louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03475082: Overcoming Analgesic Tolerance to TENS
Official title: Use of Modulating Frequency or Increasing Intensity to Overcome Analgesic Tolerance to Transcutaneous Electrical Nerve Stimulation (TENS) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial -double blind
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if changing the frequency or intensity of transcutaneous electrical nerve stimulation (TENS) can reduce the development of tolerance to TENS treatment.

Detailed description: Healthy adults will come daily for 5 consecutive days to the testing room. Pressure pain thresholds (PPT) will be the outcome measure and will be used to measure the subject's pain threshold to deep mechanical pressure. Subjects will push a button to stop the PPT test when they first begin to feel a sensation of pain. The PPT test will be done before TENS application. The TENS unit will be applied based on random assignment to 1 of 5 treatment types and subjects will not be told which group they are assigned to. Those groups are: 1) placebo TENS, 2) high frequency TENS, 3) alternating frequency TENS, 4) modulated frequency TENS, or 5) high frequency TENS with increased intensity daily. The TENS unit will be applied for 30 minutes. After 20 minutes the PPT test will be completed a second time. This procedure will occur on all 5 consecutive days of testing. Data will be measured and recorded by an assessor blind to subject group. Blinding will be assessed at the end of testing on day 5.

Eligibility criteria: Inclusion Criteria:

* 18-65 Years of Age (YOA)
* no current pain condition

Exclusion Criteria:

* Pregnancy
* Cardiac pacemaker
* Currently experiencing pain
* Abnormal sensation in dominant forearm
* History of seizures
* Prior TENS use

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: Pre TENS and post TENS at initial (day 1) and final (day 5) study visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Kathleen A Sluka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chandran P, Sluka KA. Development of opioid tolerance with repeated transcutaneous electrical nerve stimulation administration. Pain. 2003 Mar;102(1-2):195-201. doi: 10.1016/s0304-3959(02)00381-0.
citation: Desantana JM, Santana-Filho VJ, Sluka KA. Modulation between high- and low-frequency transcutaneous electric nerve stimulation delays the development of analgesic tolerance in arthritic rats. Arch Phys Med Rehabil. 2008 Apr;89(4):754-60. doi: 10.1016/j.apmr.2007.11.027.
citation: Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.
Clinical trial NCT06739382: Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center
Official title: Management of Ventilation Acquired Pneumonia Caused by Pseudomonas and Acinetobacter Organisms in a Pediatric Center: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventilation Acquired Pneumonia
Keywords: ventilator-associated pneumonia
pandrug-resistant
extensively drug-resistant
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-12-18
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the most effective empirical therapy of antibiotics for better ventilator-associated pneumonia control. The main question it aims to answer is:

• Which is better for clinical response single or combination empiric antibiotic therapies ?


Eligibility criteria: Inclusion criteria:

-Patients ranging from one month to twelve years old, who had been undergoing mechanical ventilation for over 48 hours and were diagnosed with Ventillator Associated Pneumonia.

2.1.3. Exclusion criteria:

* Patients with pneumonia prior to mechanical ventilation initiation.
* Patients who had been intubated for more than 24 hours before admission to the PICU, or those transferred from other PICUs and were already receiving antibiotic therapy.

Primary outcomes:
measure: Antimicrobial susceptibility
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Intensive Care Unit (PICU) at Cairo University's Faculty of Medicine
Study officials:
References:
Clinical trial NCT04703582: Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery
Official title: Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Artery Disease, Peripheral
Aortic Diseases
Carotid Artery Diseases
Other Disease
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 30
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: Patients undergoing vascular surgery consecutively in the first semester of 2021, for a period of one month, will be included.

Brief summary: Check whether patients with higher comorbidity and risk of complication, estimated using the V (p) -POSSUM score, ACS NSQIP and the ASA classification, present higher baseline activated clotting time values.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing vascular surgery requiring intraoperative heparinization

Exclusion Criteria:

* Pregnant women
* SARS-CoV-2 PCR positive (performed 24-72h prior to surgery)
* Severe plaquetopenia \<50,000

Primary outcomes:
measure: Change on baseline Activated Clotting Time with comorbidities
timeFrame: 1 day - surgery day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01253382: Study to Evaluate Ecallantide in Paediatric Patients With Acute Attacks of Hereditary Angioedema
Official title: A 3-Part Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Subcutaneous Ecallantide in Prepubertal Paediatric Patients Experiencing Acute Attacks of Hereditary Angioedema (HAE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is:

* assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE

The secondary objectives are:

* evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE
* assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE


Eligibility criteria: Inclusion Criteria:

1. Male or female from 2 years of age and prepubertal
2. Physician diagnosis and history of HAE (Type I or II) including laboratory results showing C1-1NH activity below the lower limit of normal or up to 15% above the lower limit of the normal range
3. Present at the site with moderate to severe signs and symptoms of an acute attack of HAE within 8 hours of recognition of the onset of the attack. Spontaneous resolution of the attack must not have begun before the administration of study drug.
4. Must have signed informed consent by parent or caregiver.

Exclusion Criteria:

1. \<2 years of age or have reached puberty
2. Received treatment with ecallantide within previous 72 hours
3. Received an investigational drug or device, other than ecallantide, within 30 days prior to the screening visit
4. Pharyngeal/laryngeal symptoms
5. Mild attacks including mild edema of the extremities and mild abdominal attacks
6. Are unable or unwilling to give informed consent (parent or caregiver)
7. Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study

Primary outcomes:
measure: safety and tolerability of ecallantide
timeFrame: 4 years
Secondary outcomes:
measure: evaluate the PK profile of ecallantide
timeFrame: 4 years
measure: assess the efficacy of ecallantide
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02995382: Health-Related Quality of Life in Cases of Cubital Tunnel Syndrome
Official title: Health-Related Quality of Life in Cases of Anterior Intramuscular Transposition for Cubital Tunnel Syndrome: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cubital Tunnel Syndrome
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2016-12-16
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: TREATMENT

Brief summary: This study aims to determine the Health Related Quality of life (HRQOL) (the physical, mental, emotional and social functioning) of patients with cubital tunnel syndrome following anterior intramuscular transposition, after one year.

Detailed description: As there are many different surgical procedures to address cubital tunnel syndrome, HRQOL will be used to determine if anterior intramuscular transposition provides patients with positive outcomes. To measure HRQOL 3 specific scales will be administered:

1. A generic scale, the Short Form-36
2. A condition specific scale, the Patient-Rated Ulnar Nerve Evaluation (PRUNE)
3. A utility scale, the EuroQOL, five dimension questionnaire

These scales are widely reported in the literature, are valid, reliable and easy to fill out. Using these scales we can determine HRQOL as well as Quality Adjusted Life Years, which, allows us to do a cost-utility analysis (economic evaluation) on this specific procedure.

Patients will be asked to fill out the above mentioned questionnaires, as well as perform 2 performance tests (grip strength, and a moving 2-point discrimination test) at the following time points:

1. 1 week prior to surgery
2. 1 day prior to surgery
3. 3 months post surgery
4. 6 months post surgery
5. 12 months post surgery

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cubital tunnel syndrome confirmed with Electromyography (EMG) testing or Ultrasound imaging
* Ability to comprehend English and complete health related quality of life questionnaires
* Willing to provide informed consent
* Age \> 18 years
* Not pregnant

Exclusion Criteria:

* Prior ipsilateral cubital tunnel release
* Evidence of symptomatic clinical double crush syndrome confirmed by EMG/Nerve Conduction Study (NCS)
* Patients with rheumatoid arthritis, connective tissue disorder, tenosynovitis, or diagnosed neurological condition that could confound the assessment of health-related quality of life with regard to the affected arm and hand

Primary outcomes:
measure: Is there improvement in Health Related Quality of Life?
timeFrame: 1 week and 1 day pre-op & 3, 6, 12 months post op
Secondary outcomes:
measure: Which Domains of Health Related Quality of Life Improve?
timeFrame: 1 week and 1 day pre-op & 3, 6, 12 months post op
measure: Is there improvement in physical performance?
timeFrame: 1 week and 1 day pre-op & 3, 6, 12 months post op
Other outcomes:
Locations:
Study officials:
affiliation: McMaster University
name: Matthew McRae, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03653182: The Relation Between Constitutional Types and Indices of Tongue, Pulse,and Ausculative Diagnosis
Official title: The Relation Between Constitutional Types and Indices of Tongue, Pulse,and Ausculative Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-disease State
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Committee on Chinese Medicine and Pharmacy
First posted: 2018-08-31
Enrollment: 281
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: aged older than 20 years old

Brief summary: This study aims to evaluate indices of tongue diagnosis, ausculative diagnosis, and pulse diagnosis in the determination of institutions.

Detailed description: Constitution differentiation is important for the prescription of Chinese medicines. In previous studies, researchers usually used constitutional questionnaires to determine constitutions.However, the importance of tongue diagnosis and pulse diagnosis remained unclear. The specific aim of this study is to evaluation indices of tongue diagnosis, auscultative diagnosis, and pulse diagnosis in the determination of constitutions. Meeting of specialists will determine the characteristics for each constitution first. This study plans to recruit 200 volunteers and determine their constitutions by constitutional questionnaires. Tongue manifestations and pulse pressure waveforms will be taken at the same time by standardized instruments. Relations between the indices and each constitution will be determined by multiple linear regression and logistic regression analysis. Then the percentage of importance of a specific index in a specific constitutional type could be determine.

Eligibility criteria: Inclusion Criteria:

* Volunteers without aged older than 20 years old

Exclusion Criteria:

* Pregnant
* taking any medicine currently
* suffering for acute disease currently

Primary outcomes:
measure: Tongue image
timeFrame: The photograph will be taken only at the first day the subject has been recruited
Secondary outcomes:
measure: Acoustic sound
timeFrame: The voice waves will be taken only once at the first day the subject has been recruited
measure: Pulse image
timeFrame: The pulse waveforms will be recorded at the first day the subject has been recruited
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: CMUH
Study officials:
References:
Clinical trial NCT01821482: A Study of DC-CIK to Treat Hepatocellular Carcinoma
Official title: A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular carcinoma, DC-CIK
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 100
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: The purpose of this study is to evaluate the efficacy of Dendritic and Cytokine-induced Killer Cells (DC-CIK) for hepatocellular carcinoma (HCC).

Detailed description: About 60 patients with HCC, who had received complete resection or TACE and got Complete remission (CR) or partial response (PR), will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients \> 18 years of age;
2. Hepatocellular carcinoma with histological or imaging and AFP diagnose, and had received complete resection or TACE and got CR or PR by imaging studies;
3. Patients who have a life expectancy of at least 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) performance status was 0 - 1;
5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L);
6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;
5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.

Primary outcomes:
measure: progression-free survival(PFS)
timeFrame: 1 month
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 1 month
measure: quality of life (QOL)
timeFrame: month
Other outcomes:
measure: Laboratory findings
timeFrame: 1 month
Locations:
city: Nanning
country: China
facility: The first Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: Guangxi Medical University
name: Hanfeng Liu
role: STUDY_CHAIR
References:
Clinical trial NCT03413982: Bladder Cancer Longitudinal Biorepository for Development of Novel Therapeutics/Biomarkers
Official title: Bladder Cancer Longitudinal Biorepository for Development of Novel Therapeutics/Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-01-29
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: Patients who are receiving care from KUMC clinics will be considered for this registry.

Brief summary: The purpose of this study is to create a registry, which is a "bank" of information about patients who have had similar medical conditions and treatments. The registry will be used by researchers to learn more about long term outcome of patients with bladder cancer, how bladder cancer tissues are related to tumor development, recurrence and survival.


Eligibility criteria: Inclusion Criteria:

* Patients who present to clinic with presumed bladder cancer or have a diagnosis of bladder cancer are eligible to participate
* Patients can participate in any additional research studies during the patients' participation within this protocol.

Exclusion Criteria:

* Patients who do not have presumed bladder cancer will not be eligible

Primary outcomes:
measure: Blood, urine and tissue characteristics of bladder cancer patients
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: John Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05382520: Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)
Official title: Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CIPN
Keywords: Neuropathic pain
Chemo Induced Peripheral Neuropathy (CIPN)
Sensory rehabilitation
Explicit Sensory Retraining
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Zefat Academic College
First posted: 2022-05-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Pilot and Feasibility study
Primary purpose: OTHER

Brief summary: Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.

Exclusion Criteria:

1. Sensory damage / neuropathy that existed even before the start of chemotherapy
2. Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)
3. Central nervous system involvement
4. Major pre-morbid orthopedic lower limb impairment
5. Hebrew language not sufficient for assessment and treatment

Primary outcomes:
measure: TNAS
timeFrame: 2 years
measure: VAS
timeFrame: 2 years
measure: FABS
timeFrame: 2 years
measure: TUG
timeFrame: 2 years
measure: NSA
timeFrame: 2 years
measure: Semmes-Weinstein monofilament testing
timeFrame: 2 years
measure: LEPT
timeFrame: 2 years
measure: Allodynia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaaqov
country: Israel
facility: Shamir medical center
Study officials:
affiliation: Assaf Harofee MC
name: Rotem Merose, Dr.
role: PRINCIPAL_INVESTIGATOR
References: