louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02539004: US-Non Contrast Computed Tomography Real-time Fusion for Urinary Stones Follow up
Official title: Ultrasound Non-contrast Computed Tomography Real-time Fusion for Urinary Stones Follow up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urolithiasis
Ureterolithiasis
Keywords: kidney stones
ureteral stones
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 70
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 proved urolithiasis on NCCT

Brief summary: Urolithiasis is a universal problem, a large part of patients will be affected by multiple stones throughout their lifetime, with estimated recurrence rates of 75% within 20 years. The high recurrence rate requires an increasing amount of imaging follow-up. US-NCCT real-time fusion (Fusion) enables lesion assessment and follow up using both modalities as reference for each other. Our study proposes a novel approach for short term follow up of patients using Fusion instead of repeat NCCT exams.

the goal of the study is to create an initial proof of concept that Fusion is effective for follow up of known urinary stones.

the study is a prospective study on Patients with an obstructing ureteral stone found on a NCCT. Patients will undergo Fusion (using General Electric Logiq E9) after NCCT. The primary endpoint was the ability to locate the ureteral stone using US with guidance of the NCCT as a "Road Map".


Eligibility criteria: Inclusion Criteria:

* NCCT within 3 months prior to the US study with proved Urolithiasis

Exclusion Criteria:

* Inability to perform a US study.
* Pacemaker

Primary outcomes:
measure: US identification of ureteral stone seen on NCCT
timeFrame: up to 3 months after NCCT
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
state: Select A State
Study officials:
affiliation: Rambam Health Care Campus
name: Eyal Bercovich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195104: Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
Official title: Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-risk Myelodysplastic Syndrome and Poor-prognosis Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 87
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 purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.

Detailed description: This is an open-label, single institution, dose-escalation study of low-dose cytosine arabinoside and arsenic trioxide.

Patients will receive a fixed dose of arsenic trioxide administered 0.25mg/kg/day on days 1-5 and 8-12 and ara-C administered at 5, 7.5, or 10 mg/m2 SC BID days 1-14 in repeated cycles of 2 weeks on therapy and 2 weeks off therapy in a standard dose escalation design (1 cycle = 2 weeks on therapy + 2 weeks off therapy).

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of high-risk MDS (IPSS int-2).
* No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine).

Exclusion Criteria:

* Pregnant or lactating women.
* Absolute QT interval \>460 msec in the presence of serum potassium and magnesium values within the normal range.
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Uncontrolled or severe cardiovascular or pulmonary disease.

Primary outcomes:
measure: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML.
timeFrame: 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML
measure: To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.
timeFrame: 4 weeks after the last study treatment
Secondary outcomes:
measure: To determine the CR and PR rates in patients with high-risk MDS and poor-prognosis AML treated with the combination of ATO and low-dose ara-C.
timeFrame: 4 weeks after the last study treatment
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: Gail Roboz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03850704: Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Multiple Myeloma
Keywords: MM
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2019-02-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an individual patient, expanded access protocol using Selinexor and dexamethasone ("Sd") for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, "19023-UMN-01" weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.

Detailed description: Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.

Eligibility criteria: Inclusion Criteria:

* Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib)
* Aged 18 years and older
* Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan

Exclusion Criteria:

* Known hypersensitivity to selinexor or any excipients.
* Patient receiving any other investigational agent.
* Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.).
* Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
* Active graft versus host disease (after allogeneic stem cell transplantation).
* Active, unstable cardiovascular function:

  * Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics)
  * Congestive heart failure of New York Heart Association Class ≥ 3 or known leftventricular ejection fraction \< 40%, or
  * Myocardial infarction within 3 months prior to C1D1.
* Significant renal impairment with ongoing dialysis treatment
* Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment.
* Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Division of Hematology, Oncology and Transplantation, University of Minnesota
name: Erica Warlick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02843204: Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
Official title: Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Solid Tumour
Keywords: Solid tumor
Anti-PD-1
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.

Detailed description: By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement
* KPS ≥ 70, lifespan \> 3 months, PD-L1 TPS of 1% or greater
* Platelet count ≥ 80×10\^9/L，white blood cell count ≥ 3×10\^9/L, neutrophil count ≥ 2×10\^9/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis
* Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.

Primary outcomes:
measure: PFS
timeFrame: 2 year
measure: OS
timeFrame: 3 years
Secondary outcomes:
measure: PD-1
timeFrame: 3 months
measure: Tumor size
timeFrame: 3 months
measure: CEA
timeFrame: 3 months
measure: CTC
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Institute in Fuda Cancer Hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin M, Luo H, Liang S, Chen J, Liu A, Niu L, Jiang Y. Pembrolizumab plus allogeneic NK cells in advanced non-small cell lung cancer patients. J Clin Invest. 2020 May 1;130(5):2560-2569. doi: 10.1172/JCI132712.
Clinical trial NCT04729504: Cultural Adaptation of a SSI for Youth Anxiety
Official title: Cultural Adaptation and Dissemination of a Single-Session Intervention (SSI) Targeting Caregivers of Youth with Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.


Eligibility criteria: Inclusion Criteria:

1. Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.
2. Affirm that they have read the consent language and study overview on REDCap by checking a box.

Exclusion Criteria:

- Not meet all of the inclusion criteria.

Primary outcomes:
measure: Change in anxiety as measured by GAD-2
timeFrame: Baseline, 2 weeks
measure: Change in anxiety as measured by the FASA
timeFrame: Baseline, 2 weeks
measure: Program Feedback Scale (PFS) Scores
timeFrame: 2 weeks
Secondary outcomes:
measure: Perceived Change in Problem-Solving, and Preparedness to Manage Distress
timeFrame: 2 weeks
measure: Change in State Hope Scale Scores
timeFrame: Baseline, 2 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05828004: The SHINE-MDT Randomized Controlled Trial
Official title: Effect of Multidisciplinary Team Support on Head and Neck Cancer Patients Receiving Radiotherapy: The SHINE-MDT Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Carcinoma
Radiotherapy Side Effects
Keywords: Head and Neck Carcinoma
Multidisciplinary Team
Radiotherapy interruption
Supportive Care
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy.

The management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. We aimed to evaluate the efficacy of the SHINE-MDT (Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team) in reducing radiotherapy interruptions and improving patients' quality of life (QoL) compared with usual care.


Eligibility criteria: Inclusion Criteria:

1. Patients had pathologically confirmed malignant head and neck tumors without distant metastasis.
2. Patient age ≥18 years;
3. Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy.
4. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2;
5. Good cognitive and reading skills, able to complete the questionnaire survey.

Exclusion Criteria:

1. Presence of other malignant tumors aside from head and neck malignancies;
2. A history of prior head and neck radiotherapy;
3. Mental illness or cognitive impairments;
4. Uncontrolled systemic diseases that could significantly affect their QoL

Primary outcomes:
measure: Radiotherapy interruption rate
timeFrame: 5 days
Secondary outcomes:
measure: Quality of life score (EORTC QLQ C30)
timeFrame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
measure: Quality of life score QLQ-HN35
timeFrame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
measure: Nutritional status (NRS 2002, PG-SGA)
timeFrame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
measure: Psychological status (DT, PHQ-9, HADS)
timeFrame: Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Xingchen Peng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01135004: Pathogenesis of Primary Spontaneous Pneumothorax
Official title: Molecular Pathogenesis of Primary Spontaneous Pneumothorax
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumothorax
Keywords: pneumothorax
thoracoscopy
pathogenesis
blebs
surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
name: National Science and Technology Council, Taiwan
First posted: 2010-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males without underlying pulmonary disease.

Brief summary: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients.

Detailed description: Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax. The pathogenesis of this benign disease remains unclear. Generally, rupture of the emphysematous change or blebs in the apex of the lung is considered as the cause of pneumothorax. The main purpose of this study is to investigate the molecular pathogenesis of blebs formation or emphysematous change of the lung in these young, healthy patients. The blebs resected from the pneumothorax patients will be used for RNA and protein levels analyses. The adjacent normal lung tissue will be used as a control for comparison.

Eligibility criteria: Inclusion Criteria:

* Age between 14 and 40 years
* Spontaneous pneumothorax
* Underwent bullectomy of the lung

Exclusion Criteria:

* With underlying lung disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yung-Chie Lee, MD, PhD
role: STUDY_CHAIR
References:
citation: Ayed AK, Chandrasekaran C, Sukumar M. Video-assisted thoracoscopic surgery for primary spontaneous pneumothorax: clinicopathological correlation. Eur J Cardiothorac Surg. 2006 Feb;29(2):221-5. doi: 10.1016/j.ejcts.2005.11.005. Epub 2005 Dec 20.
Clinical trial NCT02727504: Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
Official title: Low Flow Low Gradient Aortic Stenosis Relevance of the (re)Search for a Contractile Reserve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Keywords: Aortic valve stenosis
low flow
dobutamine stress echocardiography
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 86
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low flow low gradient aortic stenosis

Brief summary: Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.


Eligibility criteria: Inclusion Criteria:

* Patient from 45 to 90 years old
* Patient agreeing freely to participate in the study
* Aortic surface area suspected to be \< 1 cm² or \< 0.6 cms²/m²
* Low aortic gradient defined by a mean pressure gradient \< 40 mmHg
* Aortic low flow defined by: a stroke volume indexed \< 35 ml/m2
* Any contra-indication for the realization of the MRI

Exclusion Criteria:

* Heart rhythm disorders
* Presence of comorbidity altering the 2-year prognosis of a patient (cancer, terminal renal insufficiency (GFR 30 ml / min / 1,73m2), liver cirrhosis, respiratory insufficiency (VEMS 1 L)
* Presence of a concomitant valvular heart disease with stenosis or regurgitation \> moderated
* Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Primary outcomes:
measure: Number of death of all cause
timeFrame: Month 12
measure: Number of emergent hospitalization for any cardiovascular reason
timeFrame: Month 12
Secondary outcomes:
measure: Death (all causes)
timeFrame: 12 months
measure: Emergency Cardiovascular hospitalization
timeFrame: 12 months
measure: Change in left ventricular ejection fraction (LVEF), in global longitudinal strain in 2D and or 3D echocardiography
timeFrame: Inclusion, 12 months
measure: Symptoms evolution
timeFrame: Inclusion, 12 months
measure: Symptoms evolution
timeFrame: Inclusion, 12 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT04468204: Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)
Official title: Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Infection
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 95
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: This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.

Exclusion Criteria:

* Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.
* Any upper respiratory illness within last 2 weeks
* TSS will be measured at baseline as described above and must be \<9 for inclusion (Eccles etal).
* Topical decongestant use in last week
* Current nasal crusting or history of ulceration or perforation
* History of severe nose bleeding within last 3 months
* Known pregnancy
* Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy
* Allergic sensitivity to silicone or any other component of device
* Inability to read and understand English
* Inability to perform treatment due to underlying medical condition

Primary outcomes:
measure: Total Symptoms Score (TSS)
timeFrame: 60 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Sinus Center - Medical Univesity of South Carolina
state: South Carolina
Study officials:
References: