louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04306887: A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)
Official title: A Open-label, Single-arm Phase Ⅱ Clinical Trial of TQ-B3101 in Subjects With Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Relapsed/Refractory Anaplastic Large Cell Lymphoma (ALCL)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with relapsed/refractory anaplastic large cell lymphoma (ALCL) .


Eligibility criteria: Inclusion Criteria:

-1.Female or male, 10 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 3.Histologically or cytologically confirmed ALK positive relapsed or refractory Anaplastic Large Cell Lymphoma.

4.At least one measurable lesion. 5.Life expectancy ≥ 3 months. 6.Adequate organ system function. 7.Understood and signed an informed consent form.

Exclusion Criteria:

* 1.Primary cutaneous anaplastic large cell lymphoma. 2.Other malignancies occurred within 5 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.

  3.Has received ALK inhibitor. 4.Has received an allogeneic stem cell transplant. 5.Has received autologous stem cell transplant within 12 weeks before the first administration.

  6.Has received other anti-tumor medications within 4 weeks of the first administration.

  7.Has received major surgery within 4 weeks before the first administration. 8.Has received any curative radiotherapy or minor surgery within 2 weeks before the first administration.

  9.Has received palliative radiation therapy within 2 days before the first administration.

  10.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

  11.Has uncontrollable congestive heart failure. 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Baseline up to 18 months
Secondary outcomes:
measure: Progression free survival (PFS) within 2-year
timeFrame: Baseline up to 24 months
measure: Overall survival (OS) within 2-year
timeFrame: Baseline up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT01390987: Access to Care and Adherence Tuberculosis (TB) Survey
Official title: Survey Nazionale Sui Determinanti Del Ritardato Accesso Alle Cure e Della Mancata Aderenza al Trattamento Antitubercolare (National Survey on the Determinats of Delayed Access to Care and Non-adherence to Tuberculosis Treatment)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Lead sponsor: Azienda Ospedaliera San Gerardo di Monza
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All new tuberculosis (any site) diagnosed in the study time-frame, regardless of previous treatment history.

Brief summary: Prompt access to care and treatment adherence are the hearth of tuberculosis control.

This is a multicentre observational prospective study aimed at studying the factors associated with delayed access to care and low adherence to anti-tuberculosis treatment. Hetero- and self-administered questionnaires will be used at enrollment to assess clinical presentation and time and modalities of the diagnosis. Treatment adherence will be assessed during the follow-up with self administered questionnaires.


Eligibility criteria: Inclusion Criteria:

* \>= 18 yrs of age
* recent new TB diagnosis
* Tuberculosis treatment prescribed
* Ability to sign the informed consent

Primary outcomes:
measure: Time to TB diagnosis
timeFrame: Study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Triggiano
country: Italy
facility: AO Fallacara
state: BA
city: Monza
country: Italy
facility: Clinic of Infectious Diseases, AO San Gerardo
state: MB
city: Brescia
country: Italy
facility: Clinica di Malattie Infettive, Spedali Civili
city: Genova
country: Italy
facility: Clinica di Malattie Infettive, Ospedale San Martino
city: Milano
country: Italy
facility: Clinica di Malattie Infettive, Ospedale Luigi Sacco
city: Roma
country: Italy
facility: Clinica di Malattie Infettive, Policlinico Gemelli
Study officials:
affiliation: Clinic of Infectious Disease, AO San Gerardo, Monza, Italy
name: Giuseppe Lapadula, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peri AM, Bernasconi DP, Galizzi N, Matteelli A, Codecasa L, Giorgio V, Di Biagio A, Franzetti F, Cingolani A, Gori A, Lapadula G. Determinants of patient and health care services delays for tuberculosis diagnosis in Italy: a cross-sectional observational study. BMC Infect Dis. 2018 Dec 20;18(1):690. doi: 10.1186/s12879-018-3609-4.
Clinical trial NCT04304287: The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty
Official title: The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfusion
Hip Arthroplasty
Keywords: total hip arthroplasty
autologous blood donation
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.

Detailed description: Total hip arthroplasty is procedure followed with large perioperative and postoperative blood loss. In order to avoid the application of large amounts of allogeneic blood, preoperative autologous blood donation as a tipe of autologous transfusion have been developed.

In this study, the investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.

Participants were divided into three groups: the first group donated one dose of autologous blood 14 days preoperatively, the second group donated one dose of autologous blood 72 hours preoperatively and a third group was not donated autologous blood.

The blood parameters, hemodynamic stability, bleeding, the need for application of autologous or homologous blood and length of hospital stay were compared.

Eligibility criteria: Inclusion Criteria:

* subject older than 18 years
* subject has primary coxarthrosis
* subject has indication for total hip replacement

Exclusion Criteria:

* subject has secondary coxarthrosis
* subject has need for revision endoprosthesis
* history of autoimmune, malignancy or coagulation disorder
* history of myocardial infarct or cerebrovascular insult in last 6 months
* history of angina pectoris and unregulated hypertension
* history of renal or liver failure

Primary outcomes:
measure: Patient red blood cells value
timeFrame: 6 days
measure: Need for autologous blood transfusion
timeFrame: 6 days
measure: Need for homologous blood transfusion
timeFrame: 6 days
measure: Patient hemoglobin value
timeFrame: 6 days
measure: Patient hematocrit value
timeFrame: 6 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 6 days
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Domagoj Delimar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05596487: The Effect of Repetitive Standardized Patient Simulation and End of Life Care Education on Nursing Students' Knowledge Attitudes and Moods
Official title: The Effects of End of Life Care Education and Repetitive Standard Patient-Based Simulation on Nursing Students' Knowledge Level, Attitudes and Moods Towards the Patient With Dying Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End of Life Care
Keywords: End of life care
standardized patient
nursing
attitude
emotion
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This research is a randomized experimental intervention study designed to examine the effect of repetitive standard patient-based education given to nursing students with end-of-life care education nursing on the level of knowledge, attitudes, and moods of the patient's care during the death process.

Detailed description: The research Sample of the study consisted of fourth-year nursing students who agreed to participate in the study (n=50). In the study, an end-of-life care nursing education program was applied to all students. In the second stage, the standard patient-based practice was performed once with the control group nursing students and twice with the intervention group students. In data collection, an end-of-life care nursing questionnaire, Frommelt attitude scale, positive-negative affect scale, and modified simulation effectiveness tool were used.

Eligibility criteria: Inclusion Criteria:

* Not having a course in which a four-year undergraduate education is unsuccessful,
* Not participating in the pilot study of the research
* To voluntarily agree to participate in the research.
* Being a fourth-year student in the Department of Nursing

Exclusion Criteria:

* Participating in the pilot study of the research
* Wanting to leave the research.
* Being a first, second and third-year student in the Department of Nursing

Primary outcomes:
measure: Knowledge level on end-of-life care nursing
timeFrame: 21 Days
measure: Attitude score toward the care of the patient during the death process
timeFrame: 21 Days
measure: positive-negative mood level
timeFrame: 21 Days
measure: evaluate the effectiveness of the simulation environment
timeFrame: 21 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing
Study officials:
References:
Clinical trial NCT06233487: Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
Official title: Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
First posted: 2024-01-31
Enrollment: 110
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Several measurements are used to evaluate hip dysplasia in hip ultrasound of children. Despite having being used since the 1980s, reliability studies have failed to find acceptable reliaiblity values for the gold standard ultrasound methods.

This study will evaluate three ultrasound measurement methodologies in a high quality controlled setting, to investigate the best achieveable reliability and agreement of the investigated measurements used in hip dysplasia diagnostics.

Detailed description: In DDH diagnostics, measurements of acetabular alpha angles and femoral head coverages (FHC), developed by Graf and Harcke/Terjesen respectively, have been gold standard since the 1980s. Despite their widespread use, the reliability of these measurements has been questioned due to the relative complexity of acquiring the necessary corIDrect frontal 2D plane or "standard plane". In the only meta-analysis of the reliability of ultrasound (US) metrics in dysplasia, the interrater reliability of the alpha angles was mediocre while the reliability of the FHC was poor. Critics of these findings however argue that the low reliability reported in studies are due to misinterpretation and misapplication of the Graf method.

The pubo-femoral distance (PFD) was proposed in 2013 as a new measurement for assessing DDH, while the reliability is reportedly higher than the gold standard US methods, it has never been directly compared to these.

This study aims to evaluate the inter- and intrarater reliability of Graf's alpha and beta angles, the FHC and PFD in children referred for hip US in a selective ultrasound screening program for DDH.

Eligibility criteria: Inclusion Criteria:

* Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.
* Children receiving follow-up ultrasound for previously diagnosed DDH

Exclusion Criteria:

* Children deemed too agitated to participate in hip US with double measurements by two radiologists.

Primary outcomes:
measure: Reliability and agreement in Alpha/Beta angles, Femoral head coverage and Pubo-femoral distance
timeFrame: Ultrasound measurements collected during the ultrasound examination by both radiologists
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT06831487: Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in Characterization of Gingival Systemic Health, Gingivitis and Periodontitis
Official title: Analysis of Line-Field Confocal Optical Coherence Tomography (LC-OCT) in the Characterization of Gingival Systemic Health, Gingivitis and Periodontitis and Effects of Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gingival Diseases
Keywords: Periodontitis, gingivitis, LC-OCT
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Independently, patients with gingivitis, periodontitis and healthy patients will be evaluated
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to identify tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT)

Detailed description: The tissue changes among healthy patients, patients with gingivitis and with periodontitis before and after treatment, by analyzing tissues changes through Line-Field Confocal Optical Coherence Tomography (LC-OCT) will be evaluated through changes on epithelium before and after non surgical periodontal treatment

Eligibility criteria: Inclusion Criteria:

* Diagnosis of gingivitis or periodontitis by the presence of elevated bleeding or probing index or probing pocket depth

Exclusion Criteria:

* Smoking
* Any systemic diseases that could influence the gingival structure

Primary outcomes:
measure: Visual epithelial surface change
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Policlinico G. Rodolico
Study officials:
References:
Clinical trial NCT00657254: Extension Program for Bay 43-9006
Official title: Extension Program for Bay 43-9006
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasm
Metastasis
Keywords: Extension
Sorafenib
Survival
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.


Eligibility criteria: Inclusion Criteria: - Patients who had participated in a previous sorafenib study that had completed, who did not meet withdrawal criteria of the previous study and who were, in the opinion of the investigator and sponsor still benefiting from treatment. Exclusion Criteria:- The current cardiovascular situation of the patient was carefully re-evaluated by both the investigator and the sponsor and an informed decision as to inclusion was then made.- Substance abuse, medical, psychological or social conditions that may have interfered with the patient's participation in the study or evaluation of the study results.- Known or suspected allergy to the investigational agent.- Any condition that was unstable or which could jeopardise the safety of the patient and his/her compliance in the study.

Primary outcomes:
measure: Survival
timeFrame: Death
Secondary outcomes:
measure: Objective Tumour Response Rate
timeFrame: Number of confirmed partial and complete responses
measure: Overall Response Duration
timeFrame: Time from the date of the first intake of sorafenib to the date that progressive disease is documented.
measure: Time to Objective Response
timeFrame: Time from the date of the first intake of sorafenib to the date that objective response is first documented.
measure: Time to Disease Progression
timeFrame: Time from first intake of sorafenib to disease progression
measure: Safety Parameters
timeFrame: Throughout study
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Bruxelles - Brussel
country: Belgium
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Herne
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04532554: Growth Hormone in Obese Cases With Covid-19
Official title: The Impact of Growth Hormone in Obese Cases With Covid-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Covid19
Lead sponsor: ClinAmygate
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

Detailed description: It is well known that lymphoid organs such the thymus, the spleen and peripheral blood produce growth hormone (GH) and GH receptor is expressed on different subpopulations of lymphocytes. Many in vitro and in animal studies demonstrate an important role of GH in immunoregulation. GH stimulates T and B cells proliferation and immunoglobulin synthesis, enhances the maturation of myeloid progenitor cells and is also able to modulate cytokine response.

The use of growth hormone in obese cases with COVID-19 may help them to recover earlier.

Eligibility criteria: Inclusion Criteria:

* Obese with BMI \> 30

Exclusion Criteria:

* History of hypersensitivity to GH

Primary outcomes:
measure: Need for hospitalization
timeFrame: one to two weeks
Secondary outcomes:
measure: Time to recovery
timeFrame: one to four weeks
measure: Percentage of reduction in CRP
timeFrame: one to two weeks
measure: Percentage of reduction in LDH
timeFrame: one to two weeks
measure: Percentage of reduction in Ferritin
timeFrame: one to two weeks
measure: Time to recovery from leucopenia
timeFrame: one to two weeks
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Asalam
state: Cairo
Study officials:
affiliation: Assalam Clinics
name: Emad R Issak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meazza C, Pagani S, Travaglino P, Bozzola M. Effect of growth hormone (GH) on the immune system. Pediatr Endocrinol Rev. 2004 Aug;1 Suppl 3:490-5.
Clinical trial NCT00913354: Acupuncture Versus Placebo Acupuncture During In Vitro Fertilization (IVF) Embryo Transfer
Official title: Acupuncture Versus Placebo Acupuncture During Ivf Embryo Transfer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: infertility
ivf
acupuncture
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 635
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During IVF treatment, acupuncture at the time of embryo transfer may improve the pregnancy rate. This study aims to compare IVF pregnancy between two groups of patients that received either acupuncture or sham acupuncture (placebo)around embryo transfer

Detailed description: Acupuncture at the time of embryo transfer may improve the IVF pregnancy rate. This study aims to compare the IVF pregnancy between two groups of patients that undergo ivf/icsi treatment. The patients are randomized to receive either acupuncture or sham acupuncture (placebo)around embryo transfer

Eligibility criteria: Inclusion Criteria:

* infertility
* below 38 years
* ivf or icsi treatment
* fresh embryo transfer cycle
* no more than two earlier embryo transfers with "fresh" embryos
* embryo transfer on day 2 or 3 after oocyte aspiration, single or double embryo transfer

Exclusion Criteria:

* Frozen embryo transfer
* oocyte donation
* other "alternative" treatment during the cycle

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2005-2008
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Fertility Clinic, Copenhagen University Hospital, Denmark
Study officials:
affiliation: The Fertility Clinic, Copenhagen University Hospital Rigshospitalet
name: Dorthe Andersen, Study nurse
role: PRINCIPAL_INVESTIGATOR
References: