louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03925441: Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea
Official title: Post-Marketing Surveillance Study of Adalimumab (Humira) for Pediatric Chronic Severe Plaque Psoriasis Patients According to the Standard for "Re-Examination of New Drugs"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Post-marketing
Adalimumab
Humira
Pediatric
Chronic severe plaque psoriasis
Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 2
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric participants with chronic severe plaque psoriasis

Brief summary: The objective of this study is to evaluate the real world safety and effectiveness of adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents who are diagnosed with pediatric chronic severe plaque psoriasis.
* Prior to participating in the study, adalimumab treatment was determined according to clinical judgement of the physician.
* Participants (or legal representative) who voluntarily agreed to participate in this study and signed informed consent.

Exclusion Criteria:

* Participants with contraindication to adalimumab as listed in the approved Korean label.
* Participants with prior treatment with adalimumab.

Primary outcomes:
measure: Percentage of Participants Who Reported Any Treatment Emergent Serious Adverse Events (TESAE) OR Drug Reactions
timeFrame: Day 0 (informed consent) to up to 70 days following the last administration of Humira
measure: Percentage of Participants Who Reported Any Unexpected Treatment Emergent Adverse Events OR Drug Reactions
timeFrame: Day 0 (informed consent) to up to 70 days following the last administration of Humira
Secondary outcomes:
measure: Percentage of Participants Who Reported Any Treatment Emergent Non-Serious Adverse Event OR Drug Reaction
timeFrame: Day 0 (informed consent) to up to 70 days following the last administration of Humira
measure: Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 From Baseline
timeFrame: Up to approximately 40 days
measure: Percentage of Participants Achieving PASI 90 From Baseline
timeFrame: Up to approximately 40 days
measure: Percentage of Participants Achieving PASI 100 From Baseline
timeFrame: Up to approximately 40 days
measure: Change in Body Surface Area (BSA) from Baseline
timeFrame: Up to approximately 40 days
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital /ID# 207843
state: Gyeonggido
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02015741: Comparability of Bispectral Index and NeuroSENSE in Aged Patients
Official title: Comparability of Bispectral Index and NeuroSENSE in Aged Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aged patients

Brief summary: The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA).

Use of such devices is discussed in aged patients. The purpose of this study is to compare Bispectral Index and NeuroSENSE during awake periods and during natural sleep.


Eligibility criteria: Inclusion Criteria:

* patients older than 74 years

Exclusion Criteria:

* pace-maker

Primary outcomes:
measure: Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of patients with a high concordance between pairs of Bispectral Index and NeuroSENSE indices during periods of natural sleep
timeFrame: 1 year
Other outcomes:
Locations:
city: Rueil
country: France
facility: Hopital Stell
state: Hauts de Seine
city: Suresnes
country: France
facility: Hopital Foch
state: Hauts de Seine
Study officials:
affiliation: Hopital Foch
name: Julie Bresson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05135741: Role of Pressure Bio Feedback in Management of Forward Head Posture for Computer Users at BUMDC
Official title: Role of Pressure Bio Feedback in Management of Forward Head Posture for Computer Users at BUMDC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forward Head Posture
Keywords: Bio Feedback
Deep Cervical Flexor
Neck pain
Forward head posture
Neck Disability Index
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: The aim of present study is to explore the effectiveness of pressure bio feedback in treatment of occupational forward head posture on computer users.

Detailed description: Material \& Methods: This Randomized Control Trial was conducted in Bahria University College of Physical Therapy, Karachi. Ethical approval was prior taken from Institute Review Board. there were 32 participants selected randomly equally in experimental and control group. Both male and female were included with age of 25 to 55 years currently employees of Bahria University (BUMDC) having forward head posture or complaining neck pain were included. Exclusion was age less than 25 years, history of cervical trauma or surgery, any neurological conditions or cervical pathology. Experimental Group was given DCF exercises with Pressure Biofeedback Unit (PBU) and Control Group was given Conventional DCF Exercises. SPSS version 23.0 was used for analysis.

Eligibility criteria: Inclusion Criteria:

- Both male and female age of 25 to 55 currently employees of Bahria University (BUMDC) having forward head posture complaining neck pain.

Exclusion Criteria:

* Students of Bahria University history of cervical trauma or surgery any neurological conditions or cervical pathology

Primary outcomes:
measure: change in range of cervical flexion
timeFrame: 15 minutes before and after exercises for 4 weeks
measure: change in range of right and left lateral rotations
timeFrame: 15 minutes before and after exercises for 4 weeks
Secondary outcomes:
measure: improvement in capacity of heavy weight lifting
timeFrame: 4 weeks
measure: change in pain intensity
timeFrame: 4 weeks before exercise and 4 weeks after exercises
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: BUMDC
state: Sindh
Study officials:
affiliation: Bahria University and Dental College
name: Rabia Khan, Msc(PT)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902641: Muscle Relaxation for Short Procedures
Official title: Comparing Intubating Conditions and Patient Satisfaction Using Succinylcholine or Low-dose Rocuronium for Rigid Bronchoscopy: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubating Conditions
Fasciculations
Postoperative Myalgia
Patient Satisfaction
Sore Throat
Keywords: succinylcholine
rocuronium
sugammadex
Intubating Conditions
short Procedures
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application of low-dose rocuronium, reversed by low-dose sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM), as well as patient satisfaction for these two muscle relaxants.


Eligibility criteria: Inclusion Criteria:

* age \> 18 yr
* scheduled for elective rigid bronchoscopy

Exclusion Criteria:

* known neuromuscular disease
* significant hepatic or renal dysfunction
* family history of malignant hyperthermia
* known allergy to one of the drugs used in this protocol
* pregnancy or breastfeeding

Primary outcomes:
measure: Intubating condition
timeFrame: After induction of general anaesthesia (after 3-5 minutes)
Secondary outcomes:
measure: Fasciculations
timeFrame: After application of the neuromuscular blocking agent (after 3-5 min)
measure: Postoperative Myalgia (POM)
timeFrame: 72 Hours after Intervention
Other outcomes:
measure: Sore throat
timeFrame: 72 hours after intervention
measure: Patient Satisfaction
timeFrame: 72 Hours after intervention
Locations:
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Kliniken
Study officials:
affiliation: Dr. Horst Schmidt Kliniken Wiesbaden Germany
name: Grietje Beck, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01910441: Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients
Official title: A Comparative Study to Assess the Effect of Vildagliptin Versus Glimepiride on Glucose Variability in Type 2 Diabetic Patients Uncontrolled on Metformin Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, Glycemic variability
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-29
Enrollment: 95
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: Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.


Eligibility criteria: Inclusion Criteria:

1. Patients who have given written informed consent to participate in the study.
2. Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
3. Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c \> 7.5 - 9%).
4. Patients with HbA1C levels within the range \> 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).

Exclusion Criteria:

1. Age \> 75 years ; BMI \<22 or \>40 kg/m2
2. Patients who are on Insulin therapy at the time of study entry.
3. Type 1 Diabetes Mellitus patients.
4. Patients with severe renal (creatinine clearance \< 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST \> 3 x ULN).

   Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)
5. Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.

Other protocol defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Mean Amplitude of Glycemic Excursions (MAGE)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02451241: The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
Official title: The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Acupuncture
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system.

Primary end-point:

To investigate the effects of acupuncture in improving OSA severity among hypertensive patients.

Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness


Eligibility criteria: Inclusion Criteria:

* 5\<apnea-hypopnea index (AHI)\<30 e/h

Exclusion Criteria:

* body mass index \> 35 kg/m2
* Previous OSA treatment

Primary outcomes:
measure: Apnea-hypopnea index (AHI)
timeFrame: 5 weeks
Secondary outcomes:
measure: Sleep quality
timeFrame: 5 weeks
measure: Pulse Wave Velocity (PWV)
timeFrame: 5 weeks
measure: Blood pressure
timeFrame: 5 weeks
measure: Quality of life
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Rodrigo Pedrosa
state: PE
Study officials:
References:
Clinical trial NCT05638841: Prospective Cohort Study of the Risk of Recurrent Atrial Fibrillation After Radiofrequency Ablation
Official title: Prospective Cohort Study of the Risk of Recurrent Atrial Fibrillation After Radiofrequency Ablation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 300
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: In this study, atrial fibrillation patients who meet the inclusion criteria and those who do not meet the exclusion criteria were admitted to the Department of Cardiology of Peking University Third Hospital after catheter ablation from December 31, 2022 to December 31, 2023

Brief summary: In this study, the continuous inclusion of atrial fibrillation patients treated by catheter ablation in the Department of Cardiology, Peking University Third Hospital, through the collection of clinical data and outpatient follow-up, to explore the risk factors of atrial fibrillation recurrence after catheter ablation and the influencing factors of major clinical events in atrial fibrillation patients, and further guide the management mode of atrial fibrillation patients.


Eligibility criteria: Inclusion Criteria:

* 1) Age \> 18
* 2) ECG or holter electrocardiogram confirmed atrial fibrillation

Exclusion Criteria:

* 1) Hematological diseases, autoimmune diseases and malignant tumors
* 2) Immobility caused by hemiplegia or severe trauma
* 3) The expected survival time is less than 2 years
* 4) Poor compliance and high risk of expected loss of follow-up
* 5) Disorders of consciousness or Alzheimer's disease

Primary outcomes:
measure: Compound cardiovascular event
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking-University-Third-Hospital
Study officials:
References:
Clinical trial NCT03094741: Evaluation of a Mobile Digital Solution for Cancer Care and Research
Official title: Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Caregivers
Quality of Life
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
Collaborators: name: CancerLife
First posted: 2017-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary purpose of this pilot study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden data. The proposed study is meant to be the preparatory work for an intervention study to test the effect of Mobile Digital Solutions on improving patient outcomes by prompting early interventions for symptom relief and support of patient and family caregiver quality of life (QOL).

Detailed description: Demographic information and patient-reported symptoms will be collected from study participants through a mobile health application called CancerLife that they can download (FREE) from their mobile device app store (Android or iOS). Participants will be asked to broadcast their emotional and physical status through a list of symptom list within the app as well as how that symptom is impacting their quality of life and activities of daily living. This data will be collected inside the application and display in easy to understand pie charts. Participants will also have the option to broadcast their entry to their social network.

Since the objective of the current feasibility study is to evaluate the feasibility and acceptability of a Mobile Digital Solution in monitoring and collecting symptom burden and QOL data, the investigators will include a standard validated instrument (FACT-G: Functional Assessment of Cancer Therapy - General) as part of this study. Participants will be asked to complete the FACT-G after initial registration and weekly for up to 4 weeks. Participants will receive electronic mail messages with a link to CancerLife weekly as a reminder to access the website.

Eligibility criteria: Inclusion Criteria:

* Established diagnosis of cancer
* Karnofsky Index ≥50%
* Age \> 18 years

Exclusion Criteria:

* Relevant cognitive impairment
* Insufficient knowledge of English language to complete the survey

Primary outcomes:
measure: Feasibility/ Participation Rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Open Rate
timeFrame: 4 weeks
measure: Refusal rate
timeFrame: 4 weeks
measure: Retention rate
timeFrame: 4 weeks
measure: Rate of missing data
timeFrame: 4 weeks
measure: Participant Satisfaction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute at Providence Saint John's Health Center
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Santosh Kesari, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04581941: Deep Brain Stimulation Effects in Essential Tremor
Official title: Deep Brain Stimulation Effects in Essential Tremor: Time Course of Electrophysiological Changes in Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Tremor
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with essential tremor, who have been cleared for DBS surgery.

Brief summary: Deep Brain Stimulation (DBS) is an effective therapy for patients with medically refractory essential tremor. However, DBS programming is not standardized and multiple clinic visits are frequently required to adequately control symptoms. The investigators aim to longitudinally record brain signals from patients using a novel neurostimulator that can record brain signals. The investigators will correlate brain signals to clinical severity scores to identify pathological rhythms in the absence of DBS, and we will study the effects of DBS on these signals in order to guide clinical programming.

Detailed description: The development of newer technologies has allowed clinicians and researchers to better understand pathophysiological underpinnings of different disorders managed with neuromodulation. The is now the ability to stream brain signals from a newly FDA approved device, the Medtronic Percept. The investigators will study the longitudinal effects of DBS on the brain signals that are found to correlate with tremor severity as measured with wireless wearable sensors.

Eligibility criteria: Inclusion Criteria

* Patient gives an informed consent.
* Patient is over 21 years of age.
* Having a diagnosis of a essential tremor confirmed by a trained movement disorders neurologist;
* Having failed or not tolerated conventional medical management, at the discretion of the neurologist managing the patient;

Exclusion Criteria

* Having alternative diagnoses to essential tremor;
* Having comorbid neurodegenerative disorders that may affect mobility or cognition (e.g. comorbid Parkinson's disease or dystonia);
* Having sequelae of prior brain insult (e.g. prior stroke or brain tumor);
* History of prior resective brain surgery (e.g. tumor resection);
* Not being a DBS candidate;
* Receiving unilateral implants
* Having a higher surgical risk that precludes patient from having standard intraoperative mapping.

Primary outcomes:
measure: Fahn- Tolosa- Marin Tremor Rating Scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT00308841: Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a "Lost" Intrauterine Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: "Lost" IUD
Keywords: Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" IUD
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2006-03-30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD).

Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using Friedman's test with Bonferroni correction, Student's t test, and 2.


Eligibility criteria: Inclusion Criteria:

patients undergoing a minor gynecologic procedure for removal of a "lost" IUD.

Exclusion Criteria:

women with a history of cervical stenosis, known allergy to lidocaine, pregnancy, acute cervicitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Süleyman Demirel University, School of Medicine
Study officials:
affiliation: SDU
name: Mehmet Güney, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a "lost" intrauterine device: a randomized, controlled trial. Obstet Gynecol. 2006 Jul;108(1):119-23. doi: 10.1097/01.AOG.0000223201.42144.80.