louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00317226: Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Official title: Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
CKD
Chronic Kidney Disease
Iron
Maintenance Dose
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-24
Enrollment: 145
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

Detailed description: The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.

In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed or discontinued Protocol 1VIT04004

Exclusion Criteria:

* Known hypersensitivity reaction to VIT-45
* Anemia not related to CKD
* Chronic, serious infection
* Recent IV iron other than study drug in past 12 weeks
* Recent blood loss within the last 12 weeks
* Need for surgery or dialysis
* Female subjects who are pregnant or lactating

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events
timeFrame: 44 week study duration
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01246726: Multiple Oncological Serial Scans Study
Official title: The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: cancer, breast, radiotherapy, boost
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Bosum Buddies
name: Friends of the Bristol Haematology and Oncology Centre
First posted: 2010-11-23
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a pilot study comparing the appearance and volume of the post surgical region in the intact breast, as determined by 3 modalities: computed Xray tomography (CT), 3 Dimensional ultrasound (USS), Magnetic resonance imaging (MRI) after breast conserving surgery and during whole breast irradiation.

Detailed description: Consenting patients who have undergone breast conserving surgery and who are planned to receive radiotherapy will have their first MRI and CT scan within 2 weeks of treatment planning. This will be followed by 3 weeks radiotherapy treatment. 3D ultrasound scans will be performed in the first 2 weeks before radiotherapy, during the 2nd and 3rd weeks of radiotherapy and in the 2 weeks following radiotherapy.Following the radiotherapy patients will undergo both CT and MRI scans within 2 weeks of treatment completion.The whole process should take approximately 10 weeks.In this study the CT scans, MRI scan + USS are above standard care and are the additional interventions in this study group.

Eligibility criteria: Inclusion Criteria:

All female patients who, after breast conserving surgery, are to undergo whole breast irradiation with or without a boost. Ten patients will be for planned radiotherapy following both breast conservation surgery and chemotherapy and ten will be for planned radiotherapy following breast conservation surgery alone aged between 18 and 80years.

-

Exclusion Criteria:

Mastectomy T3 or T4 and N3 cases Patients who have not undergone surgery Severely claustrophobic patients Patients unable to lie flat Patients with any contraindications to MRI

-

Primary outcomes:
measure: Maximal dimensions of post operative complex will be obtained using the British Colombia Cancer Agency Seroma Clarity score scale.
timeFrame: Within 3 months of radiotherapy completion
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation trust
Study officials:
affiliation: University Hospitals Bristol and Weston NHS Foundation Trust
name: Amit K Bahl, MD,MRCP,FRCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542926: NON-COlorectal Liver METastases Undergoing Liver Resection
Official title: Electronic Dataset of NON-COlorectal Liver METastases Undergoing Liver Resection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Metastases
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a diagnosis, based on imaging methods and histologically confirmed, of NCRLM, consecutively referred to centres with expertise in hepatobiliary surgery will be evaluated for inclusion. For the diagnosis and staging of disease the participating centres will refer to the guidelines for NCRLM, together with the established clinical habits present in each centre

Brief summary: Liver metastases (LM) are common in various types of malignant diseases, either at the diagnosis of the primary tumour or at a later time point. While the resection of colorectal LM (CRLM) is a well-established procedure, with survival rates superior to chemotherapy alone, controversial data still exist on liver resection for non-colorectal LM (NCRLM) (2, 3). These patients comprise a diverse and heterogeneous group usually excluded from surgery due to advanced tumour stage or the presence of concomitant extrahepatic disease. To date, no randomized clinical trial on the surgical treatment of NCRLM has been conducted, and only few retrospective reports are available.The scope of this research project is to develop a large registry of patients undergoing liver surgery for non-colorectal liver metastases.


Eligibility criteria: Inclusion criteria:

* Signature informed consent
* Age ≥ 18 years
* Histologically confirmed diagnosis of NCRLM (first diagnosis or relapse)
* Liver resection performed.

Exclusion criteria

* ASA IV
* Severe psychiatric pathology
* Unable to follow a clinical examination pattern during observation.
* Patient submitted exclusively to interventional locoregional procedures other than liver resection.

Primary outcomes:
measure: Overall Survival
timeFrame: From date of enrollment until the date of death from any cause assessed up to 36 months
Secondary outcomes:
measure: Disease-free Survival
timeFrame: From date of enrollement until the date of first documented progression assessed up to 36 months
Other outcomes:
Locations:
Study officials:
affiliation: AOU della Carità, Novara, Italy
name: Matteo Donadon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06988826: Comparison of G-CSF & Antibiotics Versus Antibiotics Alone in Resolution of Febrile Neutropenia
Official title: Comparison of Antibiotics With and Without Granulocyte Colony-Stimulating Factor in Children With Chemotherapy Induced Febrile Neutropenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Febrile Neutropenia
Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy
Febrile Neutropenia, Drug-Induced
G-CSF
Antibiotic Therapy
Keywords: febrile neutropenia
chemotherapy-induced febrile neutropenia
Antibiotics
G-CSF
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
Collaborators: name: University of Child Health Sciences and Children's Hospital, Lahore
First posted: 2025-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aim to find the best option for children having cancer who develop low immunity state due to chemotherapy

Detailed description: Children having a cancer diagnosis and treated with chemotherapy often develop neutropenia. This creates an immunocompromised state which can result in infections manifested by fever. This study compares two treatment options to find out the best treatment for these patients.

Eligibility criteria: Inclusion Criteria:

* Age 1-16 years
* any Gender
* Febrile neutropenia
* diagnosed case of solid or hematological malignancy
* taking chemotherapy

Exclusion Criteria:

* Non-neutropenic fever
* already received G-CSF or antibiotics before presenting to hospital
* any other cause of neutropenia

Primary outcomes:
measure: Resolution of FN
timeFrame: 2 weeks
Secondary outcomes:
measure: Afebrile
timeFrame: 2 weeks
measure: Length of hospital stay
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03251326: Nabilone in Cannabis Users With PTSD
Official title: Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Cannabis
Post Traumatic Stress Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-08-16
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
Primary purpose: BASIC_SCIENCE

Brief summary: Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.

Detailed description: This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.

Eligibility criteria: Inclusion Criteria:

* Current cannabis use
* PTSD symptoms
* Able to give informed consent and comply with study procedures
* Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives

Exclusion Criteria:

* Meeting criteria for certain current psychiatric disorders
* Clinical laboratory tests outside of normal limits
* History of clinically significant cardiac or respiratory diagnoses
* Current parole or probation
* Women who are currently pregnant or breastfeeding

Primary outcomes:
measure: Cue Reactivity (Emotional Stroop Task)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
Clinical trial NCT05094726: Effect of PBM on Functional Capacity and Fatigability in Post Covid-19 Elderly
Official title: A Comparative Study Between Photobiomodulation and Placebo on Functional Capacity and Fatigability in Post Covid-19 Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Covid-19 Elderly
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will divided into two equal groups , group A will receive photobiomodulation sessions and group B will receive placebo photobiomodulation
Primary purpose: TREATMENT

Brief summary: Participants had randomly divided into two equal groups. Group (A) which is the study group will receive photobiomodulation session two times per week for four weeks. Group (B) will be the control group that will receive placebo photobiomodulation two times per week for four weeks.

Detailed description: group (A):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. submaximal exercise capacity using time up and go test will be assessed.
3. fatigability will be assessed using fatigue assessment scale.
4. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed.
5. After one month all the assessment procedure will be repeated again.

r group (B):

1. Each participant will sign a consent form after receiving a detailed explanation about the procedure.
2. submaximal exercise capacity using time up and go test will be assessed.
3. fatigability will be assessed using fatigue assessment scale.
4. hemodynamic variables including; Blood pressure, heart rate, oxygen saturation, maximum oxygen consumption will also be assessed.
5. After one month all the assessment procedure will be repeated again.

Eligibility criteria: Inclusion Criteria:

* 60 to 75 years of age
* past history of covid 19 in the last year

Exclusion Criteria:

* ( history of a histologically demonstrated malignant carcinoma , hyperthyreosis , epilepsy, light sensitivity )

Primary outcomes:
measure: effect of photobiomodulation on fatigability level
timeFrame: after one month of the trial application
measure: effect of photobiomodulation on functional capacity level
timeFrame: after one month of the trial application
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Al Agouza Outpatient Clinic
Study officials:
affiliation: Faculty of physical therapy at Cairo University
name: Rana H El Banna, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05551026: Effects of Perioperative Operating Room Environment on Postoperative Delirium
Official title: Effects of Perioperative Operating Room Environment on Postoperative Delirium in Elderly Patients With Abdominal Surgery : A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 360
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients who underwent abdominal surgery under general anesthesia.

Brief summary: Thi investigators aims to observe the impact of perioperative body temperature and the noise of operating room on postoperative delirium for elderly patients undergoing abdominal surgery. And based on this study the investigators aimed to explore the potential risk factors of postoperative delirium for elderly patients undergoing abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* Age 65-90 years old;
* ASA I-III;
* Patients who plan to undergo elective abdominal surgery under general anesthesia;
* Volunteer to participate in this study and sign informed consent.

Exclusion Criteria:

* Patients with known mental illness or lack of communication or cognitive impairment before operation;
* Severe vision, hearing, language impairment or other reasons unable to communicate with visitors;
* Severe dysfunction of important organs such as heart, brain, lung, liver, kidney, etc.;
* Long-term use of sedatives, antidepressants or alcoholism;
* Patients with severe postoperative complications and admitted to intensive care unit;
* Patients who refused or failed to complete the cognitive function test.
* Patients who could not cooperate with the study for any other reason.

Primary outcomes:
measure: Postoperative delirium during the 3 days-follow-up after anesthetic resuscitation
timeFrame: From ending of the surgery to 3 days after anesthetic resuscitation
Secondary outcomes:
measure: Postoperative delirium in the postanesthesia care unit
timeFrame: From ending of the surgery to the time when discharge from postanesthesia care unit, an average of 30 minutes
measure: Hospital stay
timeFrame: From the ending of the surgery to hospital discharge, with means of about 7 days
measure: Postoperative complication
timeFrame: From the ending of the surgery to hospital discharge, with means of about 7 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
name: Jia Tang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01513226: Cycled Light and Crying of Preterm Infants
Official title: Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crying
Sleep
Keywords: cycled light
dim light
circadian rhythm
actigraphy, sleep
premature infant
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.


Eligibility criteria: Inclusion Criteria:

* very preterm infants (≤ 32 0/7 weeks gestational age, GA)

Exclusion Criteria:

* major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound
* retinopathy of prematurity grade III and IV
* congenital malformations
* small for gestational age (birth weight \< 3rd percentile)
* prenatal infections
* intrauterine drug exposure

Primary outcomes:
measure: mean duration and change over time for total duration per 24 hours for crying variables
timeFrame: 5 and 11 weeks corrected age
Secondary outcomes:
measure: mean sleep duration per 24 hours and change over time
timeFrame: 5,11 and 25 weeks corrected age
measure: mean weight gain per day
timeFrame: during hospital stay
measure: mean activity count per 24 hours and change over time
timeFrame: 5, 11, and 25 weeks corrected age
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Zurich
name: Oskar Jenni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Very preterm infants show earlier emergence of 24-hour sleep-wake rhythms compared to term infants. Early Hum Dev. 2015 Jan;91(1):37-42. doi: 10.1016/j.earlhumdev.2014.11.002. Epub 2014 Nov 27.
citation: Guyer C, Huber R, Fontijn J, Bucher HU, Nicolai H, Werner H, Molinari L, Latal B, Jenni OG. Cycled light exposure reduces fussing and crying in very preterm infants. Pediatrics. 2012 Jul;130(1):e145-51. doi: 10.1542/peds.2011-2671. Epub 2012 Jun 11.
Clinical trial NCT00897026: Studying Tissue Samples From Women Who Underwent Chemotherapy for Lymph Node-Positive Stage II or Stage IIIA Breast Cancer on Clinical Trial CLB-9741 or CLB-9344
Official title: ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage II breast cancer
stage IIIA breast cancer
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 1195
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 years and older diagnosed with node-positive breast cancer.

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors plan the best treatment.

PURPOSE: This research study is looking at tissue samples from women who underwent chemotherapy for lymph node-positive stage II or stage IIIA breast cancer.

Detailed description: OBJECTIVES:

Primary

* To identify biomarkers that can be used to individually tailor the use of adjuvant dose-dense therapy in women with stage II or IIIA breast cancer.

Secondary

* To identify groups of patients who have a poor prognosis despite adjuvant chemotherapy and who should be prospectively targeted for new approaches to adjuvant treatment.

OUTLINE: This is a multicenter study.

Tissue samples are collected from patients. Tissue samples are analyzed by immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of node-positive breast cancer

  * Stage II-IIIA disease
* Underwent adjuvant chemotherapy on trial CLB-9741 or CLB-9344
* Hormone receptor status not specified

Primary outcomes:
measure: Disease-free survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University Siteman Cancer Center
name: Matthew Ellis, MD, PhD, FRCP
role: STUDY_CHAIR
References: