louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00203320: TNF-Alpha Inhibition for Treatment of Alzheimer's Disease
Official title: Etanercept for Alzheimer's-Type Memory Loss Pilot Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Tobinick, Edward Lewis, M.D.
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.

Detailed description: Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 30 study subjects for a period of one year with serial testing of cognition and function.

Eligibility criteria: Inclusion Criteria:

* NINCDS-ADRDA Criteria for Alzheimer's disease
* CT or MRI consistent with AD

Exclusion Criteria:

* active infection
* CHF
* demyelinating disease
* uncontrolled diabetes mellitus
* vascular dementia
* clinically significant neurologic disease other than AD
* Hachinski \>4
* history of lymphoma
* TBC
* wbc\<2500
* platelets\<100,000
* HCT\<30
* pregnancy
* premenopausal, fertile not on acceptable birth control
* change in neuroactive medication within 4 weeks of study initiation

Primary outcomes:
measure: ADAS-Cog
measure: SIB
measure: MMSE
measure: ADCS-ADLsev
Secondary outcomes:
measure: Category fluency
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: 100 UCLA Medical Plaza, Suites 205-210
state: California
Study officials:
affiliation: unaffiliated (Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA)
name: Edward L. Tobinick, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04272320: The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair
Official title: The Efficacy of Transversalis Fascia Plane Block on Postoperative Pain in Pediatric Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients undergoing lower abdominal surgery, postoperative pain management is frequently provided with systemic opioids use or neuraxial methods. Ultrasound-guided TFP block is the preferred method to reduce the use of opioids and systemic analgesics for postoperative pain management. TFP block provides anesthesia and analgesia in the inguinal region by blocking the ilioinguinal and iliohypogastric nerves.

In this study, we aimed to evaluate the effects of ultrasound-guided TFP Block on postoperative pain scores in pediatric lower abdominal surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing ınguinal hernia repair

Exclusion Criteria:

* American Society of Anesthesiologist's physiologic state III-IV

Primary outcomes:
measure: Pain Score
timeFrame: Postoperative first 24 hours
Secondary outcomes:
measure: Additional Analgesic
timeFrame: Postoperative first 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Ahiskalioglu A, Aydin ME, Doymus O, Yayik AM, Celik EC. Ultrasound guided transversalis fascia plane block for lower abdominal surgery: First pediatric report. J Clin Anesth. 2019 Aug;55:130-131. doi: 10.1016/j.jclinane.2018.12.046. Epub 2019 Jan 15. No abstract available.
Clinical trial NCT03055520: Arithmetic Training With the Kumon Method for Cognition in Schizophrenia
Official title: Arithmetic Calculation Training With the Kumon Errorless Learning Method for Cognitive Rehabilitation of Patients With Schizophrenia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
cognition
arithmetic training
Kumon method
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized placebo-controlled trial of arithmetic training (with the Kumon Method) as an errorless learning method for improvement of cognition in schizophrenia. Outpatients were included after signing an informed consent. The trial consisted of 48 sessions of arithmetic training (twice a week, for 6 months) or placebo (nonspecific recreation, 48 sessions). The patients were evaluated with a neuropsychological battery at baseline, after 6 months (end of intervention) and after 12 months after baseline. The Positive and Negative Syndrome Scale (PANSS) and the Personal and Social Performance scale (PSP) were applied at baseline, after 6 months (end of intervention) and 12 months after baseline. Primary outcome was the performance on three cognitive domains (attention, executive functions and working memory).


Eligibility criteria: Inclusion Criteria:

* Literate (≥5 years of formal education).
* Diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
* Clinically stable, with constant antipsychotic medication regimen for ≥8 weeks before screening
* No hospitalizations in the last 6 months.

Exclusion Criteria:

* Other Axis I psychiatric disorders, substance abuse or dependence.
* History of head trauma or other neurologic diseases.
* Severe or uncontrolled medical diseases, history of mental retardation or attendance in special-education classes,
* Suicide risk
* Participation in any other kind of psychosocial intervention.

Primary outcomes:
measure: improvement in attention
timeFrame: change from baseline to 6 months and to 12 months
measure: improvement in working memory
timeFrame: change from baseline to 6 months and to 12 months
measure: improvement in executive function
timeFrame: change from baseline to 6 months and to 12 months
Secondary outcomes:
measure: psychopathology
timeFrame: change from baseline to 6 months and to 12 months
measure: functioning
timeFrame: change from baseline to 6 months and to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03116620: Chewing Function in Pediatric Neuromuscular Disorders
Official title: Chewing Function in Pediatric Neuromuscular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastication Disorder
Keywords: mastication
children with neuromuscular disorders
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We aimed to evaluate chewing function (CF) in children with neuromuscular disorders, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).

Detailed description: Chewing disorders (CD) can be seen due to muscle weakness in children with neuromuscular disorders neuromuscular disorders (NMD). Normal diet consists of all food consistencies including liquid, pudding and solid foods, and CD causes inability to intake solid food. This condition can affect development, nutritional behavior and child-parent interaction in children. Thus, it is important to determine CD in an early period with appropriate assessment methods and plan appropriate therapies in NMD. We aimed to evaluate chewing function (CF) in children with NMD, and investigate reliability of the Karaduman Chewing Performance Scale (KCPS).

Eligibility criteria: Inclusion Criteria:

* Children above the age of 2 years
* Children with neuromuscular disorders

Exclusion Criteria:

* Children under the age of 2 years
* Children without neuromuscular disorders

Primary outcomes:
measure: The reliability of the KCPS in children with neuromuscular disorders
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234882: Study on Pharmacokinetics
Official title: Effect of BMS-663068 on the Pharmacokinetics of Rosuvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effect of the coadministration of multiple doses of BMS-663068 on the systemic exposure of rosuvastatin.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent Form

   * Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
2. Target Population

   * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, and clinical laboratory test results.
3. Age and Reproductive Status

   * Men and women of non-childbearing potential, ages 18 to 50 years, inclusive. Women must have documented proof that they are not of childbearing potential. Women must not be breastfeeding.
   * Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s).

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical illness
* History of rhabdomyolysis or biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to the start of study drug administration)
* Alcohol intake exceeding 2 standard drinks per days; however, no alcohol is allowed 1 week prior to the start of study drug administration and for the duration of the study
* Any other sound medical, psychiatric, and/or social reason as determined by the investigator

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of rosuvastatin
timeFrame: Days 1 through 13
measure: Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) of rosuvastatin
timeFrame: Days 1 through 13
Secondary outcomes:
measure: Trough blood samples of BMS-626529 concentration
timeFrame: Days 7 through 13
measure: Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
timeFrame: 40 days
Other outcomes:
Locations:
Study officials:
affiliation: ViiV Healthcare
name: ViiV Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00111982: Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin
Official title: Multi-Center, Open-Label Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin (Protocol 20020168)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: bilateral, idiopathic Parkinson's Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-05-30
Enrollment: 34
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.


Eligibility criteria: Inclusion Criteria: - Completion of the 20020168 protocol

Primary outcomes:
measure: Percent change in UPDRS
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of treatment emergent and device related adverse events
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01736982: Contingency Management for Smoking Cessation in the Homeless
Official title: Contingency Management for Smoking Cessation in the Homeless
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Cigarette Smoking
Homeless
Contingency Management
Smoking Cessation
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smoking cessation services are an unmet need among the homeless, who smoke at rates more than 3 times the national estimate; successful interventions in this underserved population have the potential for improving individual and public health. Contingency management (CM) is a behavioral intervention with efficacy in a number of substance use disorder populations, including smokers. However, no known studies have evaluated the effect of CM in homeless smokers. The investigators plan to examine smoking-related outcomes in homeless treatment-seeking smokers (N = 70) randomized to standard care smoking cessation (transdermal nicotine replacement therapy \[NRT\] + standard counseling + carbon monoxide \[CO\] monitoring) or standard care plus CM (NRT + standard counseling + CO monitoring + CM) conditions. Standard counseling and CO monitoring will occur for the first 4 weeks, with NRT use continuing through week 8. Participants in both conditions will meet with study staff up to twice daily on weekdays for biochemical verification of smoking status. Participants in the CM condition will have the opportunity to earn prizes for negative breath samples (CO ≤ 4 ppm) up to twice daily on weekdays. CO breath samples will be collected at all visits. The investigators expect that participants randomized to CM will have better outcomes compared to those in standard care.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* homeless
* regular smoker

Exclusion Criteria:

* non-English speaking
* contra-indications for transdermal nicotine
* in recovery for pathological gambling

Primary outcomes:
measure: Longest Duration of Abstinence
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: New Britain
country: United States
facility: The Friendship Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Carla J Rash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041182: Electronic Pre-visit Questionnaire to Prompt Discussions of Youth Violence in Primary Care
Official title: Use of an Electronic Pre-visit Questionnaire and Effect on Patient-provider Discussions of Youth Violence in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Violent Event
Bullying
Keywords: youth violence
doctor-patient communication
health risk behaviors
pre-visit questionnaires
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: HRSA/Maternal and Child Health Bureau
First posted: 2014-01-20
Enrollment: 183
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pediatricians are supposed to talk about youth violence at all heath supervision visits, however these types of conversations rarely occur. There have been no studies assessing tools to prompt these discussions. The goal of this study is to see if electronic pre-visit questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the primary care setting. Additionally, patient-provider characteristics are explored as mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ by patients and providers.

Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals will be recruited. A baseline phase was conducted to look at how often providers ask about health-related teen behaviors, assessed by exit survey. The experimental period will involve adolescents completing health-related behavior PVQ, given to their doctor prior to the visit. Exit survey will assess topics discussed. Experimental group will differ from control group based on PVQ containing extra questions about youth violence.


Eligibility criteria: Inclusion Criteria:

* adolescents ages 13-21
* presenting for annual physical exam
* provider is general pediatrician (micro-practice 1-8)
* parent present for consent (if under 18 years old)

Exclusion Criteria:

* non-English speaking
* developmental/neurologic delay
* no parent (if under 18 years old)
* presenting for sick visit or specialty clinic

Primary outcomes:
measure: Number of patient-reported patient-provider discussions about youth violence
timeFrame: One time point (single day)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Hasbro Primary Care Clinics
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Megan Ranney, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00373282: Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proliferative Vitreoretinopathy
Keywords: PVR
Retinal detachment
Silicone oil
Triamcinolone
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-08
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.


Eligibility criteria: Inclusion Criteria:

* Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade.

Exclusion Criteria:

* History of trauma
* Presence of diabetic retinopathy
* History of vein occlusion
* Giant retinal tear

Primary outcomes:
measure: Single-operation retinal reattachment rate six
measure: months after surgery.
Secondary outcomes:
measure: Visual acuity
measure: Retinal reproliferation
measure: Intraocular pressure
measure: Early silicone oil emulsification
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh,MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01991782: The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
Official title: The Impact of Telemedicine on Orthopaedic Trauma Patients With Closed Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Fracture
Keywords: Telemedicine
Fracture
Orthopaedics
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether telemedicine video calls for follow-up visits between patients and their orthopaedic trauma surgeons has an impact on patient satisfaction, quality of life, and treatment adherence. This study will also assess the feasibility of telemedicine as a medium for follow-up visits.

Detailed description: Patients who are over the age of 18 years with closed fractures treated at Vanderbilt University Medical Center by the Orthopaedic Trauma Department will be recruited into the study into one of two arms: a telemedicine arm in which the patient will have some of his or her visits conducted through video calls, and a control arm in which all of the visits for the patient will be in-person at the Vanderbilt University Orthopaedic Trauma Clinic. Comparisons between the two groups will be made through surveys administered to the patients half-way through the study and at the conclusion of the study, and comparisons will be made using standard statistical tests. The feasibility of telemedicine as a medium for follow-up visits in lieu of in-person visits will be assessed in this study.

Eligibility criteria: Inclusion Criteria:

* adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home

Exclusion Criteria:

* patients as part of vulnerable populations

Primary outcomes:
measure: Patient Satisfaction and Clinical Outcomes at Conclusion
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Manish K Sethi, MD
role: PRINCIPAL_INVESTIGATOR
References: