louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05665374: Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
Official title: General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-12-27
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with Calquence

Brief summary: To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use

Detailed description: To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as "CALQUENCE") used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use.

This investigation will be conducted as the additional pharmacovigilance activity specified in the Japan Risk Management Plan (J-RMP) of CALQUENCE, in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (PMD Act).

Eligibility criteria: Inclusion Criteria:

Patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with Calquence for the first time will be enrolled in the study after the approval date of the sJNDA for the additional indication.

-

Exclusion Criteria:

None

-

Primary outcomes:
measure: Incidence of ADRs
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References:
Clinical trial NCT01077674: Comparison of Two Electroencephalogram (EEG)-Derived Indices With Electroencephalogram Signals
Official title: Comparison of Bispectral Index and Entropy With Electroencephalogram During Sevoflurane Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaesthesia
Surgery
Keywords: Electroencephalogram
Entropy
BIS
Sevoflurane
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2010-03-01
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle aged and elderly surgical patients

Brief summary: Bispectral Index (BIS) and Entropy indices will be compared with each other, and to raw EEG signals in patients receiving sevoflurane anaesthesia. BIS and Entropy numbers often differ significantly from each other during surgery, and the reason for this has not been studied in detail, therefore remaining only poorly understood. BIS and Entropy, together with multi-channel EEG, will be collected and analyzed later on. Course of anaesthesia and surgery will be annotated. All relevant information from anaesthesia monitor will be collected on computer.


Eligibility criteria: Inclusion Criteria:

* Planned surgery necessitating general anaesthesia
* Expected duration of anaesthesia 30 min or more
* Need of endotracheal intubation
* ASA status 1, 2 or 3

Exclusion Criteria:

* Significant disorders of the autonomic or central nervous system
* Family history of malignant hyperthermia
* Clinical history of anaphylactic reaction against inhaled anaesthetics
* Disability to communicate with Finnish language

Primary outcomes:
measure: Morphology of electroencephalogram during discrepancy between Entropy and BIS index values
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, MD
role: STUDY_CHAIR
References:
citation: Aho AJ, Kamata K, Jantti V, Kulkas A, Hagihira S, Huhtala H, Yli-Hankala A. Comparison of Bispectral Index and Entropy values with electroencephalogram during surgical anaesthesia with sevoflurane. Br J Anaesth. 2015 Aug;115(2):258-66. doi: 10.1093/bja/aev206. Epub 2015 Jul 1.
Clinical trial NCT05797974: Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?
Official title: Does a Virtual Coach Offer a Better Solution for Weight Reduction in Ventral Hernia Patients With Obesity?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Ventral Hernia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-04-04
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose for this research is to create a MyChart-enabled virtual coach that assists obese patients lose weight prior to ventral hernia surgery. Researchers intend to show how the use of a virtual coach is more effective in preoperative weight reduction prior to ventral hernia repair over usual care. Correspondingly, this may lower unplanned hospital readmissions. For this clinical trial, where randomization is not possible, the study team will implement the use of propensity score matching that sorts individuals into different study arms as if randomly assigned. The primary outcome is the average net amount of time-dependent weight change per group over six months. Secondary outcomes are for the intervention group, patient satisfaction with the virtual coach and for both groups, quality of life. In addition, areas of social and economic disadvantage will be identified that may contribute to higher obesity rates. Machine learning (ML) modeling will be used to determine the important features for weight lost over the course of the study. The impact of this work will be to demonstrate efficacy and realized workflow efficiencies within a hospital-based surgery clinic.


Eligibility criteria: Inclusion Criteria:

* Subjects between 18 and 90 years of age with a Body Mass Index (BMI) of 30 and above and diagnosed with Obesity by the ICD 10 Code: E66.9 who have been evaluated by a surgeon and offered elective ventral hernia repair. Also, participants must have a complete medical record that allows for all statistical calculations to be performed.

Exclusion Criteria:

* Pregnant females, patients with severe mental disorders, prescribed psychiatric medications associated with weight gain, a history of a Substance Use Disorder, patients on long-term steroid therapy, and patients with insufficient medical records.

Primary outcomes:
measure: pounds of weight change per group
timeFrame: 6 months
Secondary outcomes:
measure: number of interactions
timeFrame: 6 months
measure: degree of quality of life
timeFrame: at baseline and 6 months
measure: degree of satisfaction with the virtual coach
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
Study officials:
affiliation: Assistant Professor
name: Jana Sacco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06186674: Prediction of Back Disability in Adults With Low Back Pain
Official title: Prediction of Back Disability Using Clinical, Functional, and Bio-mechanical Variables in Adults With Low Back Pain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Low Back Pain
Keywords: posture
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 subjects will be recruited from the university A local advertisement sent via e-mail to the university's postgraduate students and administrative staff

Brief summary: Low back pain (LBP) is one of the most enormous and challenging disorders. LBP represents a leading cause of disability worldwide. A number of variables (clinical, functional and mechanical) may predispose to back disability. Clinical variables such as pain may affect the patient ability to move and also may result in muscle spasm that led to more pain and movement restriction. Further, functional capabilities may affect the patient and when reduced may lead to disability. Moreover, biomechanical factors such as abnormal posture creates abnormal stress and strain in many spinal structures which are considered predisposing factors for pain and disability.

There is a gab of evidence to examine the relationships between those variables and to predict disability in patients with chronic nonspecific low back pain using various variables.


Eligibility criteria: Inclusion Criteria:

- age between 20 and 40 years, either sex, and symptoms lasting longer than three months, which imply chronicity

Exclusion Criteria:

* Pregnancy, Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP

Primary outcomes:
measure: back disability using oswestry disability index
timeFrame: 1 month
measure: back pain intensity using visual analogue scale
timeFrame: 1 month
Secondary outcomes:
measure: back functional ability using back performance scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Benha University
state: Benha
Study officials:
affiliation: Benha University
name: Aliaa M Elabd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311974: The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals
Official title: The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Dihydralazine
Sympathetic activation
Fractional sodium excretion
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-04-07
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.


Eligibility criteria: Inclusion Criteria:

1. Men
2. Ages 18 to 40 years.
3. Body mass index less than or equal to 30 kg/m2

Exclusion Criteria:

1. History or clinical signs of heart, lung, kidney, or endocrine organ disease.
2. Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
3. Abnormal screening of the urine regarding: albumin and glucose
4. Malignant disease.
5. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
6. Alcohol abuse.
7. Smoking.
8. Drug use or abuse.
9. Known intolerance or allergy to dihydralazine
10. Blood donation within 1 month of the start of the study.

Primary outcomes:
measure: Fractional sodium excretion
measure: Heart rate
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
Study officials:
affiliation: Department of Medical Research, Holstebro Hospital, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
affiliation: Department of Medical Research, Holstebro Hospital, Denmark
name: Henrik Vase, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06074874: Intestinal Biomarker Analysis After ECP for ICI Colitis
Official title: Intestinal Biomarker Analysis After ECP for ICI Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis
Immune Checkpoint Inhibitor-Related Colitis
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ICI colitis

Brief summary: It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.

Detailed description: It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the changes of immune cells in the peripheral blood and intestinal tract in an ICI colitis patient cohort. The analysis will include the evaluation of intestinal and peripheral blood biomarkers in patients with ICI colitis receiving ECP as a treatment.

Eligibility criteria: Inclusion Criteria:

* ICI colitis

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: T cell number and phenotype measurement in the intestinal tract
timeFrame: 6 months
Secondary outcomes:
measure: T cell number measurement by immunohistochemistry
timeFrame: 6 months
measure: Analysis of arginase amounts in the intestinal tract using qPCR
timeFrame: 6 months
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Freiburg University Medical Center
state: Baden Württemberg
Study officials:
References:
citation: Apostolova P, Unger S, von Bubnoff D, Meiss F, Becher B, Zeiser R. Extracorporeal Photopheresis for Colitis Induced by Checkpoint-Inhibitor Therapy. N Engl J Med. 2020 Jan 16;382(3):294-296. doi: 10.1056/NEJMc1912274. No abstract available.
citation: Maas-Bauer K, Kiote-Schmidt C, Bertz H, Apostolova P, Wasch R, Ihorst G, Finke J, Zeiser R. Ruxolitinib-ECP combination treatment for refractory severe chronic graft-versus-host disease. Bone Marrow Transplant. 2021 Apr;56(4):909-916. doi: 10.1038/s41409-020-01122-8. Epub 2020 Nov 17.
Clinical trial NCT00140374: Vaccination Priming and Vaccine Boosting Trial of Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines (GVAX® Vaccine for Prostate Cancer)
Official title: Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Vaccine
GVAX
Allogeneic cells
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 36
Sex: MALE
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 objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
* No evidence of measurable metastatic disease
* An ECOG performance status of 0 or 1

Exclusion Criteria:

* Transitional cell, small cell or squamous cell prostate carcinomas
* Any previous radiation therapy, prior anti-androgens or prior investigational therapy
* Previous hormonal therapy of any type for prostate cancer
* Previous biological therapy for cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05719974: Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete
Official title: Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athlete: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Ligament Injury
Anterior Cruciate Ligament Injuries
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.


Eligibility criteria: Inclusion Criteria:

* Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.
* Ranging in age from 18 to 35 years.
* Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility
* Ability to actively control the quadriceps.

Exclusion Criteria:

* ACLR with any graft other than a hamstring graft
* ACL revision surgery
* associated medial or lateral ligamentous injuries
* previous meniscectomy or meniscal repair
* simultaneous meniscectomy or meniscus repair with the ACLR
* cartilage damage.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 6 months
Secondary outcomes:
measure: limb symmetry index of hop test battery
timeFrame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 6 months
measure: knee effusion grading scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta university
state: Eldakahlyia
Study officials:
References:
Clinical trial NCT03568474: Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries
Official title: Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Deep Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel two arm groups with 1:1 allocation ratio
Primary purpose: TREATMENT

Brief summary: This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex

Detailed description: The study will be carried on young permanent molars with open apices \& with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.

Eligibility criteria: Inclusion criteria:

1. Patients free from any systematic diseases.
2. Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed.
3. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility)
4. The absence of clinical symptoms of irreversible pulpitis.
5. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption).
6. Compliant patient/ parent.

Exclusion criteria:

1. Teeth with previous restorative treatment.
2. Unrestorable teeth.
3. Uncooperative patients.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 9 months
Secondary outcomes:
measure: Tooth vitality
timeFrame: 9 months
measure: Abscess
timeFrame: 9 months
measure: Pain on percussion
timeFrame: 9 months
measure: Root lengthening
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Nevine G Waly, Professor
role: STUDY_CHAIR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Sara A Mahmoud, PhD
role: STUDY_DIRECTOR
affiliation: Oral and Maxillofacial Radiology, Faculty of Dentistry, Cairo University
name: Mohamed K Zayt, PhD
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Rehan A Ibrahim, MSc
role: PRINCIPAL_INVESTIGATOR
References: