louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00160719: HLA Sensitization Following Major Cortical Allograft Bone Procedures
Official title: HLA Sensitization Following Major Cortical Allograft Bone Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic clinic

Brief summary: The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.

Detailed description: Patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). However, sometimes this replacement bone does not heal together with the patient's bone. The reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. You have been asked to participate in this study because you are scheduled to undergo this type of surgery.

Eligibility criteria: Inclusion Criteria:

* Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces.

Exclusion Criteria:

* Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Mark T. Scarborough, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05527119: Phenotyping and Genotyping of Duffy Antigen
Official title: Phenotyping and Genotyping of Duffy Antigen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasmodium Vivax
Keywords: Malaria
Malaria, Vivax
PvDBP-DARC interaction
Plasmodium vivax
Duffy-negative
Duffy Binding Protein
PvDBP
Duffy Antigen Receptor for Chemokines
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Major subjects with malaria and willing to have their blood samples analyzed for this research

Brief summary: Malaria remains the world's leading parasitic endemic. Almost half of the world's population lives in endemic areas. Many at-risk people in African countries remain without access to malaria control. Malaria kills approximately 400,000 people each year, most of whom are children under the age of 5 in Africa. Since 2005, an increasing number of Plasmodium vivax infections have been observed in Duffy-negative populations in South America and Africa, calling into question the essential role of the PvDBP-DARC interaction. The objective of the investigators is therefore to study and understand the invasion pathways used by Plasmodium vivax in Duffy-negative subjects.


Eligibility criteria: Inclusion Criteria:

* Major subjects
* with malaria and willing to have their blood samples analyzed for this research

Exclusion Criteria:

* Subjects refusing to participate in the study

Primary outcomes:
measure: Number of blood samples tested (phenotype and genotype).
timeFrame: 2 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Laboratoire de Parasitologie et Mycologie Médicale-PTM - CHU de Strasbourg - France
Study officials:
affiliation: Service Laboratoire de Parasitologie et Mycologie Médicale-PTM - CHU de Strasbourg - France
name: Didier MENARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03051919: Reinforcement Method in Laparoscopic Sleeve Gastrectomy
Official title: Staple Line Reinforcement Methods in Laparoscopic Sleeve Gastrectomy: Comparison of Burst Pressures and Leaks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Sleeve Gastrectomy
Keywords: Laparoscopic sleeve gastrectomy
reinforcement
leak
Lead sponsor: Fatih Sultan Mehmet Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 118 patients with body mass index \>40 kg/m2 underwent sleeve gastrectomy and were enrolled into four groups

Brief summary: Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement methods are used.

Detailed description: The investigator compared non-reinforced stapling with three staple line reinforcement methods (suturing, absorbable buttressing material and fibrin glue) in laparoscopic sleeve gastrectomy.

The resected stomach specimens were treated in the same manner of reinforcement as used in the surgeries of the corresponding patients and then insufflated until a burst occurred. The burst pressures of the resected stomach specimens and postoperative events of the patients were recorded.

Eligibility criteria: Inclusion Criteria:

* body mass index \>40 kg/m2

Exclusion Criteria:

* disruption of the resected stomach during extraction from the abdomen.

Primary outcomes:
measure: assessing prevalence of leaks among different reinforcement methods
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07018219: Identification of the Seventh Cervical Vertebra by Palpation With Neck Rotation and Side Bending in Patients With Neck Pain
Official title: Identification of the Seventh Cervical Vertebra by Palpation With Neck Rotation and Side Bending in Patients With Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Identification of the Seventh Cervical Vertebra by Palpation
Keywords: Seventh Cervical vertebra
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2025-06-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: detect accuracy of that procedure in identification the seventh cervical vertebra, we aimed to determine accuracy of identification of the seventh cervical vertebra by palpation with neck rotation and side bending in patients with neck pain.

Detailed description: The ability to identify the correct vertebral level through examination is an important skill for clinicians in many different specialities (1,2). Two methods for identifying seventh cervical vertebra are commonly used; the conventional palpation method, which identifies the most prominent cervical spinous process as the seventh cervical (C7) spinous process and flexion-extension method which identifies the lowest freely moving spinous process as C6 and the following stationary cervical spinous process as C7. One study found the accuracy of the conventional palpation method is 37.5% while the accuracy of the flexion-extension is 77.1%. Another method is done by detecting the most prominent three vertebrae at cervicothoracic junction then three palpating fingers will be placed paravertebrally to the left of the cervicothoracic region against the left side of the assumed C7 and Tl spinous processes. When rotation or lateral flexion is facilitated, C7 is expected to move significantly further than the more slowly reacting Tl spinous process.

Eligibility criteria: Inclusion Criteria:

* neck pain, age (18- 60) male and female

Exclusion Criteria:

* with suspected ankylosing spondylitis, previous surgery on the cervical spine or congenital malformation of the cervical region.

Primary outcomes:
measure: The accuracy of palpation technique
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Al ahrar teaching hospital
Study officials:
References:
Clinical trial NCT03943719: Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia
Official title: The Impact of a Rapid Molecular Identification Test on Positive Blood Cultures From Critically Ill With Bacteremia: a Pre-post Intervention Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septicemia
Keywords: FilmArray
bacteremia
septicemia
clinical impact
molecular testing
identification
positive blood culture
optimal antimicrobial treatment
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2019-05-09
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult intensive care unit patients with positive blood cultures

Brief summary: Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. In our study, we specifically evaluated molecular testing in a critical care setting and measured its impact on the therapeutic management of critically ill with positive blood cultures. Through the analysis of 110 positive blood culture episodes included in both pre- and post intervention period, we measured a drastic 14h-reduction of the time to administration of the optimal antimicrobial treatment with the use of the molecular approach.


Eligibility criteria: Inclusion Criteria:

* adult intensive care unit patients with positive blood cultures

Exclusion Criteria:

* palliative care patients

Primary outcomes:
measure: Turn Around Time to optimal treatment of septicemia
timeFrame: From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires St-Luc
Study officials:
affiliation: Cliniques universitaires St-Luc
name: Alexia VERROKEN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04582318: A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19
Official title: A Randomized, Double Blind, Placebo Controlled, Combined Phase 1/2 Single Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of NGM621 in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Subjects With Confirmed SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2 Infection
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is a combined Phase 1 and Phase 2 study with IV infusion of NGM621 to evaluate the safety, tolerability, and PK in healthy volunteers (Part 1), and safety, tolerability, PK and efficacy in subjects with confirmed SARS-CoV-2 infection (Part 2).


Eligibility criteria: Inclusion Criteria:

* Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result prior to dosing.
* Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must use an effective method of contraception during the study, for at least 1 month following study completion, and must not plan to become pregnant for at least 1 month after her last study medication dose.
* BMI 18-32 kg/m2 inclusive
* Ability to understand and provide informed consent
* Subjects confirmed with SARS-CoV-2 infection by PCR and hospitalized
* If on mechanical support, less or equal than 2 days on mechanical ventilation or oxygenation

Exclusion Criteria:

* Currently enrolled in another investigational protocol to treat SARS-CoV-2 infection
* Known history of complement deficiency
* Active infection with, or history of, compllicated pneumococcal or Neisseria meningitis infection or history of unexplained, recurrent infection, within the last 60 days prior to dosing.

Primary outcomes:
measure: Treatment emergent adverse events - Part 1
timeFrame: 85 days
measure: Treatment emergent adverse events - Part 2
timeFrame: 91 days
measure: Clinical status at Day 15 and Day 29 - Part 2
timeFrame: 29 days
Secondary outcomes:
measure: Maxiumum Serum Concentration [Cmax]
timeFrame: 91 days
measure: Mortality at Day 29
timeFrame: 29 days
measure: Duration of Supplemental Oxygen Requirement
timeFrame: 91 days
measure: Change in Hemolytic Assays (CH50 and AH50) from Baseline
timeFrame: 91 days
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: NGM Clinical Study Site
Study officials:
References:
Clinical trial NCT05796518: Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Official title: A Pilot Study to Examine Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Survivorship
Keywords: Heart health
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-04-03
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Endometrial cancer survivors presenting for post-treatment surveillance visit.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigators are conducting this study to find out more about what heart health means to participants and how healthcare providers can best help to manage heart health. Participants will be asked to view an electronic tool designed to promote heart health awareness and help to manage heart health outside of the clinic. This study will provide important information to help investigators develop future programs that improve cancer patient's heart health after they complete their treatment.

Detailed description: Primary Objective: The primary objective of this pilot study is to assess the feasibility of enrolling and completing the heart health assessment among endometrial cancer patients scheduled for routine follow-up care.

Secondary Objectives:

* To assess patient satisfaction with the tool.
* To identify the proportion of patients with non-ideal cardiovascular health scores who report initiating discussions regarding cardiovascular health during their routine oncology appointment.

Eligibility criteria: Inclusion Criteria:

* Scheduled for a routine surveillance visit for pathologically confirmed stages I-IV endometrial cancer
* Greater than or equal to 3 months post-potentially curative cancer treatment
* Patients must be at least 18 years of age
* Have a working email address
* Comfortable reading medical information in English, as per self-report

Exclusion Criteria:

* Currently receiving treatment (e.g. radiation, chemotherapy, immunological treatments for endometrial cancer)
* Have a history of endometrial cancer recurrence
* Enrolled in hospice care or documentation of life expectancy \< 6 months

Primary outcomes:
measure: Number of Participants to Complete Intervention - Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Stating Satisfaction With PREVENT Tool
timeFrame: 6 months
measure: Number of Participants to Report Initiating Discussions Regarding Cardiovascular Health With Health Care Providers
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Kathryn E Weaver, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05571618: The Rechallenge of ADCs in MBC Patients
Official title: A Multicenter, Real-world Study of the Efficacy and Safety of Antibody-drug Conjugates (ADCs) Rechallenge in Patients with Prior Exposure to ADCs Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Antibody-drug conjugates
Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 100
Sex: FEMALE
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: Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To investigate the efficacy and safety of ADC rechallenge


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old.
* Diagnosed with Metastatic Breast Cancer.
* Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).
* Patients plan to or have received ADCs for the second or more time.
* Complete medical history was available.

Exclusion Criteria:

* Medical history was incomplete

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: ORR
timeFrame: 6 weeks
measure: CBR
timeFrame: 6 weeks
measure: DoR
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
measure: OS
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT04961918: The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC)
Official title: The Efficacy of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL) in Advanced Hepatocellular Carcinoma (HCC): A Prospective, Single-armed, Stage II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 36
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: To evaluate the efficacy of HAIC combine Lenvatinib and Durvalumab (HILL) in advanced HCC.


Eligibility criteria: Inclusion Criteria:

* older than 18 years old and younger than 75 years; ECOG PS≤1; proven advanced hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; cannot accepted hepatectomy; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent;

Exclusion Criteria:

* cannot tolerate HAIC or lenvatinib or durvalumab; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy;

Primary outcomes:
measure: PFS
timeFrame: From date of randomization until the date of progression, assessed up to 36 months
Secondary outcomes:
measure: ORR
timeFrame: From date of randomization until the date of death, assessed up to 36 months
measure: DCR
timeFrame: From date of randomization until the date of death, assessed up to 36 months
measure: OS
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SUN YAT-SEN University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01741818: The Cutoff Point for Caval Index and Its Correlation With Central Venous Pressure and Plasma Lactate Level for Assessing Patients in Hypovolemic Hemorrhagic States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVC Collapsibility Index
Hemorrhagic Shock
Keywords: IVC
ultrasonography
IVC collapsibility index
IVC diameter
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 106
Sex: ALL
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: cases in hypovolemic hemorrhagic status (class II or more) that presented to our ED

Brief summary: The purpose of this study is to determine the cutoff point for IVC collapsibility index (by Bedside Ultrasonographic technique) for cases in hypovolemic hemorrhagic shock with CVP measures less than 8 cmH2o.


Eligibility criteria: Inclusion Criteria:

* Hypovolemic hemorrhagic subjects (class II or more)if they were more than 18 years old and CVC insertion was indicated for them.

Exclusion Criteria:

* a history of Renal failure, Congestive Heart Failure, use of negative inotropic agents, presence of any contraindication for CVC insertion or failed ones and inability for measuring IVC by bUS were considered for exclusion.

Primary outcomes:
measure: IVC collapsibility index
timeFrame: within the first 5 minutes
Secondary outcomes:
measure: Serum lactate level
timeFrame: within the first 5 minutes
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Emergency Department of alzahra General Hospital, Isfahan University of Medical Sciences
city: Kerman
country: Iran, Islamic Republic of
facility: Kerman University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Keihan Golshani, MD.
role: STUDY_CHAIR
References: