louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00252044: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
Official title: The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizotypal Personality Disorder
Other Personality Disorders
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2005-11-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis by drug administration of 0.3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo.

Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.


Eligibility criteria: Inclusion Criteria: DSM-IV criteria for Schizotypal Personality Disorder (or meets full criteria bar one) or another personality disorder and shows impairment on markers of cognitive functioning. Medically healthy, not abusing drugs or alcohol, is at least two weeks medication-free and does not have significant neurological disease.

-

Exclusion Criteria: DSM-IV or RDC criteria for Schizophrenia or any Schizophrenia-related psychotic disorder or for Bipolar Disorder. Any other Axis I disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject's functional impairment.

-

Primary outcomes:
measure: Performance on tests of sustained attention, episodic memory and working memory at baseline and after 2, 4, 6 and 8 weeks on the study medication
Secondary outcomes:
measure: Hamilton Depression Rating Scale, Positive and Negative Symptom Scale and Clinical Global Impression scale at baseline and then weekly through the end of the trial
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Bronx VA Medical Center/Mount Sinai School of Medicine
name: Larry J Siever, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894244: Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
Official title: Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: None- Normal healthy upper arm skin will be used.
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.


Eligibility criteria: Inclusion Criteria:

* Age 30-60 y/o
* Mild to moderate laxity of arm skin
* Skin of Fitzpatrick levels I-III

Exclusion Criteria:

* Any active local arm infections
* Scarring or abnormalities in upper arm area
* Major systemic illnesses
* Any condition with delayed wound healing
* History of psychiatrist illnesses

Primary outcomes:
measure: The Change in Skin Tightening in the Upper Inner or Outer Arm (as Measured by Millimeters)
timeFrame: immediately following treatment and 30 days after last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT05224544: Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter
Official title: Exploratory Study Investigating the Acute Effect of Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Micro Hole Zone Catheter Compared to a Conventional 2-eyelet Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product.

Detailed description: This investigation is a randomized, single-blinded, parallel, single-center investigation. Up to 50 subjects (40 completers) will be included and each subject will have two test visits overseen by the Principal Investigator (PI), or designee. Each subject will be enrolled in the investigation, which can be up to 3 days (if Day 0 and Day 1 are not on same day). The subjects will be randomly assigned to test either the test product or the comparator product, with at least 20 subjects assigned to each product. The subjects will undergo cystoscopy and catheterization.

Eligibility criteria: Inclusion Criteria:

1. Has given written informed consent
2. Is at least 18 years and have full legal capacity
3. Is female
4. Has a negative urine Multistix dipstick test for erythrocytes (haematuria)

Exclusion Criteria:

1. Has used an internal urinary catheter or cystoscopy within the past month
2. Has prior history of bladder surgery
3. Is symptomatic and/or on medication for overactive bladder
4. Has evidence of ongoing, active, symptomatic urinary tract infection (UTI) (assessed by PI, or delegate)
5. Is pregnant and/or breast-feeding
6. Is participating in other clinical investigations during this investigation
7. Is menstruating during study period

Primary outcomes:
measure: Change in Appearance of the Bladder Mucosa (∆=Pre-catheterisation at Baseline and Post-catheterization and Visit 2) Rated on a 4-point Scale.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
Study officials:
affiliation: American Health Research
name: Selwyn Spangenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521544: Self-Myofascial Release in the Posterior Myofascial Chain
Official title: Self-Myofascial Release in the Posterior Myofascial Chain in Healthy Subjects With a Foam Roller
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciae (Anatomy)--Inflammation
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates the relation between different segments of the posterior myofascial chain of the human body.

The intervention consists on apply self-myofascial release with a foam roller in one of the segments of the posterior myofascial chain of the participants, and then see if the treatment has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.

Detailed description: The study investigates the relation between different segments of the posterior myofascial chain of the human body.

The intervention consists on apply self-myofascial release with a foam roller in one of the segments of the posterior myofascial chain, and then see if the treatment has produced any changes in the hamstrings, gastrocnemius and soleus flexibility.

Eligibility criteria: Exclusion Criteria:

* Pregnant women
* Musculoskeletal problems in the last month
* Surgical interventions in he knee, hip, ankle, back or neck in tha last 6 months
* Psychological or nervous alterations
* Uncomprehension of the study protocol

Primary outcomes:
measure: Hamstrings flexibility change
timeFrame: 0 seconds, 30 seconds, 2 minutes, 5 minutes, 10 minutes
Secondary outcomes:
measure: Triceps surae flexibility change
timeFrame: 0 seconds, 10 minutes
measure: Fatigue
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
affiliation: Anatomy lecturer
name: Albert Pérez Bellmunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06072144: Validity and Reliability of the Smart Speed Device
Official title: Investigating the Reliability and Validity of the Smart Speed Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be healthy young people between the ages of 18-24. All participants will be recruited from Afyonkarahisar Health Sciences University Physiotherapy and Rehabilitation Department.

Brief summary: The Smart Speed device developed at Zafer Teknopark in Turkey was developed to objectively assess reaction time. The aim of this study was to evaluate the validity and reliability of the Smart Speed device in comparison with BlazePod and Nelson Reaction Test.

Detailed description: The capacity to perceive, analyze, and react to a signal is referred to as reaction time. Reaction time is influenced by many factors such as visual and auditory factors. It is also influenced by individual factors such as age, gender, body mass index, attention and fatigue. Having reaction time within normal limits is very important for maintaining activities of daily living. BlazePod is a valid and reliable device for the assessment of reaction time. The Nelson Reaction test is also a valid and reliable test frequently used in the clinic for the assessment of reaction time due to its simple and rapid application. The Smart Speed device developed at Zafer Teknopark in Turkey was developed to objectively assess reaction time. The aim of this study was to evaluate the validity and reliability of the Smart Speed device in comparison with BlazePod and Nelson Reaction Test.

Eligibility criteria: Inclusion Criteria:

* Without having systemic disease
* To be able to speak Turkish language

Exclusion Criteria:

* Having a problem that affects physical performance

Primary outcomes:
measure: Assessment of reaction time
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Fatma EKEN
state: Center
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Emel TAŞVURAN HORATA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01194544: The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality
Official title: The Relationship Between Dietary Habit and Gastroesophageal Flap Valve Abnormality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Subjects
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: Gastroesophageal reflux disease (GERD) is commonly seen in Western countries; however, it is gaining prevalence in Asia countries recently. In addition to the lower esophageal sphincter and the crural fibers of the diaphragm, the flap valve at the gastroesophageal junction is also responsible for maintaining an antireflux barrier. Hill et al developed a grading system of gastroesophageal flap valve (GEFV) and concluded that this flap valve system is simple, reproducible, and offers diagnostic aid in the evaluation of patients with suspicious reflux disease undergoing esophagogastroduodenoscopy (EGD). It is a common belief that large meals provoke considerable postprandial reflux and it results from an increase in the rate of transient lower esophageal sphincter relaxations. One study also revealed that rapid food intake produces more gastroesophageal reflux in healthy volunteers. So this study attempted to evaluate the relationship between dietary habit and GEFV abnormality. The investigators used a questionnaire regarding the dietary habit to the population undergoing EGD in a self-paid health examination.


Eligibility criteria: Inclusion Criteria:

* The healthy subjects undergo EGD in a self-paid health examination in WanFang Hospital.

Exclusion Criteria:

* None

Primary outcomes:
measure: Grading of Gastroesophageal Flap Valve by Esophagoduodenoscopy
timeFrame: 1 year
measure: Dietary habit questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yung-Fa Chen
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Yung-Fa Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01152944: Mechanisms of Stroke in Intracranial Stenosis
Official title: Mechanisms of Stroke in Intracranial Stenosis and Stenting
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Keywords: Symptomatic intracranial atherosclerotic disease enrolled in the medical arm of SAMMPRIS
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical arm of the SAMMPRIS trial which includes recently symptomatic (\<30 days) high grade (70% or more)intracranial stenosis of the carotid, middle cerebral, vertebral or basilar arteries.

Brief summary: The objective of this SAMMPRIS-affiliated study is to understand the mechanisms the mechanisms that underlie ischemic stroke recurrence in high-grade intracranial atherosclerotic disease in order to determine predictors of recurrent stroke. MoSIS will evaluate 6 specific mechanisms of stroke in the medically-treated SAMMPRIS cohort: decreased antegrade flow, progression of stenosis, decreased proximal collateral flow, decreased distal collateral flow, impaired cerebrovascular reserve, and artery-to-artery embolism.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the medical arm of SAMMPRIS, signed consent

Exclusion Criteria:

* For QMRA testing: contraindications to MRI; for TCD testing, abscence of ultrasonographic windows.

Primary outcomes:
measure: Ischemic stroke in the territory of the stenotic artery
timeFrame: 2 years from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
References:
Clinical trial NCT03483844: Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
Official title: Diagnostic Accuracy of Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis
Keywords: scoliosis
low dose
arthrodesis
dual-energy CT
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 64
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with progression of scoliosis selected at the Rizzoli Orthopaedic Institute

Brief summary: The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis

Detailed description: CT imaging is the gold standard for assessing bone dysmorphism and vertebral morphometry during the pre-surgical planning of vertebral arthrodesis. It is necessary in the definition of the fixation points to avoid malposition of transpedicular screws and potential visceral, vascular or neurological damage.

It is known that multislice CT involves an increased radiation exposure for patients, while dual-energy CT uses a low-dose acquisition protocol and VEO reconstruction software.

The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis who are candidated for vertebral arthrodesis.

Eligibility criteria: Inclusion Criteria:

* patients with progression of scoliosis without vertebral arthrodesis
* patients able to maintain immobility for the duration of the exam
* patients from 5 to 20 years old

Exclusion Criteria:

* pregnancy
* vertebral arthrodesis
* patients unable to maintain immobility for the duration of the exam
* non-compliant patients
* obese patients
* patients younger than 5 years old or older than 20 years old

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Week 1 (post-surgery)
Secondary outcomes:
measure: Radiation exposure
timeFrame: Baseline (pre-surgery) and week 1 (post-surgery)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
affiliation: Rizzoli Orthopaedic Institute
name: Milva Battaglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914744: Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
Official title: Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Hodgkin Lymphoma
Hepatitis B Reactivation
Keywords: NHL
HBV
entecavir
lamivudine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

Detailed description: In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Eligibility criteria: Inclusion Criteria:

* Previously untreated NHL suitable for CHOP/R-CHOP treatment
* Age range 18-80 years old
* HBsAg positive with high level of HBV DNA
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Primary or secondary central nervous system involvement
* With hepatitis C virus infection
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection

Primary outcomes:
measure: Incidence rate of HBV reactivation
timeFrame: 12 months
Secondary outcomes:
measure: Incidence rate of hepatitis and HBV reactivation-related hepatitis
timeFrame: 6 months
measure: Incidence rate and median time of treatment delay due to hepatitis
timeFrame: 6 months
measure: Incidence rate and median time of HBV DNA level normalization
timeFrame: 6 months
Other outcomes:
measure: Incidence of drug resistance of viral variants
timeFrame: 3 years
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04418544: Vocal Feature Analysis Algorithm for COVID-19 Detection
Official title: Testing of Soniphi Vocal Feature Analysis Algorithm for COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Soniphi LLC
Sponsor class: INDUSTRY
Collaborators: name: UserWise, LLC
First posted: 2020-06-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being tested for COVID-19.

Brief summary: This is an observational, prospective, non-randomized, non-significant risk study collecting voice recordings from subjects who are being tested for COVID-19 by laboratory analysis of specimens obtained by nasal or naso-pharyngeal (NP) swab. Patients record their voices through an app on their mobile phone. Patients and health care providers will be blinded to the swab test results during Phase 2 of the study.

Detailed description: The primary objective of this observational study is to determine if the Vocal Feature Analysis (VFA) Algorithm developed by Soniphi can screen for the COVID-19 condition from voice recordings. Patients eligible for the study are those being tested for COVID-19 based on molecular diagnostic testing of specimens obtained by nasal or nasopharyngeal swab.

No clinical decisions will be based on the recordings. The results of the algorithm analysis will not be made available to the subjects or their healthcare providers during or after the study.

Eligibility criteria: Inclusion Criteria:

1. Male or female, aged \> 18 years
2. Provide a valid electronic informed consent form
3. Eligible patients are those meeting SOC guidelines for swab tests for COVID-19 and those providing an evaluable sample.
4. Stated willingness to provide evidence of their lab test results
5. Pregnant or lactating women may participate

Exclusion Criteria:

1. Presence of tracheostomy or past tracheostomy with permanent change to the voice due complications that involved the vocal cords.
2. Prior surgery which may influence the vocal cords, e.g., laryngeal, tracheal or esophageal surgery
3. Prior head, neck or throat cancer treated with radical neck dissection and/or radiation therapy that may influence the vocal cords
4. Treatment with another investigational drug or device within 30 days prior to signing Consent Form

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sebastopol
country: United States
facility: Soniphi
state: California
Study officials:
affiliation: Soniphi LLC
name: Stephen Steady, MD
role: PRINCIPAL_INVESTIGATOR
References: