louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05982574: Tumor Microenvironment
Official title: Tumor Microenvironment in Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Adenocarcinoma
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with completely resected lung adenocarcinoma stage IB and II

Brief summary: Cancer immunotherapy has the great potential to achieve long-term survival in patients with a solid malignancy. However, the beneficial effect of cancer immunotherapy is seen in only a minority of patients. Mounting evidence suggests that immunosuppressive features in the tumor microenvironment prevent an effective antitumor defense. The aim of the investigators is to comprehensively analyze the cytokine profile and the tumor immune infiltrate in the tumor microenvironment and to investigate its prognostic significance in patients with radically resected lung adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Lung adenocarcinoma
* Tumor stage IB and II
* With or without adjuvant therapy
* Complete surgical resection (R0)
* No distant metastasis at the time of surgery (M0)

Exclusion Criteria:

• Second cancer within 5 years

Primary outcomes:
measure: Overall survival
timeFrame: From date of surgery until the date of death from any cause assessed up to 100 months
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Other outcomes:
Locations:
Study officials:
affiliation: Technical University of Munich
name: Seyer Safi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck C, Ramanujam D, Vaccarello P, Widenmeyer F, Feuerherd M, Cheng CC, Bomhard A, Abikeeva T, Schadler J, Sperhake JP, Graw M, Safi S, Hoffmann H, Staab-Weijnitz CA, Rad R, Protzer U, Frischmuth T, Engelhardt S. Trimannose-coupled antimiR-21 for macrophage-targeted inhalation treatment of acute inflammatory lung damage. Nat Commun. 2023 Jul 28;14(1):4564. doi: 10.1038/s41467-023-40185-1.
citation: Safi S, Messner L, Kliebisch M, Eggert L, Ceylangil C, Lennartz P, Jefferies B, Klein H, Schirren M, Dommasch M, Lobinger D, Multhoff G. Circulating Hsp70 Levels and the Immunophenotype of Peripheral Blood Lymphocytes as Potential Biomarkers for Advanced Lung Cancer and Therapy Failure after Surgery. Biomolecules. 2023 May 22;13(5):874. doi: 10.3390/biom13050874.
citation: Safi S, Yamauchi Y, Hoffmann H, Weichert W, Jost PJ, Winter H, Muley T, Beckhove P. Circulating Interleukin-4 Is Associated with a Systemic T Cell Response against Tumor-Associated Antigens in Treatment-Naive Patients with Resectable Non-Small-Cell Lung Cancer. Cancers (Basel). 2020 Nov 24;12(12):3496. doi: 10.3390/cancers12123496.
Clinical trial NCT05329974: Computer Guided Buccal Cortical Plate Separation for Removal of Calcified Benign Odontogenic Tumors Affecting Mandibular Angle Region
Official title: Computer Guided Buccal Cortical Plate Separation for Removal of Calcified Benign Odontogenic Tumors Affecting Mandibular Angle Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Odontogenic Tumors
Odontoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Detailed description: Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.

Eligibility criteria: Inclusion Criteria:

* Patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique

Exclusion Criteria:

* Patients with any medical condition contraindicating the surgical procedures were excluded

Primary outcomes:
measure: Intra-operative time
timeFrame: during the surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: 2, 5, and 10 days after the surgery
measure: Edema
timeFrame: 5 and 10 days after the surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry, Cairo university
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
citation: Omara M, Gouda A, Ali S. Computer-guided buccal cortical plate separation for removal of calcified benign odontogenic tumors affecting the mandibular angle region. Maxillofac Plast Reconstr Surg. 2022 Sep 22;44(1):30. doi: 10.1186/s40902-022-00354-6.
Clinical trial NCT01450774: Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
Official title: A Single Centre, Randomised, Double-blind, Double-dummy, 2-way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 Pmdi (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and the Free Combination of Licensed Beclomethasone Dipropionate and Formoterol Fumarate in Asthmatic Children Already Treated With Inhaled Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Childhood Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.


Eligibility criteria: Inclusion Criteria:

* Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment
* Clinical diagnosis of mild asthma during at least two months prior to screening visit
* Forced Expiratory Volume during the first second (FEV1) \> 80% of predicted normal values at screening visit

Exclusion Criteria:

* Endocrinological diseases including growth impairment or other chronic diseases
* Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids

Primary outcomes:
measure: Lower leg growth rate measured by knemometry
timeFrame: after a 2 week treatment
Secondary outcomes:
measure: 24-hour urinary free cortisol/creatinine levels
timeFrame: after a 2 week treatment period
measure: Changes in pre-dose morning and evening PEF (L/min)
timeFrame: pre and after a 2 week treatment period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: BørneAstmaKlinikken
Study officials:
affiliation: BørneAstmaKlinikken
name: Hans Bisgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02512874: Does Pulmonary Rehabilitation Improve Frailty?
Official title: Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disease, Pulmonary
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-07-31
Enrollment: 65
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: Frailty is a state of health with predisposition to adverse events, morbidity and mortality. Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting. Frailty is associated with increased hospitalizations and death in lung disease. It is unknown if pulmonary rehabilitation will improve frailty markers.

Detailed description: Individuals referred to pulmonary rehabilitation will be examined for frailty markers. After completing pulmonary rehabilitation, the same tests will be performed. The effects of pulmonary rehabilitation will be examined.

Eligibility criteria: Inclusion criteria:

* Referred for pulmonary rehabilitation
* consenting to research

Exclusion criteria:

-Under 18 years of age

Primary outcomes:
measure: Number of Participants With Frailty Phenotype at Baseline and 6 Months
timeFrame: Baseline, Six months
Secondary outcomes:
measure: Wasting
timeFrame: after pulmonary rehabilation completion, appoximately 8 weeks
measure: Change in Strength
timeFrame: after completion of pulmonary rehab, approximately 8 weeks
measure: Change in Gait Speed
timeFrame: pre and post pulmonary rehab, approximately 8 weeks
measure: Improvement in Exhaustion
timeFrame: pre and post pulmonary rehab, approximately 8 weeks
measure: Change in Physical Activity Level
timeFrame: pre and post pulmonary rehab, approximately 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cassie Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130374: Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Official title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tracheal Stenosis
Laryngeal Stenosis
Mesenchymal Stem Cells
Keywords: mesenchymal stem cells
Tracheal Stenosis
Laryngeal Stenosis
cell therapy
Lead sponsor: The Republican Research and Practical Center for Epidemiology and Microbiology
Sponsor class: OTHER
Collaborators: name: Belarusian Medical Academy of Post-Graduate Education
name: The Republican Center for Research and Practice in Otolaryngology
First posted: 2017-04-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Detailed description: Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis.

Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of chronic laryngeal or tracheal stenosis;
* absence of cartilage damage.

Exclusion Criteria:

* refuse of patient to participate in the trial;
* acute infectious diseases;
* chronic mental disorders with severe manifestations;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction;
* cachexia of any origin;
* malignant neoplasms.

Primary outcomes:
measure: Number of patients who didn't require the repeated surgical interventions
timeFrame: 1 year
Secondary outcomes:
measure: Tracheostomy decannulation
timeFrame: 6 month
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: The Republican Center for Research and Practice in Otolaryngology
city: Minsk
country: Belarus
facility: The Republican Research and Practical Center for Epidemiology and Microbiology
Study officials:
affiliation: Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
name: Andrei Y Hancharou, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of the Belarusian Medical Academy of Post-Graduate Education
name: Valery L Chekan, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03177174: Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Official title: the General Hospital of PLA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug-Related Side Effects and Adverse Reactions
Keywords: locally advanced nasopharyngeal carcinoma
Concurrent chemoradiotherapy
Toxic reaction
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18, \<70 years old, with locally advanced nasopharyngeal carcinoma.

Exclusion Criteria:

* patients who had accepted radiotherapy before patients with any ather types of cancer

Primary outcomes:
measure: changes in toxic reaction
timeFrame: 5 years
Secondary outcomes:
measure: over survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA general hospital
Study officials:
References:
citation: Luo Y, Cai B, Li B, Liu F, Du L, Zhao D, Fan W, Meng L, Zhang X, Ma L. The Acute Toxicities and Efficacy of Concurrent Chemotherapy With Docetaxel Plus Cisplatin, or Docetaxel, or Cisplatin and Helical Tomotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Single-Center Phase II Trial. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221109974. doi: 10.1177/15330338221109974.
Clinical trial NCT03400774: The Acute Effect of Moderate Intensity Stair-Climbing on Postprandial Blood Glucose
Official title: The Acute Effect of Moderate Intensity Stair-Climbing on Postprandial Blood Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effect of moderate intensity stair-climbing bouts of various durations on postprandial blood glucose. Participants will perform a standard oral glucose tolerance test (OGTT) using 75g of dextrose and with fingerstick blood glucose measurements at baseline and every 15 minutes after consuming the drink for one hour. On separate subsequent visits, participants will perform the same OGTT combined with three stair-climbing bouts lasting 1, 3, and 10 minutes starting 27, 25, and 18 minutes respectively after finishing the drink. Participants performed maximal aerobic capacity (VO2max) using a ramp treadmill test in order to assess the relative intensity of each stairclimbing trial.


Eligibility criteria: Inclusion Criteria:

* Defined as low risk per the American College of Sports Medicine (ACSM, Guidelines for Exercise Testing \& Exercise Prescription, 20014 pg 30)
* Physical Activity Recall Questionnaire (PAR-Q) screening

Exclusion Criteria:

* Glucose intolerance
* Diabetes

Primary outcomes:
measure: Postprandial Blood Glucose
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bartholomae EM, Moore J, Ward K, Kressler J. Sex differences in postprandial glucose response to short bouts of exercise: A randomized controlled trial. J Sci Med Sport. 2019 Feb;22(2):181-185. doi: 10.1016/j.jsams.2018.07.009. Epub 2018 Jul 20.
Clinical trial NCT00629174: Prevention of the Age-Related Cognitive Impairment by Exercise and Mental Activity - Berlin Bleibt Fit
Official title: Randomized, Controlled Study About the Effects of an Exercise Program and Mental Activity on the Age-Associated Impairment of Cognitive Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cognition
Mood
Keywords: Cognitive function
Elderly
Exercise
Mental activity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Gertrude and Hugo Adler Foundation
First posted: 2008-03-05
Enrollment: 252
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial will evaluate the effects of frequent exercise and increased mental activity on the age-related impairment of cognitive function in elderly women. Furthermore, we will assess the effects of exercise and mental activity on the mood, physical performance and mental status of participants. We will also search for genetic factors which may be responsible of the observed outcomes.

Detailed description: Two-hundred and fifty-two women older than 70 years will be randomize to one of three groups. The first (exercise) will participate at an exercise program three times weekly for 90 minutes. The training will consist of an endurance and resistance training and will be carried out in a group. Participants in the second group (mental training) will take computer lessons, three times weekly for 90 minutes. Both interventions will be carried out for 26 weeks. Participants in the third group (control) will not participate at an structured intervention.

Eligibility criteria: Inclusion Criteria:

* All healthy women older than 70 years with sufficient knowledge of German can participate.

Exclusion Criteria:

* Chronic mental disorders
* Chronic neurological, cardiological, pulmonary or renal diseases.
* Severe osteoarthritis
* Disorders which can be aggravated by exercise (arterial hypertension, coronary heart disease, COLD).
* Cancer in current therapy
* Treatment with glucocorticoids or cytostatic drugs.
* Patients who received an organ transplantation
* Exercise-induced osteoarticular pain

Primary outcomes:
measure: Improvement of cognitive and physical performance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Section Sports Medicine, Charité - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Department of Psychiatry
Study officials:
affiliation: Charite University, Berlin, Germany
name: Isabella Heuser, Professor
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Fernando C Dimeo, PhD
role: STUDY_CHAIR
affiliation: Charite University, Berlin, Germany
name: Friedel Reischies, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04499274: Ondansetron and Blood Coagulation
Official title: The Effect of an Ondansetron on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Coagulation Disorder
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ondansetron may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of ondansetron. The investigators therefore will perform the present study to measure the effect of ondansestron on the blood coagulation pathway according to the drug concentration level using a thromboelastography test.


Eligibility criteria: Inclusion Criteria:

* Healthy vonlunteers
* Age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication

Primary outcomes:
measure: Citrated Functional Fibrinogen
timeFrame: During the thromboelastography analysis/ an average of 1 hour
Secondary outcomes:
measure: Citrated Kaolin
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Citrated Kaolin Heparinase
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Citrated Rapid Thromboelastography
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Heparinized Kaolin Heparinase
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Activator F
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Adenosine diphosphate
timeFrame: During the thromboelastography analysis/ an average of 1 hour
measure: Arachidonic acid
timeFrame: During the thromboelastography analysis/ an average of 1 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyo-Seok Na, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: