louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05600491: A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
Official title: A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anaplastic Oligoastrocytoma
Glioblastoma
Keywords: Glioblastoma Multiforme
chemotherapy
Temozolomide
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.

Detailed description: This study was to explore the effectiveness and safety of early temozolomide chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen. Patients were treated with a standard therapy regimen (Stupp) plus early postsurgical temozolomide.

Eligibility criteria: Inclusion Criteria:

Age: 18 years to 70 years; Newly diagnosed Glioblastoma in the supratentorial cerebral hemisphere; Gross total resection or large resection of \>70% in imaging studies; Eastern Cooperative Oncology Group performance status of 0-2; Adequate bone marrow, liver and renal function; Ability of subject to understand character and individual consequences of the clinical trial Written informed consent; anticipating survival ≥7 months.

Exclusion Criteria:

Refusal to participate the study; Current diagnosis or history of malignancies within the 3-year period preceding enrollment; Recurrent or multiple malignant gliomas, including gliomatosis cerebri, or metastatic extracalvarial or subtentorial lesions; Known hypersensitivity or contraindication to temozolomide; Pregnant or lactating females; Malignant tumor other than brain tumor; Contraindicated for MRI examination; Unable to comply with the follow-up studies of this trial; Uncontrolled psychotic disorders or epilepsy.

Primary outcomes:
measure: Overall survival
timeFrame: 5-year
Secondary outcomes:
measure: Progression free survival
timeFrame: 5-year
measure: Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
timeFrame: 5-year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Department of Neurosurgery/Neuro-oncology, Sun Yat-sen University Cancer Center
name: Mou Y Gao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550791: Evaluating the Anticancer Learning Circle Lifestyle Program in Endometrial Cancer Survivors
Official title: A Prospective Feasibility Study Evaluating the Implementation of the Anticancer Lifestyle Program in Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neoplasm, Uterine
Keywords: Endometrial Cancer
Holistic Cancer Treatment
Lifestyle Change
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to promote positive lifestyle change among endometrial cancer survivors by using a group-based intervention. Endometrial cancer survivors are at an increased risk of other health conditions like heart disease, diabetes, and other cancers. The study team at the University of Virginia wants to explore new ways to lower these risks. This study will be evaluating the Anticancer Lifestyle program, which takes a more holistic approach and uses web-based learning modules along with weekly group sessions to discuss each topic of the web-based learning modules.


Eligibility criteria: Inclusion Criteria:

* History of stage I-IV endometrial cancer, any histologic subtype
* Completed cancer treatment, and in surveillance
* Have no evidence of endometrial cancer as determined by primary oncologist
* Be at least 18 years of age
* Be able to read and communicate in English
* Have a smartphone with access to cellular service or computer access with internet service
* Must have technological competency/proficiency to use their Smartphone and/or computer, as self-reported by potential subject
* Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Pregnant women
* Prisoners
* Subject is blind

Primary outcomes:
measure: Number of participants that complete the program
timeFrame: Week 7
Secondary outcomes:
measure: Change from Week 0 of the Automated Self-administered 24-hour Dietary Assessment (ASA24) at Week 7
timeFrame: 7 weeks
measure: Change from Week 0 of Generalized Anxiety Disorder (GAD-7) Survey from Baseline at Week 32
timeFrame: 32 weeks
measure: Change from Week 0 of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) from Baseline at Week 32
timeFrame: 32 weeks
measure: Change from Week 0 of the Cancer Worry Scale (CWS) to Week 32
timeFrame: 32 weeks
measure: Change from Week 0 of the Patient Health Questionnaire (PHQ-9) to Week 32
timeFrame: Baseline and Week 32
measure: Assess Attitudes Toward Group-Based Lifestyle Therapy Program Utilizing Internal Scale at Week 7 and Week 32
timeFrame: Week 7 and Week 32
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kari Ring, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02087891: Stress Free Now in a Corporate Call Center
Official title: Stress Free Now in a Corporate Call Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Psychosocial stress increases the risk for a multitude of diseases, including obesity, hypertension, and cardiovascular disease. Stress may also result in increased utilization of health care services. In the workplace, stress leads to emotional exhaustion, job dissatisfaction, lower productivity and impaired performance. Stress management programs and those based on mindfulness meditation have gained popularity in recent years. The purpose of this study is to evaluate the feasibility of an 8-week web-based mindfulness stress reduction program and its effectiveness in reducing work related stress and improving well-being in a large corporate call center.


Eligibility criteria: Inclusion Criteria:

* Frontline employee of large corporate call center
* Internet access

Exclusion Criteria:

* Manager or supervisor of large corporate call center

Primary outcomes:
measure: Assess whether an 8-week mindfulness stress reduction online program is effective in improving mindfulness.
timeFrame: 8 weeks
measure: Assess whether an 8-week mindfulness stress reduction online program is effective in reducing stress mindfulness.
timeFrame: 8 weeks
measure: Assess whether an 8-week mindfulness stress reduction online program is effective in decreasing burnout mindfulness.
timeFrame: 8 weeks
measure: To see whether a one-hour weekly group at work enhances amount of meditation practice.
timeFrame: 8 weeks
measure: To see whether a one-hour weekly group at work improves mindfulness.
timeFrame: 8 week
measure: To see whether a one-hour weekly group at work reduces stress.
timeFrame: 8 weeks
measure: To see whether a one-hour weekly group at work decreases burnout.
timeFrame: 8 weeks
measure: To see whether a one-hour weekly group at work enhances engagement.
timeFrame: 8 weeks
Secondary outcomes:
measure: Assess if the program is effective at increasing emotional well-being.
timeFrame: 8 weeks, 16 weeks, and 1 year
measure: Assess whether the program leads to an increase in work productivity.
timeFrame: 8 weeks, 16 weeks, and 1 year
measure: Assess if the program is effective at increasing vitality.
timeFrame: 8 weeks, 16 weeks, 1 year
measure: Assess if the program is effective at increasing emotional role functioning.
timeFrame: 8 weeks, 16 weeks, 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Adam Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Didier Allexandre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692091: Comparing Two Methods of Subacromial Space Injection
Official title: Comparing Two Methods of Subacromial Space Injection - A Randomised Blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Aneurin Bevan University Health Board
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Subacromial shoulder injections can be approached from the front or side of the shoulder. The investigators are comparing both methods, to find which one has better spread in the subacromial space.

Detailed description: Both lateral and posterio-lateral methods of subacromial injections are widely used for diagnostic and therapeutic purposes. It is not known which method allows the most accurate access into the subacromial space and is more effective.

The investigators have been using a novel approach from the anterior aspect of the shoulder for years with good clinical effect and propose comparing this approach to the described approach. This study will indicate which method is best and will be of practical clinical importance. The investigators feel the technique is easier to perform than other described methods and could be taught to clinicians throughout the country and adopted as the standard approach.

Eligibility criteria: Inclusion Criteria:

* Shoulder pain for at least 6 weeks duration along the lateral aspect of the shoulder.
* Positive impingement signs.

Exclusion Criteria:

* History of compensation claim due to shoulder problems.
* Allergy to radiographic dye.
* Recent shoulder fracture.
* Bleeding disorder.
* Previous shoulder surgery.

Primary outcomes:
measure: The spread of dye in subacromial space
timeFrame: With in One hour
Secondary outcomes:
measure: Pain control after subacromial injection
timeFrame: With in One hour
Other outcomes:
Locations:
city: Newport
country: United Kingdom
facility: Aneurin Bevan University Health Board
Study officials:
References:
citation: Eustace JA, Brophy DP, Gibney RP, Bresnihan B, FitzGerald O. Comparison of the accuracy of steroid placement with clinical outcome in patients with shoulder symptoms. Ann Rheum Dis. 1997 Jan;56(1):59-63. doi: 10.1136/ard.56.1.59.
citation: Calis M, Akgun K, Birtane M, Karacan I, Calis H, Tuzun F. Diagnostic values of clinical diagnostic tests in subacromial impingement syndrome. Ann Rheum Dis. 2000 Jan;59(1):44-7. doi: 10.1136/ard.59.1.44.
citation: Yamakado K. The targeting accuracy of subacromial injection to the shoulder: an arthrographic evaluation. Arthroscopy. 2002 Oct;18(8):887-91. doi: 10.1053/jars.2002.35263.
citation: Partington PF, Broome GH. Diagnostic injection around the shoulder: hit and miss? A cadaveric study of injection accuracy. J Shoulder Elbow Surg. 1998 Mar-Apr;7(2):147-50. doi: 10.1016/s1058-2746(98)90226-9.
Clinical trial NCT05311891: Variants of SARS-CoV-2 Causing COVID-19 in Africa
Official title: Variants of SARS-CoV-2 in Central and West Africa: Frequency of Circulating Viruses and Implications for the Management and Control of the Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Recherche pour le Developpement
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-04-05
Enrollment: 12600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant presenting for a SARS COV2 diagnosis, with or without symptoms

Brief summary: The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

Detailed description: The main objective of this research is to identify and characterize the different molecular variants of SARS-CoV-2, emerging and / or circulating in several countries of Sub-Saharan Africa (Burkina Faso, Côte d'Ivoire, Gabon, Mali, Chad and Republic of Congo) and determine their role in the evolution of the pandemic.

The research will combine retrospective and prospective approaches to determine the evolutionary dynamics of the virus since the start of the pandemic. It is planned to sequence the entire Spike protein gene for 1550 viruses and make 300 entire genomes. This work will be supplemented by antibody seroneutralization and respiratory transcriptomics tests, in order to estimate the immuno-virological response of the COVID-19 disease associated with the identified SARS-CoV-2 variants.

Eligibility criteria: Inclusion Criteria:

* Major subject (cf. country)
* Presenting for a SARS-COV-2 diagnosis, whether symptomatic or not
* Not objecting to participating in the research

Exclusion Criteria:

* NA

Primary outcomes:
measure: Number of SARS-CoV-2 sequences generated partially and in whole genome
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Number of individuals tested positive for COVID-19
timeFrame: Up to six months
measure: Number of new SARS-CoV-2 variants identify
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Centre de Référence pour les pathogènes émergents et réémergent
city: N'Djamena
country: Chad
facility: Centre Hospitalier Universitaire la Référence Nationale (CHU-RN)
city: Brazzaville
country: Congo
facility: Laboratoire National de Santé Publique Brazzaville
city: Abidjan
country: Côte D'Ivoire
facility: CIRBA
city: Libreville
country: Gabon
facility: Unité Mixte de Recherche CIRMF-SSM
city: Bamako
country: Mali
facility: SEREFO
Study officials:
References:
Clinical trial NCT05463991: Bioengineered Collagen Implant for Urethral Stricture Repair
Official title: Bioengineered Collagen Scaffold Implant as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Distal Urethral Strictures. - A Pilot Stud
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urethral Stricture
Lead sponsor: Regenosca SA
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral strictures.

Detailed description: Urethral stricture is defined as the abnormal narrowing of the urethral lumen in the area of the corpus spongiosum. A stricture is the result of ischemic spongiofibrosis manifesting as scar tissue in the corpus spongiosum. Long-term consequences are chronic fistulation through the skin, recurrent sepsis, bladder stones, obstructive uropathy, obstructive nephropathy, and finally renal failure.

Current available surgical techniques for urethral stricture repair require harvesting of grafts from autologous sites resulting in additional risks of complications at the tissue harvest site and additional pain to the patient.

The hypothesis of this study is that the developed bioengineered collagen implant can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients.

Eligibility criteria: Inclusion Criteria:

Adult males with urethral stricture less than 3 cm (anywhere from penile to bulbar urethra not including the membranous urethra) with existing lumen of at least 6 Fr suitable for augmentation urethroplasty. The stricture may be due to trauma or infection.

Exclusion Criteria:

* Known bovine collagen allergy
* Current urinary tract infection
* Chronic renal failure
* Diabeted
* Neurological diseases
* Chronic obstructive pulmonary diseases
* Sleep disturbances
* Depression
* Former cancer treatment
* Smokers
* Recurrent stricture

Primary outcomes:
measure: Urethral patency
timeFrame: four weeks post-surgery
Secondary outcomes:
measure: Voiding symptoms
timeFrame: two months up-to twenty-four months post-surgery
measure: Urine flow
timeFrame: two months up-to twenty-four months post-surgery
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
Study officials:
affiliation: University of Malaya Medical Center
name: Teng Aik Ong, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005891: Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Fanconi's Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fanconi's Anemia
Keywords: Fanconi's Anemia
aplastic anemia
hematologic disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2000-06-05
Sex: ALL
Minimum age (years): 0
Maximum age (years): 54
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid radiotherapy in terms of improving the survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.

Detailed description: PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day -6 through -3 and total lymphoid radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.

Patients are followed for at least 100 days.

Eligibility criteria: * Diagnosis of severe aplastic anemia with the typical phenotype of Fanconi's anemia: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility
* Family history of Fanconi's anemia
* Histocompatible related donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fairview University Medical Center
state: Minnesota
Study officials:
affiliation: Fairview University Medical Center
name: Daniel J. Weisdorf
role: STUDY_CHAIR
References:
Clinical trial NCT03001791: Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa
Official title: Clinical and Histopathological Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibrous Hyperplasia on Oral Mucosa
Keywords: CO2 laser
thermal damage zone
Er:YAG laser
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the RCT is to analyse clinical and histopathological particularities for excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser, CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding, the need for additional electrocoagulation or sutures and patient's postsurgical perception of pain, other postsurgical effects and use of analgesics.


Eligibility criteria: Inclusion Criteria:

* Clinical tentative diagnosis of fibrous hyperplasia in the buccal mucosa
* Fibrous hyperplasia dimensions 0.5 to 2 cm
* Patient understands and reads the German language
* Written informed consent

Exclusion Criteria:

* Untreated diabetes Typ II
* Severe infectious disease (HIV, hepatitis)
* Severe psychiatric disease
* Immunosuppressive therapy
* Anticoagulation
* Pregnancy; a pregnancy test (Clearblue®) is performed in women of childbearing age

Primary outcomes:
measure: Histopathological thermal damage zone
timeFrame: Three months
Secondary outcomes:
measure: Postoperative Pain
timeFrame: Two weeks
measure: Number of patients with other postoperative effects
timeFrame: Two weeks
measure: Time of surgery
timeFrame: 15 minutes
measure: Bleeding during surgery
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of oral Surgery and Stomatology, Dental school, University Bern
Study officials:
affiliation: Department of Oral Surgery and Stomatology, Dental School, University of Bern
name: Valerie GA Suter, Dr med dent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suter VGA, Altermatt HJ, Bornstein MM. A randomized controlled trial comparing surgical excisional biopsies using CO2 laser, Er:YAG laser and scalpel. Int J Oral Maxillofac Surg. 2020 Jan;49(1):99-106. doi: 10.1016/j.ijom.2019.05.012. Epub 2019 Jun 21.