louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00169221: Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
Official title: CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.


Eligibility criteria: Inclusion Criteria:

* Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
* Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
* Patients receiving post-operative radiation (\>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.

Exclusion Criteria:

* previous history of cancer (except skin basal cell carcinoma)

Primary outcomes:
measure: Disease free survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Rene-Jean Bensadoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thariat J, Bensadoun RJ, Etienne-Grimaldi MC, Grall D, Penault-Llorca F, Dassonville O, Bertucci F, Cayre A, De Raucourt D, Geoffrois L, Finetti P, Giraud P, Racadot S, Moriniere S, Sudaka A, Van Obberghen-Schilling E, Milano G. Contrasted outcomes to gefitinib on tumoral IGF1R expression in head and neck cancer patients receiving postoperative chemoradiation (GORTEC trial 2004-02). Clin Cancer Res. 2012 Sep 15;18(18):5123-33. doi: 10.1158/1078-0432.CCR-12-1518. Epub 2012 Aug 1.
Clinical trial NCT03077321: Improving Access to a Primary Care Based Positive Parenting Program
Official title: Improving Access to a Primary Care Based Positive Parenting Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Program Implementation
Child Behavior Problem
Positive Parenting
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT 1:1:1
Primary purpose: PREVENTION

Brief summary: This is a randomized clinical trial of the impact of incorporating a peer mentor into a primary care based group parenting program on increasing program participation by parents and improving program outcomes.

Detailed description: The investigators will perform a randomized controlled trial of the impact of Child Adult Relationship Enhancement (CARE) plus peer mentor on increasing program adoption, acceptability, and appropriateness among 2-6 year old children and their parents at UNC Children's Primary Care Clinic. The investigators will also examine the effectiveness of CARE plus peer mentor on dysfunctional parenting and child behavior problems. Participants will be randomized to CARE plus peer mentor or standard CARE. Program attendance, acceptability, and appropriateness will be measured upon completion of the 6-week program. Dysfunctional parenting and child behavior will be measured at baseline and 6 weeks. The investigators will conduct semi-structured interviews among a sample of parents (\~20-30) in order to understand the impact of the peer mentors on program implementation, as well as barriers and facilitators to program initiation and long-term participation.

Eligibility criteria: Inclusion Criteria:

* 2-6 year old child at UNC Children's Primary Care Clinic and their parent
* English speaking

Exclusion Criteria:

* child is developmentally younger than 2 years old
* child is already received mental health services for behavioral problems

Primary outcomes:
measure: Program Adoption
timeFrame: 6-12 weeks
Secondary outcomes:
measure: Child Behavior
timeFrame: 0 weeks and 6-12 weeks
measure: Dysfunctional Parenting Behaviors
timeFrame: 0 weeks and 6-12 weeks
measure: Dysfunctional Parenting Attitudes
timeFrame: 0 weeks and 6-12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samantha Schilling, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schilling S, Ritter V, Wood JN, Fine J, Zolotor AJ. Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation. J Dev Behav Pediatr. 2020 May;41(4):272-280. doi: 10.1097/DBP.0000000000000759.
Clinical trial NCT01978821: Stem Cell Therapy for Cerebral Palsy
Official title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
autologous bone marrow mononuclear cells
stem cell therapy
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the purpose of this study was to study the effect of stem cell therapy on common symptoms of cerebral palsy patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed cases of any type of Cerebral Palsy
* age above 12 months.

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia.

Primary outcomes:
measure: Change in clinical symptoms of cerebral palsy after 6 months
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
citation: Li Y, Tu L, Chen D, Jiang R, Wang Y, Wang S. [Study on functional recovery of hypoxic-ischemic brain injury by Rg1-induced NSCs]. Zhongguo Zhong Yao Za Zhi. 2012 Feb;37(4):509-14. Chinese.
citation: Sharma A, Sane H, Paranjape A, Gokulchandran N, Kulkarni P, Nagrajan A, Badhe P. Positron emission tomography-computer tomography scan used as a monitoring tool following cellular therapy in cerebral palsy and mental retardation-a case report. Case Rep Neurol Med. 2013;2013:141983. doi: 10.1155/2013/141983. Epub 2013 Feb 3.
citation: Wang X, Cheng H, Hua R, Yang J, Dai G, Zhang Z, Wang R, Qin C, An Y. Effects of bone marrow mesenchymal stromal cells on gross motor function measure scores of children with cerebral palsy: a preliminary clinical study. Cytotherapy. 2013 Dec;15(12):1549-62. doi: 10.1016/j.jcyt.2013.06.001. Epub 2013 Oct 5.
citation: Alvarez P, Carrillo E, Velez C, Hita-Contreras F, Martinez-Amat A, Rodriguez-Serrano F, Boulaiz H, Ortiz R, Melguizo C, Prados J, Aranega A. Regulatory systems in bone marrow for hematopoietic stem/progenitor cells mobilization and homing. Biomed Res Int. 2013;2013:312656. doi: 10.1155/2013/312656. Epub 2013 Jun 17.
Clinical trial NCT05561621: Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers
Official title: Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Digital Biomarker
Non-Motor symptoms
Fatigue
Cognition
Depression
Voice Analysis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Audeering GMBH
name: Biogen
First posted: 2022-09-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing MS and healthy controls

Brief summary: The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.


Eligibility criteria: Inclusion Criteria:

* Relapsing MS
* Age over 18
* EDSS \< 4.0
* Capability of written informed consent

Exclusion Criteria:

* Not fluent in german language
* Relapse or Steroids per os/intra venous \< 4 weeks prior to examination
* KM enhancing lesion in MRI \< 4 weeks prior to examination
* Other previous disease affecting the speech
* Pregnant patients
* Mental disability and not able to understand the protocol and study tasks in german languagePatients with greater physical and cognitive disability or history of major depressive disorder and suicide attempt/suicidal thoughts
* Patients with sleep disorders and comorbidities associated with extreme fatigue (e.g., fibromyalgia)

Primary outcomes:
measure: Identification of a voice signature that separates between pwMS with and without fatigue
timeFrame: One year
Secondary outcomes:
measure: Identification of a voice signature that separates between pwMS with and without cognitive impairment
timeFrame: One year
measure: Identification of a voice signature that separates between pwMS with and without depression
timeFrame: One year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital University Hospital Bern
Study officials:
affiliation: Inselspital, University Hospital Bern
name: Helly Hammer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03161821: Circulating Tumor Cells in Solid Tumors
Official title: Quantification and Characterization of Circulating Tumor Cells in Solid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor, Adult
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancerous solid tumors

Brief summary: The purpose of this study is to identify circulating tumor cells in patients with solid tumors. Quantify and characterize these cells, collect patient information in regards to the patient's cancer. Develop a database and a sample repository where future analysis could be done.

Detailed description: The primary purpose of this correlative study is to create a prospective database documenting the quantity and characterization of circulating tumor cells (CTCs) in solid tumor patients as identified by a various laboratory techniques and analyses. The investigators are developing this resource to provide data to achieve the following objectives: 1) correlate CTCs with known prognostic factors, 2) correlate CTCs with burden of disease, 3) evaluate the ability of CTCs to be used in the surveillance of disease recurrence, and 4) evaluate CTCs ability to be used as a biomarker for treatment response.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age
* Biopsy proven solid tumor malignancy
* Seen at UNC Chapel Hill Hospital and Health Care System
* Consents to abstraction of their medical records
* Signed an institutional review board (IRB)-approved informed consent document for this protocol

Exclusion Criteria:

* \< 18 years of age
* Dementia, altered mental status, incarceration or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Primary outcomes:
measure: Documentation of the Quality of CTCs from Patients with Solid Tumors
timeFrame: Through study completion, an average of 5 years
measure: Documentation of the Characterization of CTCs from Patients with Solid Tumors
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Radiation Oncology Clinic - UNC Cancer Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Lisa A Carey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chera BS, Kumar S, Shen C, Amdur R, Dagan R, Green R, Goldman E, Weiss J, Grilley-Olson J, Patel S, Zanation A, Hackman T, Blumberg J, Patel S, Thorp B, Weissler M, Yarbrough W, Sheets N, Mendenhall W, Tan XM, Gupta GP. Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer. J Clin Oncol. 2020 Apr 1;38(10):1050-1058. doi: 10.1200/JCO.19.02444. Epub 2020 Feb 4.
Clinical trial NCT06541821: Physical Activity, Kinesiophobia, and Stoma Compliance in Urostomy Patients
Official title: Investigation of Physical Activity, Kinesiophobia, and Stoma Compliance in Patients Undergoing Urostomy for Bladder Cancer
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bladder Cancer
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients using ostomy after Urostomy Surgeries for Bladder Cancer

Brief summary: In this study, it is aimed to determine the level of physical activity, to investigate kinesiophobia, to determine compliance with the stoma and to compare with healthy controls in patients with bladder cancer who have undergone urostomy surgery and live with a stoma.


Eligibility criteria: Inclusion Criteria:

* The patient group will include people between the ages of 40-75 who underwent urostomy surgery and a stoma after being diagnosed with bladder cancer.
* The control group will include age-matched healthy people with similar age, body weight and height, without a previous history of cancer.

Exclusion Criteria:

* Orthotopic surgeries will not be included in the patient group
* Being under the age of 40,
* Being diagnosed with lymphedema,
* Presence of active metastasis,
* Neurological pathologies that limit voluntary mobility,
* Orthopedic and cardiovascular pathologies,
* Having a learning disability or other cognitive or communication impairment.
* The control group will be excluded if they have any history of cancer.

Primary outcomes:
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: 10 minutes
measure: Tampa Kinesiophobia Scale
timeFrame: 10 minutes
measure: Ostomy Compliance Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selçuklu
Study officials:
References:
Clinical trial NCT04247321: Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure
Official title: Non-invasive Near-infrared Spectroscopy (NIRS) Versus Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 0
Sex: ALL
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: Researchers are trying to assess how accurately and safely NIRS non-invasive monitoring can detect changes in intracranial pressure to determine if this noninvasive device can be used instead of invasive monitoring with Licox in the future.


Eligibility criteria: Inclusion:

* Subjects with acute brain injury who are age ≥ 18
* Glasgow coma scale score (GCS) ≤ 8
* Neuroimaging concerning for ICP crises, or have active ICP treatment
* Have Licox Brain Tissue Oxygen monitor placed as standard of care treatment

Exclusion:

* CNS infection
* Bleeding diathesis or thrombocytopenia \< 50,000 platelets
* Subjects with subdural hematomas who have had surgical decompression and bone flap removal

Primary outcomes:
measure: Correlation between changes in Licox and NIRS oxygenation measurements
timeFrame: 3 to 5 days of the monitoring duration
Secondary outcomes:
measure: Correlation between changes in pressure reactivity index and Licox versus NIRS
timeFrame: 3 to 5 days of the monitoring duration
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alejandro A Rabinstein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04155021: Knowledge and Attitude in Perioperative Erythrocyte Transfusion in Medical Personnel in Siriraj Hospital
Official title: Knowledge and Attitude in Perioperative Erythrocyte Transfusion in Medical Personnel of the Department of Anesthesiology and Department of Orthopedic Surgery in Siriraj Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusion-dependent Anemia
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-graduated medical personnel in Siriraj Hospital who associated with erythrocyte transfusion practice.

Brief summary: This study is designed to explore the correlation between knowledge and attitude in perioperative erythrocyte transfusion in medical personnel.

Detailed description: Inappropriate erythrocyte transfusion is still have high incidence even lots of the transfusion guidelines and researches was launched. Unnecessary or delayed transfusion can cause morbidity and mortality. This study is descriptive research, questionnaire based survey conducted to explore the correlation between knowledge and attitude in perioperative erythrocyte transfusion in medical personnel in Siriraj Hospital.

Eligibility criteria: Inclusion Criteria:

* Post-graduated medical personnel in Siriraj Hospital

Exclusion Criteria:

* Post-graduated medical personnel in Siriraj Hospital who refuse to participate

Primary outcomes:
measure: Knowledge in perioperative erythocyte transfusion in medical personnel in Siriraj Hospital
timeFrame: 10 minutes
Secondary outcomes:
measure: Attitude in perioperative erythocyte transfusion in medical personnel in Siriraj Hospital
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital
name: Mingkwan Wongyingsinn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646321: Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT
Official title: A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
children
adolescents
Symbicort
budesonide/ formoterol
budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 540
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years


Eligibility criteria: Inclusion Criteria:

* At least 6 and maximally 15 years of age
* Diagnosis of asthma and baseline lung function tests as determined by the protocol
* Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Primary outcomes:
measure: Change in evening PEF
timeFrame: Daily throughout the 12 week treatment period
Secondary outcomes:
measure: Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes
timeFrame: Daily throughout the 12 week treatment period
measure: Routine safety assessments described in the protocol
timeFrame: 2-4 assessments within 12 week treatment period
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_DIRECTOR
References:
citation: Eid NS, Noonan MJ, Chipps B, Parasuraman B, Miller CJ, O'Brien CD. Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma. Pediatrics. 2010 Sep;126(3):e565-75. doi: 10.1542/peds.2009-2970. Epub 2010 Aug 16.