted and asked to participate completing a VAS-score, a VISA-A score and agreeing with a clinical examination.

Approving by the Ethical Committee of UZLeuven is pending.

Eligibility criteria: Inclusion Criteria:

* patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy

Exclusion Criteria:

* insertional tendinopathy
* open intervention
* (partial) Achilles tendon rupture

Primary outcomes:
measure: VISA-A-score
timeFrame: 3 months
Secondary outcomes:
measure: SF-36-score
timeFrame: 3 months
measure: VAS-score
timeFrame: 3 months
Other outcomes:
Locations:
city: Pellenberg
country: Belgium
facility: University Hospitals of Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Foot and ankle surgeon
name: Giovanni Matricali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04756271: Safety and Immunogenicity of Oxford AstraZeneca Vaccine Against COVID-19 Infection
Official title: Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccine Adverse Reaction
Seroconversion
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-02-16
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: After SARS-COV-2 inactivated vaccine authorization for use in different countries including Egypt, investigating its immunogenicity, safety, and efficacy in preventing COVID-19 infection is highly needed. In Egypt, immunization of HCWs in isolation hospitals by SARS-COV-2 inactivated vaccine is now a national priority. Moreover, data and reports regarding the application of vaccine are still limited and deficient.

Detailed description: This study will be conducted at Zagazig University hospital. Laboratory work will be implemented at Immunology Research Laboratory at Microbiology and Immunology Department, Faculty of Medicine, Zagazig University. A representative sample will be drawn from healthcare workers (HCWs) at Zagazig University Hospital. Assessment of inclusion and exclusion criteria by history taking. Blood samples will be drawn from HCWs by direct venipuncture before the start of immunization and 14 days after immunization. The incidence of any adverse reactions after each immunization will be recorded. SARS-CoV-2 neutralizing antibodies will be detected by enzyme-linked immunosorbent assay.

Eligibility criteria: Inclusion Criteria:

-Healthy healthcare workers

Exclusion Criteria:

* Healthy healthcare workers' refusal.
* Pregnancy and lactation.
* Confirmed acute cases of SARS-CoV-2 Infection
* Having a history of SARS-CoV-2 infection in the past 3 months.
* Fever (body temperature \> 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
* History of allergy to any vaccines
* Previous vaccination within the last 30 days

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: 7 days after each dose
measure: Seroconversion rate of neutralizing antibody
timeFrame: 84 days after each dose
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of Medicine
state: Sharkia
Study officials:
affiliation: Faculty of Medicine, Zagazig University , Zagazig, Egypt
name: Noha M Hammad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06331078: Square Step Exercises in Healthy Young Adults
Official title: Comparison of the Effects of Square Step Exercises and Aerobic Exercise on Cognitive Functions and Physical Fitness in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise
Square Step Exercises
Aerobic Exercise
Cognitive Function
Physical Fitness
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness of Square Stepping Exercise and aerobic exercise on cognitive function and physical fitness in young adults. Participants aged 18-30 with low physical activity levels will be randomly assigned to either the Square Stepping Exercise Group or Aerobic Exercise Group. Both interventions will be supervised by a physiotherapist, performed twice a week for 40 minutes over 4 weeks. Cognitive function will be assessed using various tests, including attention, short-term memory, and executive function evaluations. Physical fitness will be evaluated through jump tests and balance assessments. Blinded assessors will conduct evaluations at baseline and post-intervention in both groups to determine the impact of square stepping exercise and aerobic exercise on cognitive and physical health in young adults.


Eligibility criteria: Inclusion Criteria:

* International Physical Activity Questionnaire score \<600 Metabolic Equivalents (METs),
* No neurological or orthopedic problems affecting gait, balance and lower extremities
* No vision or hearing problems, and no history of musculoskeletal surgery.

Exclusion Criteria:

* Participants who have pain due to a musculoskeletal problem
* Participants who are continuing another routine exercise program

Primary outcomes:
measure: Schulte Grid Test
timeFrame: Baseline and after the interventions (4th week)
measure: Stroop Test
timeFrame: Baseline and after the interventions (4th week)
measure: Verbal Fluency Test
timeFrame: Baseline and after the interventions (4th week)
measure: Digit Span Test
timeFrame: Baseline and after the interventions (4th week)
measure: Vertical jump test
timeFrame: Baseline and after the interventions (4th week)
measure: Horizontal jump test
timeFrame: Baseline and after the interventions (4th week)
measure: Y Balance Test
timeFrame: Baseline and after the interventions (4th week)
Secondary outcomes:
Other outcomes:
Locations:
city: Maltepe
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT01644578: Prospective Use of Real-time MRI
Official title: Prospective Use of Real-time MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluate the Role of Real-time Imaging in Needle Placement
Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging
Keywords: MRI
real-time imaging
workflow
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study is being done to look at a new MRI imaging software, Siemens Interventional Software, to see if we can improve our ability to see and treat cancerous tumors.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for a percutaneous MR guided procedure

Exclusion Criteria:

* Pregnant Women

Primary outcomes:
measure: Determine the time required for each step for needle placement
timeFrame: Intra-procedure
Secondary outcomes:
measure: Determine ease of use of the software
timeFrame: Intra-procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Woodrum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133078: Impact of Fatigue on Jumping Performance
Official title: Impact of Fatigue on Jumping Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Side Hop
Forward Hop
Step test
Vertical Jump
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to determine the effects of a 2-minute single limb lateral step-down fatigue test versus a 30 second side hop test on single limb forward hop distance.

Detailed description: Current methods to induce fatigue often incorporate equipment not available in all clinical settings or include tasks that are difficult to standardize. One of the tests to fatigue the leg muscles is the leg extensor fatigue test using a unilateral weight machine. There are drawbacks to this testing including the clinician having access to the equipment, testing only fatigued a single muscle group, and it is less sport/task specific compared to jump testing. Our previous work has incorporated the use of a side hop task that is performed by hopping over two lines 40 cm apart for 30 seconds. While this does induce fatigue and decreases single leg forward hop performance the overall decrease was relatively small (\<10 cm). It is likely necessary to induce a greater amount of fatigue; thus further limiting single leg forward hop performance.

Eligibility criteria: Inclusion Criteria:

* No history of knee surgery
* Tegner score \>5

Exclusion Criteria:

* Participants with traumatic spine or lower extremity injury within past 6 months
* Participants who are unable to give consent or are unable to understand procedures of experiment

Primary outcomes:
measure: Single limb hop distance (cm)
timeFrame: Change from baseline single limb hop distance immediately after fatigue exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Terry L Grindstaff, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03268278: Efficacy of Buprenorphine on Postoperative Endodontic Analgesia
Official title: Efficacy of Buprenorphine on Postoperative Endodontic Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Postoperative Pain
Keywords: analgesia
endodontic
postoperative
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see whether the addition of buprenorphone to local anesthesia will lengthen postoperative analgesia for endodontic pain


Eligibility criteria: Inclusion Criteria:

* persons with preoperative pain to percussion of a tooth with pulpal disease requiring endodontic therapy, healthy individuals, ASA Class I and II, no known allergies to the drugs being administered

Exclusion Criteria:

* pregnancy, allergy to buprenorphine, allergy to local anesthetic

Primary outcomes:
measure: The Efficacy of Buprenorphine in addition to Local Anesthetic in Providing Prolonged Postoperative Endodontic Analgesia
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References: