louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03109548: Pre-treatment Factors for the Development of Chronic Pain in Low Back Pain Patients
Official title: Pre-treatment Factors for the Development of Chronic Pain in Low Back Pain Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Research Unit for General Practice in Aalborg
First posted: 2017-04-12
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects will be recruited through general practitioners in The North Denmark Region. When a patient with low back pain reports to his/her general practitioner, the doctor will present the project to the patient, and in case the patient shows interest, the doctor asks him/her to contact the contact person of the study. Thus, the recruitment does not take place through advertisements, but through the normal patient flow in the general practice.

Brief summary: The purpose of the project is to associate pre-treatment pain sensitivity level, levels of pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back Screening Tool in patients with acute low back pain and patients' progression after 12 weeks of treatment by general practitioners.


Eligibility criteria: Inclusion Criteria:

* Patients with low back pain, who have a mobile phone.

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Alcohol addiction
* Lack of ability to cooperate
* Surgery to the spine

Primary outcomes:
measure: Roland Morris Disability Questionnaire, RMDQ
timeFrame: 12 weeks follow-up
Secondary outcomes:
measure: The StarT Back Screening Tool
timeFrame: Baseline, 12 weeks follow-up
measure: The Pain Catastrophizing Scale
timeFrame: Baseline, 12 weeks follow-up
measure: Predicting the Inception of Chronic Pain
timeFrame: Baseline, 12 weeks follow-up
measure: Basic information
timeFrame: Baseline, 12 weeks follow-up
measure: Assessment of the Pain Area
timeFrame: Baseline, 12 weeks follow-up
measure: Cuff Algometry
timeFrame: Baseline, 12 weeks follow-up
measure: Handheld Algometry
timeFrame: Baseline, 12 weeks follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Lægerne Sløjfen
state: Aalborg East
Study officials:
affiliation: Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
name: Martin B Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06206148: Comparison of Methods for Recording Post Operative Pain
Official title: Comparison of Methods for Recording Post Operative Pain: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Keywords: Pain Recorder
Device
Self-report
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post-operative orthopedic surgery patients will be randomly assigned to one of three pain collection methods and instructed to record their pain level as often as they like. The three methods of pain collection are: a hand-written pain journal, a smartphone app, and a novel electronic pain recorder device.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the current study is to identify the optimal method of collection of pain intensity data. The study will compare three collection methods: a hand-written pain journal, a smartphone app, and a novel electronic pain recorder device. Patients will be randomly assigned to one of three methods and instructed to record their pain level as often as they like. The number of pain intensity recordings per day will then be compared across groups.

Detailed description: Pain is a universal experience and at the forefront of all things medicine; however, the way medical professionals deal with it lacks coherence. Clinicians often ask their patients how their pain is, but seldom document it with enough information to be useful. The purpose of this study is to determine how we can collect the most self-reported pain intensity data. The investigators will collect this data with time and date-stamped Visual Analogue Scale-a pain rating scale from 0-10-scores for each patient in the study, randomized to one of three groups (pen \& paper, app, and pain recorder device). As pain is a universal experience and a hallmark sign of many disease states, having a detailed recording of the patient's pain journey is of utmost importance, and understanding that pain with further granularity can only help with the diagnosis of worsening disease, personalization of treatment, and outcomes assessment.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old

Exclusion Criteria:

* Patient cannot use a smartphone
* Patient cannot use his hands to write or press a button
* Patient has a nerve catheter (has no pain)
* Altered mental status
* Neuropathy causing loss of pain sensation

Primary outcomes:
measure: Comparing Methods for Pain Score collection
timeFrame: On patient discharge, up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Meir T Marmor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03002948: Effect of Clitoris Location on Orgasm
Official title: Effect of Clitoris Topography on Orgasm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexual Dysfunction
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: sexually active women

Brief summary: Topography and location of clitoris and its parts may affect the orgasm

Detailed description: Orgasm measurement via Orgasm domain of Female Sexual Function Index, clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses.

Eligibility criteria: Inclusion Criteria:

* Sexually active women between 18 and 50 years old
* BMI below 40 kg/m2

Exclusion Criteria:

* BMI over 40 mhg/m2,
* Women younger than 18 years old
* Virgins
* No active sexual intercourse, women with
* Handicapped to get lithotomy position
* Active vulvar and vaginal infection
* Psychiatric diseases
* Drug usage that may cause sexual dysfunction, menopause.

Primary outcomes:
measure: orgasm score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02984748: Outcome Prediction in Cochlear Implant Recipients
Official title: Prediction of Outcomes in Adult Cochlear Implant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: cochlear implants
hearing loss
Lead sponsor: The Hearing Cooperative Research Centre
Sponsor class: OTHER
Collaborators: name: Cochlear
name: Attune Hearing
name: Sydney Cochlear Implant Clinic
First posted: 2016-12-07
Enrollment: 267
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: Adult Cochlear Implant Recipients

Brief summary: The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. The approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. The study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. Questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.


Eligibility criteria: Inclusion Criteria:

1. Clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery
2. Willing and able to attend the study visits
3. Able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation
4. Able to read and understand study documents and follow investigator instructions
5. Able to understand and follow study personnel instructions during audiological measurements
6. Native speaker in the language used to assess clinical speech perception performance

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment in the clinical investigation.

Primary outcomes:
measure: Speech recognition in quiet
timeFrame: Testing over 12 months
measure: Speech recognition in noise
timeFrame: Testing over 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The HEARing CRC
state: Victoria
Study officials:
References:
Clinical trial NCT06103448: Prediction of the Risks of Cardiovascular Mortality
Official title: Prediction of the Risks of Cardiovascular Mortality
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Diseases
Cardiovascular Morbidity
Stroke
Embolism
Cardiac Arrest
Keywords: ankle-brachial index
cardiovascular mortality
prevention
Lead sponsor: Jan Evangelista Purkyne University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Working individuals with employment contract in Ustecky Region, that are able to consent to assessment, are adults and understand written and spoken Czech language. Random companies from Ustecky region will be approached with the opportunity to participate.

Brief summary: Monitoring risks of cardiovascular diseases in working population (18 - 65 years old) by monitoring their BMI, ankle-brachial index with pulse wave velocity, cholesterol and glycemia.

Detailed description: Monitoring working population in their workplace by measuring their ankle-brachial index with pulse wave velocity, BMI, glycemia and cholesterol. Putting acquired data in correlation to their work habits, type of employment, work demands, job type, activity levels. Trying to find common predictors of cardiovascular disease. All assessed subjects must understand written and spoken Czech, must be employed in a company that consents with our data collections, must be older than 18 year old, doesn't have any bleeding disorder, doesn't have deep vein thrombosis (as it produces inaccurate data with ankle brachial index). Study will be conducted in Ustecky Region in the Czech Republic on approximately 200 subjects.

Eligibility criteria: Inclusion Criteria:

* employed in Ustecky Region Czech Republic
* adult
* understands spoken and written Czech
* consents with assessment
* works in a company that consents to assessments of their employees

Exclusion Criteria:

* deep vein thrombosis
* not currently employed
* on sick leave
* bleeding disorder

Primary outcomes:
measure: Detection of glycemia, HDL, LDL and triacylglyceride levels
timeFrame: 5 minutes
measure: Body composition
timeFrame: 3 minutes
measure: Ankle-brachial index
timeFrame: 2 minutes
measure: Ankle brachial pulse wave velocity (baPWV) and carotid femoral pulse wave velocity (cfPWV)
timeFrame: 2 minutes
measure: Weight
timeFrame: 1 minute
measure: Height
timeFrame: 1 minute
Secondary outcomes:
measure: BMI
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: University of Jan Evangelista Purkyně
Study officials:
References:
Clinical trial NCT05263648: Virtual Reality Software to Reduce Stress in Cancer Patients
Official title: Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Head and Neck Cancer
Keywords: Virtual Reality
Radiation Therapy
Education
Distress
Stress
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.

Detailed description: This study will involve patients who have been diagnosed with breast or head and neck cancer and are suitable to receive radiation therapy. It is a single arm pilot trial designed to provide information on the safety, feasibility, and impacts of incorporating virtual reality (VR) software into the treatment plan of patients receiving radiation therapy with the goal of increasing patient adherence to radiation therapy.

Patients will be provided with VR-based education sessions prior to and during the course of radiation therapy. Patients' emotional and social distress levels will be assessed with questionnaires to measure the impacts of the VR software. Patients will be in the study for up to 3 months during regular cancer care, but the total time for the study procedures is anticipated to be 2-4 hours in total. Results from this study will be for research only and will not impact treatment decisions.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Must be able to read and speak English
3. Diagnosis of breast or head and neck cancer
4. Treatment plan includes radiotherapy within the next 2 months
5. Signed study-specific informed consent prior to study entry

Exclusion Criteria:

1. Previous radiation therapy treatment
2. Neurologic deficits
3. Visual disorder
4. Neuro-psychiatric disorder
5. Use of neuro-psychiatric drugs

Primary outcomes:
measure: Proportion of patients who complete 2 VR sessions
timeFrame: Up to 3 Months
measure: Proportion of patients reporting ease of use for VR sessions
timeFrame: Up to 3 Months
measure: Proportion of overall adherence to radiation therapy
timeFrame: Up to 3 Months
Secondary outcomes:
measure: Change in state trait anxiety scale
timeFrame: Up to 3 Months
measure: Change in brief symptom inventory
timeFrame: Up to 3 Months
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)
timeFrame: Up to 3 Months
Other outcomes:
Locations:
Study officials:
affiliation: Stephenson Cancer Center
name: Christina Henson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01155648: Pressure Support During Chest Wall Compression
Official title: Increasing Pressure Support During Chest Wall Compression is Useful During Respiratory Therapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration, Artificial
Critical Care
Keywords: Mechanical ventilation
Chest physiotherapy
Chest wall compression
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.

Detailed description: 1. After being placed in the supine position in bed, with head angle elevation at 30°, patients were randomized to:group 1 (G1): chest wall compression for ten minutes in chest or group 2 (G2): chest wall compression plus increase of 10 cmH2O in IP in PSV for ten minutes in chest.
2. Clinical variables and APACHE II were registered.
3. Parameters analyzed at the beginning (1) and at the end (2) of the protocol were: variation of peak pressure (ΔPp=Pp2-Pp1),variation of tidal volume (ΔVT =VT2-VT1), variation of dynamic compliance (ΔCdyn= Cdyn2-Cdyn1).
4. The amount of variation of mucus secretion aspirated (ΔSa= Sa2-Sa1) at the end was also measured

Eligibility criteria: Inclusion Criteria:

* Patients on mechanical ventilation over 48 hours
* With ventilatory drive
* Hemodynamically stable MAP\> 60 mmHg
* With treatment of respiratory therapy

Exclusion Criteria:

* Contra indication of increased positive inspiratory pressure
* Peak pressure in the upper airway \> 40 cmH2O
* Osteoporosis diagnosis
* Deny to participate in the study

Primary outcomes:
measure: Variation of mucus secretion aspirated.
timeFrame: Two years
Secondary outcomes:
measure: Hemodynamic and pulmonary parameters.
timeFrame: Two years
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
name: Silvia R Vieira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naue Wda S, Forgiarini Junior LA, Dias AS, Vieira SR. Chest compression with a higher level of pressure support ventilation: effects on secretion removal, hemodynamics, and respiratory mechanics in patients on mechanical ventilation. J Bras Pneumol. 2014 Jan-Feb;40(1):55-60. doi: 10.1590/S1806-37132014000100008.
citation: Naue Wda S, da Silva AC, Guntzel AM, Condessa RL, de Oliveira RP, Rios Vieira SR. Increasing pressure support does not enhance secretion clearance if applied during manual chest wall vibration in intubated patients: a randomised trial. J Physiother. 2011;57(1):21-6. doi: 10.1016/S1836-9553(11)70003-0.
Clinical trial NCT04843657: Precise Care for Cancer Related Fatigue
Official title: Objective Data for Cancer Related Fatigue in Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer-Related Condition
Keywords: Cancer-related fatigue
smart bracelet device
symptoms for subjective and objective
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with some cancer treatment side effects.

Brief summary: This project expects to enroll 200 cancer patients and their subjective-objective measurements on fatigue, stress, symptoms, and total steps will be validated so that the information can be used in further care and improvement of life of quality of the patients.


Eligibility criteria: Inclusion Criteria:

- Age ≧ 20 years old; One group had a cancer diagnosis, one group no cancer diagnosis; Can continuous wearing bracelet for 7 days or more

Exclusion Criteria:

- Unclear and unable to answer the questionnaire

Primary outcomes:
measure: fatigue
timeFrame: 7-8 days
measure: Heart Rate Variability (HRV) monitor
timeFrame: 7-8 days
Secondary outcomes:
measure: Distress Thermometer(DT)
timeFrame: 7-8 days
measure: Leeds Sleep Evaluation Questionnaire(LSEQ）
timeFrame: 7-8 days
measure: International Physical Activity Questionnaire(IPAQ）
timeFrame: 7-8 days
measure: Perceived Stress Scale (PSS）
timeFrame: 7-8 days
measure: ESAS (Edmonton Symptom Assessment Scale)
timeFrame: 7-8 days
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Tsai-Wei Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02230657: A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Official title: A Prospective, Randomized Trial Comparing Same Day Discharge and Overnight Hospital Stay Among Total Hip Arthroplasties Done by the Direct Anterior Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Hip
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: The Anderson Orthopaedic Clinic
First posted: 2014-09-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to identify differences in satisfaction, pain and length of stay between patients undergoing hip replacement who are discharged from the hospital on the day of surgery compared to patients who stay one night in the hospital.


Eligibility criteria: Inclusion Criteria:

* Primary THA without acute hip fracture or prior hardware that would need to be removed at the time of surgery
* Unilateral THA
* Pre-operative Body Mass Index (BMI) \< 40 kg/m2
* Age \< 75 years at time of surgery
* Pre-operative hemoglobin \> 10 g/dL if pre-operative hemoglobin data is available
* No history of cardiopulmonary disease that would necessitate inpatient monitoring after surgery
* Pre-operative ambulatory status does not require the use of a walker or wheelchair
* No chronic pre-operative opioid medication use or opioid addiction
* Assistance available at home after discharge from hospital
* No other condition or circumstance that would preclude rapid discharge from the hospital after surgery
* Subject's English proficiency allows understanding of study and Informed Consent
* Subject consented to participate in this study

Exclusion Criteria:

* Revision THA
* Bilateral THA
* Pre-operative BMI ≥ 40 kg/m2
* Age ≥ 75 at time of surgery
* Pre-operative hemoglobin ≤ 10 g/dL if pre-operative hemoglobin data is available
* History of cardiopulmonary disease requiring acute inpatient monitoring
* Pre-operative ambulatory status requiring the use of a walker or wheelchair
* Chronic pre-operative opioid medication use or opioid addiction
* Limited or no assistance available at home after discharge from hospital
* Any other condition or circumstance that would preclude rapid discharge from the hospital
* Subject not proficient in English
* Subject did not consent to participate in this study

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Discharge through 30 days post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Alexandria
country: United States
facility: The Anderson Orthopaedic Clinic
state: Virginia
Study officials:
References: