louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02082938: The Use of Brace to Retrain Hemiparetic Gait
Official title: The Use of a Brace to Retrain Hemiparetic Gait in Patients With Genu Recurvatum: Effects on Plantar Pressure Distribution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Nos Without Residual Deficits
Keywords: stroke,
rehabilitation,
hemiparesis,
gait training
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients.

Detailed description: Objective To compare the behavior of plantar pressure peak distribution, before and after training using a brace for gait rehabilitation.

Method The brace was developed with the aim of promoting better biomechanical alignment, as well as providing proprioceptive information in order to stimulate action in the knee's flexor muscle groups, thus facilitating the activation pattern contrary to what occurs during genu recurvatum. We conducted a quasi-experimental "before and after" study with twelve hemiparetic adult patients who had genu recurvatum in the gait. The plantar pressure peaks were compared at the various moments of the study.

Eligibility criteria: Inclusion Criteria:

* the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.

Exclusion Criteria:

* conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language

Primary outcomes:
measure: distribution of plantar pressures during walking
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Éder K Cardoso, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972738: Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)
Official title: A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-09-07
Enrollment: 1214
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.


Eligibility criteria: Inclusion Criteria:

* Patient has a documented history of season allergic rhinitis symptoms that flare up during the study season
* Patient is a nonsmoker
* Patient is in good general health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast-feeding
* Patient has had major surgery in the past 4 weeks
* Patient intends to move or vacation away during the study
* Patient is a current or past abuser of alcohol or illicit drugs

Primary outcomes:
measure: Mean Change From Baseline in Daytime Nasal Symptoms Score Over the 2-week Treatment Period
timeFrame: Baseline and over the 2-week treatment period
Secondary outcomes:
measure: Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period
timeFrame: Baseline and over the 2-week treatment period
measure: Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period
timeFrame: Baseline and over the 2-week treatment period
measure: Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
timeFrame: End of the 2-week treatment period
measure: Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period
timeFrame: End of the 2-week treatment period
measure: Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period
timeFrame: Baseline and at the end of 2-week treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22. doi: 10.1016/S1081-1206(10)62144-8.
Clinical trial NCT00821938: Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study
Official title: CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Narrow QRS
CRT
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2009-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters


Eligibility criteria: Inclusion Criteria:

* EF \< 35%
* CHD or dilate cardiomyopathy
* sinus rhythm
* NYHA III (or IV but stable recompenstated)
* QRS \< 120 ms 2-3 of the following:
* LV-fillingtime \< 40% of the cyclelength
* TDI septal-lateral (LV basal) \> 60ms
* 2D-Strain-Score \> 9 points

Exclusion Criteria:

* tricuspid or artificial valve
* AV block II or III or PQ time \> 250ms
* revasculisation or condition after cardiac surgery \< 3 months
* myocardial infarction or bypass OP \< 3 months
* hytertrphic obstructive cardiomyopathy, constrictive pericarditis
* intravenous catecholamines because of HF
* manifeste hyperthyreoses
* kidney failure (creatine \>2,5 mg/dl)
* no written informed consent
* no compliance
* participation in another study
* life expectancy \< 1 year
* patients \< 18 years
* pragnancy or no safe contraception

Primary outcomes:
measure: Indexed left ventricular volume
timeFrame: 12 months
Secondary outcomes:
measure: NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Rothenfelde
country: Germany
facility: Schuechtermann-Kliniken
Study officials:
affiliation: Schuechtermann-Kliniken
name: Guido Luedorff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05115838: Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
Official title: A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Human Immunodeficiency Virus
HIV
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant. Participants will receive an implant placed in the upper arm for approximately 52 weeks with 8 weeks of follow-up in the Base Study. A subset of participants will also receive a second implant for an additional 12 weeks before 8 weeks of follow-up in the Substudy.


Eligibility criteria: Inclusion Criteria:

* Is in good health
* Is confirmed human immunodeficiency virus (HIV)-uninfected
* Is at low risk of HIV infection
* For males, uses contraception in accordance with local regulations regarding contraception use for those participating in clinical trials
* For females, is not pregnant or breastfeeding and one of the following applies:
* Is not a participant of childbearing potential (POCBP)
* Is a POCBP and uses an acceptable contraception method or is abstinent

Exclusion Criteria:

* Has an active diagnosis of hepatitis (B or C) due to any cause
* Has a history of malignancy ≤5 years before signing informed consent
* Has a history or current evidence of any condition that might confound study results or interfere with study participation
* Has a history of keloid in upper arm or presence of tattoo, scar, or other physical finding that could interfere with implant placement (the contralateral arm may be used if the findings are limited to 1 arm)
* Is taking or is expected to take immunosuppressants during the study

Primary outcomes:
measure: Percentage of participants with ≥1 adverse events (AEs)
timeFrame: Up to 60 weeks
measure: Percentage of participants withdrawing from study treatment due to adverse event (AE)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Plasma concentration of islatravir (ISL) 12 weeks after placement of an ISL-eluting implant (ISL C12weeks)
timeFrame: Week 12
measure: Plasma concentration of islatravir (ISL) 52 weeks after placement of an ISL-eluting implant (ISL C52weeks)
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05481138: Predicting Burnout in Nurses
Official title: Wearable Augmented Prediction of Burnout in Nurses: A Synergy of Engineering, Bioethics, Nursing and Wellness Sciences
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Burnout, Healthcare Workers
Keywords: Registered Nurses
Artificial intelligence
Wearable
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-08-01
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registered Nurses (RNs) at Mayo Clinic from Emergency Department, Intensive Care Units (including neonatal), selected Medical/Surgical units, and Inpatient Psychiatry. RNs from Inpatient Psychiatry will be recruited only from Mayo Rochester.

Brief summary: The purpose of this study is to develop a technology to predict burnout in RNs by measuring workplace, psychological, and physiological factors experienced by nurses.


Eligibility criteria: Inclusion Criteria:

* Employed as a registered nurse at Mayo Clinic Rochester or Mayo Clinic Florida.
* Primary work assignment is one of the following: medical-surgical units, operating and recovery rooms, emergency room, intensive/cardiac care units, or other special care units (including neonatal intensive care units and newborn nurseries).
* Proficient in written and spoken English.
* Able to provide written informed consent.

Exclusion Criteria:

- Any exception to above criteria.

Primary outcomes:
measure: Change in Maslach Burnout Inventory-Human Services Survey (MBI-HSS)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptomatology (QIDS-SR)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in LASA Quality of Life Scale
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Sense of belonging
timeFrame: Baseline
measure: Change in Food Intake Questionnaire
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Sleep quality
timeFrame: Every day over 12-month study period
measure: Daily heart rate
timeFrame: 12 months
measure: Daily physical activity
timeFrame: 12 months
measure: Daily step count
timeFrame: 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Arjun P. Athreya, Ph.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05752838: A Questionnaire Survey Study for Exploring Outcomes for Patients With Disc Herniation
Official title: Are Primary Outcomes Really Primary? A Questionnaire Survey Study for Exploring Outcomes for Patients With Disc Herniation Reflecting Real Patient Symptoms and Needs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All 19-69 patients who were diagnosed with LDH and had LDH-related radiating leg in Korea

Brief summary: Background: The selection of primary outcomes that reflect the real symptoms and conditions of patients is instrumental in clinical studies on the effectiveness of specific treatment modalities. This study aimed to explore the appropriate outcomes that reflect the real-world needs and concerns of patients with lumbar disc herniation (LDH) and provide a basis for designing related clinical trials.

Methods and Findings: This cross-sectional nationwide web-based survey study was conducted in South Korea in November 2022. Patients who were diagnosed with LDH and had LDH-related radiating leg pain were enrolled. The questionnaire consisted of 5 parts: basic characteristics, disease onset, symptom and severity, priority symptoms for improvement, and important factors in treatment. Overall, 500 patients (100 patients from the each age group) were enrolled.


Eligibility criteria: Inclusion Criteria:

* diagnosed of LDH
* age 19-69 years
* presence of LDH-related symptoms such as pain, numbness, weakness, or tingling in the legs
* agree to informed consent form

Exclusion Criteria:

* severe mental illness and intellectual disabilities that prevented independence in answering the questionnaire

Primary outcomes:
measure: survey basic characteristics
timeFrame: 1 day
measure: disease onset survey
timeFrame: 1 day
measure: symptom and its severity survey
timeFrame: 1 day
measure: priority symptoms for improvement survey
timeFrame: 1 day
measure: important factors in treatment survey
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
state: Gangnam-gu
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03280238: Pupil Dilation and Analgesia Nociception Index
Official title: Do Pupil Dilation and Analgesia Nociception Index Reflect Pain: a Pilot Study in Healthy, Conscious Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Pain assessment is crucial in clinical practice. Currently, subjective self-report is considered the most appropriate method to evaluate pain. Although several methods to assess pain objectively exist, the lack of a golden standard still remains. This pilot study assesses the changes in pupil dilation (PD) and the analgesia nociception index (ANI) as a measure of pain in healthy, conscious, male volunteers in a highly standardized and individualized environment. Nineteen subjects received three blocks of 4 individualized electrical stimulus intensities, ranging from no to severe pain. Subjects reported their perceived severity of each individual stimulus, enabling the comparison of changes in PD and ANI in relation to both administered stimulus intensities and perceived pain severities. PD and ANI were measured before and after each administration of a stimulus.


Eligibility criteria: Inclusion Criteria:

* good health
* no acute or chronic pain conditions
* well rested

Exclusion Criteria:

* chronic treatment
* bad health
* daily use of analgetics or other medication
* weekly tobacco use
* weekly use of recreational drugs
* more than 10 alcohol consumptions a week

Primary outcomes:
measure: Pupil dilation in relation to pain
timeFrame: 2sec before until 4sec after each painful stimulus
Secondary outcomes:
measure: Analgesia nociception index in relation to pain
timeFrame: 30sec before until 60sec after each painful stimulus
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Wendy Van Bogaert, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrije Universiteit Brussel
name: Reginald Deschepper, PhD
role: STUDY_CHAIR
References:
citation: Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Eur Heart J. 1996 Mar;17(3):354-81. No abstract available.
citation: Chapman CR, Oka S, Bradshaw DH, Jacobson RC, Donaldson GW. Phasic pupil dilation response to noxious stimulation in normal volunteers: relationship to brain evoked potentials and pain report. Psychophysiology. 1999 Jan;36(1):44-52. doi: 10.1017/s0048577299970373.
citation: Koenig J, Jarczok MN, Ellis RJ, Hillecke TK, Thayer JF. Heart rate variability and experimentally induced pain in healthy adults: a systematic review. Eur J Pain. 2014 Mar;18(3):301-14. doi: 10.1002/j.1532-2149.2013.00379.x. Epub 2013 Aug 6.
Clinical trial NCT01787838: Improving Pneumococcal Vaccination Rates in an Ambulatory Pre-surgical Testing Setting
Official title: A Quality Improvement Study to Improve Pneumococcal Vaccination Rates Through Targeted Health Education for Patients in an Ambulatory Pre-surgical Testing Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community Acquired Pneumonia
Keywords: Pneumococcal vaccination rates, ambulatory settings
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-02-11
Enrollment: 2509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this quality improvement project is to improve the immunization rates of an at-risk adult population seen in an ambulatory healthcare environment, through the use of targeted health education messages regarding pneumococcal immunization. Patients seen in an out-patient pre-surgical testing center will receive 1) a one-page written information sheet that outlines the benefits of pneumococcal immunization and 2) verbal reinforcement of this message, provided by the clinical staff, during the patient's interview.

At-risk adult patients (as defined by Centers for Disease Control) seen in an ambulatory healthcare environment (a pre-surgical testing center) will receive a one page, "gain-framed" message that emphasizes the benefits of pneumococcal vaccinations. This educational material will be reviewed and reinforced by clinical staff during the assessment phase of the clinical visit. Among this group, there will be increased vaccination rate compared with at-risk adult patients who did not receive this communication (prospective vs retrospective data).

Detailed description: The purpose of this project was to improve the immunization rates of an at-risk adult population seen in an ambulatory environment, through the use of targeted and evidence-based health education messages regarding pneumococcal immunization and staff training on the use of gain-framed messaging.

We hypothesized that there would be an increase in immunization rates for at-risk adults following implementation of the intervention.

The objective of the project was to increase our local immunization rate by 30% (from 20% to 50%) and to provide tools and processes that can be utilized in other ambulatory healthcare settings.

Eligibility criteria: Inclusion Criteria:

* Patient seen in out-patient pre-surgical testing center
* At-risk adult patient as defined by the Centers for Disease Control (CDC)

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Rebecca C Clark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02433938: Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
Official title: Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Colorectal Cancer
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.

Detailed description: Patients were randomized in two groups. The first group underwent a three days postoperative transcutaneous tibial nerve stimulation. The second group underwent a sham stimulation. Aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

Eligibility criteria: Inclusion Criteria:

* Patients that underwent colorectal surgery

Exclusion Criteria:

* Severe comorbidities
* Postoperative or intraoperative complications

Primary outcomes:
measure: bowel function recovery (Time to first bowel movement or flatus)
timeFrame: 7 days
Secondary outcomes:
measure: Length of postoperative hospital stay
timeFrame: 30 days
measure: Post-operative vomiting (episodes of vomiting)
timeFrame: 30 days
measure: Use of NG Tubes (Nasogastric tube (re)insertions)
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Florence
name: Jacopo Martellucci, MD, PhD
role: STUDY_CHAIR
References: