louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03642236: Combination of BTK Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant AML
Official title: Combination of Brutons Tyrosine Kinase (BTK) Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: FLT3-ITD Mutation
Acute Myeloid Leukemia
Brutons Tyrosine Kinase
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 122
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant AML. BTK is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, the efficacy and safety of combination of BTK inhibitor with chemotherapy with/without FLT3 inhibitor in refractory/relapsed FLT3 mutant AML are evaluated.

Detailed description: Clinical efficacy of FLT3 inhibitors combining with chemotherapy is usually transient and followed by emergence of drug-resistance in FLT3-ITD mutant acute myeloid leukemia (AML). How to overcome the resistance to FLT3 inhibitors or chemotherapy needs further study. Bruton's tyrosine kinase (BTK) is reported to be a therapeutic target in this subtype leukemia. Our previous study showed inhibition of BTK onvercome drug-resistance to FLT3 inhibitors/chemotherapy in refractory/relapsed FLT3 mutant AML. In this prospective randomized controlled study, we are going to inhibit BTK with BTK inhibitor ibrutinib in the patients with refractory/relapsed FLT3 mutant AML, and then test the enhancing effect and safety of combination of ibrutinib with chemotherapy with/without FLT3 inhibitor, to make sure inhibition of BTK overcomes drug-resistance in FLT3 mutation AML.

Eligibility criteria: Inclusion Criteria:

Refractoty/relapsed FLT3-ITD mutation AML Age 14-60

Exclusion Criteria:

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: CR rate
timeFrame: After the first and second cycle induction
measure: OS
timeFrame: 2 years
measure: DFS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Guopan Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868449: Question Prompt List for Common Hand Conditions
Official title: Does Giving a Question Prompt List to Patients With Common Hand Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Trigger Finger
Trigger Thumb
Dupuytren Contracture
Ganglion Cysts
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Patients with common hand conditions will be randomized to one of two groups- one will receive a question prompt list, the other will receive a list of 3 questions


Eligibility criteria: Inclusion Criteria:

* patients with common hand conditions

Exclusion Criteria:

-

Primary outcomes:
measure: Perceived Involvement in Care scale
timeFrame: Immediately after visit
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Robin N Kamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06491836: Oligoantigenic Diet and Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).
Official title: The Effect of an Oligoantigenic Diet on Core Symptomatology of Children With Attention-Deficit /Hyperactivity Disorder (ADHD).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fifty patients who diagnosed as ADHD syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) Criteria aged from 6 to 16 years old will be assigned randomly into 2 arms: arm 1: the patients will follow food regimen that cover recommended daily allowance (RDA) for macronutrients and micronutrients suitable for their ages without any food restriction, arm 2: the patients will follow food regimen that cover (RDA) for macronutrients and micronutrients suitable for their ages based on Oligoantigenic diet (OAD). Psychiatric assessment will be done before intervention and after 3 months of intervention.


Eligibility criteria: Inclusion Criteria:

* Children fulfilled DSM (5) Criteria for ADHD syndrome aged from 6 to 16 years old on stable pharmacotherapy 8 weeks prior to enrollment with intention to maintain ongoing therapies constant throughout the trial.

Exclusion Criteria:

* Presence of other medical conditions as chronic medical illness or other neuropsychiatric disorders
* Intelligence quotient (IQ) of patients less than 80%.

Primary outcomes:
measure: Conner's Parent Rating Scales-Revised (CRS-R)
timeFrame: 3 months
measure: Child Behavior Checklist (CBCL/6-18)
timeFrame: 3 months
measure: The Continuous Performance Test (CPT)
timeFrame: 3 months
measure: Clinical Global Impression
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04745936: Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants
Official title: Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 114
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.


Eligibility criteria: Inclusion Criteria:

① Infants under 1 year old scheduled for elective surgery under general anesthesia

② American Society of Anesthesiology physical status I, II

Exclusion Criteria:

* Any pulmonary disease

Primary outcomes:
measure: Tube handling time
timeFrame: during procedure
Secondary outcomes:
measure: Total intubation time
timeFrame: during procedure
measure: Time to reaching glottis
timeFrame: during procedure
measure: The location of the initial tube tip
timeFrame: during procedure
measure: Successful tracheal intubation
timeFrame: during procedure, within 30 sec
measure: Additional manipulation of stylet angle
timeFrame: during procedure
measure: Number of external laryngeal manipulation
timeFrame: during procedure
measure: Easiness of tracheal intubation
timeFrame: during procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04541849: Database for Predicting Clinical Outcomes of Critically Ill Patients
Official title: Predicting Clinical Outcomes of Critically Ill Patients in Intensive Care Units With De-identification Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to intensive care units

Brief summary: Australian and New Zealand Intensive Care Society (ANZICS) has built a Center of Outcome and Resource Evaluation (CORE) adult patients database (APD) of adult critically ill patients. ANZICS CORE APD has built an international collaboration of ICU database. National Taiwan University Hospital has joined this international collaboration and built the data according to the APD data dictionary with same value domain attributes and data element attributes. We retrospectively collected the data of patients discharged from the March 1, 2019 to June 30, 2022. Data of this database are permitted to study clinical problems and predict the clinical outcomes of these critically ill patients using statistical methods and machine learning techniques.

Detailed description: Data of this database are permitted to study the following clinical issues: including delirium, sepsis, acute kidney injury, acute respiratory distress syndrome, disseminated intravascular coagulation, multiple organ injuries, nutrition, survival status, number of days on ventilators, need for renal replacement therapy, length of stays in intensive care unit, length of stay in hospital, and other relevant clinical outcomes. It is also planned to analyze the clinical prognosis of special disease subgroups and establish a prediction model according to the type of patient's disease.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients admitted to intensive care units

Exclusion Criteria:

* patients aged less than 18 years

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay in intensive care unit
timeFrame: Time of discharge from intensive care unit, a median of 2-7 days
measure: Delirium
timeFrame: 48 hours
measure: Acute kidney Injury
timeFrame: 48 hours
measure: Length of stay in intensive care unit
timeFrame: Time of discharge from hospital, more than 1 day
measure: Disseminated intravascular coagulation
timeFrame: 48 hours
measure: Acute respiratory distress syndrome
timeFrame: 48 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02996149: Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure
Official title: Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Emphysema
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 1
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: Patients with severe emphysema and chronic hypercapnic respiratory failure, in whom endoscopic lung volume reduction coil treatment is performed

Brief summary: Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) \< 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
* Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
* Informed consent

Exclusion Criteria:

* Therapeutic anticoagulation
* Anti-platelet therapy exceeding the use of acetylsalicylic acid
* Severe pulmonary hypertension

Primary outcomes:
measure: Changes in PaCO2
timeFrame: 3 months after endoscopic lung volume reduction (ELVR)
Secondary outcomes:
measure: Changes in PaCO2
timeFrame: 6 and 12 months after ELVR
measure: Changes in FEV1
timeFrame: 3, 6 and 12 months after ELVR
measure: Changes in vital capacity
timeFrame: 3, 6 and 12 months after ELVR
measure: Changes in residual volume
timeFrame: 3, 6 and 12 months after ELVR
measure: Changes in 6-minute walk distance
timeFrame: 3, 6 and 12 months after ELVR
measure: Changes in quality of life (St. George's Respiratory Questionnaire, SGRQ)
timeFrame: 3, 6 and 12 months after ELVR
measure: Changes in BMI
timeFrame: 3, 6 and 12 months after ELVR
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT05659849: Effectiveness of Manual Therapy and Neuromuscular Training in the Management of Knee Osteoarthritis
Official title: Effectiveness of Manual Therapy VS Conventional Physical Therapy With Neuromuscular Training in the Management of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Manual therapy
TENS
Neuromuscular training
Lead sponsor: University of Tabuk
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the short-term effectiveness of manual therapy with neuromuscular training and conventional physical therapy with neuromuscular training in patients with knee osteoarthritis.

Detailed description: Knee osteoarthritis (OA) is a major public health problem, characterized by progressive degeneration and loss of articular cartilage, resulting in pain, limitation of movement, imbalance, functional disability, and diminished patient quality of life. Regular participation in physical activity has been recognized for several years as being beneficial in the management of knee OA. The role and effectiveness of manual therapy techniques and conventional physical therapy are evident from the existing literature, but no comparison was found for the combination of neuromuscular training (NMT) in patients with knee OA. Thus, the aim of this study is to compare the short-term effectiveness of manual therapy (MT) versus conventional physical therapy (CPT) with NMT in the management of knee OA after six weeks of treatment.

Eligibility criteria: Inclusion Criteria:

* Complaining of knee pain that has lasted longer than 3 months.
* Pain level that is medium (pain score greater than or equal to 4).
* No knee injuries.
* Treatment not received in another physical therapy clinic in the past three months.
* Painful range of motion in the knee.

Exclusion Criteria:

* History of knee surgery
* A systemic arthritic condition
* Any other muscular, joint, or neurological condition affecting lower limb function.
* Received physical therapy or an intra-articular injection in the knee within the past 3 months.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6 weeks
measure: Goniometric measurement for ROM
timeFrame: 6 weeks
measure: Western Ontario and Mc Master Osteoarthritis Index (WOMAC)
timeFrame: 6 weeks
measure: Short-Form Health Survey (SF-36)
timeFrame: 6 weeks
measure: Single-leg stance time test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tabuk
country: Saudi Arabia
facility: University of Tabuk
state: North West
Study officials:
References:
Clinical trial NCT01770249: Evaluation of a Novel Endoscopic Treatment for Achalasia
Official title: Evaluation of a Novel Endoscopic Treatment for Achalasia: Per-oral Endoscopic Esophagomyotomy (POEM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achalasia
Keywords: dysphagia
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is to evaluate outcomes of a less invasive surgical procedure for the treatment of achalasia.

Detailed description: This study will assess the feasibility and efficacy of a novel endoscopic procedure, Per-oral Endoscopic Esophagomyotomy (POEM)in treating patients with achalasia.

Eligibility criteria: Inclusion Criteria:

* o Subjects with a manometric/radiologic diagnosis of primary achalasia; EGD shows no neoplasm

  * Ability to undergo general anesthesia
  * The subject is \> 18 yrs.of age
  * Ability to give informed consent

Exclusion Criteria:

* o Sigmoid achalasia

  * Contraindicated for EGD
  * Pregnancy

Primary outcomes:
measure: The success of the POEM procedure is measured by improved symptoms as compared to pre-op, including the ability to swallow with low incidence of GERD and significantly reduced resting LES pressure
timeFrame: Within the first 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Ponsky Jeffrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05896449: Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
Official title: Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioma, Malignant
Glioma Glioblastoma Multiforme
Keywords: glioma
PSMA
PET/CT
[68Ga]Ga-PSMA-11 PET/CT
glial tumours
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to analyse usefulness of \[68Ga\]Ga-PSMA-11 PET/CT scans in preoperative differentiation between HGG and LGG in patients with suspicion of a tumor of glial origin in previously performed imaging examinations. The PET/CT scan will be compared with postoperative histopathological results and with additional immunohistochemical staining for PSMA expression.


Eligibility criteria: Inclusion Criteria:

* primary lesion found in CT/MRI with radiological features of glial neoplasm
* untreated disease, planned surgery
* negative medical history of other neoplastic diseases
* age over 18
* informed, voluntary consent to participate in the study

Exclusion Criteria:

* pregnant women, breastfeeding women
* persons with a known allergy to PSMA
* age under 18
* patient's lack of cooperation

Primary outcomes:
measure: PET/CT vs histopathological diagnosis
timeFrame: through study completion, an average of 1.5 year
Secondary outcomes:
measure: PET/CT semiquantitive parameter - SUVmax vs histopathological diagnosis
timeFrame: through study completion, an average of 1.5 year
measure: PET/CT semiquantitive parameter SUVmean vs histopathological diagnosis
timeFrame: through study completion, an average of 1.5 year
measure: PET/CT semiquantitive parameter - TBR vs histopathological diagnosis
timeFrame: through study completion, an average of 1.5 year
measure: PET/CT semiquantitive parameter - TLR vs histopathological diagnosis
timeFrame: through study completion, an average of 1.5 year
measure: PET/CT semiquantitive parameter - SUVmax vs immunohistopathological staining
timeFrame: through study completion, an average of 1.5 year
measure: PET/CT vs progession free survival time.
timeFrame: 1 year after the study
measure: PET/CT vs overall survival time.
timeFrame: 1 year after the study
measure: PET/CT semiquantitive parameter - SUVmax vs progession free survival time.
timeFrame: 1 year after the study
measure: PET/CT semiquantitive parameter - SUVmax vs overall survival time.
timeFrame: 1 year after the study
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Nuclear Medicne Department Medical University of Warsaw
state: Mazowieckie
Study officials:
References:
Clinical trial NCT05219149: CNS Qualitative Interview
Official title: Exploring Factors in Patient and Family Consideration of Treatment for Pediatric Central Nervous System Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Children's Hospital Colorado
First posted: 2022-02-01
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parents and caregivers will be eligible for participation if their child is newly diagnosed with or has had a recent relapse of a CNS tumor that will require further therapy. Therapy may be either standard of care or dictated by an open clinical trial.

For patients 12 years of age and younger, caregivers only will be included in the interviews. For patients 13-17 years of age, caregivers will have the option to include the patient in the interviews. For patients 18 years of age and older, patients will have the option to include their caregivers in the interviews.

Brief summary: Explore factors involved in decision making for patients with new or recurrent CNS tumors and their families surrounding treatment planning and clinical trial enrollment.

Detailed description: Explore factors involved in decision making for patients with new or recurrent CNS tumors and their families surrounding treatment planning and clinical trial enrollment. The team will conduct qualitative interviews with a diverse group of patients and families considering treatment for new and recurrent CNS tumors to determine challenges surrounding treatment and study enrollment that may be modifiable through community, hospital, and University of Colorado Cancer Center resources. The team will then assess the impact of these resources on decision making through follow-up interviews.

Eligibility criteria: Inclusion Criteria:

1. Be the parent or caregiver of a child or young adult receiving treatment at CHCO

   a. Child must meet one criterion below: i. Newly diagnosed with a CNS tumor ii. Relapse of a CNS tumor requiring further therapy. Therapy may be standard of care of dictated by an open clinical trial
2. Patient 18 years of age or older a. Must meet one of the criteria below: i. Newly diagnosed with a CNS tumor ii. Relapse of a CNS tumor requiring further therapy. Therapy may be standard of care of dictated by an open clinical trial

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Identify barriers to trial enrollment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Adam Green
role: PRINCIPAL_INVESTIGATOR
References: