louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01176981: Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Official title: Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteosarcoma
Keywords: pediatrics
Osteosarcoma
Methotrexate
Outpatient
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

Detailed description: High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.

Eligibility criteria: Inclusion Criteria:

* ≥ 6 years of age;
* Localized or metastatic osteosarcoma;
* Adequate renal function (GFR \> 70 ml/1.73m2) prior to each cycle;
* No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle;
* Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English.

Exclusion Criteria:

* Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal.
* Pregnant females
* Breastfeeding females

Primary outcomes:
measure: The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Abha Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00933881: Gestational Diabetes and Sleep-Disordered Breathing
Official title: A Pilot Study to Evaluate the Association Between Gestational Diabetes, Heart Rate Variability and Sleep-Disordered Breathing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Keywords: GDM
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Gestational Diabetes Mellitus (GDM)

Brief summary: This study is designed to evaluate the amount of heart rate variability (HRV) for women with gestational diabetes mellitus (GDM) and to determine whether women with GDM have transient sleep-disordered breathing (SDB) during pregnancy.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women aged 18-40 years old.
2. Pregnant women at gestational age 30 to 34 weeks.

Exclusion Criteria:

1. Pregnant women with known type 1 or type 2 diabetes mellitus.
2. Pregnant women carrying more than one fetus.
3. Pregnant women with pre-gestational hypertension.
4. Pregnant women with pre-eclampsia during current pregnancy.
5. Pregnant women with a history of coronary artery disease or acute ischemia.
6. Pregnant women who currently smoke.
7. Pregnant women without results for the 3 hour 100 gram oral glucose tolerance test.
8. Pregnant women with preterm labor, cervical shortening, premature rupture of membranes or any other obstetric complications that may predispose to preterm labor.
9. Pregnant women using 17-P (progesterone) to prevent recurrent pre-term labor.
10. Pregnant women with known SDB.

Primary outcomes:
measure: Improvement in heart rate control post-GDM
timeFrame: Two months after delivery
Secondary outcomes:
measure: Improvement in SDB post-GDM
timeFrame: Two months after delivery
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
Study officials:
References:
Clinical trial NCT02397681: Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
Official title: Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Diseases
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Mayo Clinic
First posted: 2015-03-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the effects of procedural differences during the Valsalva maneuver and deep breathing test in autonomic nervous system testing.


Eligibility criteria: Inclusion Criteria:

* male
* ≥ 18 year
* normal ECG-12

Exclusion Criteria:

* any known disease
* smoking
* any intake of regular medicine

Primary outcomes:
measure: Blood pressure changes to cardiovascular adrenergic activation
timeFrame: 3 hours
measure: Heart rate changes to parasympathetic activation
timeFrame: 3 hours
Secondary outcomes:
measure: Expiratory pressure during the Valsalva maneuver
timeFrame: 3 hours
measure: Expiratory duration during the Valsalva maneuver
timeFrame: 3 hours
measure: Air volume exchanged per respiratory cycle during deep respiration
timeFrame: 3 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center
name: Astrid J. Terkelsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00158795: Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
Official title: Assess the Safety & Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3,4 & 5 Mths of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Haemophilus Influenzae Type b Disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 454
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)

Detailed description: All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.

Eligibility criteria: Inclusion Criteria:

* A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.

Exclusion Criteria:

* Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
* Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Primary outcomes:
measure: Occurrence of solicited symptoms of grade 3 intensity, during the specific follow-up period after vaccination.
Secondary outcomes:
measure: - Occurrence of solicited symptoms during the specific follow up period after vaccination.
measure: - Occurrence of unsolicited symptoms during the specific follow up period after vaccination.
measure: - Occurrence of serious adverse events during the study period.
Other outcomes:
Locations:
city: Nanning
country: China
facility: GSK Investigational Site
state: Guangxi
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00603395: A Prospective Clinical Study On A Total Hip Resurfacing System
Official title: A Prospective Clinical Study On A Total Hip Resurfacing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Avascular Necrosis
Lead sponsor: St. Anna Ziekenhuis, Geldrop, Netherlands
Sponsor class: OTHER
First posted: 2008-01-29
Enrollment: 298
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.


Eligibility criteria: Inclusion Criteria:

* intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:

  * Osteoarthritis
  * Avascular necrosis
  * Traumatic arthritis
  * Legg Perthes
  * Rheumatoid arthritis

Primary outcomes:
measure: Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Complications
timeFrame: Anytime
Other outcomes:
Locations:
city: Geldrop
country: Netherlands
facility: Knowledge Center for Orthopedic Surgery, St. Anna hospital
Study officials:
affiliation: St. Anna hospital, Geldrop
name: H J Hoekstra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Anna hospital, Geldrop
name: T Sybesma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.
Clinical trial NCT05503095: PCSK9 Polymorphism and Risk of Cardiac Rupture
Official title: PCSK9 Polymorphism and Risk of Mechanical Complications Following Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-Infarction Heart Rupture
Gene Polymorphism
Keywords: PCSK9
Cardiac rupture
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who develop cardiac rupture following acute myocardial infarction (case group) and patients with acute ST-elevation myocardial infarction not complicated by cardiac rupture (control group)

Brief summary: Protein convertase subtilisin/kexin type 9 (PCSK9) plays a regulatory role in cholesterol homeostasis by promoting low-density lipoprotein receptor (LDLr) degradation. Although the vast majority of the studies have focused on the role of PCSK9 in LDLr expression in the liver, an increasing body of evidence suggests that PCSK9 gene is also present in extra-hepatic tissues. A recent publication showed for the first time that PCSK9 is expressed in the ischemic heart and the expression is highest in the zone bordering the infarcted areas. Furthermore, the expression of PCSK9 is maximal early, at 1 week of ischemia.

Mechanical complications (or cardiac ruptures) are uncommon but potentially lethal sequelae of acute myocardium infarction (AMI) and are commonly associated with early mortality without appropriate surgical intervention. It's unknown why some patients develop these devasting complications following AMI, while others not. Interestingly, studies have shown that post-infarction cardiac rupture affect the border zone between the ischemic and normal area and occur within the first 3 to 5 days after AMI.

Based on the aforementioned observations, it's likely to assume a relationship between PCSK9 expression and the development of post-AMI cardiac rupture. Therefore, the main purpose of the this project is to study the PCSK9 gene polymorphism and its association with cardiac rupture. Investigators hypothesize that PCSK9 expression/secretion and development of post-AMI cardiac rupture may be a part of the dynamic changes at cellular levels occurring in the ischemic heart of genetically predisposed patients.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of acute myocardial infarction with ST sopra-elevation (control group)
* clinical diagnosis of acute myocardial infarction complicated by cardiac rupture

Exclusion Criteria:

* absence of coronary artery disease

Primary outcomes:
measure: PCSK9 gene polymorphism
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Matteo Matteucci
Study officials:
References:
Clinical trial NCT06832995: Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties
Official title: Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties: a Single-center Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Arthropathy of Hip
Arthropathy of Knee
Lead sponsor: Hôpital Privé Sévigné
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each patient who underwent unilateral knee, total knee and total hip arthroplasty at the Sévigné Private Hospital between January 1, 2023, and December 31, 2023.

Brief summary: Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization.

The association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure


Eligibility criteria: Inclusion Criteria:

* Total hip arthroplasty
* Total Knee Arthroplasty
* Uni-compartmental knee arthroplasty (UKA)

Exclusion Criteria:

* Bilateral surgery Surgical revision Hip fracture surgery Other osteoarticular procedure(s) associated to hip/knee arthroplasty Refusal to use data Contra-indication of paracetamol, ketoprofen and dexamethasone

Primary outcomes:
measure: morphine titration
timeFrame: after surgery, in the post-anesthetic care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Cesson-Sévigné
country: France
facility: Hôpital Privé Sévigné
Study officials:
References:
Clinical trial NCT05759195: Biomolecular Analysis for Predicting Response to Regorafenib
Official title: Tumor Biomolecular Analysis for Defining Predictive Factors for Response to Regorafenib in Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glioblastoma
Glioblastoma, IDH-wildtype
Keywords: regorafenib
NGS
predictive biomarker
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.


Eligibility criteria: Inclusion Criteria:

1. recurrent glioblastoma after surgery and chemoradiation with temozolomide;
2. indication to treatment with regorafenib per standard of care;
3. written informed consent.

Exclusion Criteria:

None.

Primary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02253095: Combined Package of Interventions for Environmental Enteropathy
Official title: Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Enteropathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Malawi
First posted: 2014-10-01
Enrollment: 253
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.


Eligibility criteria: Inclusion Criteria:

* children residing in catchment area of Limela, Machinga District, Malawi
* aged 12-35 months
* youngest eligible child in each household

Exclusion Criteria:

* severe acute malnutrition
* severe chronic illness
* children unable to drink 20 mL of dual sugar solution
* children in need of acute medical treatment for illness or injury at time of enrollment

Primary outcomes:
measure: Dual Sugar Absorption Test
timeFrame: 12 weeks
measure: Dual Sugar Absorption Test
timeFrame: 24 weeks
Secondary outcomes:
measure: Lactulose Excretion
timeFrame: 12 weeks
measure: Lactulose Excretion
timeFrame: 24 weeks
measure: Mannitol Excretion
timeFrame: 12 weeks
measure: Mannitol Excretion
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Limela
country: Malawi
facility: Limela Rural Site
state: Machinga Distric
Study officials:
affiliation: Washington University in St. Louis; University of Malawi
name: Mark J Manary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malawi
name: Chrissie Thakwalakwa, PhD
role: STUDY_DIRECTOR
affiliation: Washington University in St. Louis; University of Malawi
name: Indi Trehan, MD MPH DTM&H
role: STUDY_DIRECTOR
References:
citation: Wang AZ, Shulman RJ, Crocker AH, Thakwalakwa C, Maleta KM, Devaraj S, Manary MJ, Trehan I. A Combined Intervention of Zinc, Multiple Micronutrients, and Albendazole Does Not Ameliorate Environmental Enteric Dysfunction or Stunting in Rural Malawian Children in a Double-Blind Randomized Controlled Trial. J Nutr. 2017 Jan;147(1):97-103. doi: 10.3945/jn.116.237735. Epub 2016 Nov 2.
Clinical trial NCT05400395: Clinical Trial for GNX80 in Intermittent Claudication
Official title: A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients With Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intermittent Claudication
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.

Detailed description: A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication

Eligibility criteria: Inclusion Criteria:

* Age of at least 20 years
* Angiographically confirmed peripheral arterial disease
* Intermittent claudication for more than 6 months

Exclusion Criteria:

* Severe impairment of heart, liver, or kidney function
* Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition
* Poorly controlled diabetes mellitus
* Positive pregnancy test
* Planned surgical or endovascular procedures other than for the treatment of IC

Primary outcomes:
measure: Walking Distance in comparison with the findings from at baseline
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: