louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01602497: Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder
Official title: A Sham-controlled Trial of Effect of High-frequency Transcranial Magnetic Stimulation in the Management of Borderline Personality Disorder Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline personality disorder
repetitive transcranial magnetic stimulation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 40
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: This study is going to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on Borderline Personality Disorder patients symptoms.

Detailed description: There is a great body of literature about the positive effects of rTMS therapy on various psychiatric disorders. In this study we are going to evaluate the effects of high-frequency rTMS over the left dorsolateral prefrontal cortex (DLPFC)region in borderline personality disorder (BPD) patients. patients will be assessed by subjective measures for BPD.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed borderline personality disorder according to DSM IV.

Exclusion Criteria:

* Epilepsy
* Any metal device
* Psychotic disorders
* Bipolar mood disorder type 1

Primary outcomes:
measure: Patients' reports
timeFrame: Change from baseline to two weeks
Secondary outcomes:
measure: patient's report
timeFrame: Change from baseline to 1 month
measure: Patient's report
timeFrame: Change from baseline to 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Arbabi, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01091597: Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Official title: PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Radiofrequency Ablation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 30
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: TREATMENT

Brief summary: Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.

Exclusion Criteria:

* Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

Primary outcomes:
measure: freedom from atrial fibrillation
timeFrame: 3 months following ablation
Secondary outcomes:
measure: safety of Box isolation
timeFrame: 3 months following procedure
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
References:
citation: Chilukuri K, Scherr D, Dalal D, Cheng A, Spragg D, Nazarian S, Barcelon BD, Marine JE, Calkins H, Henrikson CA. Conventional pulmonary vein isolation compared with the "box isolation" method: a randomized clinical trial. J Interv Card Electrophysiol. 2011 Nov;32(2):137-46. doi: 10.1007/s10840-011-9587-8. Epub 2011 May 26.
Clinical trial NCT01346397: Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation
Official title: Prospective Randomized Trial Comparing CsA Versus Tacro After Campath Induction In Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Graft Rejection
Chronic Allograft Nephropathy
Polyomavirus-related Transplant Nephropathy
Keywords: rejection
survival
alemtuzumab
cyclosporine
tacrolimus
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Russian Scientific Center of Surgery
First posted: 2011-05-03
Enrollment: 170
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recipients of kidney allograft who underwent previous Campath induction and do receive calcineurine inhibitor (CNI)

Brief summary: After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.

The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.

Detailed description: Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.

Eligibility criteria: Inclusion Criteria:

* first kidney allograft recipients
* alemtuzumab induction

Exclusion Criteria:

* CNI intolerance

Primary outcomes:
measure: Patient Survival
timeFrame: 5 years
measure: Graft Survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Centre of Surgery
Study officials:
affiliation: Russian Scientific Center of Surgery RAMS
name: Michael M Kaabak, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04627597: Patients' Comprehension and Internalization of Operative Consent Form
Official title: Informed Pre-operative Consent: Are We There Yet?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients planned for common elective ENT operations in a tertiary hospital between July and December 2016

Brief summary: This is a prospective pilot study conducted within otolaryngology (ENT) clinics in a tertiary hospital between July and December 2016. 22 patients planned for common elective ENT operations were given a self-administered one-page survey on the same day after preoperative counselling. The investigators aim to identify if there are any associations between perceived and actual understanding of information given during pre-operative counselling and patient satisfaction with the process.

Detailed description: As above and in later sections.

Eligibility criteria: Inclusion Criteria:

* Planned for common elective ENT operations
* English-speaking
* Unaccompanied
* Counselled with the use of a structured surgery-specific consent form

Primary outcomes:
measure: Patient's perceived understanding of information given during pre-operative counselling (nominal score on questionnaire)
timeFrame: Through study completion, up to 6 months
measure: Patient's actual understanding of information given during pre-operative counselling (numeric score on questionnaire)
timeFrame: Through study completion, up to 6 months
measure: Patient's satisfaction with pre-operative counselling (nominal score on questionnaire)
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Singhealth Foundation
name: Tze Choong Charn, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03560297: SeRenade Parent-Child Music Class Program
Official title: SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Endowment for the Arts, United States
First posted: 2018-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being.

Detailed description: This pilot study evaluates the impact of the SeRenade Parent-Child Music Class Program on families of children with and without autism spectrum disorders (ASD). This study examines the impact of this program on social development in children with ASD, parental stress and efficacy, and parent-child relationships. A primary goal of this study is to examine multiple levels of analysis including families' experience within and outside of the music class program.

Eligibility criteria: Inclusion Criteria:

* children diagnosed with ASD or children without ASD

Exclusion Criteria:

* currently enrolled in music therapy or parent-child music classes (for children with ASD); significant behavior problems (e.g., aggression toward other children); significant hearing or visual impairments

Primary outcomes:
measure: Motor Imitation Scale
timeFrame: Change from pre to post program (baseline and 12-weeks)
measure: Actions & Gestures
timeFrame: Change from pre to post program (baseline and 12-weeks)
measure: Parenting Stress Index, 4th edition Short Form
timeFrame: Change from pre to post program (baseline and 12-weeks)
measure: Parenting Efficacy/Quality
timeFrame: Change from pre to post program (baseline and 12-weeks)
Secondary outcomes:
measure: Parent-Child Interaction
timeFrame: Change from pre to post program (baseline and 12-weeks)
measure: social visual attention eye-tracking paradigm
timeFrame: Change from pre to post program (baseline and 12-weeks)
Other outcomes:
measure: parent mood/connection
timeFrame: change from before/after the class session at class 1 (week 1) to 12 (week 12) (a session of classes is 12-weeks on average)
measure: Program acceptability
timeFrame: post program (12 weeks)
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Geretsegger M, Fusar-Poli L, Elefant C, Mossler KA, Vitale G, Gold C. Music therapy for autistic people. Cochrane Database Syst Rev. 2022 May 9;5(5):CD004381. doi: 10.1002/14651858.CD004381.pub4.
Clinical trial NCT04706897: Opioid Sparing Anaesthesia for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
Official title: Opioid Sparing Anaesthesia Via Dexmedetomidine, Ketamine and Lidocaine Infusion for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PONV
Opioid Sparing Anaesthesia
Keywords: Laparoscopic Gynecological Surgery
Dexmedetomidine
Ketamine
Lidocaine
PONV
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In spite of multimodal analgesic strategies, which consist of opioids, dexamethasone, non-steroidal anti-inflammatory drugs, and local anesthetics applied into the surgical wound, postoperative pain and postoperative nausea and vomiting (PONV) are still common complaints reported after laparoscopic gynecological surgery.

So, it is hypothesized that the infusion consisting of lidocaine, dexmedetomidine and ketamine, as an opioid substitute was a feasible technique for laparoscopic gynecological surgery and would be associated with less incidence of PONV and lower opioid requirements in the early postoperative period.

The aim of this study was to evaluate the effect of opioid sparing technique via infusion of Dexmedetomidine, Ketamine and Lidocaine on post-operative nausea and vomiting in laparoscopic gynecological surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective laparoscopic gynaecological surgery, who:

  * had the American Society of Anesthesiologists (ASA) I or II physical status,
  * were 21-60 years of age

Exclusion Criteria:

* A body mass index \>35 kg/ m2
* Pregnant, breast feeding women
* Hepatic, renal or cardiac insufficiency
* Diabetes mellitus
* History of chronic pain
* Alcohol or drug abuse
* Psychiatric disease
* Allergy or contraindication to any of the study drugs

Primary outcomes:
measure: The incidence of postoperative nausea and vomiting (PONV)
timeFrame: First 24 hours postoperative
Secondary outcomes:
measure: Intraoperative isoflurane consumption
timeFrame: Intraoperative 3 hours
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperative 3 hours
measure: Postoperative 24 hours morphine consumption.
timeFrame: First 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Tanta University
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT04615897: Efficiency of New Technologies in the Aging Process
Official title: Effectiveness of New Technologies in the Balance, Gait and Cognitive Function in Healthy Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: gait
attention
memory
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tries to analyze the effectiveness of the application of the new technology in the maintenance of an active time. To do this, the investigators performed a laboratory test where they evaluated the physical and cognitive variables before and after the intervention and analyzed the improvement in the psychocognitive abilities in the experimental group and the use of physical and cognitive functions in the control group.

Detailed description: The main objective of this study is the demonstration of the effectiveness of a motor task, making use of the Nintendo Wii video game console, in healthy elderly people, as well as demonstrating the interaction between the physical and cognitive aspects and the decline that in these functions causes the aging process. Methodology: A double blind, controlled and randomized clinical trial was developed on a total sample of 46 subjects, with a mean age of 72.59 years. For the collection of data, the following evaluation scales and computerized tests were passed (Cognitive Miniexamen, Depression Scale, Berg Scale, Tinetti Scale, Timed Up and Go test, Oddball Test and the Attention Network Test).

Eligibility criteria: Inclusion criteria:

* Be 60 years old or older.
* Have compensated the auditory or visual deficits that could suffer
* Absence of musculoskeletal problems that hinder functionality

Exclusion criteria:

* Presents cognitive impairment
* Obtain values in the Geriatric Depression Scale\> 9.
* Presenten pathologies where the development of a motor task is counterproductive
* Sleep less than 6 hours a day

Primary outcomes:
measure: Attention
timeFrame: At the start and the end of the study (65 days)
measure: Memory
timeFrame: At the start and the end of the study (65 days)
measure: Balance
timeFrame: At the start and the end of the study (65 days)
measure: Gait
timeFrame: At the start and the end of the study (65 days)
measure: Global autonomy and risk of falls
timeFrame: At the start and the end of the study (65 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Seville
name: Benitez Lugo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01776697: Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects
Official title: A Randomized, Open-labeled, Comparative 3-way Crossover Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR TID and Pelubiprofen SR (as a Pelubiprofen 90 mg) Tablet QD in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-01-28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: A randomized, open-labeled, comparative 3-way crossover study to compare the pharmacokinetic characteristics and food effect of pelubiprofen (30mg) tablet IR TID and pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Adult Healthy males aged 20\~45 years
2. weight over 45 kg, ideal body weight ±20%\[Ideal weight\] = \[Height(cm)-100\] X 0.9
3. Subjects who voluntarily agreed with written consent

Exclusion Criteria:

1. Patients with acute disorder within 28 days before clinical trial drugs administration
2. History of disorders(inflammatory GI tract disease, stomach ulcer, gastrectomy, liver disease) which can affect ADME of drugs
3. Patients with active GI tract, cardiovascular, respiratory, renal, endocrinal, haematological, central nerval, psychiatric disease or malignant tumor

Primary outcomes:
measure: AUC of pelubiprofen(30mg) tablet IR TID
timeFrame: 0, 1, 2, 8, 9, 15, 16, 22 day
measure: AUC of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD
timeFrame: 0, 1, 2, 8, 9, 15, 16, 22 day
measure: Cmax of pelubiprofen(30mg) tablet IR TID
timeFrame: 0, 1, 2, 8, 9, 15, 16, 22 day
measure: Cmax of pelubiprofen SR (as a pelubiprofen 90 mg) tablet QD
timeFrame: 0, 1, 2, 8, 9, 15, 16, 22 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01861197: Phase II Study of Dovitinib for FGFR1 Amplified Squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous NSCLC
Keywords: Efficacy
Dovitinib
Squamous NSCLC
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy of Dovitinib for Squamous NSCLC.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed squamous NSCLC
* Previously treated with one or two lines of chemotherapy
* FGFR amplification (FISH \> 5 copies of genes)
* 20 years or older
* ECOG PS 0-2

Exclusion Criteria:

* active infection
* uncontrolled brain metastasis
* unstable angina or MI

Primary outcomes:
measure: response rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Myung-Ju Ahn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00857597: Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Official title: A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
endoscopic
fundoplication
Proton Pump Inhibitors
heartburn
anti-reflux surgery
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: EndoGastric Solutions
name: Sandhill Scientific
name: Crospon
First posted: 2009-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* Proven gastroesophageal reflux (pH \< 4 for \> 4.3% time while off PPIs for 7-14 days)
* On daily PPIs for \> 1 year
* Recurrence of GERD symptoms (GERD-HRQL score difference of \> 10 between on and off PPIs)
* Normal or hypotonic LES resting pressure (5-40 mmHg)
* Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
* Signed informed consent

Exclusion Criteria:

* BMI \> 35
* Hiatal hernia \> 2 cm
* Esophagitis grade D
* Barrett's esophagus
* Esophageal stricture
* Esophageal ulcer
* Esophageal motility disorder
* Gastric motility disorder
* Prior splenectomy
* Gastric paralysis
* Pregnancy (in females)
* Immunosuppression
* ASA \> 2
* Portal hypertension
* Coagulation disorders
* Previous antireflux procedure
* Any other health condition, which the investigator believes would prevent the patient from completing the study
* Lack of fluency in English

Primary outcomes:
measure: GERD symptoms
timeFrame: Baseline
measure: GERD symptoms
timeFrame: 6 month follow-up
measure: GERD symptoms
timeFrame: 12 month follow-up
Secondary outcomes:
measure: PPI usage
timeFrame: at 0, 6 and 12 month follow- up
measure: Lower esophageal acid exposure
timeFrame: at 0, 6 and 12 month follow- up
measure: Esophagitis
timeFrame: at 0, 6 and 12 month follow- up
measure: Rate of adverse events
timeFrame: at 0, 6 and 12 month follow- up
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
state: Limburg
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Blair A Jobe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Maastricht, The Netherlands
name: Nicole D Bouvy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: