louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01798212: Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
Official title: A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 40
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: A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD.

The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement


Eligibility criteria: Inclusion Criteria:

Written informed consent; ≥ 18 years of age;

GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria:

* Total Number of Reflux Events ≥ 73/24h;
* DeMeester Score ≥ 14.7;
* Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks.

Exclusion Criteria:

Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction;

≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia \>2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification \>II

Primary outcomes:
measure: Quality of Life using the Gastrointestinal Quality of Life Index
timeFrame: change from baseline in Quality of Life at 3 months, one year and three years after the intervation
Secondary outcomes:
measure: lower esophageal sphincter pressure using oesophageal manometry
timeFrame: change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion
measure: DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment
timeFrame: change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus Barmherzige Schwestern
city: Zell am See
country: Austria
facility: Krankenhaus Zell am See
Study officials:
References:
Clinical trial NCT03732612: Inflammation in Vascular Disease
Official title: The Role of Inflammation in Vascular Disease (Inflammationens Roll i kärlsjukdom)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vascular Diseases
Atherosclerosis
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients planned for vascular reconstruction surgery at our center.

Brief summary: Increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. Thus, we will investigate the role of inflammation in cardiovascular disease.

Detailed description: Vascular reconstruction surgeries usually require a small piece of the vessel wall to be excised. The excised vessel is generally discarded as medical waste: however, for patients participating in the study, the excised tissue will be placed in saline and collected for research use.

Tissue collected from individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue will be cultured ex vivo in the presence or absence of therapeutic agents, to determine if these attenuate the inflammation associated with the atherosclerotic phenotype. Furthermore, the protocol will also be carried out using vascular tissue from control patients, which have undergone vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc).

Eligibility criteria: Inclusion Criteria:

* Patient is planned to undergo vascular surgery.
* Signed informed consent has been obtained from the patient.

Exclusion Criteria:

* Patient has difficulty to understand information.
* Patients under 18 years of age.
* Patients participating in any drug-related study.

Primary outcomes:
measure: Inflammatory status
timeFrame: 2019-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: University of Gothenburg
state: Vastragotaland
Study officials:
affiliation: The University of Gothenburg
name: Jan Boren, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03437512: Non-invasive Brain Stimulation in Adults Who Stutter
Official title: Non-invasive Brain Stimulation in Adults Who Stutter
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stuttering, Developmental
Keywords: transcranial direct current stimulation
MRI
Speech
fluency
tDCS
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 29
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: Research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. The purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.


Eligibility criteria: Inclusion Criteria:

* history of persistent developmental stuttering
* stuttering severity ranging from mild to very severe, specifically Stuttering Severity Instrument (SSI) total score of 20 (mild) or higher and stuttering rates of 3% or higher
* scores within 1 standard deviation of the norm on the standardized tests for the study

Exclusion Criteria:

* received any treatment for stuttering within the past year
* other neurological conditions such as Tourette's syndrome or post-traumatic stress disorder
* taking any medications/drugs that affect brain function
* history of past or current mental illness for example, schizophrenia that may affect brain development and function
* history of serious medical or neurological illness such as epilepsy and Parkinson's disease
* history of closed head injury (e.g., concussion)
* history of reading disorders
* hearing loss
* taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study
* metal or electronic implants such as cochlear implants, and pacemakers

Primary outcomes:
measure: Changes in Brain Activation as Assessed by fMRI Images
timeFrame: Baseline, 1 week (post), 4 weeks (follow up)
measure: Change in Percentage of Stuttered Syllables Produced During Speech Sample
timeFrame: Baseline, 1 week (post), 4 weeks (follow up)
Secondary outcomes:
measure: Changes From Baseline on the Overall Assessment of Speakers Experience of Stuttering (OASES)
timeFrame: Baseline, 1 week (post), 4 weeks (follow up)
Other outcomes:
measure: Changes From Baseline on Rhythm Judgement Task
timeFrame: Baseline, 1 week, 4 weeks
measure: Changes From Baseline on Tapping Tasks
timeFrame: Baseline, 1 week, 4 weeks
measure: Changes From Baseline on Self-rated Measure of Speech Fluency
timeFrame: Baseline, 1 week, 4 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Emily O Garnett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06509412: Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis
Official title: Nd:YAG Laser Versus Diode Laser Assisted New Attachment Procedure (Lanap) in the Management of Stage II Periodontitis: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study was to assess and compare the clinical and microbiological changes following Laser assisted new attachment procedure (LANAP®) using diode 940 nm versus ND:YAG 1064 nm, and to compare the outcome to conventional periodontal therapy


Eligibility criteria: Inclusion Criteria:

* Periodontal diagnosis of stage II periodontitis.
* Residual periodontal pocket ≥4 mm, 3-4 mm clinical attachment loss with horizontal bone loss higher than 15% in radiography.
* O'Leary plaque index \<10%.

Exclusion Criteria:

* Patients with furcation involvement.
* Class II/III tooth mobility.
* Smokers who smoke more than 10 cigarettes per day.
* Patients with any systemic condition possibly affecting the outcome of periodontal therapy.
* Patients who had received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months.
* Alcohol consumers.
* Pregnant or lactating women.
* Patients with parafunctional habits.

Primary outcomes:
measure: Microbiological assessment of Treponima denticola
timeFrame: up to six months
measure: Microbiological assessment of Prevotella intermedia
timeFrame: up to six months
measure: Gingival health
timeFrame: up to six months
measure: Clinical attachment loss (CAL)
timeFrame: up to six months
measure: Pocket probing depth (PPD)
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT01769612: Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
Official title: Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases, Parasitic
Keywords: Leishmaniasis, Leishmania
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: InBios International, Inc.
name: Institut Pasteur of Tunis, Tunisia
First posted: 2013-01-16
Enrollment: 168
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: Primary care clinic

Brief summary: The purpose of the study is to evaluate the sensitivity and specificity of CL Detect, in subjects with suspected CL in Tunisia.

Detailed description: Subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (CL). Study compared the CL Detect Rapid Test vs microscopic identification of Leishmania amastigotes in a stained lesion sample. Two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the CL Detect Rapid Test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. Samples were analyzed by microscopy and CL Detect Repaid Test by different operators who evaluated each sample independently blinded to the other assay result.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and generally healthy
* Subject able to give written informed consent
* Subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion:

  * less than 4 months in age
  * primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
  * in a location suitable for collecting samples by dental broach, scraping, and aspiration
* In the opinion of the investigator, the subject is capable of understanding and complying with the protocol

Exclusion Criteria:

• Received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome

Primary outcomes:
measure: Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
timeFrame: within 1 hour after taking samples
Secondary outcomes:
Other outcomes:
Locations:
city: Gafsa
country: Tunisia
facility: Primary Health Clinic
city: Sidi Bouzid
country: Tunisia
facility: Primary Health Clinics
Study officials:
affiliation: Institut Pasteur de Tunis
name: Afif Ben Salah, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595712: Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genovarum
Keywords: Genovarum
Medial opening-wedge high tibial osteotomy
allograft
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.


Eligibility criteria: Inclusion Criteria:

* Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia\< 82 degrees
* at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning

Exclusion Criteria:

* symptomatic lateral compartment osteoarthritis of knee
* rheumatoid arthritis or other inflammatory joint diseases
* less than 100 degrees of knee range of motion
* grade III laxity in knee collateral ligaments
* history of surgery or fracture in the limb
* \>15 degrees flexion contracture
* age \<16 or \>60 years
* \>20 degrees varus deformity
* failure to attend follow-up visits
* sever bone loss in medial tibial plateau or medial femoral condyle
* \>1cm joint subluxation
* presence of lateral trust during walking
* presence of patella baja
* skin derangements on medial proximal tibia
* any form of nicotine addiction

Primary outcomes:
measure: Range of motion of the knee
timeFrame: before op and at follow ups
measure: knee score (womac)
timeFrame: before op and at final follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Seyyed Mohammad J Mortazavi, M.D.
role: STUDY_DIRECTOR
References:
citation: Haghpanah B, Kaseb MH, Espandar R, Mortazavi SMJ. No difference in union and recurrence rate between iliac crest autograft versus allograft following medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2021 Oct;29(10):3375-3381. doi: 10.1007/s00167-020-06240-w. Epub 2020 Aug 24.
Clinical trial NCT01726712: Network Supported Engagement In HIV Care
Official title: Network Supported Engagement In HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Patient Acceptance of Health Care
Keywords: Patient Care Management
Primary Health Care
HIV
Patient Acceptance of Health Care
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: ACCESS Community Health Network
First posted: 2012-11-15
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Network Supported Engagement in Care (NSEC) intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (YBMSM) who have been recently diagnosed with HIV. The intervention has been developed with input from clients and their support network members, case managers, social workers, HIV primary care providers and pastoral care at a Federally Qualified Health Center. The goal of the intervention is to improve retention in care for newly diagnosed YBMSM who present for their first HIV primary care clinic appointment.


Eligibility criteria: Inclusion Criteria:

Index subjects

* Self-identify as African-American and male;
* same gender anal/oral sex in the past 2 years;
* English speaking;
* have at least one SC in their network;
* own a cell phone not shared with other persons;
* agreeable to text-message mini-booster sessions; and
* between the ages of 16-29 years old.

Supportive Contact:

* Index participant has agreed to including the supportive contact;
* Supportive contact is willing to attend face to face and telephone mini-booster sessions;
* 18 years of age or older;
* English speaking; and
* owns a cell phone that is not shared with other persons.

Exclusion Criteria:

Index Subject:

* unable to provide assent/consent;
* plan to move out of the area within the next 12 months;
* are not willing to attend intervention sessions; or
* not willing to return for assessments

Supportive Contact:

* unable to provide informed consent; or
* not willing to return for 3 and 12 month assessments.

Primary outcomes:
measure: Missed Visit Proportion (MVP)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: John A Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758212: Influenza Vaccination at a Reduced Dose Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem
Official title: Influenza Vaccination at a Reduced Dose of 1:10 Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza
Acquired Immune Deficiency Syndrome
HIV Infections
Keywords: Influenza in Humans
Acquired Immune Deficiency Syndrome
Immunization, Active
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Influenza vaccination has proved it's effectiveness over many years of usage including HIV/AIDS patients who are immunocompromised. In those patients, however, a noted rise in HIV viral load which follows intramuscular injection of the vaccine is of unknown significance over the long run. Mesotherapy is a procedure developed and practiced in france by which a reduced and diluted amounts of antigens is being introduced by multiple intradermal injections over the torso and upper back. Mesotherapy is mainly used as a vehicle for introducing pain medicine and cosmetics.

Detailed description: We will test the effectiveness of mesotherapy as a vehicle for influenza vaccination.We will use 1:10th of the amount of seasonal trivalent influenza vaccine in approx.50 HIV/AIDS patients.A control group of approx.50 matched patients for age ,treatment schedule and immune status will receive the regular injection of trivalent vaccine. We will follow patients clinically for symptoms compatible with seasonal influenza and for direct side effects of the vaccine.In addition we will measure anti influenza antibody in the two groups .Follow up will be for 6 months following vaccination.Anti influenza antibody will be measured at 1,3,6months using hemagglutination inhibition (HAI) test.

Eligibility criteria: Inclusion Criteria:

* Virologic diagnosis of HIV/AIDS.
* Any immune derangement is acceptable

Exclusion Criteria:

* Allergy to eggs

Primary outcomes:
measure: anti influenza antibody using Hemagglutination inhibition
timeFrame: 1 , 3 , 6 months
Secondary outcomes:
measure: acceptability of influenza vaccination using mesotherapy
timeFrame: 1month
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah U. hospital
Study officials:
affiliation: Hadassah Medical Organization
name: shlomo maayan, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin JC, Nichol KL. Excess mortality due to pneumonia or influenza during influenza seasons among persons with acquired immunodeficiency syndrome. Arch Intern Med. 2001 Feb 12;161(3):441-6. doi: 10.1001/archinte.161.3.441.
citation: Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. doi: 10.1056/NEJMoa043540. Epub 2004 Nov 3.
Clinical trial NCT01018212: Cicatrix Cream in Cutaneous Groves
Official title: Effect the Cicatrix Cream in Cutaneous Groves Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Groves
Keywords: Cutaneous Groves
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will be 4 months.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent

Exclusion Criteria:

* Patient that refer manifestations of high sensibility to the medication or to some of the components of the product.
* Patient that don't want to participate in the study.
* Patient not very cooperative.
* Responsible family not very cooperative.

Primary outcomes:
measure: They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.
timeFrame: 4 month
Secondary outcomes:
measure: Extension of the groves and the reduction of these expressed in centimetres
timeFrame: 4 months
measure: Adverse effects
timeFrame: 4 months
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: Pediatric Hospital Juan Manuel Marquez
state: Havana
Study officials:
affiliation: Pediatric Hospital Juan Manuel Marquez
name: Fernanda Pastrana, MD
role: PRINCIPAL_INVESTIGATOR
References: