louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02849366: Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Adult Soft Tissue Sarcoma
Keywords: Sarcoma
Cryosurgery
NK Immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent sarcoma.

Detailed description: By enrolling patients with recurrent sarcoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03633266: Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Official title: Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anti-VEGF
Proliferative Diabetic Retinopathy
PRP
Vitrectomy
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years old;
2. type 1 or type 2 diabetes.
3. proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;
4. The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus

Exclusion Criteria:

1. Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;
2. Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;
3. anterior chamber neovascularization or neovascular glaucoma;
4. other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;
5. received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.

Primary outcomes:
measure: Mean change from baseline in best-corrected visual acuity (BCVA)
timeFrame: 3 years
Secondary outcomes:
measure: Mean change from baseline in visual field
timeFrame: 3 years
measure: chang from baseline in sructure of retina
timeFrame: 3 years
measure: chang from baseline in retinal neovascularization
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: The Eye Hospital of Wenzhou Medical University
name: Yong Wei, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04530266: Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
Official title: Reliability of Measuring Walking-related Performance Fatigability Using Six Minute Walk Test in Persons With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis, Knee
Keywords: osteoarthritis
six minute walk test
reliability
fatigue
fatigability
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
Collaborators: name: Hasselt University
First posted: 2020-08-28
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Evidence has shown that knee osteoarthritis causes an increase in base of support and a decrease in stride length and gait velocity which results in an increase in energy expenditure during walking. This increase in energy cost of walking is suggested to result in walking related performance fatigability. However, fatigue is not commonly considered in the clinical settings in term of neither assessment nor management of knee osteoarthritis. One common tool used to evaluate walking relate performance is six minute walk test and the purpose of this study is to determine the reliability of using six minute walk test to determine walking related performance fatigability in persons with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Age 40-70 years
* Knee OA with history not less than three months.
* Radiological evidences of grade III or less on Kellgren classification.
* Knee pain on VNRS no more than 8/10.

Exclusion Criteria:

* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
* History of trauma or fractures in lower extremity.
* Signs of lumbar radiculopathy or myelopathy.
* History of knee surgery or replacement.
* Patients on intra-articular steroid therapy within two months before the commencement of the study.
* Impaired skin sensation and renal function.

Primary outcomes:
measure: Assessment of walking related performance fatigability using six minute walk test
timeFrame: Day 1
measure: Assessment of walking related performance fatigability using six minute walk test
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences.
state: Federal
Study officials:
affiliation: Foundation University Islamabad
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086966: PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Official title: PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Prostate Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging
* Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines
* Be at least 18 years of age

Exclusion Criteria:

* Inability to tolerate or undergo PET/MRI or PET/CT
* Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
* Recurrent prostate adenocarcinoma
* Known distant metastatic disease
* Current or prior treatment for prostate cancer
* Known allergy to glucagon
* Previous diagnosis of insulinoma or pheochromocytoma

Primary outcomes:
measure: The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
timeFrame: 1 scan
Secondary outcomes:
measure: The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI
timeFrame: 1 scan
measure: Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered
timeFrame: 1 simulation scan
measure: Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities
timeFrame: 18 months
measure: The Total Number of Pelvic Nodal Metastases Detected on MRI
timeFrame: 1 scan
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
Study officials:
References:
Clinical trial NCT04691466: Study Evaluating the Efficacy of Joint Replacement
Official title: Assessment of Clinical Outcome Following Total Hip and Knee Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Replacement
Arthroplasty
Patient-relevant outcome measure (PROM)
KOOS
HOOS
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
Collaborators: name: Warmia and Mazury Oncology Centre
First posted: 2020-12-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population with osteoarthritis of the hip or knee.

Brief summary: Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.


Eligibility criteria: Inclusion Criteria:

Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.

Exclusion Criteria:

1. An inability to understand the Polish language,
2. Presence of neuromuscular disease and cognitive impairment,
3. Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,
4. Having rheumatoid arthritis,
5. Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.

Primary outcomes:
measure: Assessment of the patients' opinion about their hip. Change over time
timeFrame: 12 months
measure: Assessment of the patients' opinion about their knee. Score change over time
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of the quality of life. Score change over time
timeFrame: 12 months
measure: Pain intensity. Change over time
timeFrame: 12 months
measure: Hip abductors muscle strength. Change over time
timeFrame: 12 months
measure: Range of motion.
timeFrame: 12 months
Other outcomes:
measure: Body mass index (BMI)
timeFrame: 12 months
measure: Activity
timeFrame: 12 months
Locations:
city: Bydgoszcz
country: Poland
facility: Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15
Study officials:
References:
Clinical trial NCT00783666: Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid) - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINBACK Tangerine Mix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).


Eligibility criteria: Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin II and III;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History of photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
measure: The sensibility will be evaluated according to the skin type.
timeFrame: Throghout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT04268966: An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
Official title: An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ebola Virus Disease
Lead sponsor: Chimerix
Sponsor class: INDUSTRY
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2020-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.

Detailed description: The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD

Eligibility criteria: Inclusion Criteria:

* Individuals have high-risk exposure to Ebola Virus based on CDC definitions
* Must be able to ingest, absorb and tolerate oral medication
* As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV

Exclusion Criteria:

-

Primary outcomes:
measure: The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04349566: Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
Official title: Fast Troponin as a Biomarker to Assess Exercise-induced Muscle Damage in Muscle Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Becker Muscular Dystrophy
McArdle Disease
Limb-Girdle Muscular Dystrophy Type 2
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Edgewise Therapeutics, Inc.
First posted: 2020-04-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with McArdle disease and patients with two sub-typesof Limb-girdle and Becker muscular dystrophies will be included as well as healthy controls.

Brief summary: The purpose of the study is to explore the biomarker Fast Troponins response to exercise in patients with Becker muscular dystrophy, Limb-girdle muscular dystrophy and McArdle disease


Eligibility criteria: Inclusion Criteria:

* The ability to cycle
* No concurrent medical condition that could interfere with interpretation of the results
* Molecular diagnosis of the specific condition in specified patient groups or healthy control
* No active muscle injury on the test day (caused by recent exercise, seizures, trauma, etc.)

Exclusion Criteria:

* Competing conditions at risk of compromising the results of the study
* Cardiac or pulmonary disease contraindicating peak exercise testing or strenuous exercise
* Veins that are too difficult to puncture for blood sampling, evaluated by the investigator
* Severe muscle weakness, that prevents the subject completing the exercise test, evaluated by the investigator

Primary outcomes:
measure: Change in biomarkers
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit, 3342
Study officials:
References:
Clinical trial NCT02166866: Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Care Recipient
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caregivers will be recruited through the Mayo Clinic inpatient and outpatient services, including but not limited to referrals from staff of the Divisions of Medical Oncology, Hematology, and Radiation Oncology and other clinics in the outpatient setting, and Divisions of HospitalMedicine, Hospice and Palliative Medicine, and other inpatient services in the hospital setting. This population was chosen as they are likely to experience caregiver-related distress for which the intervention will be beneficial.

Brief summary: This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent.
* Ability to speak, read, write and understand English language
* Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting.
* Has a care recipient:

  * ≥ 18 years of age who
  * has a malignancy (either solid tumor or hematologic) diagnosis.
  * who has signed a research authorization form
  * who is undergoing or in the last 6 months has undergone cancer treatment
* Ability to use and access to a computer, tablet or other device with internet access and video capabilities

Exclusion Criteria:

* Diagnosis within the past 12 months of active substance abuse (alcohol or drugs)
* Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization
* Diagnosis within the past 12 months of suicidal thoughts or attempt
* Care recipient is currently participating in another psychosocial clinical trial

Primary outcomes:
measure: calculate the average number of caregivers participating in each offered web-based session
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: