louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01132105: Vestibular Evoked Myogenic Potential: A New Device Propose
Official title: Vestibular Evoked Myogenic Potential: A New Device Propose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evoked Potentials, Motor, Vestibular
Lead sponsor: Universidade Estadual de Ciências da Saúde de Alagoas
Sponsor class: OTHER
Collaborators: name: Aline Carabl de Oliveira
name: José Fernando Colafêmina
First posted: 2010-05-27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, Normal Hearing, Normal Vestibular fuction,

Brief summary: The bioelectrical responses of muscle, evoked by sound, obtained with a device considered the gold standard (widely used in clinics and hospitals) are similar to those obtained with a new device developed


Eligibility criteria: Inclusion Criteria:

* hearing thresholds equal to or less than 20 dB HL with differences between the ears, by frequency, equal to or less than 10 dB.

Exclusion Criteria:

* Occupational noise exposure
* Ear surgeries
* More than three ear infections in the current year
* Use of ototoxic medication
* Tinnitus, vertigo, dizziness or other vestibular-cochlear diseases
* Systemic diseases that may contribute to cochlear-vestibular pathologies, such as hypertension and dyslipidemia
* Hormonal diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maceió
country: Brazil
facility: Universidade Estadual de Ciências da Saúde de Alagoas - UNCISAL
state: Alagoas
Study officials:
affiliation: Universidade Estadual de Ciências da Saúde de Alagoas
name: Pedro L Menezes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05008705: Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly
Official title: Effects of Protein Intake Plus Neuromuscular Electrical Stimulation on Muscle Mass in Hospitalized Elderly: a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophy, Muscular
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission and mortality of hospitalized elderly.

Detailed description: Hospitalized elderly people show malnutrition, physical inactivity, and pronounced systemic inflammation which may be exacerbated the catabolic state and promote drastic muscle wasting during the hospitalization and, thus increasing the length of stay, morbidity, and mortality. Therefore, the aim of this study is to investigate the effects of supplementation of protein plus sessions of electrostimulation on muscle mass, length of hospital stay, readmission, and mortality of hospitalized elderly.

Eligibility criteria: Inclusion Criteria:

* both sex;
* 65 years and older;
* hospital stay less than 48 hours;

Exclusion Criteria:

* cancer in the last 5 years;
* delirium;
* cognitive deficit that impossibility the patient to read and sign the informed consent form;
* neurological disease;
* neurodegenerative muscular disease;
* impossibility to receive the intervention.

Primary outcomes:
measure: Vastus Lateralis Muscle Cross-sectional Area
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
Secondary outcomes:
measure: Muscle function
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Nutritional status
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Handgrip strength
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Functional independence
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Length of hospital stay
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Mortality
timeFrame: From date of admission until the date of medical discharge. Up to 30 days.
measure: Hospital readmission post-medical discharge
timeFrame: 6 months post-medical discharge
measure: Health costs
timeFrame: 6 months post-medical discharge
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Hamilton Roschel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060005: Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
Official title: Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sjögren's Syndrome
Meibomian Gland Dysfunction
Keywords: Sjögren's syndrome
meibomian gland dysfunction
dry eye disease
Lead sponsor: Tung Wah Hospital
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that the dry eye caused by SS may include the evaporative type, resulting from the MGD. Furthermore, the investigators hypothesize that both pSS and sSS are associated with MGD.To test our hypothesis, we conducted a prospective clinical study in patients with SS (both pSS and sSS) and MGD, and the normal population All subjects were matched for both age and gender and assessed for tear function and ocular surface signs and symptoms.


Eligibility criteria: Inclusion Criteria:

* All the subjects are female and age between 50-60 years
* Patients with primary SS fulfilled the criteria established by the European Study Group
* Patients with SLE and RA met the criteria set by the American College of Rheumatology

Exclusion Criteria:

* The control history of autoimmune disease

Primary outcomes:
measure: meibomian gland function
timeFrame: up to 3 months after tear substitutes apply
measure: Ocular Surface Disease Index
timeFrame: up to 3 months after tear substitutes apply
measure: noninvasive tear breakup time
timeFrame: up to 3 months after tear substitutes apply
measure: fluorescein staining of the cornea
timeFrame: up to 3 months after tear substitutes apply
measure: Schirmer's test with and without anesthesia
timeFrame: up to 3 months after tear substitutes apply
measure: tear meniscus
timeFrame: up to 3 months after tear substitutes apply
Secondary outcomes:
measure: rose bengal staining of the conjunctiva
timeFrame: up to 3 months after tear substitutes apply
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Tungwah Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Tungwah Hospital of Sun Yat-Sen University
name: Shaolin Du, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02848105: Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD
Official title: Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral Blood Stem Cell Transplantation
aGVHD
Keywords: aGVHD
valproic acid
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2016-07-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1\~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.

Detailed description: To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.

Eligibility criteria: Inclusion Criteria:

* Grade II-IV aGVHD
* No previous history of allergy to valproic acid
* No active and severe infection

Exclusion Criteria:

* Inclusion in other clinical trial
* GVHD Prophylaxis with valproic acid
* severe organ dysfunction: heart, lung, liver and kidney

Primary outcomes:
measure: complete response
timeFrame: 28 days after the treatment
Secondary outcomes:
measure: Overall response (complete + partial response)
timeFrame: 28 days after the treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Blood & Marrow Transplantation Center, RuiJin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Jiong HU, M.D.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01818505: The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
Official title: The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antiphospholipid Syndrome
Endothelial Dysfunction
Hyperuricemia
Gout
Metabolic Syndrome
Keywords: antiphospholipid syndrome
gouty arthritis
Hyperuricemia
metabolic syndrome
osteoarthritis
cardiovascular co-morbidities
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, the investigators will analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. The investigators expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.

Detailed description: Patients with hyperuricemia were confirmed to have higher risks of cardiovascular disease, but the exact mechanism remained to be elucidated. Many connective tissue diseases such as rheumatoid arthritis are often associated with antiphospholipid antibodies-associated endothelial impairment. In the present study, we'll analyze the presence of antiphospholipid antibodies in the serum of the patients with gout/ asymptomatic hyperuricemia, with a comparison to the patients of osteoarthritis but without hyperuricemia and gout. We expect to find a correlation between these pathogenic antibody and those cardiovascular co-morbidities.

Patient eligibility：

1. Patients with gout
2. Patients with asymptomatic hyperuricemia
3. Patients of osteoarthritis but without hyperuricemia and gout Exclusion Criteria： Patients younger than 20 years old

Eligibility criteria: Inclusion Criteria:

1. Patient with gouty arthritis
2. Patient with asymptomatic hyperurecemia
3. Patient of osteoarthritis but without hyperuricemia and gout

Exclusion Criteria:

1.Patient younger than 20 y/o.

Primary outcomes:
measure: development of metabolic syndrome or cardiovascular events
timeFrame: 36 months
Secondary outcomes:
measure: Acute myocardial infarct or stroke
timeFrame: 36 months or more
Other outcomes:
Locations:
city: Dou-Liou City
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
state: Yun-Lin County
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Min Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01862705: Using fMRI to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Manipulation in Individuals With Mechanical Neck Pain
Official title: Using fMRI to Determine if Cerebral Hemodynamic Responses to Pain Change Following Thoracic Spine Manipulation in Individuals With Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Thoracic spine thrust manipulation (TSM) has been shown to be an effective intervention in the management of patients with neck pain. However the mechanisms for pain relief associated with this intervention remain largely unexplained. Recent evidence suggests structures within the brain may have a role in creating responses of pain relief. This study aims to use functional magnetic resonance imaging (fMRI) to determine if there is a change in blood flow to structures within the brain following TSM in patients with neck pain. All patients will undergo fMRI while receiving painful stimuli directed to two separate sites, the cuticle of the index finger and the great toe. Subjects will then receive either TSM or sham-manipulation and then immediately undergo a second fMRI scan receiving the same painful stimuli. The primary outcome of interest is the shift in blood flow within the brain before and after TSM or sham manipulation as measured by Blood Oxygen Level Dependent (BOLD) technology. This study will be the first to examine this type of response to manual therapy within the brain in patients with neck pain.


Eligibility criteria: Inclusion Criteria:

* Primary complaint of mechanical neck pain of less than 6 weeks in duration as identified in the patient's initial physical examination. Mechanical neck pain is defined as generalized neck and/or shoulder, peri-scapular pain with symptoms provoked by neck postures, neck movements, or palpation of the cervical musculature

Exclusion Criteria:

* Any medical red flags suggestive of non-musculoskeletal origin of pain, such as metabolic disorders, osteoporosis, tumor, and/or rheumatoid arthritis
* No contraindications to spinal mobilization
* No contraindications to MRI (claustrophobia, presence of cardiac pacemakers, cochlear implants, metal implants, implanted hearing aids, and previous injuries caused by bullets or shrapnel, pregnancy or thought to be pregnant

Primary outcomes:
measure: BOLD response to noxious stimuli
timeFrame: Immediately following TSM or sham-manipulation. Time frame to initiate MR scanning following thrust or sham-manipulation not to exceed 5 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT03689205: The Effect of Obesity on Venous Puncture Pain
Official title: Assessment of the Effect of Obesity on Venous Puncture Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Cannulation
Body Mass Index
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After surgery patients

Brief summary: Before surgery, patients will fill the Beck anxiety, distress tolerance test and Pain katastrophizing test. Patients will be divided into two groups according to BMI\> 30kg / m2 (Group A) and BMI \<30kg / m2 (Group B). Compared to body weight, venous vascular pain of the groups will be compared.

Detailed description: Seventy patients will be randomized to two groups(BMI\> 30kg / m2 (Group A) and BMI \<30kg / m2 (Group B) during peripheral venous cannulation (PVC). The patients' visual analog scores will be measured during peripheral venous cannulation.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) physical status 1 and 2, between the ages of 18 and 65, were scheduled for elective surgery

Exclusion Criteria:

* Patients with a history of anxiety disorders or hearing problem and preoperative pain, emergency surgery

Primary outcomes:
measure: Visual analog scale
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03396705: Liver Regeneration
Official title: Understanding the Molecular Basis of Normal Liver Regeneration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Diseases
Liver Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 2
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 undergoing partial hepatectomy for colorectal cancer metastases, and meeting the eligibility criteria will be invited to participate.

Brief summary: The liver is the only visceral organ with a tremendous capacity to regenerate. We don't yet understand how normal liver regeneration occurs (on a molecular level) or how to distinguish between normal and "abnormal"/neoplastic regeneration. This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types.

Detailed description: New studies are demonstrating that rodent models of the liver and liver disease are inadequate. The human liver is quite different and needs to be studied directly. The cell expression of human liver cells during regeneration has many implications for treatment of patients with cirrhosis and cancer.

This study will characterize the role of the different liver cell types in the regeneration process and will examine gene expression changes in the various liver cell types. We hypothesize that there is significant crosstalk among hepatocytes, macrophages, and T-cell subsets in the human liver, stimulating the regenerative process.

Tissue will be obtained from serial biopsies of "healthy" liver that is regenerating in patients who undergo liver resection for metastatic colorectal cancer. All participants must first provide written informed consent and meet study eligibility criteria. The first tissue sample will be collected intraoperatively, then serial fine-needle aspiration biopsies (FNAB) will be performed approx. 1 week following surgery, and 1 month following surgery. Liver regeneration will also be assessed using routine imaging of the liver at approx. 3 months.

Retrospective (previously collected diagnostic or biobanked) tissue is also being included for study, given lower than anticipated enrollment.

Eligibility criteria: Inclusion Criteria:

* willing and able to provide written informed consent
* No history of liver disease or dysfunction

Exclusion Criteria:

* Patients who receive chemotherapy within the 6 weeks prior to their hepatectomy and/or would be started on active chemotherapy within the first 4 weeks post-hepatectomy.
* Patients requiring long-term anticoagulation

Primary outcomes:
measure: Gene expression
timeFrame: week 1 post-resection
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Mamatha Bhat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06827405: Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula
Official title: Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula in the Management of Secondary Lactose Intolerance in Persistent and Severe Persistent Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Lactose Intolerance
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to fill the gaps by comparing the effectiveness of oral lactase enzyme and lactose free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea.

Detailed description: Although it is well understood that oral lactase enzyme can play a pivotal role in hastening recovery due to secondary lactose intolerance in persistent diarrhea, there is limited local data available in this regard. If exogenous oral lactase enzyme is found to be more effective, it would help children receive uninterrupted milk and milk-based diet during the diarrheal episode, as the former would aid digestion and absorption of lactose, thus providing the necessary nutrients especially (calcium) and vitamins so vital in this period of rapid growth.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Aged 6-24 months
* Presented with persistent or severe persistent diarrhea due to secondary lactose intolerance
* Patients on formula or mixed feeding, or formula/cow/buffalo milk

Exclusion Criteria:

* Severe acute malnutrition
* Hemodynamic instability (shock)
* Those on oral antibiotics or on excessive juices
* With conditions of malabsorptive states (celiac disease, protein losing enteropathy, or irritable bowel syndrome)

Primary outcomes:
measure: Resolution of diarrhea
timeFrame: 5 days
measure: Reduction in abdominal pain
timeFrame: 5 days
measure: Lessening in bloating
timeFrame: 5 days
measure: Resolution of nausea/vomiting no perianal rash or only
timeFrame: 5 days
measure: Resolution of perianal rash
timeFrame: 5 days
Secondary outcomes:
measure: Treatment successful
timeFrame: 6 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin University Hospital, Kemari
state: Sindh
Study officials:
affiliation: Hamdard University Hospital, Karachi
name: Fatima Ghayas, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziauddin University Karachi
name: Heena Ghayas, FCPS
role: STUDY_DIRECTOR
References: