louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05629195: The Effect of Skin Laxity on the PICC
Official title: Study on the Influence of Skin Laxity on the Application Effect of Different PICC Catheterization Methods
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complications; Catheter
Lead sponsor: First People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 356
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: To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).

Detailed description: In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old;
* Patients who need PICC catheterization according to the doctor's advice;
* There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;
* There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before catheterization
* Patients who have not participated in other clinical studies;
* Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up

Exclusion Criteria:

* Known allergy to catheter material;
* The puncture site has a history of infection, injury and radiotherapy;
* The puncture site has a history of venous thrombosis or surgery;
* Severe abnormal bleeding and coagulation function;
* Superior vena cava compression syndrome;
* Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
* The ipsilateral limb of the pacemaker and the arteriovenous fistula;
* patient or her/his family members refuse to sign the informed consent form.

Primary outcomes:
measure: rate of PICC complications
timeFrame: 120 days
Secondary outcomes:
measure: time of PICC insertion
timeFrame: 1 hour
measure: Success rate of catheterization
timeFrame: 1 hour
measure: score of operation pain
timeFrame: 1 hour
measure: rate of unplanned extubation
timeFrame: 120 days
measure: rate of difficulty in decannulation
timeFrame: 120 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02150395: Impact of Music Therapy on Anxiety in Patients With Cancer Undergoing Simulation for Radiation Therapy
Official title: The Impact of Music Therapy on Anxiety in Patients Newly Diagnosed With Cancer & Undergoing Simulation for Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety and Distress
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study looks at the effects of a protocolized music therapy intervention on state anxiety for patients with cancer undergoing simulation for radiation therapy. Simulation, which is an imaging and diagnostic procedure, has been identified as producing significantly high levels of anxiety in many cancer patients.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with breast cancer, and newly diagnosed patients with head and neck cancer.
* 18 or over.
* Fluent in English.

Exclusion Criteria:

* Under 18 years.
* Pre-existing anxiety disorders.

Primary outcomes:
measure: Reduction in state anxiety
timeFrame: 20 minutes
Secondary outcomes:
measure: reduced distress
timeFrame: 20 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Joanne V Loewy, DA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03975595: Meditation Effects on Brain Function in Rheumatoid Arthritis
Official title: Meditation Effects on Brain Function in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Maryland, Baltimore
name: University of California, San Diego
name: University of Utah
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-06-05
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
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 the neural mechanisms supporting meditation-based pain relief in rheumatoid arthritis (RA) patients. The scientific premise is that RA patients' use of different meditation practices during noxious thermal stimulation will alter neural function in brain areas associated with pain, evaluation, and emotional appraisal. The investigators will randomize RA patients to a brief 4-session course of Intervention A (n=20) or Intervention B (n=20). At post-intervention, participants will undergo functional MRI (fMRI) using a perfusion-based arterial spin labeling (ASL) technique during noxious thermal stimulation to determine if the meditation practices differentially alter neural function during noxious thermal stimulation.


Eligibility criteria: Inclusion Criteria:

* Withheld to preserve recruitment integrity.

Exclusion Criteria:

* Withheld to preserve recruitment integrity.

Primary outcomes:
measure: Lateral Orbital Frontal Cortex Activation
timeFrame: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes.
measure: Nucleus Accumbens Activation
timeFrame: Measured at the post-Intervention time point during an MRI scan, approximately 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Claudia Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03434795: Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy
Official title: Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy: a Multicenter Validation of Clinical Decision Rule
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Ligue contre le cancer, France
First posted: 2018-02-15
Enrollment: 1900
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with hematology or cancer who consults for febrile neutropenia post-chemotherapy

Brief summary: Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia


Eligibility criteria: Inclusion Criteria:

* Child aged 1 to 18 years
* Child with hematology or cancer
* Child with a febrile neutropenia post-chemotherapy
* Child with social security
* No opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor.

Exclusion Criteria:

* Febrile neutropenia at diagnosis of tumor disease
* Child with palliative care
* Child having had a hematopoietic stem cell allo-graft in the preceding year
* Febrile neutropenia immediately post auto-transplant
* Antibiotherapy prior to admission
* Initial care in a non-investigative center.

Primary outcomes:
measure: Blood culture
timeFrame: On average between 5 days and 1 month
measure: Positive bacterial culture from a normally sterile site
timeFrame: on average between 5 days and 1 month
measure: microbiological culture
timeFrame: On average between 5 days and 1 month
measure: Fungal culture
timeFrame: On average between 5 days and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandre - CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: François Dubos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delebarre M, Gonzales F, Behal H, Tiphaine A, Sudour-Bonnange H, Lutun A, Abbou S, Pertuisel S, Thouvenin-Doulet S, Pellier I, Mansuy L, Piguet C, Paillard C, Blanc L, Thebaud E, Plantaz D, Blouin P, Schneider P, Guillaumat C, Simon P, Domenech C, Pacquement H, Le Meignen M, Pluchart C, Verite C, Plat G, Martinot A, Duhamel A, Dubos F. Decision-tree derivation and external validation of a new clinical decision rule (DISCERN-FN) to predict the risk of severe infection during febrile neutropenia in children treated for cancer. Lancet Child Adolesc Health. 2022 Apr;6(4):260-268. doi: 10.1016/S2352-4642(21)00337-0. Epub 2021 Dec 3.
Clinical trial NCT00232895: Pain of Injection of Lipuro Propofol in Children Aged 1-7 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-10-05
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation


Eligibility criteria: Inclusion Criteria:

* ASA 1 or 2 requiring intravenous general anaesthetic

Exclusion Criteria:

-

Primary outcomes:
measure: pain scores on induction of anaesthesia with propofol
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Mark Thomas, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04520295: ctDNA Screening in Advanced HER2 Positive Gastric Cancer
Official title: Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HER2-positive Gastric Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-08-20
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: PROBABILITY_SAMPLE
Study population: HER2 positive gastric cancer patients

Brief summary: To identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.

Detailed description: Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.

Eligibility criteria: Inclusion Criteria:

1. Male/female patients aged over 18 years.
2. Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive, HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative.
4. At least one measurable lesion should be confirmed by imaging examination.
5. Eligible peripheral blood samples
6. Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.
7. For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.
8. For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.
9. Willing to provide clinicopathological information and imaging information.

Exclusion Criteria:

1. Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
2. With second primary malignant diseases.
3. Other situations assessed by investigator can disturb quality control of the investigation.

Primary outcomes:
measure: Change from baseline in molecular biomarkers at time on best overall response
timeFrame: 36 months
Secondary outcomes:
measure: Change from baseline in molecular biomarkers at time on disease progression
timeFrame: 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Oncology, Ruijin Hospital
Study officials:
affiliation: Ruijin Hospital
name: Jun Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02596295: Human Milk Sample Composition in Israeli Mothers and Correlation With Their Diet
Official title: Human Milk Sample Collection From Israeli Mothers and Its Analysis and Correlation Between Composition, Demographics and Diet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Milk Collection
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2015-11-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General healthy lactating mothers

Brief summary: The study will collect human milk from 100 mother of term infants 2-3m after delivery and from 50 mothers of preterm infants 14 and 30 days after delivery. Sample content will be analysed and statistical analysis will look at correlation between demographics, dietary habits and milk composition.


Eligibility criteria: Inclusion Criteria:

Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) Mothers who intend to breastfeed the infant at least 80% of the daily feeding Mothers who can comply with the study requirements Mothers who sign the informed consent form in writing and can read and write Hebrew.

Exclusion Criteria:

* Participation in any other studies involving investigational or marketed products Is consuming alcoholic drinks and is a drug abuser. Is suffering from chronic disease Presence of psychosis and severe post-partum depression. Mothers who have given birth to twins or multiples Mothers who received chemotherapy or isotopes during pregnancy investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.

Infants:

Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.

Primary outcomes:
measure: Analysis of natural lipids in human breast milk of Israeli's mothers
timeFrame: 30-60 days after delivery
Secondary outcomes:
measure: Maternal diet survey
timeFrame: 30-60 days after delivery
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Hospital
state: State
Study officials:
affiliation: Employee
name: Yael Lifshitz, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00924495: Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
Official title: Regulatory Central Mechanisms in Chronic Nonspecific Low Back Pain With Lumbar Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Keywords: low back pain
motor control
cortical regulation
transcranial magnetic stimulation
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 80
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. These (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. Furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of normalizing motor control deficits.


Eligibility criteria: Inclusion Criteria:

* chronic nonspecific low back pain for at least six months
* male gender
* age 25-50 yrs
* average pain during last week 4-8/10 by VAS
* Oswestry disability index 20-80 %

Exclusion Criteria:

* former spinal operations
* rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs

Primary outcomes:
measure: Correlation between cortical activity and other motor control tests
timeFrame: day 1 and day 19
Secondary outcomes:
measure: The effect of rTMS-therapy for clinical outcome and motor control tests
timeFrame: day 19, 1 month, 2 months, 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Marja T Kilpiäinen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Markku Kankaanpää, MD,PhD
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital
name: Olavi Airaksinen, MD, PhD
role: STUDY_CHAIR
affiliation: Kuopio University Hospital
name: Timo Miettinen, MD,PhD
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Eeva Leino, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03670095: Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions
Official title: Interventional, Randomized, Single-dose, Open-label, Crossover, Bioequivalence Study in Healthy Subjects to Compare Two Pharmaceutical Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the release of memantine into the bloodstream of two different formulations: one formulation containing lactose and one without lactose.

Detailed description: The study consists of two cohorts: A1 and A2.

Subjects in Cohort A1 will be administered the investigational medicinal product (IMP) in a fasted state and subjects in Cohort A2 will be administered the IMP in a fed state.

Each subject will change cohort during study participation, so that dosing will be done over two periods: either first fed and then fasted, or first fasted and then fed. The two periods will be separated by a period of 28 days (+7 days) where no investigational medicinal product is given.

All subjects will be confined to the clinic from one day prior to dosing until Day 4 (72 hours post-dose) in each dosing period.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women ≥18 years of age with a body mass index (BMI) ≥18.5 and ≤28 kg/m2.
* Women must be non-pregnant and non-lactating.

Exclusion Criteria:

- The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: AUC0-72h in fed state for test and reference treatment
timeFrame: From zero to 72 hours post dose
measure: AUC0-72h in fasted state for test and reference treatment
timeFrame: From zero to 72 hours post dose
measure: Cmax of memantine in fed state for test and reference treatment
timeFrame: From zero to 72 hours post dose
measure: Cmax of memantine in fasted state for test and reference treatment
timeFrame: From zero to 72 hours post dose
Secondary outcomes:
measure: tmax in fed state for test and reference treatment
timeFrame: From zero to 72 hours post dose
measure: tmax in fasted state for test and reference treatment
timeFrame: From zero to 72 hours post dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital, Shanghai TCM University
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: