louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04650256: Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Official title: Application of Chinese Herbal Complementary and Alternative Medicine (CAM) to Improve Human Health and to Further Botanical and Horticultural Sciences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Toxicity
Keywords: Breast cancer
Radiotherapy
Complementary and alternative medicine
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: VAUGHN-JORDAN FOUNDATION, INC.
name: Florida Breast Cancer Foundation
First posted: 2020-12-02
Enrollment: 40
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 research is to study a Chinese herbal Complementary and Alternative Medicine (CAM) product for the temporary relief of pain and itching after radiotherapy (RT). This is an over-the-counter product with 1% menthol as an active ingredient.


Eligibility criteria: Inclusion Criteria:

* Female subjects with newly diagnosed breast carcinoma
* \> 18 years of age
* Post-mastectomy with or without reconstruction
* Stage II-IIIb with any receptor status
* All races and ethnicities are eligible
* Patients must be able to consent in English or Spanish
* Plan to receive adjuvant radiotherapy to the chest wall +/- regional lymph nodes
* RT will involve standard fractionation use of 3D conformal or Intensity-modulated RT (IMRT)
* Willing to sign protocol consent form
* Patients are allowed to receive adjuvant hormonal therapy and/or targeted therapies such as trastuzumab prior to, during and/or after radiation therapy.
* Patients may receive chemotherapy before or after radiation therapy

Exclusion Criteria:

* Prior radiation to the involved breast or chest wall
* Concurrent chemotherapy
* Unable or unwilling to sign informed consent
* Unable to speak English or Spanish
* Pregnant women
* Clinical or pathologic stage T4
* Metastatic disease
* Connective tissue disorder including Systemic Lupus Erythematosus and Scleroderma

Primary outcomes:
measure: Proportion of patients free of clinically relevant skin toxicities
timeFrame: Up to 18 weeks.
Secondary outcomes:
measure: SD-16 scores
timeFrame: Up to 18 weeks.
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B) scores
timeFrame: Up to 18 weeks.
measure: High-sensitivity C-reactive protein (hsCRP) values
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: U. of Miami
name: Jennifer J Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00191256: Efficacy Trial of Gemcitabine Containing Regimens As Preoperative Chemotherapy in Non Small Cell Lung Cancer
Official title: Randomized Phase II Trial to Outline the Efficacy of Gemcitabine Containing Regimens (Gemcitabine/Carboplatin and Gemcitabine/Paclitaxel) When Used as Preoperative Chemotherapy In Patients With Stage I and II NSCLC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non Small Cell Lung
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the rate of complete pathological response after 3 cycles of gemcitabine containing chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed non small cell lung cancer
* No prior chemotherapy or radiation for non small cell lung cancer
* No prior malignancy

Exclusion Criteria:

* Pregnancy or breastfeeding
* Serious concomitant disorders

Primary outcomes:
measure: Pathological complete response rate, in previously untreated patients with clinical Stage I and II non-small cell lung cancer (NSCLC).
Secondary outcomes:
measure: Response rate, disease free survival,toxicities including pulmonary toxicity, operative mortality, and quality of life.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: North Carolina
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05152056: MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
Official title: Role of MRI and Fine Needle Aspiration in the Diagnosis of Parotid Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parotid Tumor
Keywords: Parotid Tumor
Diffusion MRI
Perfusion MRI
Aspiration cytology
Fine-needle biopsy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 133
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor and major subjects operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020 and having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.

Brief summary: What value is given to MRI diffusion and perfusion sequences in the diagnosis of parotid tumors? Is a fine needle aspiration associated with MRI systematically necessary? The aim of the research is to study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Minor subject (\<18 years old)
* Operated for a parotid tumor at Strasbourg University Hospital between January 2009 and June 2020
* Having had in the preoperative assessment an MRI of the parotid, also carried out at the Strasbourg University Hospital.
* Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject (or his parents) who expressed his (their) opposition to participating in the study
* Lack of pathological or MRi results
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Study the performance of diffusion and perfusion MRI sequences in the diagnosis of parotid tumors on a large series of cases
timeFrame: Files analysed retrospectively from January 1, 2009 to June 30, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'ORL et de Chirurgie Cervico-Faciale - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT06098456: Epigallocatechin Gallate and Other Antural Compounds in HPV Infections
Official title: Treatment With Epigallcoatechin Gallate, Hyaluronic Acid, Folic Acid and Vitamin B12 in Women HPV Positive With Abnormal Cytology Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Papilloma-induced Cervical Lesions
Keywords: EGCG
HPV
Folic acid
Hyaluronic acid
Vitamin B12
LSIL
Lead sponsor: Centro di Ricerca Clinica Salentino
Sponsor class: NETWORK
First posted: 2023-10-24
Enrollment: 178
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients decide wheter to receive the experimental treatment or to undergo routine clinical practice.
Primary purpose: TREATMENT

Brief summary: The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.

Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.

After three months of treatment PAP-test and HPV-DNA test will be repeated.


Eligibility criteria: Inclusion Criteria:

* Positivity to HPV-DNA test
* PAP-test reporting LSIL or ASCUS

Exclusion Criteria:

* HPV-related pathologies or complicances apart from LSIL or ASCUS
* Diagnosis of cancer

Primary outcomes:
measure: Positivity to HPV infection
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Occurrence of lesions
timeFrame: 3 and 6 months
measure: Lesions-related symptmos
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Scorrano
country: Italy
facility: Ospedale Veris delli Ponti
state: Lecce
Study officials:
References:
Clinical trial NCT04890756: The Greek Version of Modified Baecke Questionnaire
Official title: Validity and Reliability of the Greek Version of the Modified Baecke Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: validation
reliability
adaptation
questionnaire
Greek version
Baecke
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy

Brief summary: The purpose of this study was to translate and investigate the validity and reliability of the modified Baecke Physical Activity Questionnaire (mBQ) in the Greek adult population.

Detailed description: The purpose of this study was to translate and investigate the validity and reliability of the modified Baecke Physical Activity Questionnaire (mBQ) in the Greek adult population. The cross-cultural adaptation of the mBQ was performed according to official guidelines.The reliability was determined by filling out the mBQ, two times, one week apart. For validation, the scores between the mBQ and the IPAQ were compared and the correlation between mBQ and VO2max and between mBQ and interview (METS) were assessed.

Eligibility criteria: Inclusion Criteria:

1. age above 18
2. Greek native speakers
3. Greek inhabitants
4. sufficient cognitive functioning.

Exclusion Criteria:

1. poor health status,
2. diagnosed with cardiovascular diseases
3. cardiac pacemaker,
4. medication that prevents exercise activity
5. neurological disorders with effect on the lower body
6. musculoskeletal disorders or injuries on the lower body in the last 3 months
7. PAR-Q health risk assessment form

Primary outcomes:
measure: Reliability
timeFrame: one week apart
measure: Validity
timeFrame: 1) IPAQ ( Time Frame: 30 min) 2) Astrand-Rhyming Cycle Ergometer Test (Time Frame: 20 min) 3) Interview (Time Frame: 45 min) 4)Modified Baecke Questionnaire (Time Frame: 30 min)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stefanouli V, Kapreli E, Anastasiadi E, Nakastsis A, Strimpakos N. Validity and reliability of the Greek version of modified Baecke questionnaire. Public Health. 2022 Feb;203:58-64. doi: 10.1016/j.puhe.2021.11.017. Epub 2022 Jan 13.
Clinical trial NCT06394856: Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
Official title: Comparison of Outcomes of Rotator Cuff Repair With a Modified Versus Classic Double-Row Suture -Bridge Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 89
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: rotator cuff tears are one of the most common shoulder issues , affecting 20.7% of the general population .

Detailed description: accompanied by shoulder pain and dysfunction

Eligibility criteria: Inclusion Criteria:

* full-thickness supraspinatus
* degenerative tears
* age range 40 :65

Exclusion Criteria:

* subscapularis tear
* small and massive tears
* traumatic tears
* partial -thickness tear
* revisioin surgery
* glenohumeral arthretic changes and shoulder instability

Primary outcomes:
measure: retear rate
timeFrame: 3 years
Secondary outcomes:
measure: time
timeFrame: 3 years
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: university Hospital
Study officials:
affiliation: Sohag University
name: Hossam M azab, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05967156: Empagliflozin in Heart Failure Dialysis Patients
Official title: Safety and Efficacy of Empagliflozin on Heart Failure Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Hemodialysis
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Empagliflozin is not still approved for glomerular filtration rate \< 20 cc/min/1.73m2. Considering the cardiac and renal benefits of this drug, the evaluation of the safety and efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.

Detailed description: Heart failure dialysis patients with residual renal function will be followed up on Empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels, diuresis volume, and serum acidity.

Eligibility criteria: Inclusion Criteria:

* Heart failure on dialysis with residual renal function

Exclusion Criteria:

* Dialysis patients with no residual urine

Primary outcomes:
measure: Brain Natriuretic Peptide
timeFrame: one month after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: SMBU
name: Dalili
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01873456: Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Official title: Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older Adults
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.


Eligibility criteria: Inclusion Criteria:

* Screening for nutritional risk

Exclusion Criteria:

* terminal condition or do not wish to participate

Primary outcomes:
measure: Quality of life
timeFrame: up to 6 months
Secondary outcomes:
measure: Nutritional status
timeFrame: up to 6 months
measure: Hand grip strength
timeFrame: up to 6 months
measure: Costs
timeFrame: up to 6 months
measure: Activities of Daily Living and cognitive performance
timeFrame: up to 6 months
measure: physical strength
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Home care and nursing homes
Study officials:
affiliation: University of Copenhagen
name: Anne Marie Beck
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beck AM, Keiding H, Christensen AG, Hansen BS, Svendsen SD, et al. (2015) Multidisciplinary Nutritional Support for Page 2 of 7 Undernutrition in Older Adults in Nursing Home and Home-Care is Cost-Effective. SOJ Nur Health Care 1(1): 1-7.
citation: Beck AM, Gogsig Christensen A, Stenbaek Hansen B, Damsbo-Svendsen S, Kreinfeldt Skovgaard Moller T, Boll Hansen E, Keiding H. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial. Nutr J. 2014 Aug 28;13:86. doi: 10.1186/1475-2891-13-86.
citation: Beck AM, Christensen AG, Hansen BS, Damsbo-Svendsen S, Moller TK. Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial. Nutrition. 2016 Feb;32(2):199-205. doi: 10.1016/j.nut.2015.08.009. Epub 2015 Sep 3.
Clinical trial NCT03118856: Electronic Chromoendoscopy for Polyp Characterization
Official title: Real-time Assessment of the Histology of Colorectal Polyps Using Electronic Chromoendoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Polyp
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing screening or surveillance colonoscopy

Brief summary: To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.


Eligibility criteria: Inclusion Criteria:

* patients undergoing screening or surveillance colonoscopy
* written informed consent

Exclusion Criteria:

* inadequate bowel preparation
* polyposis syndromes
* history of colectomy
* use of anticoagulants

Primary outcomes:
measure: Accuracy of predicting histology with EC
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
affiliation: University Hospital Erlangen
name: Timo Rath, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01356056: Tele-diagnostics for Remote Parkinson's Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Cincinnati
First posted: 2011-05-19
Enrollment: 12
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 Parkinson's disease

Brief summary: The purpose of this research study is to design, implement, and clinically assess a portable, user worn system for monitoring Parkinson's disease (PD) motor symptoms. The current standard in evaluating symptoms is the Unified Parkinson's Disease Rating Scale (UPDRS), a subjective, qualitative ranking system. The main goal of this research is to develop a quantitative system, Kinesia HomeView, to assess tremor as well as different features of bradykinesia in a home based system which can capture those symptom changes over the course of a day and aid in evaluating treatment protocol efficacy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* Inability to follow the required clinical instruction
* Subjects with cognitive impairments that would prohibit them from properly using the Kinesia HomeView system
* Subjects without the cognitive ability to respond to researchers and let them know when any parameters of the study may become uncomfortable
* Subjects found on examination by our clinicians to have any physical limitations which would be counter productive to participation in this study.

Primary outcomes:
measure: UPDRS
timeFrame: Every 4 weeks
measure: PDQ-39
timeFrame: Every 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
References:
Clinical trial NCT00241956: Impact of Diabetes and Glucose Control During Rehabilitation After Stroke
Official title: Impact of Diabetes and Glucose Control During Rehabilitation After Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebrovascular Accident
Diabetes
Hyperglycemia
Lead sponsor: Melbourne Health
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2005-10-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke rehab patients

Brief summary: To assess whether patients with diabetes have less clinical improvement during inpatient rehabilitation than those without diabetes and whether hyperglycaemia during rehabilitation is an adverse prognostic indicator.

Detailed description: Patients with diabetes have a higher mortality rate and more severe disability from stroke compared to those without diabetes. Those with hyperglycaemia tend to progress to a larger final stroke size. Diabetes and hyperglycaemia may affect the ability of the patient to clinically improve, independent of the degree of initial impairment. We will perform a retrospective review of medical records of stroke patients admitted to an inpatient rehabilitation unit. We will compare outcomes of changes in disability scales (FIM and Barthel) from admission to discharge, length of stay and hospital events between those with and without diabetes. Amongst those with diabetes, we will also assess whether those with higher mean blood glucose levels during their inpatient rehabilitation stay have worse outcomes.

Eligibility criteria: Inclusion Criteria:

* Inpatient rehabilitation for acute stroke

Exclusion Criteria:

* Medical records unavailable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Leo Rando, MBBS FRACP
role: PRINCIPAL_INVESTIGATOR
References: