louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01824134: Aloe Vera on Irradiated Breast Tissue
Official title: A Phase III Double Blind Study on the Efficacy of Topical Aloe Vera Gel on Irradiated Breast Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irradiated Breast Tissue
Lead sponsor: John D. Archbold Memorial Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators are testing two over the counter aloe veras on irradiated breast tissue.


Eligibility criteria: Inclusion Criteria:

1. Women over 18 years of age who had undergone lumpectomy or partial mastectomy for breast cancer, and who then received postoperative radiation therapy using tangential fields, with or without a boost to the tumor bed. Chemotherapy as part of the treatment regimen was acceptable.
2. No major medical or psychiatric illness that might interfere with patient's completion of study requirements
3. Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

1. Those requiring nodal radiation therapy were excluded.
2. Subjects who have a breast infection at the commencement of radiation treatment
3. Before randomization, subjects who have agreed to participate are asked if they are allergic to any topical preparation. Those allergic to aloe vera were ineligible.

Primary outcomes:
measure: erythema
timeFrame: one year
Secondary outcomes:
measure: itching
timeFrame: one year
Other outcomes:
Locations:
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
state: Georgia
Study officials:
References:
Clinical trial NCT03697434: Acceptability of Palliative Care in Parkinson Disease Care
Official title: Pilot to Assess the Acceptance of Palliative Care Referral Among Those With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: American Academy of Neurology
First posted: 2018-10-05
Enrollment: 20
Sex: ALL
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: This study will assess the feasibility of using specific criteria to standardize the referral of individuals with Parkinson disease to a group of medical providers known as palliative care specialists. Palliative care specialists provide supportive care to individuals living with serious illnesses. The specialty focuses on providing relief from the symptoms and stress of serious illness.


Eligibility criteria: Subjects with Parkinson disease:

Inclusion Criteria:

* Diagnosis of idiopathic PD confirmed as most likely diagnosis with participant's treating provider
* 18 years of age or older
* Participant or care partner able to provide informed consent
* Presence of one or more of the following:

Uncontrolled symptoms (over prior week):

* Depression
* Pain
* Fatigue

Critical events (over prior 6 months):

* ≥3 falls
* Unintended weight loss
* Wheelchair dependence (\>50% of time)

Exclusion Criteria:

* Diagnosis of atypical or secondary parkinsonism
* Outpatient palliative care visit scheduled or within the prior 6 months of the screening visit

Subjects who are care partners:

Inclusion Criteria:

* Care partner of enrolled participant in the study
* 18 years of age or older
* Able to provide informed consent

Exclusion Criteria:

• No care partner specific exclusion criteria

Primary outcomes:
measure: Proportion of enrolled participants who have at least 1 visit with a palliative care provider within 3 months of referral
timeFrame: 3 months
Secondary outcomes:
measure: Change in mean symptom burden
timeFrame: Baseline to 3 months
measure: Change in mean quality of life as assessed by the Quality of Life-Alzheimer Disease questionnaire (QoL-AD)
timeFrame: Baseline to 3 months
measure: Change in mean caregiver burden
timeFrame: Baseline to 3 months
measure: Change in mean caregiver self-efficacy
timeFrame: Baseline to 3 months
measure: Barriers to palliative care referral
timeFrame: Baseline
measure: Barriers to palliative care referral
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: URMC Neurology; 919 Westfall Rd, Building C
state: New York
Study officials:
References:
Clinical trial NCT06849934: Reliability of Kinovea Software for Measurement of Transtibial Amputee Knee Kinematics
Official title: Reliability of Kinovea Software for Measurement of Transtibial Amputee Knee Angle During Walking
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Amputee
Amputees
Keywords: amputee
motion analysis
kinematics
reliability
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have unilateral transtibial amputation

Brief summary: The primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. The secondary objective was to calculate the absolute reliability by calculating the Standard Error of Measurement (SEM), SEM% and Minimal Detectable Change at 95% confidence interval (MDC95). The SEM value represents the extent to which a score changes during the repetition of the measurement. The MDC is the minimum change in the measurement that is considered a true change in the measured activity that is not due to error.


Eligibility criteria: Inclusion Criteria:

* Having a unilateral below-knee (transtibial) level amputation,
* Using a prosthesis and being able to walk with the prosthesis,
* Body mass index less than 30,
* No contracture in the intact or amputated knee.
* Not having had any surgery related to the knees.

Primary outcomes:
measure: Vİdeo Recording
timeFrame: From enrollment to the end of video record (10 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University Health Sciences
Study officials:
References:
Clinical trial NCT02562534: Creation of an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease.
Official title: Use of a New ElectroCardioGraph to Create an ECG Database in 3T MRI With Healthy Heart and Several Kind of Cardiac Disease in Order to Let go of Artifacts.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Diseases
Keywords: ECG
MRI
rhythm troubles
conductive troubles
ECG artifacts
Database
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim is to create a database including recordings of ECG data recorded in an MRI acquisition

Detailed description: ECG monitoring is an essential tool during MRI, especially for cardiac MRI (CMR). Indeed, the system needs to synchronize the acquisitions on the cardiac cycles. To identify the cycle, the system is based on the ECG. Furthermore, patients having a CMR can be at risk of presenting cardiac rhythm troubles, and must be monitored with a trustable system.

The problem is that in MRI, a lot of artefacts occur, leading to dramatic disturbances of the signal. A lot of tools are used to try to remove the artefacts. The aim of this study is to create a database that can be used to test the different tools to remove the artefacts.

The investigators intend to include all types of ECG patterns that can exist, to allow to test the tools in all situations.

Eligibility criteria: Inclusion Criteria:

* For all subjects:

  * To be more than 18
  * To be enroled in a social security plan
  * To have signed an informed consent
  * To have preliminary medical examination
* For the groups :

  * "normal ECG" group : sinus rhythm without conductive troubles. Normal pattern of the QRS
  * "conductive troubles group" : patients with typical right bundle branch block, or typical left bundle branch block pattern.
  * "rhythm trouble group" : patients with premature atrial beats or premature ventricular beats

Exclusion Criteria:

* Contraindication: implantable devices (cardiac stimulators, defibrillators, cochlear implants, etc.), metallic foreign bodies
* Impossibility to undergo MRI: claustrophobia, morbid obesity.
* Pregnancy or risk of pregnancy.
* Patients under a measure of legal protection

Primary outcomes:
measure: Evaluation of the ECG signal quality
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Christian De Chillou, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154634: Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Official title: A Double-blind, Randomized, Placebo-controlled, Two-centre, Phase IIa Pharmacodynamic Cross-over Study to Assess the Effect of AZD2516 on the Total Number of Reflux Episodes in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Reflux
Keywords: Pharmacodynamic effect
Reflux inhibition
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Detailed description: A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* Provision of signed informed consent
* Healthy male subjects
* Age 18-45 years, inclusive

Exclusion Criteria:

* Clinically significant illness within the 2 weeks prior to the first dose of study drug
* History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease
* Need for concomitant medications during the study

Primary outcomes:
measure: Reflux Episodes 0 to 3 Hours Post Meal
timeFrame: 0 to 3 hours post meal
Secondary outcomes:
measure: Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal
timeFrame: 0 to 3 hours post meal
measure: Area Under the Plasma Concentration Curve(AUC)
timeFrame: 0 to 12 hours post dose
measure: Average Plasma Concentration (C Average)
timeFrame: 1 to 4 hours post dose
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0 to 12 hours post dose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: 0 to 12 hours post dose
measure: Terminal Half-life (T Half)
timeFrame: 0 to 12 hours post dose
measure: Clinically Relevant Change of Laboratory Variables
timeFrame: Pre-entry to follow-up
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Molndal
name: Mark Berner Hansen
role: STUDY_DIRECTOR
References:
Clinical trial NCT04309734: Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Official title: A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Hepatitis C
Hepatitis C, Chronic
Chronic Hepatitis C
Hepatitis C Virus Infection
HCV Infection
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.


Eligibility criteria: Inclusion Criteria:

All:

* Body mass index (BMI) of 18-35 kg/m2
* Must agree to use protocol-specified methods of contraception
* Negative pregnancy test
* Willing to comply with the study requirements and to provide written informed consent

Additional for Part A:

-18-55 years of age

Additional for Part B:

* 18-65 years of age
* HCV genotype 1, 2 or 3
* Documented history compatible with chronic hepatitis C
* HCV RNA ≥ 10,000 IU/mL at Screening

Exclusion Criteria:

All:

* Pregnant or breastfeeding
* Abuse of alcohol or drugs
* Use of other investigational drugs within 30 days of dosing
* Other clinically significant medical conditions

Additional for Part B:

* Prior exposure to any HCV NS5A inhibitor
* Cirrhosis
* Co-infection with hepatitis B virus or HIV

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through Day 6 for subjects in Part A
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Through 4 weeks after end of treatment for subjects in Part B
measure: Antiviral Activity of AT-777 and AT-527
timeFrame: Through 2 weeks of treatment for subjects in Part B
Secondary outcomes:
measure: AT-777 maximum plasma concentration (Cmax)
timeFrame: Day 1 for subjects in Part A
measure: AT-777 area under the concentration-time curve (AUC)
timeFrame: Day 1 for subjects in Part A
measure: Proportion of subjects achieving sustained virologic response (SVR)
timeFrame: 12 weeks after end of treatment for subjects in Part B
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Clinical Trial Site
Study officials:
affiliation: Atea Pharmaceuticals
name: Xiao-Jian Zhou
role: STUDY_DIRECTOR
References:
Clinical trial NCT05296434: Delta Radiomics for Liver Function Evaluation
Official title: Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Liver Disease
Keywords: liver function
magnetic resonance imaging
radiomics
chronic liver disease
quantitative assement
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and patients with different degrees of liver function impairment.

Brief summary: To evaluate the feasibility and efficacy of delta radiomics-derived index based on Gd-EOB-DTPA enhanced MRI as a new imaging biomarker for the quantitative assessment of liver function.

Detailed description: Delta radiomics is a novel concept proposed on the basis of radiomics. It can be used to evaluate the dynamic changes of imaging features in the time dimension, reflecting functional information of the tissue.

In clinical practice, liver function can be evaluated by gadoxate enhanced MRI by measuring signal intensity. Most often, simple visual assessment is performed, but quantitative measurements are also done. Theoretically, liver function should also be possible to quantify by using delta radiomics, ie by subtracting MR imaging features obtained in the earlier phase from the latter phase.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old, no gender limit.
* Patients with chronic liver disease and different degrees of liver damage (Child-Pugh A, B and C) and healthy controls.
* No history of liver-related surgery (except for cholecystectomy).
* No cardiopulmonary diseases or other diseases which may impair liver function.
* Agree to participate in the study and provide written informed consent.

Exclusion Criteria:

* Alcoholic hepatitis, non-alcoholic fatty liver disease, or autoimmune hepatitis.
* Liver tumors or metastasis or other extraheptic tumor.
* Splenectomy or other cases where the spleen is absent.
* Chronic kidney disease, renal damage.
* Allergy to contrast agents or other conditions that cannot undergo Gd-EOB-DTPA enhanced MRI exam.

Primary outcomes:
measure: Correlation between delta radiomics parameter and ICG test in assessment of liver function
timeFrame: within 3 days
Secondary outcomes:
measure: Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function
timeFrame: with 3 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Department of Hepatobiliary Surgery, Zhujiang Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00184834: Quality of Life and Liver Metastases
Official title: Quality of Life After Surgical Treatment of Colorectal Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Liver Metastases
Quality of Life
Keywords: colorectal
liver
metastases
health-related quality of life
surgery
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.

Detailed description: In a prospective study several patients groups were identified. Patients undergoing liver resection and/or local ablative therapy. Patients with non operable disease at (explorative) laparotomy and outpatients with non operable disease as shown during work up for liver resection. Several validated instruments on HRQoL were ompleted preoperatively (baseline), a half month after operation and then every three months.

Eligibility criteria: Inclusion Criteria:

colorectal liver metastases (operable and non operable disease) and participation by means of filling in quality of life instruments

Exclusion Criteria:

drop out and therefore loss of quality of life instruments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Theo Ruers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langenhoff BS, Krabbe PF, Wobbes T, Ruers TJ. Quality of life as an outcome measure in surgical oncology. Br J Surg. 2001 May;88(5):643-52. doi: 10.1046/j.1365-2168.2001.01755.x.
Clinical trial NCT04377334: Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
Official title: Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: ARDS
COVID-19
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 40
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: To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).


Eligibility criteria: Inclusion Criteria:

* COVID-19-positive subject
* Horowitz index ≤ 200
* Bilateral opacities on frontal chest radiograph, and
* requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
* no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
* Subject's Age ≥ 18 years

Exclusion Criteria:

* COVID-19-negative subject
* Subject's Age \< 18 years
* More than 7 days since initiation of mechanical ventilation
* Patient, surrogate or physician not committed to full intensive care support.
* Positive Pregnancy test at the time of screening.
* Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug

Primary outcomes:
measure: lung injury score
timeFrame: day 10
Secondary outcomes:
measure: D-dimers
timeFrame: day 0, 1, 2, 3, 10 and 15
measure: phenotype
timeFrame: day 0, 1, 2, 3, 10 and 15
measure: pro-resolving lipid mediators
timeFrame: day 0, 1, 2, 3, 10 and 15
measure: cytokines
timeFrame: day 0, 1, 2, 3, 10 and 15
measure: chemokines
timeFrame: day 0, 1, 2, 3, 10 and 15
measure: Survival
timeFrame: day 10 and 28
measure: extubation
timeFrame: day 28
measure: lymphocyte subpopulations
timeFrame: day 0, 3, 5 and 10
measure: SARS-CoV-2-specific antibody titers
timeFrame: day 0, 5 and 10
measure: complement molecules (C5-C9)
timeFrame: day 0, 5 and 10
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tübingen
name: Peter Rosenberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370734: Effect of Percutaneous Botulinum Toxin A Injection on Natural Course of Upper Lid Retraction in Thyroid Eye Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Eye Diseases
Keywords: botulinum toxin
thyroid eye disease
lid retraction
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In active phase of thyroid eye disease some patients have obvious upper lid retraction , and sometimes exposure keratopathy .To date there is not any standard treatment for this situation . We are going to compare the natural course of the upper lid retraction with injection of botulinum toxin A injection to upper lid percutaneously.


Eligibility criteria: Inclusion Criteria:

* all the patients wiht oper lid retraction in active phase of thyroid ophthalmopathy

Exclusion Criteria:

* patients in non active phase

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Babak Babsharif, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Babak Babsharif, MD
role: PRINCIPAL_INVESTIGATOR
References: