louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01195233: Comparative Analysis of BioXtra on Xerostomia
Official title: Comparison Study of BioXtra Spray and Mouth Rinse in Patient With Radiation-induced Xerostomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Radiation-Induced Xerostomia
Keywords: Xerostomia
Radiotherapy of head and neck
BioXtra
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Imam Khomeini Hospital
First posted: 2010-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study compared the efficacy of BioXtra spray and mouth rinse in the relief of radiotherapy-induced xerostomia in patients referred to Cancer Institute, Tehran Imam Khomeini Hospital.

Detailed description: Xerostomia or dry mouth is an important complication of radiotherapy for head and neck regions producing serious discomfort for patients with a significant reduction in their quality of life. Symptomatic treatments for the disease include maintain oral hygiene and use of artificial saliva substitutes.

Due to limited studies on efficacy compounds BioXtra, present study compared the effects of spray and mouth rinse BioXtra in symptoms of xerostomia in patients under head and neck cancer radiotherapy .

Eligibility criteria: Inclusion Criteria:

* complaint of xerostomia after head and neck radiotherapy
* patient must have given written informed consent

Exclusion Criteria:

* age under 18 years
* history of any treatment for cancer in the last 3 months
* recurrence of cancer and end stage of it
* diabetes mellitus
* sjogren syndrome or other medical causes of xerostomia
* drug therapy which might induce xerostomia
* refusal of cooperation or consent

Primary outcomes:
measure: improvement of xerostomia
timeFrame: 2 weeks
Secondary outcomes:
measure: comparative analysis of improvement xerostomia between 2 drugs
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
Study officials:
affiliation: Qazvin University Of Medical Sciences
name: Mahin Bakhshi, DDS/MS
role: STUDY_CHAIR
affiliation: QUMS
name: Touba Karagah, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Imam Khomeini Hospital
name: Soheila Manifar, DDS/MS
role: STUDY_DIRECTOR
affiliation: QUMS
name: Navid Mohamadi, PHD
role: STUDY_DIRECTOR
affiliation: QUMS
name: Abbas Hosseinmardi, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00042133: Socio-economic Status and Age-related Disability in a Biracial Community
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: aging
disability
longitudinal studies
neighborhood factors
socio-economic status
race
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-26
Enrollment: 6000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The overall goal of the proposed project is to examine the reasons for the higher levels of disability in older people of lower socio-economic status.

Detailed description: This application is a continuation of an epidemiologic study that investigates the effect of socio-economic disadvantage and neighborhood conditions on disability in older blacks and whites. The proposed project takes place in the context of a population-based, longitudinal study of persons aged 65 years and over who live in a geographically defined, urban, biracial community area in Chicago. During the initial funding period, we have successfully collected yearly disability outcome data, and detailed information on neighborhood conditions using self-report instruments and a systematic neighborhood survey of study area.

The first overall goal of this continuation is to determine the relative contribution and specific nature of the neighborhood conditions that are associated with disability in older adults. The second overall goal is to determine the biological mechanisms through which neighborhood conditions lead to increased disability, focusing specifically on hyperactivity of the hypothalamus-pituitary-adrenal (HPA) axis, via salivary cortisol, and inflammatory processes, via interleukin-6 (IL-6) and C-reactive protein (CRP), obtained from blood samples. To accomplish these goals, we propose to continue yearly collection of disability outcome data and obtain blood samples and salivary cortisol from over 7,000 participants. These data will be integrated with a rich set of existing data on personal characteristics, health conditions, and neighborhood factors to test of series of specific hypotheses related to the overall goals.

Disability is a common and highly prevalent consequence of age-related chronic diseases, and a critical indicator of overall health among older people. Prevention of disability is essential to improve the lives of older people and reduce health care costs. The proposed work will contribute to a better understanding of the specific neighborhood conditions that are associated with increased disability, laying the foundation for more effective policies to prevent disability in future generations of older adults.

Eligibility criteria: inclusion criteria: adults aged 65 years and over exclusion criteria: none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Carlos F. Mendes de Leon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05890833: The Risk of Falls Index for Patients With Neuromuscular Disorders
Official title: The FBIndex to Determine the Risk of Falls and Its Translation to Assistive Gait Device Care for Patients With Neuromuscular Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inclusion Body Myositis
Myotonic Dystrophy
Facioscapulohumeral Muscular Dystrophies
Myasthenia Gravis
The Falls Efficacy Scale International
The Morse Fall Scale
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Following neuromuscular diseases are included in the study: inclusion body myositis, myotonic dystrophies, limb girdle and facioscapulohumeral muscular dystrophies, and myasthenia gravis.

Brief summary: The combination of short quantitatively assessing muscular function and balance in combination with short clinical scores, can be a new valid approach to evaluate the patient risk of fall and help to create a quick checkup test to prescribe an appropriate assistive device.

The primary goal of this project is to provide a short battery of clinical assessments used to determine risk of falling for patients with neuromuscular diseases (NMD) based on correlation between clinical assessments between two groups of NMD patients and scales used to assess risk of falling for patients.


Eligibility criteria: Inclusion Criteria:

* Patients between 18- and 65-year-old
* Patients with adequate cognitive and communication function to fill out the scales assessing risk of falling
* The neuromuscular disease needs to be confirmed by genetic report and/or disease deepening neurophysiological examination.

Exclusion Criteria:

- Patients which are not able to perform motoric functional assessments without assistive gait device.

Primary outcomes:
measure: FBIndex
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Marko Mijic
state: Bavaria
Study officials:
References:
Clinical trial NCT05933733: Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
Official title: A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients who underwent standard treatment for initial breast cancer and experienced locoregional recurrence without distant metastasis which is eligible for salvage treatment can be enrolled for this study.

Brief summary: The purpose of this study is to evaluate clinical outcomes and adverse events of salvage treatment for locoregional recurrence of breast cancer.

The main questions it aims to answer are:

* Clinical outcomes after salvage treatment for locoregional recurrence
* Adverse events and quality of life after salvage treatment for locoregional recurrence
* Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events
* Molecular signature associated with treatment resistance

Participants will be assessed by multi-dimensional methods during and after radiation therapy:

* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0
* Assessment for the molecular signature using residual tissue after pathologic diagnosis
* Assessment for the quality of life using questionnaires (BREAST-Q)


Eligibility criteria: Inclusion Criteria:

* Female patients with age 18 to 100.
* Previous standard definitive treatment for initial breast cancer
* Locoregional recurrence without distant metastasis
* Planned salvage treatment for locoregional recurrence
* Informed consent of the participant

Exclusion Criteria:

- Not anticipated for complying the study protocol

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 years from the initiation of the salvage therapy
measure: Rate of adverse events
timeFrame: 5 years from the initiation of the salvage therapy
Secondary outcomes:
measure: Locoregional failure rate
timeFrame: 5 years from the initiation of the salvage therapy
measure: Cancer-specific survival
timeFrame: 5 years from the initiation of the salvage therapy
measure: Quality of life (BREAST-Q)
timeFrame: 5 years from the initiation of the salvage therapy
measure: Breast cosmesis
timeFrame: 5 years from the initiation of the salvage therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Haeyoung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03747133: SABR for Renal Tumors
Official title: Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Tumor
Keywords: Stereotactic Body Radiation Therapy
SABR
Radiation Therapy
Renal Cell Carcinoma
RCC
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.


Eligibility criteria: Inclusion Criteria:

* Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm
* Histological or radiological diagnosis of renal tumor
* Inoperable: High risk for surgery or declined surgery
* ECOG performance status of 0-3

Exclusion Criteria:

* ≥5 active metastases
* Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR
* Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney
* Patients with end stage renal failure \> 4(KDOQI guidelines)
* Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

Primary outcomes:
measure: To evaluate the radiation induced renal impairments in patients receiving SABR.
timeFrame: 2 years
Secondary outcomes:
measure: Chronic Kidney Disease Stage Progression
timeFrame: 2 years
measure: 2-year Local recurrence rate
timeFrame: 2 years
measure: Patient Reported Outcomes
timeFrame: 2 years
measure: Incidence of acute and late toxicities
timeFrame: 2 years
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: Andrew McPartlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837733: Endometrial Local Injury and Implantation Failure
Official title: Endometrial Local Injury Improves the Pregnancy Rate Among Recurrent Implantation Failure Patients Undergoing IVF/ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Endometrial biopsy
IVF/ICSI
Pregnancy outcome
Recurrent implantation failure
Lead sponsor: Yazd Research & Clinical Center for Infertility
Sponsor class: OTHER
Collaborators: name: Yazd Medical University
First posted: 2009-02-05
Enrollment: 115
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.

Detailed description: In a randomized control trial study, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group.

The implantation rate was determined as 10.9% in biopsy group compared with 3.38% in controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1% and 8.9% respectively

Eligibility criteria: Inclusion Criteria:

* women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred

Exclusion Criteria:

* age over than 40 years old
* poor responders to ovarian stimulation

Primary outcomes:
measure: Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Research and Clinical Center for Infertility
Study officials:
affiliation: Research and Clinical Center for Infertility
name: Mohammad Ali Karimzadeh, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
Clinical trial NCT02959333: Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
Official title: Human Amniotic Epithelial Cells for Treatment of Bronchial Fistula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Bronchial Fistula
Lead sponsor: The Second Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2016-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bronchial fistula (BF), an abnormal passage or communication between a bronchus and another part of the body, may develop when there are penetrating wounds of the thorax and after lung surgery. Without effective therapy, treatment of BF is a challenge, with a high rate of mortality and teratogenicity.

The investigators will conduct endoscopic injection of human amniotic epithelial cells to fistula, observe the recovery of bronchial fistula and systemic reactions, to investigate the application of human amniotic epithelial cells in the treatment of bronchial fistula.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with bronchial fistula by Imaging or bronchoscopic examination
* typical symptom of bronchial fistula, such as fever, cough, purulent sputum, weight loss...
* patients present compromised conditions, who can only accept a conservative treatment.

Exclusion Criteria:

* absolute contraindication of bronchoscopic examination and treatment
* with previous treatment of cell therapy, including stem cells.

Primary outcomes:
measure: median time for fistula closure
timeFrame: 12 weeks
Secondary outcomes:
measure: complication
timeFrame: 1 year
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The Second Affiliated Hospital of Fujian Medical University
name: Yimin Zeng, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01122433: Airway Management Study to Evaluate the C-MAC Video Laryngoscope as an Alternative to the Direct Laryngoscopy
Official title: Evaluation of the C-MAC Video Laryngoscope After Failed Direct Laryngoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unexpected Difficult Airway
Keywords: difficult airway
indirect laryngoscopy
C-MAC video laryngoscope
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2010-05-13
Enrollment: 50
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 purpose of this study is to evaluate the C-MAC video laryngoscope in difficult airway situations.

Detailed description: Unanticipated difficulties during tracheal intubation and failure to intubate are among the leading causes of anaesthesia related morbidity and mortality. Using the technique of video laryngoscopy, the alignment of the oral and pharyngeal axis to facilitate endotracheal intubation is obsolete. In this study we evaluate the C-MAC video laryngoscope (STORZ, Tuttlingen, Germany) for endotracheal intubation in difficult intubation situations (Cormack \& Lehane (CL) grade 3 and 4) validated by Macintosh laryngoscope. We hypothesize that endotracheal intubation is possible using the C-MAC in patients after failed direct laryngoscopy. We also examine whether visualisation of the glottis is improved with this device compared to direct laryngoscopy and possible complications such as soft tissue injury.

Eligibility criteria: Inclusion Criteria:

* Unexpected difficult airway

Exclusion Criteria:

* History of difficult or impossible mask ventilation
* Age \< 18 years
* ASA grade \> 3
* Emergency surgery

Primary outcomes:
measure: Success rate of endotracheal intubation using the C-MAC video laryngoscope
Secondary outcomes:
measure: - improved glottic view
measure: - complications
measure: - numbers of intubation attempts
measure: - size of blade (C-MAC)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Univeritätsmedizin of the JG University, Department of Anaesthesiology
Study officials:
affiliation: Department of Anaesthesiology, Universitätsmedizin Mainz
name: Tim Piepho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology, Universitätsmedizin Mainz
name: Rüdiger R Noppens, MD
role: PRINCIPAL_INVESTIGATOR
References: