louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00482430: MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paranoid Schizophrenia
Schizophrenia
Keywords: Undifferentiated schizophrenia
Residual schizophrenia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug for the treatment of cognitive impairment in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Patient is clinically stable, on current antipsychotic medication for at least 3 months and current dose for 2 months
* Patient has a 6th grade reading level or better and has completed at least 6 years of formal education
* Females are not pregnant, and those who can have children agree to remain abstinent or use acceptable birth control throughout study
* Patient has had a stable living arrangement for at least 3 months prior to study start
* Patient is in general good health based on screening assessments

Exclusion Criteria:

* Patient has a major disease/disorder that may interfere with cognitive testing (such as mental retardation) and/or pose a risk upon study participation
* Patient has a history of head trauma with loss of consciousness greater than 15 minutes
* Patient has had warfarin treatment, MAO inhibitors, clonazepam, clozapine or St. John's wort within 1 month of screening
* Patient has had ECT treatment within 6 months of screening
* Patient requires treatment with antihistamines or certain other medications listed in the protocol
* Patient has a history of liver disease that has been active within the last 2 years, or a history of cancer within past 5 years
* Patient has a history of alcohol or drug dependence within past year or alcohol or drug abuse within 3 months of screening

Primary outcomes:
measure: Mean change from baseline at 4 weeks of treatment on a sequence of cognitive tests and that MK0557 generally well tolerated
timeFrame: at 4 weeks of treatment
Secondary outcomes:
measure: Mean change from baseline at 4 weeks of treatment on neuropsychological tests for executive functioning, episodic memory and working memory
timeFrame: at 4 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01315730: The Effects of Tactile Speech Feedback on Stuttering Frequency
Official title: The Effects of Tactile Speech Feedback on Stuttering Frequency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Stuttering
Keywords: stuttering
haptic
feedback
fluency
Lead sponsor: University of Mississippi, Oxford
Sponsor class: OTHER
Collaborators: name: West Virginia University
name: Auburn University
name: University of Louisiana at Lafayette
First posted: 2011-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.

Detailed description: A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences \& Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.

Eligibility criteria: Inclusion Criteria:

* Adults diagnosed with persistent developmental stuttering

Exclusion Criteria:

* Subjects below 18 years of age

Primary outcomes:
measure: Speech Fluency
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: University
country: United States
facility: The University of Mississippi
state: Mississippi
Study officials:
affiliation: The University of Mississippi
name: Dwight E Waddell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Snyder GJ, Blanchet P, Waddell D, Ivy LJ. Effects of digital vibrotactile speech feedback on overt stuttering frequency. Percept Mot Skills. 2009 Feb;108(1):271-80. doi: 10.2466/PMS.108.1.271-280.
Clinical trial NCT01599130: Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss
Official title: The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B
Keywords: Hepatitis B
sequential peg-interferon-2a to entecavir
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Detailed description: For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years old
* HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
* Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion Criteria:

* Pregnant women
* Decompensated liver disease
* Combination infection of HCV, HAV, or HEV
* Combination infection of HIV
* Any contraindication of interferon α

Primary outcomes:
measure: HBeAg sericonversion rate
timeFrame: 72 weeks
Secondary outcomes:
measure: HBeAg loss rate
timeFrame: 72 weeks
measure: HBeAg quantification dynamic change
timeFrame: 72 weeks
measure: HBsAg loss rate
timeFrame: 72 weeks
measure: HBsAg seroconversion rate
timeFrame: 72 weeks
measure: HBsAg quantification dynamic change
timeFrame: 72 weeks
measure: ALT normalization rate
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Zhiliang Gao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03917030: Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade II Furcation Defects
Official title: Treatment of Grade II Furcation Defects in Teeth With Low Interproximal Crestal Bone Height, With and Without Osteoplasty, in Conjunction With Open Flap Debridement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Furcation Defects
Periodontal Diseases
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design, all subjects receive both interventions
Primary purpose: TREATMENT

Brief summary: Teeth with furcation grade II defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade II defects with open flap debridement.


Eligibility criteria: Inclusion Criteria:

* Periodontal disease stage III or IV according to 2018 criteria
* Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs
* Competent to give consent

Exclusion Criteria:

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class II according to ASA classification
* Previous surgical therapy of included furcation defects
* Inability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected fractures/infractions
* Caries lesions in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention

Primary outcomes:
measure: Sites with no signs of inflammation
timeFrame: 12 months after treatment
measure: Sites with no signs of inflammation
timeFrame: 24 months after treatment
Secondary outcomes:
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 24 months after treatment
measure: Changes in patient-reported quality of life (QoL)
timeFrame: Preoperatively compared to 12 months after treatment
measure: Loss of clinical attachment level
timeFrame: 12 after treatment
measure: Loss of clinical attachment level
timeFrame: 24 months after treatment
measure: Number of participants with caries lesions
timeFrame: 24 months after treatment
measure: Radiographic changes
timeFrame: 12 months after treatment
measure: Radiographic changes
timeFrame: 24 months after treatment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
Study officials:
References:
Clinical trial NCT03010930: Repeated Exposure to Umami Taste on Taste Perception, Hedonics, and Satiety
Official title: Does Repeated Dietary Exposure to Umami Taste Affect Umami Perception, Hedonics, or Satiety? A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umami Taste Perception
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how repeated dietary exposure to umami taste affects umami taste perception, hedonics, food preferences, and satiety. Healthy adult subjects will consume a low glutamate vegetable broth daily for one month, where the experimental group's broth is supplemented with the umami-rich stimuli of monosodium glutamate (MSG) and the control group's low glutamate broth is matched for sodium (NaCl).

The investigators hypothesize that repeated dietary exposure to umami taste will:

1. diminish umami suprathreshold intensity perception and hinder the ability to discriminate varying MSG concentrations
2. decrease liking of umami-rich foods and shift preferences upwards towards more intense umami stimuli
3. decrease satiation and decrease the satiating effect of a test meal


Eligibility criteria: Inclusion Criteria:

* Have normal sense of taste and smell (self-report)
* Likes soups or broths (self-report)
* Able to report to study site daily (self-report)

Exclusion Criteria:

* Restrained eater (score \> 12 on restrained eating subscale from Three Factor Eating Questionnaire)
* BMI \< 18 or \> 25 kg/m2 (self-report)
* Vegan (self-report)
* Hypertensive or on low-sodium diet (self-report)
* Allergic or sensitive to MSG (self-report)

Primary outcomes:
measure: Change in umami taste intensity perception
timeFrame: 1 month (at baseline and post intervention)
measure: Change in umami taste discrimination
timeFrame: 1 month (at baseline and post intervention)
Secondary outcomes:
measure: Change in umami liking and preference
timeFrame: 1 month (at baseline and post intervention)
measure: Change in liking and wanting of high protein foods
timeFrame: 1 month (at baseline and post intervention)
measure: Change in satiation
timeFrame: 1 month (at baseline and post intervention)
measure: Change in satiety
timeFrame: 1 month (at baseline and post intervention)
Other outcomes:
measure: Height
timeFrame: 1 month (at baseline and post intervention)
measure: Weight
timeFrame: 1 month (at baseline and post intervention)
measure: Habitual glutamate consumption
timeFrame: 1 month (at baseline and post intervention)
Locations:
Study officials:
References:
citation: Noel CA, Finlayson G, Dando R. Prolonged Exposure to Monosodium Glutamate in Healthy Young Adults Decreases Perceived Umami Taste and Diminishes Appetite for Savory Foods. J Nutr. 2018 Jun 1;148(6):980-988. doi: 10.1093/jn/nxy055.
Clinical trial NCT03046030: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Pain
Official title: Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this proposal is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy and patient populations to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.


Eligibility criteria: Inclusion Criteria:

* Right handed healthy male and female adults aged 18-60
* No contraindications to fMRI scanning

Exclusion Criteria:

* Current or past history of major medical, neurological, or psychiatric illness
* Any pain disorder
* Pregnancy
* Non-fluent speaker of English

Primary outcomes:
measure: fMRI signal increases
timeFrame: 4 days; Sessions 2-5
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01415830: Compare Two Anti-Scorpion Venom Serum In Children
Official title: Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scorpion Sting
Keywords: Anti-Scorpion venom serum
venom
efficacy
safety
children
Lead sponsor: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.

On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).

Detailed description: We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

This is a randomized clinical trial, which included 120 subjects of both sexes aged 0 and 15 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum (Alacramyn).

Eligibility criteria: Inclusion Criteria:

1. Scorpion sting
2. Either sex
3. Age 1 to 15 years
4. Signing an informed consent (signed by parent or guardian)
5. Being residents of the state of Guanajuato

Exclusion Criteria:

1. Previous treatment with gamma globulin or immunoglobulin
2. Blood transfusion at any stage of life
3. Patients treated with drugs that interact with anti-scorpion serum
4. History or history of sensitivity or intolerance to anti-scorpion serum or horse products
5. Pregnancy
6. Any immunodeficiency
7. Patients who have participated in a research protocol in the previous month.

Primary outcomes:
measure: Resolution of signs and symptoms of scorpion envenomation
timeFrame: after treatment (expected average of 12 hrs)
Secondary outcomes:
measure: Evaluate the adverse events in every treated child
timeFrame: inmediately after treatment and until 5 days later
Other outcomes:
Locations:
city: León
country: Mexico
facility: Hospital General Regional de León
state: Guanajuato
Study officials:
affiliation: Laboratorios de Biologicos y Reactivos de México SA de CV
name: Ma. Eugenia Jimenez-Corona, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04455230: A Long Term Follow-Up Study of Fabry Disease Subjects Treated With FLT190
Official title: A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT190) in Subjects With Fabry Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fabry Disease
Lysosomal Storage Diseases
Keywords: Gene Therapy
Lead sponsor: Spur Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-07-02
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Multicenter, Long-term, Follow-up Study to Investigate the Safety and Durability of Response Following Dosing of an Adeno-associated Viral Vector (FLT190) in Subjects with Fabry Disease
Primary purpose: OTHER

Brief summary: Fabry disease is a rare, X-linked inborn error of glycosphingolipid metabolism caused by an abnormal gene encoding the α-galactosidase A (αGLA) enzyme. The αGLA enzyme is ubiquitously expressed throughout the body and is responsible for the breakdown of glycosphingolipids, deficiency of which results in the accumulation of specific glycosphingolipids that are associated with the pathophysiology of the disease. Current treatment for Fabry disease is limited to the symptomatic management of pain, conventional management of complications, and methods to increase the availability of functional αGLA.

This clinical study aims to investigate the long-term safety and durability of αGLA in patients who have been dosed with a new gene therapy product (FLT190) in earlier clinical studies.


Eligibility criteria: Inclusion Criteria:

* Subjects who have previously received FLT190
* Provision of full informed consent and able to comply with all requirements of the study including long-term follow-up for 60 months (5 years) post-treatment.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Safety endpoint will be assessed by the reporting of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
timeFrame: Entry to 5 years post dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: London
country: United Kingdom
facility: Royal Free London
Study officials:
References:
Clinical trial NCT03755830: Prostaglandin F2-alpha (PGF2α) in Vitiligo
Official title: Study of the Cutaneous Expression of Prostaglandin F2-alpha (PGF2α) in Vitiligo Patients: a Case-control Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal control subjects.

Detailed description: Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.

Eligibility criteria: Inclusion Criteria:

* Patients with non-segmental vitiligo.
* Both sexes.
* Age \< 18 years old.
* New cases or cases not receiving any medications for at least 3 months ago.

Exclusion Criteria:

* Age: Patients \< 18 years.
* Segmental or universal vitiligo.
* Pregnant and lactating females.

Primary outcomes:
measure: Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: