louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05788679: A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS
Official title: A Phase II Multicenter Single-armed Study Using Subject-specific Minimal Residual Disease Markers to Adopt Treatment After Allogeneic Stem Cell Transplantation for Subjects With Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts
Mixed Myelodysplastic/Myeloproliferative Disease
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Nordic MDS Group
First posted: 2023-03-29
Enrollment: 200
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 goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.


Eligibility criteria: Inclusion Criteria:

Signed informed consent

* Age ≥ 18 years
* Subjects eligible for SCT
* Subjects having the disease MDS, mixed myelodysplastic/myeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts
* All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study

Exclusion Criteria:

* No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis
* Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders
* Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation

Primary outcomes:
measure: Clinical event defined as relapse or death within 1 year from first MRD+ sample
timeFrame: Within 1 year from first MRD+ sample
Secondary outcomes:
measure: Number of MRD+ patients achieving MRD negativity
timeFrame: From MRD positivity until 2y after transplantation
measure: Incidence and severity of graft-versus host disease
timeFrame: From transplantation until 2y after transplantation
measure: Safety, adverse events reporting
timeFrame: After start of Azacitidine until 30 days after last azacitidine injection
measure: Relapse-free survival
timeFrame: From transplantation until 2y after transplantation
measure: Overall survival
timeFrame: From transplantation until 2y after transplantation
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Hematology, Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Magnus Tobiasson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01450579: A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers
Official title: Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Recombinant Influenza HA vaccine
Immunogenicity of ASP7373
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Body weight: Female: ≥40.0 kg, \<70.0 kg, Male: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained

Exclusion Criteria:

* Scheduled to receive another vaccine during study period
* History of H5 influenza infection or received H5 influenza vaccine
* Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
* Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
* Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
* History of seizures
* Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Primary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs
timeFrame: up to 43 days
measure: Immunogenicity (HI antibody titer)- first vaccine
timeFrame: on Day 21
measure: Immunogenicity (HI antibody titer)- second vaccine
timeFrame: on Day 43
Secondary outcomes:
Other outcomes:
Locations:
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02134379: Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation
Official title: Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation: A Pilot Trial of the "Dynamic Thoracic Impedance Bed Rest Test"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure; With Decompensation
Keywords: Thoracic Impedance
Diagnostic Marker
Bed Rest Test
Transthoracic Impedance
Heart Failure
HF
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-05-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified from the KU Hospital Cardiology clinic.

Brief summary: This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.

Detailed description: Improved metrics derived from the transthoracic impedance (Z) available from implanted Medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. Quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.

Eligibility criteria: Inclusion Criteria:

* Patients with systolic dysfunction
* Able to provide informed consent
* Have a Medtronic manufactured device with Thoracic Impendence Monitoring capabilities

Exclusion Criteria:

* Patients with severe congestive heart failure who are intubated
* Patients who are oxygen dependent on continuous positive or bilevel positive ventilation
* Inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.Unable to complete proposed testing
* Subjects who cannot giveWill not give written, informed consent on their own behalf

Primary outcomes:
measure: Change from sitting to supine to standing in thoracic impedance
timeFrame: Baseline, 30 Days
Secondary outcomes:
measure: Rate of change in thoracic impedance
timeFrame: Baseline, 30 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Charles Porter, MD, FACC, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523379: Efficacy of Parecoxib on Patients With CRPS
Official title: Efficiacy of the Selctive COX-2-inhibitor Parecoxibe on the Pathological Low Pressure Pain Threshold (PPT) of Patients With Complex Regional Pain Syndrome (CRPS)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Causalgia
Keywords: Causalgia
CRPS
complex regional pain syndrome
Dynastat
Parecoxib
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2012-02-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The complex regional pain syndrom is a weighty disease that often results in a lifelong disability. Mostly this disease appears unilateral after comparatively mundane fractures or operations. In early stages CRPS shows inflammatory processes. These inflammatory components can be seen as edema and vasodilatation. These inflammatory processes lead us to the hypothesis that selective COX-2-inhibitors might help patients with CRPS.


Eligibility criteria: Inclusion Criteria:

* Patients with saved diagnosis of CRPS of the upper extremity based on the current used criteria for diagnosis plus a positiv 3-phase-sceletal-scintilgraphy, if they show pathological PPT-values in QST on the ipsilateral site (Z-values \> 2 in age- and gender-based Z-transformation of the raw values)• age ≥ 18 years• Existence of an age-based normal creatinin-clearance (calculated with a defined formula)

Exclusion Criteria:

* Important cardiovascular illness for the purpose of heart failure (NYHA II - IV), coronary heart disease (CHD), peripheral artery occlusive disease (PAOD) or unstable hypertension (values constantly over 140/90 mm Hg)

  * Florid kidney disease
  * Cerebral disease
  * Neurological systemic disorder (exception: beginning polyneuropathy with normal values of the PPT on the opposite side)
  * Lesion of the median nerve (ipsi- oder contralateral)
  * Acute bleeding disease
  * Known ulcer of the stomach or duodenum
  * Inflammatory bowel disease
  * Positive anamnesis of a gastrointestinal bleeding in the last 5 years
  * Important hepatic dysfunction (Child- pugh \> 9)
  * Hypersensitivity to the agent or to sulfonamides
  * Known allergy to acetylsalicylic acid, nonsteroidal antiinflammatory drugs or other selectiv cyclooxygenase-inhibitors
  * Pregnancy and lactation period
  * Intake of one of the following drugs (current or in the last 3 days)

    * selective-serotonin-reuptake-inhibitor
    * cetoconazole
    * rifampicin
    * phenytoin
    * carbamazepine
    * dexamethasone or other systemic corticoids
    * traditional nonsteroidal antiphlogistics
    * cyclooxygenase-inhibitors
    * immunsupressives
    * TNF-α-inhibitors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05175079: Acupressure in Hyperemesis Gravidarum
Official title: A Randomised Controlled Trial On Effect Of Acupressure On Nausea And Vomiting In Women With Hyperemesis Gravidarum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperemesis Gravidarum
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum

Detailed description: A prospective RCT conducted at Department of Obst and Gynae, UKMMC. All pregnant women with a normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be assessed by the medical officer/ specialist/ consultant in charge. Explanation regarding the research study will be given for patients who fulfill the inclusion and exclusion criteria. Patients who have understood the research study and consented will be recruited as subjects for the study.

Eligibility criteria: Inclusion Criteria:

1. Onset of vomiting before 16 weeks
2. Vomiting at least 2 times per day
3. Ketonuria on admission
4. Mid stream urine specimen that did not indicate infection

Exclusion Criteria:

1. Non viable pregnancy
2. Molar pregnancy
3. Overt clinical features of thyrotoxicosis
4. Known case of medical illness that associated with nausea and vomiting
5. Patient refusal or patients who are not able to give consent

Primary outcomes:
measure: Degree of nausea and vomiting
timeFrame: day 1 to day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
Study officials:
References:
citation: Mohd Nafiah NA, Chieng WK, Zainuddin AA, Chew KT, Kalok A, Abu MA, Ng BK, Mohamed Ismail NA, Nur Azurah AG. Effect of Acupressure at P6 on Nausea and Vomiting in Women with Hyperemesis Gravidarum: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 1;19(17):10886. doi: 10.3390/ijerph191710886.
Clinical trial NCT02611479: Understanding Non-Response in Spine Fusion Surgery
Official title: Understanding Non-Response in Spine Fusion Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Fusion
Keywords: patient reported outcomes
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2015-11-20
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 and over) undergoing spine fusion surgery in Washington State.

Brief summary: To identify patient characteristics associated with non-response after spine fusion surgery for the treatment of degenerative disc disease (DDD).


Eligibility criteria: Inclusion Criteria:

* Subject has diagnosis of degenerative disc disease
* Subject is undergoing lumbar spine fusion surgery

Exclusion Criteria:

* Subject is less than 18 years of age
* Subject is not fluent in English
* Subject requires a caretaker for medical decision making

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline, 60 day, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Seattle
country: United States
facility: Proliance Surgeons
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Wenatchee
country: United States
facility: Confluence Health
state: Washington
Study officials:
affiliation: University of Washington
name: Amy M Cizik, MPH, PhC
role: STUDY_DIRECTOR
References:
Clinical trial NCT06272279: Neuromodulation With Spinal Stimulation Methods
Official title: Neuromodulation With Spinal Stimulation Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Injury at C5-C7 Level
Paraplegia, Spinal
Paraplegia, Incomplete
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Semi-blinded, randomized block entry design, crossover intervention study.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a pilot research study to test the protocols needed for transcutaneous spinal electrical stimulation in persons living with spinal cord injury (SCI). Up to 24 participants will be enrolled. A variety of stimulation parameters and outcome measures will be assessed.

Detailed description: Purpose of this project

Spinal cord stimulation has the potential to improve motor function recovery after spinal cord injury. Commonly used approaches include low-intensity, direct current (DC) stimulation applied across multiple segments, electrical transcutaneous (ETC) stimulation, and magnetic transcutaneous stimulation (MTC).

Objective: to evaluate and compare the voluntary and reflexive motor performance in the same subjects, including people with and without spinal cord injury, after non-invasive spinal cord stimulation interventions. Comparing two different interventions applied in different experimental sessions and the respective sham stimulation is the goal of this study.

corticospinal and spinal motor pathways in paraplegics and in non-injured humans will be tested.

Eligibility criteria: Inclusion Criteria:

* spinal cord injury C4 to L4
* ability to understand and follow directions

Exclusion Criteria:

* history of seizures, head injury, concussion, unexplained loss of consciousness or if they lived with an implanted cochlear stimulator, brain/neurostimulator, cardiac pacemaker, medication infusion device or live with metal implants in their body or if they are pregnant.

Primary outcomes:
measure: Motor response
timeFrame: Immediately after stimulation (within 1-15 min)
measure: Motor evoked potentials
timeFrame: Immediately after stimulation (within 1-15 min)
Secondary outcomes:
measure: Blood pressure
timeFrame: During the procedure/stimulation and up to 15 min after stimulation.
measure: Perception of discomfort due to stimulation
timeFrame: During and after procedure/stimulation and up to 15 min after stimulation.
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT02104479: Diagnostic Accuracy of Pleural Effusion Aspergillosis Biomarker Testing
Official title: Open Multicenter Diagnostic Study on the Accuracy of Biomarker Testing (Galactomannan (GM), (1-3)-β-D-glucan (BDG), Aspergillus-specific Polymerase Chain Reaction (PCR) Assay) in Pleural Effusion Samples of Immunocompromised Patients With Suspected Invasive Pulmonary Aspergillosis (IPA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Aspergillosis
Pleural Effusion
Immunosuppression
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - Immunocompomised Patients based on the following conditions: prolonged neutropenia \> 10 d, patients after allogeneic stem cell transplantation or solid organ transplantation, Patients wth acute leukemia in induction treatment, patients witrh graft-versus-host-disease, patients under chronic immunusuppressive therapy such as ciclosporin, patients with HIV, patients with chronic steroid treatment,

Brief summary: Diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Detailed description: A multicentre, open, prospective diagnostic study on the diagnostic accuracy of biomarker testing (galactomannan (GM), (1

Eligibility criteria: Inclusion Criteria:

* prolonged neutropenia \> 10 d, patients
* after allogeneic stem cell transplantation or solid organ transplantation,
* Patients wth acute leukemia in induction treatment,
* patients witrh graft-versus-host-disease,
* patients under chronic immunusuppressive therapy such as ciclosporin,
* patients with HIV,
* patients with chronic steroid treatment

Exclusion Criteria:

* Age \< 18 years
* missing informed consent
* contraindication for pleural centesis

Primary outcomes:
measure: Test Sensitivity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Hospital Mannheim
state: Baden-Wuerrtemberg
city: Wuerzburg
country: Germany
facility: Wuerzburg University Hospital
state: Bayern
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Dieter Buchheidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reinwald M, Spiess B, Heinz WJ, Heussel CP, Bertz H, Cornely OA, Hahn J, Lehrnbecher T, Kiehl M, Laws HJ, Wolf HH, Schwerdtfeger R, Schultheis B, Burchardt A, Klein M, Durken M, Claus B, Schlegel F, Hummel M, Hofmann WK, Buchheidt D. Aspergillus PCR-based investigation of fresh tissue and effusion samples in patients with suspected invasive Aspergillosis enhances diagnostic capabilities. J Clin Microbiol. 2013 Dec;51(12):4178-85. doi: 10.1128/JCM.02387-13. Epub 2013 Oct 9.
Clinical trial NCT06302179: Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery
Official title: Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Venous Thromboembolism
Keywords: colorectal cancer surgery
thromboprophylaxis
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: Aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. There were 137 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2016 to December 2017. Compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.


Eligibility criteria: Inclusion Criteria:

operated for incisional hernia in Saveljev University Surgery Clinic. No Exclusion Criteria

Primary outcomes:
measure: Venous Thromboembolism
timeFrame: was performed with median 4 days (min 2 day, max 14 days, interquartile range 2-5 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
References: