louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05309681: Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome
Official title: Salivary Melatonin Levels and Sleep Quality in Patients With Burning Mouth Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burning Mouth Syndrome
Melatonin
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with burning mouth syndrome and age-matched female controls without burning mouth syndrome or oral lesions will be included in the study. A sample of unstimulated saliva will be taken from all patients and frozen. All patients will also fill in Epworth's sleepiness scale.

Brief summary: Burning mouth syndrome is an idiopathic condition characterized by symptoms burning and / or pain of the oral mucosa with an orderly clinical finding. So far not found a unique way of treatment. It is a diagnosis that impairs the quality of life of patients, and consequently it can affect the quality of sleep. Melatonin is a hormone secreted from pineal gland and regulates the day-night rhythm of man, and whose production in the body decreases aging. The level of melatonin in saliva correlates well with the level of melatonin in plasma, therefore they are advantages of determining from saliva painlessness and non-invasiveness of the procedure itself. The purpose of this study was to compare the level of melatonin in saliva and the quality of sleep with help of the Epworth Sleepiness Scale in patients with burning mouth syndrome and control groups of patients without subjective oral disorders and with an orderly clinical finding.


Eligibility criteria: Inclusion Criteria:

* female patients
* primary burning mouth syndrome
* without oral lesions

Exclusion Criteria:

* secondary burning mouth syndrome
* male gender
* patients with oral lesions

Primary outcomes:
measure: determining the level of salivary melatonin
timeFrame: January 2021-July 2021
Secondary outcomes:
measure: determining the difference in Epworth's sleepiness scale
timeFrame: January 2021-July 2021
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine, University of Zagreb
Study officials:
References:
Clinical trial NCT02700581: Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
Official title: Impact of Moderate Positive End-expiratory Pressure on Hepatic Venous Flow in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Valvular Heart Disease
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the difference in the impact of moderate positive end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac surgery: conventional versus protective ventilation strategy The possible changes in forward and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in conventional and protective ventilation strategies are analyzed by using intraoperative transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .

Detailed description: Following data would be determined after 5 min-exposure volume controlled ventilation employing tidal volume of 10 ml/kg and 6 ml/kg with low PEEP (with 2 mmHg) and moderate PEEP (7 mmHg) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=12)

1. sum of forward hepatic venous flow
2. sum of backward hepatic venous flow
3. peak velocity of diastolic hepatic venous flow
4. lung compliance
5. peak airway pressure
6. mean airway pressure
7. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery
* Patients provide written informed consents

Exclusion Criteria:

* Re-do or tri-do surgery
* Patients with active infection
* Patients with endocrine disease
* Patients ischemic heart disease
* patients with tricuspid valve regurgitation greater than mild degree

Primary outcomes:
measure: forward hepatic venous flow
timeFrame: 3 min after intervention
Secondary outcomes:
measure: reversed hepatic venous flow
timeFrame: 3 min after intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00833781: A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects
Official title: A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV-1 Infection
HIV Infections
Keywords: HIV vaccine
Dendritic cells
treatment experienced
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-02-02
Enrollment: 15
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: The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.

Detailed description: This is a randomized trial to evaluate whether mRNA-transfected dendritic cell vaccination is safe and immunogenic in HIV-infected participants who are on antiretroviral therapy.

Eligibility criteria: Inclusion Criteria:

* HIV-1 positive
* CD4+ T Cell count \>200
* Undetectable HIV viral load for 6 months prior to screening
* On antiretroviral treatment for 12 months prior to screening

Exclusion Criteria:

* Hepatitis C positive
* Detectable HIV viral load within 6 months prior to study entry
* Females who are pregnant or nursing

Primary outcomes:
measure: Safety of the DC Vaccine (as Measured by Frequency of Adverse Events)
timeFrame: After vaccination
measure: Change From Baseline to Week 14 in ELISPOT Response to Gag and Nef
timeFrame: Baseline and 14 weeks
Secondary outcomes:
measure: T Cell Proliferation
timeFrame: Baseline to week 14
measure: IL2 and IFN Gamma Production
timeFrame: Baseline to week 14
Other outcomes:
Locations:
city: Boston
country: United States
facility: Infectious Disease Unit; Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rajesh Gandhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gandhi RT, Kwon DS, Macklin EA, Shopis JR, McLean AP, McBrine N, Flynn T, Peter L, Sbrolla A, Kaufmann DE, Porichis F, Walker BD, Bhardwaj N, Barouch DH, Kavanagh DG. Immunization of HIV-1-Infected Persons With Autologous Dendritic Cells Transfected With mRNA Encoding HIV-1 Gag and Nef: Results of a Randomized, Placebo-Controlled Clinical Trial. J Acquir Immune Defic Syndr. 2016 Mar 1;71(3):246-53. doi: 10.1097/QAI.0000000000000852.
Clinical trial NCT01865981: Investigating Hereditary Cardiac Disease by Reprogramming Skin Cells to Heart Muscle
Official title: Cellular Reprogramming as a Tool to Characterise the Cellular Electrophysiology of Familial Arrhythmia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eletrophysiology of iPS-derived Cardiomyocytes
Keywords: iPS cells
cardiomyocytes
Brugada
Ventricular Fibrillation
electrophysiology
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arrhythmic patients participating in the Familial Arrhythmia Network Scotland (FANS)

Brief summary: Hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. Due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. The investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells.

The hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. These abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management


Eligibility criteria: Inclusion Criteria:

* Clinical features of Brugada Syndrome (ECG findings)
* mutation positive or mutation negative
* Idiopathic ventricular fibrillation

Exclusion Criteria:

* not able to give informed consent
* Age less than 18 years
* clinical diagnosis ambiguous

Primary outcomes:
measure: Derivation of iPS cells
timeFrame: 12 months
Secondary outcomes:
measure: Differentiation of iPS cells to cardiomyocytes
timeFrame: 12 months
measure: Electrophysiology on iPS-derived cardiomyocytes
timeFrame: 12 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: University of Dundee
state: Angus
Study officials:
affiliation: University of Dundee
name: Marios P Stavridis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811081: Effective Maneuver for Post-laparoscopic Shoulder Pain
Official title: The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Diseases
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 144
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Detailed description: Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopy for benign gynecologic diseases
* patients aged 19-65 years
* patients with american society of anesthesiology physical status I-II
* patients obtaining written informed consent

Exclusion Criteria:

* patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
* patients with past history of pneumothorax or any pulmonary surgical history
* patients with any shoulder surgery histories
* patients who required to conversion to open surgery from laparoscopic surgery
* patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
* patients with inability to understand or express 10 point visual analogue scale
* pregnant women

Primary outcomes:
measure: Shoulder pain evaluated by 10 point visual analogue scale
timeFrame: after two day of procedure
Secondary outcomes:
measure: Wound pain evaluated by 10 point visual analogue scale
timeFrame: after two day of procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031781: The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
Official title: The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Episodic Migraine
Prophylaxis
Keywords: rTMS = repetitive transcranial magnetic stimulation
LDLPFC = Left dorsolateral prefrontal cortex
HIT 6 = Headache Impact test
NPRS = Numeric Pain Rating Scale
ICHD = The international classfication of Headache disorder
MT= Motor threshold
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment.

A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output


Eligibility criteria: Inclusion Criteria:

* cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition
* With a headache frequency of 4-14 per month for the last six months
* Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications.

Exclusion Criteria:

* Patients with past family history of seizures
* Other chronic pain disorders
* Severe depression (Beck Depression Inventory of 30 or more)
* Other significant neurologic or psychiatric diagnosis including substance misuse
* Metal implants in the head
* Pregnant or breastfeeding ladies
* Prior experience with TMS

Primary outcomes:
measure: Migraine attack frequency
timeFrame: 2 months
Secondary outcomes:
measure: Migraine days
timeFrame: 2 months
measure: Migraine attack severity
timeFrame: 2 months
measure: Functional disability
timeFrame: 2 months
measure: Use of abortive pills
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04256681: SNAP: Measurement of the Subjective Perception of the Symptom in Hereditary Spastic Paraparesis (HSP)
Official title: SNAP: Measurement of the Subjective Perception of the Symptom in Hereditary Spastic Paraparesis (HSP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Spastic Paraparesis
Keywords: OUTCOME MEASURE, HEREDITARY SPASTIC PARAPLEGIA
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Self-Notion and Perception (SNAP) questionnaire developed at IRCCS E.Medea by Eleonora Diella and Roberta Morganti, arises from the need to quantify the subjective perception of the patient suffering from HSP of the typical symptoms of pathology, such as spasticity, weakness, changes in balance, resistance in walking, pain and fatigue. The purpose of this study is to validate this instrument and test its reliability, looking for correlations with the measurement scales used in the literature for the evaluation of the patient with HSP. The most used for this population are the Spastic Paraplegia Rating Scale (SPRS) and the Six-Minute Walk Test (6MWT) which assess the severity of the disease and the level of endurance (8-9) respectively.


Eligibility criteria: Inclusion Criteria:

* diagnosis of genetically determined hereditary spastic paraparesis or subjects without defined genetics but who unequivocally show at the time of evaluation a dominant or recessive familiarity with exclusive involvement of the pyramidal system
* age\> 9 years
* IQ\> 80
* The patient must be able to walk for at least 10 meters. Indoors, even with help

Exclusion Criteria:

* Age less than 9 years
* IQ \<80,
* loss of gait
* psychopathological aspects that can affect the validity of the data collected

Primary outcomes:
measure: Test the validity, investigating the correlation with Spastic Paraplegia Rating Scale and with Six-Minute Walk Test, and the reliability (through test-retest mode) of the SNAP questionnaire in the aforementioned population.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Eleonora Diella
Study officials:
References:
Clinical trial NCT01048281: Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
Official title: Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stomach Cancer
Gastro-Esophageal(GE) Junction Cancer
Gastric (Stomach) Cancer
Esophageal Cancer
Gastrointestinal Stromal Tumor (GIST)
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-01-13
Enrollment: 100
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: Adults with gastric or esophageal cancer

Brief summary: Our research of the biology of upper gastrointestinal cancers involves the study of tissue samples and cells from biopsies of persons with gastric or esophageal cancer or blood samples from upper gastrointestinal cancer patients and persons at high inherited risk for these cancers. We hope to learn the role genes and proteins play in the development of gastric and esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. Over 18
2. Diagnosed with gastric or esophageal cancer OR at an increased hereditary risk for upper GI cancer

Exclusion Criteria:

1. Under 18
2. No family or personal history of gastric or esophageal cancer

Primary outcomes:
measure: p53 activity by routine pathologic analysis
timeFrame: time of collection
measure: NER activity by routine pathologic analysis
timeFrame: time of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: James M Ford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06909981: Community-Based Engagement to Improve Lung Cancer Screening and Outcomes
Official title: Community-Based Engagement to Improve Lung Cancer Screening and Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer Screening
Keywords: Lung Cancer Screening
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this pilot study is to understand the impact of a mobile lung cancer screening clinics in individuals from neighborhoods and communities with less access to resources in Boston, Massachusetts who are at high risk for lung cancer. The main questions it aims to answer includes:

* Is mobile lung cancer screening is feasible and acceptable?
* Is collecting social needs data during the mobile lung cancer screening clinics feasible?

Participants will:

* Complete an intake survey, providing information about their demographic, medical, and social needs information.
* Undergo a shared decision-making conversation to determine whether lung cancer screening should be done.
* Undergo lung cancer screening.
* Undergo a debriefing conversation and fill out an acceptability survey.
* Undergo a semi-structured phone interview between four and eight weeks after lung cancer screening date.


Eligibility criteria: Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document prior to any study-related procedures.
* Willing to undergo treatment.
* Adults between the ages of 50 and 80 years.
* No recent CT or MRI imaging within the last year.
* Currently smokes tobacco or has quit smoking tobacco within the past 15 years.
* Has a tobacco smoking history of at least 20 pack years (i.e. one pack per day for the last 20 years or equivalent).
* Has never been diagnosed with lung cancer.

Exclusion Criteria:

* Adults/children less than 50 years, or greater than 80 years of age.
* Has never smoked tobacco.
* Has smoked tobacco but quit more than 15 years ago.
* Has a tobacco smoking history of less than 20 pack years.
* Presence of major comorbidity(ies) that could prevent treatment.
* Previous diagnosis of lung cancer.
* In the opinion of the investigator, the subject is not an appropriate candidate for the study.

Primary outcomes:
measure: Feasibility of mobile lung cancer screening in target communities in Boston, Massachusetts.
timeFrame: During the intervention.
measure: Acceptability of mobile lung cancer screening in target communities in Boston, Massachusetts.
timeFrame: Between four and eight weeks after the intervention
Secondary outcomes:
measure: Feasibility of collecting social determinants of health data during mobile lung cancer screening clinics in underserved communities in Boston, Massachusetts.
timeFrame: Pre-intervention
Other outcomes:
Locations:
Study officials:
References: