louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04078347: Infrared Thermography to Evaluate the Effect of Paravertebral Block
Official title: Changes of Skin Temperature for Evaluation of Paravertebral Block: A Prospective Observational Study Using Infrared Thermography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paravertebral Block
Keywords: Paravertebral block
Infrared thermography
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery with planned paravertebral block for multimodel analgesia.

Brief summary: The aim of this prospective observational study was to evaluate the changes of skin temperature after the paravertebral block measured by infrared thermography.

Detailed description: Methods: Patients scheduled for elective surgery with paravertebral block will receive infrared thermography measures 5 min before the block and continous to 20 min after the block. The sensitivity, specificity of infrared thermography as diagnostic methods will be determined by receiver operator characteristic analysis.

Eligibility criteria: Inclusion Criteria:

* With informed consent
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* Undergo elective surgery with planned paravertebral block

Exclusion Criteria:

* Refusal to participate in the study
* pre-existing infection at the block site
* younger than 18-yr-old
* BMI\>35
* significant thoracic kyphoscoliosis
* Those who had taken vasodilatory drugs before surgery
* history of previous thoracic or breast surgery
* Preoperative analgesic medications
* Any contraindications to peripheral nerve block such as coagulation abnormalities, allergy to local anaesthetics, peripheral neuropathy.

Primary outcomes:
measure: Changes of skin temperature
timeFrame: From baseline up to 20 minutes after block
Secondary outcomes:
measure: Noinvasive blood pressure
timeFrame: From baseline up to 20 minutes after block
measure: Heart rate
timeFrame: From baseline up to 20 minutes after block
measure: SPO2
timeFrame: From baseline up to 20 minutes after block
measure: Sensory block level
timeFrame: From baseline up to 20 minutes after block
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Wei Mei
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang S, Liu Y, Liu X, Liu T, Li P, Mei W. Infrared thermography for assessment of thoracic paravertebral block: a prospective observational study. BMC Anesthesiol. 2021 Jun 11;21(1):168. doi: 10.1186/s12871-021-01389-4.
Clinical trial NCT04634747: Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer
Official title: A Single-Arm, Open-Label, Multi-Center Phase II Study to Evaluate the Combination of PVX-410 + Pembrolizumab + Chemotherapy for Frontline Therapy of Metastatic, PD-L1+ Triple-Negative Breast Cancer (TNBC) in HLA-A2-Positive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Triple-Negative Breast Carcinoma
Lead sponsor: OncoPep, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-18
Enrollment: 53
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: Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1 and HLA A2 positive.


Eligibility criteria: Inclusion Criteria:

- HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Progression Free Survival
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01792947: Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
Official title: Percutaneous Electroneurostimulation of Dermatome T6 for Appetite Reduction and Weight Loss in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite Reduction
Weight Loss
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the creation of a somato-autonomic reflex, the stimulation of sensory nerve terminals located in dermatome T6 may cause a reflex, whose efferent pathways end in vagal nerve branches stimulating the gastric wall, similarly to the gastric pacemaker.

The aim of this study was to evaluate the effect of percutaneous electroneurostimulation (PENS) of T6 dermatome on appetite, weight loss and dietary compliance.


Eligibility criteria: Inclusion Criteria:

* patients candidates to bariatric surgery
* BMI \> 40 Kg/m2 or a BMI \> 35 Kg/m2 with comorbidities associated to the obesity status
* Failure of dietary treatment.

Exclusion Criteria:

* untreated endocrine disease causing obesity
* serious psychiatric illness.

Primary outcomes:
measure: Appetite reduction
timeFrame: 3 months
Secondary outcomes:
measure: Weight loss
timeFrame: 3 months
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital general Universitario de Elche
state: Alicante
Study officials:
affiliation: General University Hospital Elche
name: Jaime Ruiz-Tovar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Tovar J, Oller I, Diez M, Zubiaga L, Arroyo A, Calpena R. Percutaneous electrical neurostimulation of dermatome T6 for appetite reduction and weight loss in morbidly obese patients. Obes Surg. 2014 Feb;24(2):205-11. doi: 10.1007/s11695-013-1091-z.
Clinical trial NCT00530647: fMRI Study of Brain Neural Network and Plasticity After Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Brain motor network, Plasticity, functional MRI, Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-09-17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purposes of this study are to investigate the functional connectivity of motor network in patients of stroke and investigate the mechanism of brain plasticity for recovery after stroke.


Eligibility criteria: Inclusion Criteria:

* 1st-ever-stroke
* whose corticospinal tract was injured
* less than 1 month after stroke onset

Exclusion Criteria:

* Claustrophobia
* who use cardiac pacemaker
* intracranial metal
* uncontrolled hypertension or hypotension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Suk Hoon Ohn, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00373347: Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma
Official title: Identification of New Serum Diagnostic Markers of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 600
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 diagnosed with liver cancer

Brief summary: The purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with alpha-feto protein (AFP)

Detailed description: Liver cancer is a deadly cancer that is typically hard to diagnose and treat. The currently used blood marker for the clinical diagnosis of liver cancer is alpha-feto protein (AFP), which misses 40-60% of patients with liver cancer because it lacks sufficient specificity and sensitivity. The purpose of this study is to identify blood markers that have the ability to diagnose liver cancer with improved accuracy, so that it can be used alone or in conjunction with AFP. The aim of this study is to identify new blood markers of liver cancer that can be used to increase the rate of accurate diagnosis of this malignancy.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI.
* Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia.
* Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer.

Exclusion Criteria:

-Patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.

Primary outcomes:
measure: Identify new blood markers of liver cancer
timeFrame: upto 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Samuel So
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02258347: HIFU in Patients With Non-malignant Thyroid Nodules
Official title: Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-malignant Thyroid Nodules
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 4
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: Use of a high intensity focused ultrasound (HIFU) in patients with non-malignant thyroid nodules.


Eligibility criteria: Inclusion Criteria:

* Male or female patient 18 years or older.
* Patient presenting with at least one thyroid nodule with no signs of malignancy:

  1. Non suspect clinically and at ultrasonography imaging
  2. Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months
  3. Normal serum calcitonin
  4. No history of neck irradiation
* Normal thyroid-stimulating hormone (TSH).
* Targeted nodule accessible and eligible to HIFU
* Absence of abnormal vocal cord mobility at laryngoscopy.
* Nodule diameter ≥ 10mm measured by ultrasound.
* Nodule volume inferior to 10 cc
* Composition of the targeted nodule(s) : no more than 30% cystic

Exclusion Criteria:

* Head and/or neck disease that prevents hyperextension of neck.
* Known history of thyroid cancer or other neoplasias in the neck region.
* History of neck irradiation.
* Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment
* Posterior position of the nodule if the thickness of the nodule is \<15mm
* Pregnant or lactating woman
* Any contraindication to the assigned analgesia/anaesthesia.

Primary outcomes:
measure: Evaluation of thyroid nodule's volume changes following HIFU therapy assessed by ultrasonography (US)
timeFrame: Month 6 and Month 12
measure: Evaluation of thyroid nodule's structure changes following HIFU therapy assessed by ultrasonography (US)
timeFrame: Month 6 and Month 12
measure: Evaluation of thyroid nodule's vascularisation changes following HIFU therapy assessed by ultrasonography (US)
timeFrame: Month 6 and Month 12
Secondary outcomes:
measure: Number of subjects with adverse events as a measure of safety and tolerability
timeFrame: Day 1, Month 1, Month 3, Month 6 and Month 12
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Istituto in tecnologie avanzate e modelli assistenziali in oncologia
Study officials:
name: Andrea Frasoldati, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222647: Investigation of Efficacy and Tolerability of a Lactic Acid Containing Vaginal Suppository in Post-menopausal Women With VVA
Official title: Prospective, Open-label, Monocenter, Trial to Investigate the Efficacy and Tolerability of WO533, a Lactic Acid Containing Vaginal Suppository, in a Panel of Post-menopausal Women Suffering From Vulvovaginal Atrophy (VVA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvovaginal Atrophy
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: proDERM Institut für Angewandte Dermatologische Forschung GmbH
name: Bremer Pharmacovigilance Service GmbH
First posted: 2020-01-10
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal women with subjective symptomatology of vulvovaginal atrophy
* Signed written informed consent before participation in the trial

Exclusion Criteria:

* Known hypersensitivity against any of the ingredients of the investigational product
* Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial
* Local hormonal therapy (vagina/vulva) within 3 months before the trial
* If in the opinion of the investigator the patient should not participate in the study for any reason

Primary outcomes:
measure: VMI
timeFrame: Day 1 to 43
Secondary outcomes:
measure: Vaginal pH
timeFrame: Day 1 to 8, day 8 to 43, and day 1 to 43
measure: Subjective vulvovaginal atrophy symptoms
timeFrame: Day 1 to 8, day 8 to 43, and day 1 to 43
measure: Global judgment of the tolerability by the Investigator
timeFrame: Day 1 to 43
measure: Global judgment of the tolerability by the patient
timeFrame: Day 1 to 43
measure: Adverse events
timeFrame: Day 1 to 43
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: proDERM Institute for Applied Dermatological Research
Study officials:
affiliation: proDERM Institute for Applied Dermatological Research, Germany
name: Kirstin Deuble-Bente, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02726347: Pneumococcal Post-Vaccination Titers
Official title: Pneumococcal Post-Vaccination Titers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smokers, Elderly, Asthma, COPD, Recurrent Infections
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.

Detailed description: One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.

Eligibility criteria: Inclusion Criteria:

Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:

1. smokers between the ages of 19-80.
2. elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma.
3. COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections.
4. Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.
5. individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency.

Exclusion Criteria:

The following groups will be excluded:

1. Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.
2. subjects who are on immune suppressive agents.
3. Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year.
4. subjects on antiepileptic agents.
5. Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women

Primary outcomes:
measure: Change from pre-to post-vaccination antibody titer
timeFrame: day one- day of vaccine and one month later
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
Clinical trial NCT00197847: Infection Surveillance in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Pneumonia
Sepsis
Cross Infection
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Purpose of the study is to investigate and quantify known and possible new riskfactors for nosocomiel infection and death in the intensive care setting.

As new riskfactors Mannose Binding Lechtin and Procalcitonin are chosen and compared to established riskfactors.


Eligibility criteria: Inclusion Criteria:Admission to ICU -

Exclusion Criteria:Absence of informed consent and age less than 18 years

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Intensive Care
state: Copenhagen Couty
Study officials:
affiliation: Department of Intensive Care, Herlev University Hospital
name: Dorthe H Olsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05884047: The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients
Official title: The Effect Of Virtual Reality Glasses On Vital Signs And State Anxiety Level In Cancer Patients Receiving Chemotherapy For The First Time- Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients
Keywords: Chemotherapy
Virtually Reality
Anxiety
Nursing
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 30
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: Semi-experimental
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels.

Detailed description: Purpose This study was conducted as a non-randomized control group experimental study to determine the effect of virtual reality glasses on vital signs and state anxiety levels in cancer patients receiving chemotherapy for the first time.

Methods and Sample The population of the study was composed of adult patients admitted to an oncology hospital in Ankara province with a diagnosis of stage I-II-III cancer to undergo chemotherapy treatment for the first time. The sample of the study consisted of 30 patients who were assigned to the intervention and control groups by the stratified sampling method (considering such characteristics as age, gender, marital status). The patient identification form, Spielberger state anxiety scale, patient opinion form, vital signs follow-up form, and virtual reality glasses were used to collect the data.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with stage 1,2,3 cancer
* Receive radiotherapy and chemotherapy for the first time
* Volunteer patients who agreed to participate

Exclusion Criteria:

-Patients outside the inclusion criteria

Primary outcomes:
measure: Vital signs- Blood pressure
timeFrame: first measurement just before the start of the chemotherapy infusion
measure: Vital signs-pulse
timeFrame: first measurement just before the start of the chemotherapy infusion
measure: Vital signs- Blood pressure
timeFrame: the last measurement just after the end of the chemotherapy infusion
measure: Vital signs-pulse
timeFrame: the last measurement just after the end of the chemotherapy infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Bahar İnkaya
Study officials:
affiliation: Hacettepe University Adult Oncology Hospital
name: SEBILE OZDAG
role: STUDY_CHAIR
References:
Clinical trial NCT06280547: The Effect of Oral Health Education on Knowledge, Attitude, Practice and Dental Caries Among Egyptian School Children
Official title: Assessing the Effect of an Oral Health Education Program on Knowledge, Attitude, Practice and Dental Caries Among a Group of Children in a Governmental School in Fayoum, Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Knowledge, Attitudes, Practice
Keywords: dental caries in children
Knowledge, attitude and practice
dental caries experience
oral health education
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 115
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: A group of Egyptian children aged between 6-15 years attending a public school in Fayoum

Brief summary: Aim of the study Assessing the effect of an oral health education program on knowledge, attitude, practice, and dental caries among a group of school children in a governmental school in Fayoum, Egypt.

Detailed description: Study type Others: Observational Before and after study

Eligibility criteria: Inclusion Criteria:

* School children aged (6 to15) years old.
* Children with or without previous dental experience.

Exclusion Criteria:

* Refusal of participation.
* Children with a mental or physical disability

Primary outcomes:
measure: Oral health related attitude
timeFrame: 6 months
Secondary outcomes:
measure: Change in oral health related Knowledge, attitude and practice
timeFrame: 6 months
Other outcomes:
measure: Caries experience
timeFrame: 6 months
Locations:
city: Cairo
country: Egypt
facility: Cairo University Faculty of Dentistry
Study officials:
References: