louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05455866: Central Venous Catheter-related Complications in Patients Under Anticancer Treatment
Official title: Central Venous Catheter-related Complications in Patients Under Anticancer Treatment: a Prospective Monocentric Study on Incidence and Consequences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Venous Catheter Thrombosis
Central Venous Catheter Related Bloodstream Infection
Solid Tumor
Hematologic Malignancy
Lead sponsor: Centre Hospitalier Alpes Leman
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients at Oncohematology Outpatient Department

Brief summary: Oncology and hemotology patients under anticancer treatments are exposed to increased risks of central venous catheter-related complications due to the underlying cancer and its treament.

This prospective observational monocentric french study aims at describing the incidence of such complications, their morbimortality, and analyzing some risk factors in order to contribute to propose some strategies to reduce these complications' rate and consequences


Eligibility criteria: Inclusion Criteria:

All patients older than 18 years, with solid cancer or hematological malignancy receiving anticancer treatment in the outpatient medical department of Alpes Leman Hospital and having a central venous catheter been placed between the 11th of July 2022, and the 1st of January 2023.

Primary outcomes:
measure: Incidence rate and density of central venous catheter-related complications (infections, thromboses, extravasation)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence rate of severe central venous catheter-related complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Alpes Leman
name: Florence OBERKAMPF
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591666: A Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
Official title: A Non-randomized Phase II Study of Anlotinib in Recurrent/Metastatic Head and Neck Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Carcinoma
Adenocarcinoma
Recurrent Disease
Distantly Metastatic Malignant Neoplasm
Keywords: head and neck adenocarcinoma
Anlotinib
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a non-randomized, phase II, open label study of anlotinib hydrochloride capsules in recurrent/metastatic adenocarcinomas of head and neck. The primary purpose of this study is to evaluate the efficacy of anlotinib.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed head and neck adenocarcinoma.
2. Patients with recurrent or metastatic head and neck adenocarcinoma who are not candidates for curative surgery or radiotherapy.
3. Measurable disease per the RECIST criteria.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Provision of written informed consent.
6. Childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (IUD, birth control pills, or barrier device) during and for 3 months after completion of trial therapy.

Exclusion Criteria:

1. Prior treatment with Anlotinib
2. With pleural effusion or ascites, cause respiratory syndrome
3. Accepted the vascular endothelial growth inhibitor class targeted drug treatment of patients
4. Plan to take systemic anti-tumor therapy within 4 weeks before grouping or during the medicine-taking period of this research, including Cytotoxic Therapy, 5.Signal Transduction Inhibitor, and Immunotherapy (or who use Mitomycin C within 6 weeks before taking the treatment with experimental drug); The patients who have already taken Extended Field Radiotherapy (EF-RT) within 4 weeks before grouping or Limited Field Radiotherapy with proposed assessment of nidus within 2 weeks before grouping

6.Symptoms of brain metastases cannot be controlled and treated within less than 2 months 7.severe and failed to controlled diseases 8.Occurred venous thromboembolic events within 6 months

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 24 months
Secondary outcomes:
measure: Progress free survival (PFS)
timeFrame: up to 24 months
measure: Disease Control Rate (DCR)
timeFrame: up to 24 months
measure: Overall Survival (OS)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ninth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Guopei Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04567966: Cortical Bone Plate Versus Cortico-cancellous Block Graft
Official title: Cortical Bone Plate Versus Cortico-cancellous Block Graft for Horizontal Ridge Augmentation: Histomorphometric and Cone Beam Computed Tomography Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Horizontal Atrophy of Edentulous Alveolar Ridge
Keywords: Split-bone block technique
Cortical bone plate
Cortico-cancellous block graft
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Horizontal ridge augmentation using either cortical bone plate technique or cortico-cancellous block graft was the aim of the study. Bone quality was analyzed histomorphomterically, and horizontal dimensional changes were assessed using CBCT.


Eligibility criteria: Inclusion Criteria:

* Eligible patients aged 18 years or older with partial edentulism of the mandible
* The residual ridge width must be 4 mm or less
* Intra-oral donor sites should be available in the external oblique ridge and symphyseal area

Exclusion Criteria:

* Patients with general contraindications for implant surgery such as uncontrolled diabetes
* Irradiation of the head and neck region
* Intravenous bisphosphonate
* Pregnancy
* Smokers, alcoholics and drug abusers

Primary outcomes:
measure: Evaluation of bone quality
timeFrame: 4 months
Secondary outcomes:
measure: Horizontal ridge dimensional changes
timeFrame: 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References:
Clinical trial NCT03791866: The Th9/IL-9 and Early Enteral Nutrition in Sepsis
Official title: The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Intestinal Mucosal Barrier
Th9 Cells
Enteral Nutrition
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 60
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 investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis. In addition, the investigators also aim to evaluate the effects of different proportions of target total enteral nutrition on the prognosis of sepsis.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of sepsis
2. Within 3 days of sepsis onset before ICU admission
3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

Exclusion Criteria:

1. Ileus
2. Digestive tract hemorrhage
3. Inflammatory bowel disease
4. Abdominal hypertension (IAP \>25mmHg)
5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
6. Malnutrition or immunodeficiency
7. Long-term use of hormones

Primary outcomes:
measure: 28-d mortality
timeFrame: 28 days
Secondary outcomes:
measure: Serum Th9 lymphocyte percentages
timeFrame: 7 days
measure: Concentration of serum IL-9
timeFrame: 7 days
measure: Concentration of serum iFABP
timeFrame: 7 days
measure: Concentration of serum DAO
timeFrame: 7 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jia-Kui Sun
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun JK, Zhou J, Sun XP, Shen X, Zhu DM, Wang X, Zhou SM, Mu XW. Interleukin-9 promotes intestinal barrier injury of sepsis: a translational research. J Intensive Care. 2021 May 3;9(1):37. doi: 10.1186/s40560-021-00550-y.
Clinical trial NCT05054166: Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study
Official title: Efficacy of Everolimus-containing Chemotherapy in HER2 Negative Metastatic Breast Cancer Patients With PI3K/AKT/mTOR Mutations: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
PI3K/AKT/mTOR Pathway Mutation
Everolimus
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 14
Sex: FEMALE
Minimum age (years): 29
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy.

Brief summary: The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.14 cases of HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Detailed description: The PI3K/AKT/mTOR pathway is frequently altered in breast cancer. Everolimus is a selective inhibitor of mammalian target of Rapamycin (mTOR).The benefit of everolimus in metastatic breast cancer patients with PI3K/AKT/mTOR mutations remains unclear, especially in TNBC patients. The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.

14 cases of HER2- metastatic breast cancer participants with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Eligibility criteria: Inclusion Criteria:

1. Patients with HER2- metastatic breast cancer
2. Patients with PI3K/AKT/mTOR mutation

Exclusion Criteria:

1. Patients treated with endocrinotherapy and everolimus.
2. The efficacy evaluation could not be available.

Primary outcomes:
measure: PFS
timeFrame: The PFS was defined as the interval from the date of taking the everolimus-containing chemotherapy to the date of the first occurrence of disease progression or death from any cause,whichever came first, assessed up to 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiao-jia Wang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01899066: Efficacy Study of Lucentis in the Treatment of Retinoblastoma
Official title: Lucentis in the Treatment of Retinoblastoma - A Phase II, Single Center, Randomized Study to Evaluate the Efficacy of Ranibizumab in Subjects With Retinoblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Retinoblastoma
Keywords: Efficacy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

Detailed description: This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.

Exclusion Criteria:

* History of surgical intervention for retinoblastoma in the study eye.
* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Primary outcomes:
measure: all cause mortality
timeFrame: two years
Secondary outcomes:
measure: Efficacy of Lucentis(intravitreal injection) in the Treatment of Retinoblastoma
timeFrame: two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huasheng Yang
role: STUDY_CHAIR
References:
Clinical trial NCT00479466: Dose-Range Finding Study for MK0893 (0893-008)
Official title: A Multicenter, Double-Blind, Randomized, Placebo and Active Comparator Controlled Dose-Range Finding Study of MK0893 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 342
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).


Eligibility criteria: Inclusion Criteria:

* Patients who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy

Exclusion Criteria:

* Patients have a history of Type 1 Diabetes Mellitus
* Patients taking insulin or thiazolidinedione (TZD, a peroxisome proliferator-activated receptor \[PPAR\]-gamma agonist)
* Patients who have a contraindication to metformin

Primary outcomes:
measure: Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c)
timeFrame: Week 12
measure: Change From Baseline to Week 12 in 2-Hour Post Prandial Glucose (PPG)
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290766: Two Versus Four Implant-supported Fixed Full-arch Prosthesis
Official title: Two Versus Four Implant Supporting Fixed Full-arch Screw-retained Metal Acrylic Hybrid Mandibular Prosthesis.(A Study of Patient Satisfaction)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be the evaluation of patient satisfaction and oral health-related-quality of life (OHRQoL) of two versus four implants supporting fixed full-arch screw-retained metal acrylic hybrid mandibular prosthesis.

Detailed description: * Six completely edentulous patients will be selected for this study from the outpatient clinic of the prosthodontic department
* All patients will be informed about all surgical and prosthodontics procedures that will be done for them. All patients will sign the consent form of the ethical committee in faculty dentistry Mansoura University.

The patients will be divided into 2 groups

1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis on 4 implants that were placed according to the "All on four concept".
2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on two implants placed according to "All On two concept".

Eligibility criteria: Inclusion Criteria:

* • Eligible patients needed must have Sufficient interarch space (at least 15 mm from the occlusal plane to the mandibular ridge) to provide space for fixed prosthesis construction all patients should be completely edentulous patients with resorbed mandibular ridge all patients must be angle class I

Exclusion Criteria:

* systemic diseases that contraindicate implant placement bone metabolic diseases such as diabetes mellitus irradiation of the head and neck region chemotherapy within the past 3 years smoking habits.

Primary outcomes:
measure: Visual analog scale (VAS) questionnaire
timeFrame: one year
Secondary outcomes:
measure: Quality of Life (Secondary Outcome).
timeFrame: one year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Eldakahlia
city: Mansoura
country: Egypt
facility: Christine Ibrahim
Study officials:
References:
Clinical trial NCT00261066: Outcome Following Orthopaedic Surgery
Official title: A Prospective Database for Orthopaedic Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis of Knee
Keywords: Functional outcome
Orthopaedic surgery
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2005-12-02
Enrollment: 8439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo orthopaedic surgery at The Ottawa Hospital.

Brief summary: By investigating the long-term functional status of patients who have undergone various types of orthopaedic surgery we will have a basis for devising guidelines for future patients and surgeons.

Detailed description: The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of orthopaedic surgery. These data will yield a valuable database that can be used to address future research questions. For example, there are three common surgical treatments for medial osteoarthritis of the knee: tibial osteotomy, Oxford partial knee replacement, or total knee replacement. No clear guidelines exist regarding which treatment options are optimal for which patients. By gathering functional data from patients who have undergone these treatments, we will have a basis for devising such guidelines.

Eligibility criteria: Inclusion Criteria:

* All patients who are scheduled to undergo orthopaedic surgery are eligible to be included in the database.

Exclusion Criteria:

* Those patients who do not meet the above inclusion criteria will be excluded from the study.

Primary outcomes:
measure: Koos
timeFrame: 10y
Secondary outcomes:
measure: ShortForm-12
timeFrame: 10Years
measure: Tegner-ulca
timeFrame: 10Years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Geoffrey Dervin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269666: P200TxE Diseased Eye Image Collection
Official title: P200TxE Diseased Eye Image Collection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Disease
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to collect images on the P200TxE device in diseased eyes.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 22 years of age or older who have full legal capacity to subject on the date the informed consent is signed;
2. Subjects who can follow the instructions by the clinical staff at the clinical site;
3. Subjects who agree to participate;
4. Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve.

For glaucoma subjects:

a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable images.

Primary outcomes:
measure: Number of images
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Bennett and Bloom Eye Centers
state: Kentucky
Study officials:
References: