louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03465527: Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
Official title: A Phase 2 Trial of Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Kosin University Gospel Hospital
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL

Detailed description: R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.

Eligibility criteria: Inclusion Criteria:

1. Histologically the first large-scaled B-cell lymphoma patient
2. Diagnosis time 65 years old or older
3. Patients planning R-CHOP chemotherapy
4. Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4
5. The International Prognostic Index (IPI) is a high intermediate or high risk
6. Patients without prior history of lymphoma
7. The decision to participate voluntarily in this study and the written consent of the patient

Exclusion Criteria:

1. Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma
2. Large B-cell lymphoma involving the central nervous system
3. Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials
4. If the drug used in this study is allergic
5. If you do not agree to participate in the study

Primary outcomes:
measure: (treatment-related mortality rate; TRM)
timeFrame: an average of 1 year
Secondary outcomes:
measure: IMWG fragility score before and after pre-phase treatment
timeFrame: an average of 1 year
measure: TRM and RR according to IMWG fragility score
timeFrame: an average of 1 year
measure: response rate; RR
timeFrame: an average of 1 year
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: an average of 1 year
measure: Incidence of neutropenic fever
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
state: Sue-gu
Study officials:
References:
Clinical trial NCT06361927: A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
Official title: A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.

Detailed description: This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Eligibility criteria: Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: ORR
timeFrame: 12 months
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 12 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: The Hunan Cancer Hospital
name: Lin Wu, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04326127: Evaluation of Compumedics "Somfit" Device
Official title: Performance Evaluation of the Compumedics "Somfit" Sleep Monitoring Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Lead sponsor: Compumedics Limited
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 30 volunteers were invited to participate in this study. 15 participants will be selected among healthy volunteers, by advertising to the general public. The remaining 15 will be among patients with diagnosed sleep apnea who visit SleepMetrics clinic as part of their routine treatment.

Brief summary: To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.

Detailed description: Sleep is recognized as one of the three pillars of health (i.e. nutrition, exercise and sleep). Poor quality and fragmented sleep leads to an increase in the risk for development of chronic health conditions. Given the importance of good quality sleep and its critical role in overall well-being, there is a need for regular monitoring and assessment of sleep quality in individuals. However, current technologies will only allow for this to be performed in sleep clinics and with the help of full polysomnography (PSG) systems which require the patients to spend a night at the clinic with several wired electrodes connected to their scalp. This will cause discomfort for the patients in a long run. To solve this problem, Compumedics has recently developed a miniaturized, portable and affordable sleep monitoring system with code name of "Somfit" which can be used in the comfort of patients' home. The aim of this study is to validate Somfit for home based sleep studies.

Eligibility criteria: Inclusion Criteria:

* Individuals age between 18 to 75
* Be able to give informed consent
* Individuals with diagnosed Obstructive Sleep Apnoea (OSA)

Exclusion Criteria:

* Less than 18 years of age
* Greater than 75 years of age
* Unable or not willing to provide informed consent
* Need for nursing care
* Currently working nightshift

Primary outcomes:
measure: Comparison between raw EEG signals
timeFrame: single night recording for each subject
Secondary outcomes:
measure: Comparison between Manual and Automatic sleep Scoring - Sleep hypnogram
timeFrame: single night recording for each subject
Other outcomes:
measure: Validation of the new device for detection of sleep apnea
timeFrame: single night recording for each subject
Locations:
city: Melbourne
country: Australia
facility: SleepMetrics Pty Ltd
state: Victoria
Study officials:
affiliation: Sleepmetrics
name: Elizabeth Kealy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00571727: Long-Term Treatment With rhIGF-1 in GHIS
Official title: A Study of Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Growth Hormone Insensitivity Syndrome
Keywords: growth
insulin like growth factor
Laron syndrome
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
Collaborators: name: University of Oklahoma
First posted: 2007-12-12
Enrollment: 92
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).


Eligibility criteria: Inclusion Criteria:

* Height \<-2SD for age and gender
* IGF-1 \<-2SD for age and gender
* Evidence of GH resistance

Exclusion Criteria:

* closed epiphyses
* prior active malignancy
* major organ disfunction
* treatment with medications that would diminish growth
* clinically significant cardiac abnormalities

Primary outcomes:
measure: Annualized Height Velocity Up to 12 Years
timeFrame: Baseline (Pre-dose) and up to 12 years
measure: Number of Naive Participants With Height Velocity <5 cm/y at the End of 1 Year of Study Treatment
timeFrame: Baseline (Pre-dose) and 1 year
Secondary outcomes:
measure: Height Velocity Standard Deviation Score Up to 12 Years
timeFrame: Baseline (Pre-dose) and up to 12 years
measure: Height Standard Deviation Score Up to 12 Years
timeFrame: Baseline (Pre-dose) and up to 12 years
measure: Approximate Increase in Height Over Expected for Naïve Participants With Near-Adult Height
timeFrame: Baseline (Pre-dose) and up to 19 years
Other outcomes:
Locations:
city: Brisbane
country: United States
facility: Ipsen
state: California
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Chernausek SD, Backeljauw PF, Frane J, Kuntze J, Underwood LE; GH Insensitivity Syndrome Collaborative Group. Long-term treatment with recombinant insulin-like growth factor (IGF)-I in children with severe IGF-I deficiency due to growth hormone insensitivity. J Clin Endocrinol Metab. 2007 Mar;92(3):902-10. doi: 10.1210/jc.2006-1610. Epub 2006 Dec 27.
Clinical trial NCT02636127: Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis
Official title: Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma, Systemic
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition.

Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.


Eligibility criteria: Inclusion Criteria:

* patients affected by SSc of more than 18 years
* Healthy patients

Exclusion Criteria:

* Impossibility to take some blood
* Current infection
* Ongoing cancer
* chemotherapy or a current radiotherapy
* pregnant or breast-feeding women

Primary outcomes:
measure: blood sample will be done for dosage of Fractalkine in the serum
timeFrame: 12 months
Secondary outcomes:
measure: blood sample for functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC)
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Brigitte GRANEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827227: Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)
Official title: Values of the Immune Activation Markers CD38 and HLA-DR and the Ratio CD4/CD8 According to the Delay of Combined AntiRetroviral Therapy (c-ART) Initiation in Primary HIV-infected Patients (PRIMIMMUNO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-infected Patients
Keywords: HIV-infected patients
cART
immune restoration
markers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 99
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: HIV patients

Brief summary: The objective was to identify factors associated with the normalization of the CD4/CD8 ratio (\>=1) in patients with a history of primary HIV infection (PHI) and long-term combined antiretroviral therapy (cART).


Eligibility criteria: Inclusion Criteria:

all HIV patients with a known history of PHI and a minimum of 2 years of effective cART (\< 200 copies/mL) without interruption or virological failure

Exclusion Criteria:

Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH

Primary outcomes:
measure: percentage of CD4+ and CD8+ T lymphocytes with activation markers (CD38 + and HLA-DR)
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon / Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT02893527: Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN)
Official title: Implementation and Evaluation of a Social Journey Accompanied for Women With Breast Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
Collaborators: name: Cemka-Eval
First posted: 2016-09-08
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate and compare the return to work rate at 12 months

Detailed description: Evaluate and compare the return to work rate at 12 months (from J1C1 \[first day of the first adjuvant chemotherapy regimen\]) between the "intervention" group (which has accompanied the career) and the standard group course

Eligibility criteria: Inclusion Criteria:

* Patient major\> 18
* Have a diagnosis of localized breast cancer requiring surgery immediately adjuvant therapy sequence including chemotherapy and radiotherapy
* Being more than 3 years of retirement at diagnosis
* Have a work contract valid at the time of diagnosis (before surgery)
* Do not practice a profession
* Be in possession of his rights (excluding guardianship, curatorship)
* Raise the general social security scheme and have rights to cash benefits in the Languedoc-Roussillon region

Exclusion Criteria:

* Patient minor
* Patient diagnosed with metastatic breast cancer
* Patients refusing to sign the consent
* Patients do not have sufficient understanding of the French language
* Patients for whom it is impossible to give clear information

Primary outcomes:
measure: Evaluate and compare the return to work rate
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: describe the conditions of the resumption of work
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut réginal du Cancer de Montpellier
Study officials:
affiliation: Institut régional du Cancer de Montpellier
name: William JACOT
role: STUDY_CHAIR
References:
Clinical trial NCT05810727: Atrial Fibrillation Data Linkage Non-Interventional Study
Official title: Temporal Changes in Clinical Characteristics and Functions, and Their Relationship With Outcomes of Atrial Fibrillation: a Retrospective Study Utilizing Data Linkage of a Signle Center Patient Data and National Claims Database in Korea
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 19388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include adult patients with Atrial Fibrillation diagnosis code at Seould National Universit Hospital(SNUH) from Jan 2010 to Dec 2020.

Brief summary: The purpose of this study is to understand temporal changes in clinical features and functions, and the relationship with outcomes of atrial fibrillation (AF). AF is a problem with speed or pattern that the heart beats. It is the most common type of arrythmia. The study will use data linkage of a single center patient data and national claims database in Korea. This study does not include an actual patient enrollment process.


Eligibility criteria: Inclusion Criteria:

* Patients had incident AF diagnosis (International Classification of Diseases 10th Revision \[ICD-10\]; I48) in an inpatient or outpatient setting at SNUH between 1 Jan 2010 and 31 Dec 2020
* Patients aged 18 years or older on the index date

Exclusion Criteria:

* Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis, or prosthetic heart valve during 12 months period prior to first AF diagnosis

Primary outcomes:
measure: Event Rate of Stroke/Systemic embolism (SE)
timeFrame: Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment
measure: Event Rate of Major bleeding
timeFrame: Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
measure: All-Cause Mortality Rates
timeFrame: Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04047927: A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)
Official title: A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Omeq Medical
Sponsor class: INDUSTRY
First posted: 2019-08-07
Enrollment: 15
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 EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle tip has entered the epidural space. The objective of this First In Human study is to evaluate the safety and performance of using the EpiFinder to identify the epidural space in subjects with a clinical indication to receive a lumbar Epidural Steroid Injections.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years or older
* Subject with clinical indication for lumbar ESI based on subject's clinical problem (e.g. DDD hernia disc, spinal stenosis)
* Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

Exclusion Criteria:

* Subject with marked spinal deformities
* Previous back surgery
* Contraindication for epidural injections (e.g. continuous use of anticoagulants, infection, allergic reactions to the injected substances)
* Subject has known hypersensitivity to contrast media that cannot be pre-medicated
* Subject with severe obesity (body mass index \>35 kg/m2)
* Subject observed seizure within 7 days prior to study enrollment
* Subject presenting for emergency
* Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region
* Subject is pregnant (to be determined by urine pregnancy test)
* Subject who is currently participating or has participated in an investigational study, within the past 30 days

Primary outcomes:
measure: Safety - Device Related Serious Adverse Events
timeFrame: 14 days
Secondary outcomes:
measure: Device Efficacy - Epidural Space Identification
timeFrame: Procedure
measure: Device Performance - Physician satisfaction
timeFrame: Procedure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sponsor GmbH
name: Lior Margalit
role: STUDY_CHAIR
References:
Clinical trial NCT00471627: New Type of a Pancreaticojejunostomy
Official title: New Type of a Pancreaticojejunostomy - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreaticojejunostomy After Pancreatic Head Resection
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-05-10
Enrollment: 30
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: Previously we have demonstrated in animal experiments,that pancreas is extremely vulnerable to handling, reacting with the development of pancreatitis. In human pancreatic surgery, post-operative pancreatitis mediates many other post-operative complications. A new anastomosis was developed to diminish the injury, as being without any stitches going through the pancreas. The aims were to study up to 30 patients as phase one study, with an interim analysis in this open uncontrolled trial after the first few patients.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo peancreatic head resection

Exclusion Criteria:

* Those who refuse from the study

Primary outcomes:
measure: Pancreatic fistula, other complications
timeFrame: One year from operation
Secondary outcomes:
measure: Patency of the pancreaticojejunostomy
timeFrame: One year
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Isto H Nordback, M.D.
role: PRINCIPAL_INVESTIGATOR
References: