louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04986748: Using QPOP to Predict Treatment for Sarcomas and Melanomas
Official title: Q-SAM (Using QPOP to Predict Treatment for Sarcomas and Melanomas)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Melanoma
Keywords: Tumour-derived models
Organoids
Ex vivo drug testing
Personalised therapy
QPOP
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged between 21 to 99 diagnosed with sarcoma or melanoma.

Brief summary: This is a multi-cohort proof of concept study involving patients with sarcomas or melanomas. Patient models, both two- and three-dimensional, will be derived from tumour samples. These will then be used to evaluate drug sensitivities ex vivo.

Enrolled patients will undergo resections or biopsies as part of standard-of-care, which will be used to generate patient models. Patients will receive standard-of-care systemic treatment. Patient models will also be subjected up to a 14-drug screening panel. The majority of drugs in the respective drug panels has been shown to have activity in the respective cancers and would be used in the standard-of-care setting by treating physicians.

Detailed description: Hypothesis: Ex vivo drug testing on patient-derived models using QPOP can identify drug sensitivities and combinations which may have clinical efficacy against sarcomas and melanomas.

Specific aim 1: To derive patient models, both two- and three-dimensional, of sarcomas and melanomas

Specific aim 2: To perform ex vivo drug testing on patient models of sarcoma and melanoma using QPOP

Specific aim 3: To assess the efficacy of phenotype directed therapy using QPOP to assign treatment after progression on standard-of-care treatment in sarcoma and melanoma

Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoma or melanoma
* At least 1 tumour lesion amenable to fresh biopsy or resection
* Signed informed consent from patient or legal representative
* Able to comply with study-related procedures

Exclusion Criteria:

* There are no specific exclusion criteria if patients meet the inclusion criteria

Primary outcomes:
measure: Percentage of patients with successful model generation for each tumour subtype.
timeFrame: 8 years.
measure: Rates of radiological response from QPOP-directed treatment regimens.
timeFrame: 8 years.
measure: Survival outcomes from QPOP-directed treatment regimens.
timeFrame: 8 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Valerie Shiwen Yang, BSc, MB BChir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03291730: A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting
Official title: A Nurse Led Project to Introduce Hand Lettering as a Form of Creative Art Expression to Patients in an Ambulatory Oncology Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are conducting a project to provide a new type of resource called "hand lettering" to patients receiving chemotherapy. This is a type of art therapy. The goal of this project is to understand if it is feasible to use art-therapy and to describe anxiety before and after completing hand-lettering.

Detailed description: This study is being done to understand if it is feasible to use a form of art-therapy called hand-lettering at Dana-Farber Cancer Institute. We would also like to explore the anxiety a person has before and after using hand-lettering.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>age 18) with a cancer diagnosis receiving oral or IV chemotherapy at Dana-Farber on Yawkey 10.
* Able to read and speak English
* Has a minimum appointment time of 60 minutes

Exclusion Criteria:

-Individuals with visual impairment or blindness will be excluded

Primary outcomes:
measure: Evaluate the feasibility of implementing nurse-led hand-lettering in an ambulatory infusion setting
timeFrame: 2 years
Secondary outcomes:
measure: Describe patient self-reported anxiety before and after utilizing hand-lettering
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Cindy L Cao, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349830: Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy
Official title: Development of Novel Serum Markers for Monitoring Response to Anti-Cancer Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinomas (Including Squamous Cell and Adenocarcinoma)
Neoplasms
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients

Brief summary: The purpose of this study is to measure the levels of serum proteins and other biomarkers in cancer patients and in patients suspected of having cancer. We believe that some of these markers may be useful for confirming the diagnosis or for selecting patients for specific types of cancer therapies. These markers may also help to predict response to therapy, relapse after therapy, and survival after therapy.

Detailed description: This is a blood serum collection study at Stanford University for patients with cancer at a variety of disease sites. The purpose of this study is to collect and store blood serum from patients before, during, and after anti-cancer therapy to find new biomarkers that signal disease or response to anti-cancer therapy. The collection and analysis of these biomarkers may lead to improved diagnostic and treatment therapies for certain cancers in the future. We are also interested in collecting blood serum from healthy individuals such as the spouses, relatives, and friends of cancer patients to obtain healthy controls for comparison

Eligibility criteria: 1. Age \> or = 18; for the samples collected under the NIH grant, no subjects below the age of 20 will be enrolled.
2. Prior diagnosis of cancer or suspected of having cancer
3. Karnofsky performance status of greater than 70
4. Standard pretreatment evaluation
5. Signed Stanford University Human Subjects Committee consent

Primary outcomes:
measure: Biomarkers for disease
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Maximilian Diehn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00126230: Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer
Official title: A Prospective Phase II Trial of Docetaxel-Samarium in Patients With Hormone-Refractory Advanced Prostate Cancer Who Achieve a Response or a Stabilization to Docetaxel-Estramustine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-08-03
Enrollment: 55
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective phase II trial of docetaxel-samarium in patients with hormone-refractory advanced prostate cancer who achieve a response or a stabilization to docetaxel-estramustine.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years and less than 80 years
* Histologically-proven adenocarcinoma of the prostate
* Evidence of bone metastases and progressive, hormone-refractory, disease
* No previous chemotherapy
* No previous radiotherapy, except radiotherapy directed to the prostate and/or to a single bony lesion
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance \> 60 ml/min
* Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria:

* Patients infected by the Human Immunodeficiency Virus (HIV)
* Patients who do not fit inclusion criteria

Primary outcomes:
measure: Time to progression
Secondary outcomes:
measure: Prostate specific antigen (PSA) response rate
measure: Toxicity
measure: Overall survival
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04070430: Crutch Use After Arthroscopic Hip Surgery
Official title: Crutch Use After Arthroscopic Hip Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Hip Injuries
Keywords: Arthroscopic hip surgery
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether crutch use for 4 weeks following hip arthroscopic surgery is superior to crutch use for 2 weeks following hip arthroscopic surgery. The primary objective of the study is to compare PRO scores between patients who have used crutches for 2 weeks and patients who have used crutches for 4 weeks.

Detailed description: This will be a single-center, randomized prospective study. The study will compare post-operative patient reported outcome (PRO) scores including the modified Harris hip score (mHHS) and the non arthritic hip score (NAHS), both are externally-validated surveys for hip function. One cohort will be assigned a rehabilitation regimen that includes 2 weeks of partial weight bearing on crutches, and the other will be assigned a regimen of 4 weeks of partial weight.

Eligibility criteria: Inclusion Criteria:

* Hip arthroscopic surgery

Exclusion Criteria:

* Any surgery other than hip arthroscopy
* Age: less than 18 years of age
* Age: greater than 64 years of age
* Pregnant patients

Primary outcomes:
measure: Change in patient-reported-outcome (PRO) survey
timeFrame: 6 weeks, 6 months, 12 months, and 24 months post-operatively.
measure: Change in modified Harris hip score (mHHS)
timeFrame: 6 weeks, 6 months, 12 months, and 24 months post-operatively.
measure: Change in Non arthritic hip score (NAHS)
timeFrame: 6 weeks, 6 months, 12 months, and 24 months post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Thomas Youm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05473130: Breethe Abiomed Recovery RegisTry (BART)
Official title: Breethe Abiomed Recovery RegisTry (BART)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
ARDS
Heart Failure
Keywords: Breethe Oxy-1 System
Extracorporeal Membrane Oxygenation
Cardiopulmonary bypass
ARDS
Heart failure
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-25
Enrollment: 48
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: Subjects supported with Breethe Oxy-1 System

Brief summary: The BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as a resource to inform us on the design of future studies.


Eligibility criteria: Inclusion Criteria:

* all adult subjects supported with Breethe Oxy-1 System

Exclusion Criteria:

* subjects under 18 years of age

Primary outcomes:
measure: Survival up to the hospital discharge
timeFrame: Up to the hospital discharge, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: Philadelphia
country: United States
facility: UPenn Health System
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT02919930: Interface Selection for Adaptive Servo Ventilation
Official title: Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Sleep Apnea
ASV
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.


Eligibility criteria: Inclusion Criteria:

* Patients with central sleep apnea, not responding to treatment with CPAP
* Indication for treatment with ASV

Exclusion Criteria:

* Patients \< 18 years old

Primary outcomes:
measure: Apnea/hypopnea index
timeFrame: Two nights
Secondary outcomes:
measure: Mask comfort VAS
timeFrame: Two nights
measure: Device leaks data
timeFrame: Two nights
measure: Sleep efficiency
timeFrame: Two nights
measure: Sleep architecture
timeFrame: Two nights
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT06881030: Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation
Official title: Comparison of the Efficacy of Different Modes of Accelerated Transcranial Magnetic Stimulation in Treatment-resistant Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Treatment Resistant Depression (TRD)
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for TRD, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for TRD patients.


Eligibility criteria: Inclusion Criteria:

1. The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects
2. After a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the Maudsley staging method

3.24-item Hamilton depression Scale score ≥20

4.The age ranged from 18 to 45 years, both sexes

5.Right handed

6.Written informed consent was obtained and patients volunteered to participate in the study and be evaluated.

Exclusion Criteria:

* 1. Comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc.

  2. Suffering from serious or unstable physical diseases

  3, pregnant, lactating women, women of childbearing age screening period urine HCG test results are positive

  4. Subjects with metal objects in the body or other contraindications to MRI scanning

  5. There are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.

Primary outcomes:
measure: Hamilton Depression Scale (24-items) Total Score Change
timeFrame: Baseline to end of stimulation period, an average of 5 days
Secondary outcomes:
measure: Change in the rate of Hamilton Anxiety Scale score
timeFrame: Time Frame: Baseline to end of stimulation period, an average of 5 days
Other outcomes:
measure: Change in the rate of Beck Scale of Suicidal Ideation score
timeFrame: Baseline to end of stimulation period, an average of 5 days
measure: Change in neuroimaging using functional magnetic resonance
timeFrame: Baseline to end of stimulation period, an average of 5 days
measure: Change in electroencephalogram
timeFrame: Baseline to end of stimulation period, an average of 5 days
measure: Change of blood factor levels
timeFrame: Baseline to end of stimulation period, an average of 5 days
Locations:
Study officials:
References:
Clinical trial NCT00318630: The Effect Of AVANDIA On The Late Asthmatic Response
Official title: A Randomised Double-blind Two-period Crossover Study to Investigate the Effect of Treatment With Repeat Doses of a PPAR Gamma Agonist on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma Compared With Repeat Doses of Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma AVANDIA Inflammation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effects of AVANDIA on the asthmatic response.


Eligibility criteria: Inclusion criteria:

* Mild asthmatic treated with short-acting beta agonists only, non-smoker.

Exclusion criteria:

* Inability to abstain from medications other than short-acting beta agonists and paracetamol.
* Recent administration of steroids.
* Recent respiratory infection or exacerbation of asthma.

Primary outcomes:
measure: The effect of repeat oral doses of AVANDIA for 28 days on the late asthmatic response to inhaled allergen. Measured as lung function 4-10 hours after allergen challenge after 28 days dosing.
timeFrame: Up to 43 days
Secondary outcomes:
measure: The early asthmatic response to allergen, bronchial challenge, nitric oxide, markers of inflammation and safety/tolerability.
timeFrame: Up to 43 days
Other outcomes:
Locations:
city: Wellington
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: This study has not been published in the scientific literature.
citation: Richards DB, Bareille P, Lindo EL, Quinn D, Farrow SN. Treatment with a peroxisomal proliferator activated receptor gamma agonist has a modest effect in the allergen challenge model in asthma: a randomised controlled trial. Respir Med. 2010 May;104(5):668-74. doi: 10.1016/j.rmed.2009.11.006. Epub 2009 Nov 26.
Clinical trial NCT04968730: Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
Official title: Establishment and Application of Early Postoperative Activity Plan for Patients After Hemi-laminectomy for Lumbar Spinal Tumor Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor of Spinal Cord
Keywords: early rehabilitation training
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The routine group was given routine nursing, and the control group was given early rehabilitation nursing
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective to construct the related early activity program for patients with lumbar intraspinal tumor after hemilaminectomy, and evaluate the postoperative limb function exercise according to the content of the program. In order to improve the self-care ability and quality of life of patients, reduce postoperative complications, shorten the average length of stay, reduce hospitalization expenses and improve patient satisfaction.

Objective to evaluate the efficacy and safety of establishing early activity program after hemilaminectomy for patients with lumbar intraspinal tumors


Eligibility criteria: Inclusion Criteria:

1. Patients with primary benign intraspinal tumors at the level of L1-L5 who underwent semi laminectomy;
2. The age of the patients ranged from 14 to 80 years old;
3. The GCS score was 15 points, and the lower limb muscle strength was more than or equal to grade 3 before operation; The patients agreed to the operation and were willing to accept and cooperate with the concept of early rehabilitation nursing and related measures;

Exclusion Criteria:

1. patients with rapid development of disease, difficult to exclude malignant tumors, and non neoplastic lesions in spine or spinal canal;
2. Have a history of severe hypertension, heart disease or other mental illness;
3. Patients with major organ damage or coagulation dysfunction;
4. The patients and their family members had poor communication and compliance;
5. There are factors that may progress or worsen the patient's condition (such as uncontrolled infection, severe respiratory disease, pulmonary infection, etc.);

Primary outcomes:
measure: Patient rehabilitation and leave hospital
timeFrame: up to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Wangping Neurosurgical
Study officials:
References: