louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02558686: Exercise and Post-dry Needling Soreness
Official title: Effects of Eccentric Exercise, Sham or Placebo on Post-Needling Soreness by Dry Needling on Active Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: trigger points
disability
post-dry needling soreness
eccentric exercise
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 90
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: Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Manual therapies and exercise strategies targeting to decrease post-dry needling soreness need to be investigated.


Eligibility criteria: Inclusion Criteria:

* Unilateral non-traumatic shoulder pain
* Shoulder pain from at least 6 months
* Shoulder pain of more than 3 points on a NPRS
* Presence of active trigger point in the infraspinatus muscle

Exclusion Criteria:

* bilateral shoulder pain
* younger than 18 or older than 65 years
* shoulder injury
* upper extremity surgery
* fibromyalgia syndrome
* neck or shoulder surgery
* cervical radiculopathy
* whiplash
* any type of intervention for the neck-shoulder the previous year

Primary outcomes:
measure: Changes in post-dry needling pain intensity before and after the intervention
timeFrame: Baseline, 24 hours after, 48 hours after and 72 hours after treatment
Secondary outcomes:
measure: Changes in spontaneous shoulder pain before and after the intervention
timeFrame: Baseline and 72 hours after treatment
measure: Changes in disability before and after the intervention
timeFrame: Baseline and 72 hours after treatment
measure: Changes in functionality before and after the intervention
timeFrame: Baseline and 72 hours after treatment
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Cesar Fernández-de-las-Peñas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02894086: A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014
Official title: A Retrospective Study of the Feasibility of Ambulatory Appendicectomy for Acute Appendicitis (Based on Data From the PMSI French National Hospital Information System) in the Adults Hospitalized Between December 2013 and December 2014
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Appendicitis
Keywords: acute appendicitis
ambulatory appendicectomy
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated on for acute appendicitis between December 2013 and December 2014

Brief summary: Acute appendicitis is a frequent surgical emergency, with an estimated incidence of about 80,000 cases a year (in France). It mainly affects young adults but is associated with a low complication rate and a short stay in hospital. Ambulatory treatment is an innovative type of care in which the patient is hospitalized for less than 12 hours and does not stay overnight in hospital.

Ambulatory care is based on the guidelines issued by three French learned societies (the SFCD, the ACHBT and the AFCA) and has been defined by the French government as a national priority.

The literature data show that 20% of patients undergoing appendicectomy for acute appendicitis can be treated on an ambulatory basis. However, the success factors for short-stay care (hospitalization \<24 hours) or ambulatory care (hospitalization \<12 hours) have yet to be identified.

The investigators thus intend to perform a retrospective study of data from the PMSI French national hospital information system, in order to identify factors that are predictive of a length of hospital stay below 24 hours in patients having undergone appendicectomy for acute appendicitis during 2013 in France. The objective is to define the population of patients that could potentially benefit from ambulatory care.


Eligibility criteria: Inclusion Criteria:

Medical criteria:

* Patients operated on for acute appendicitis between December 2013 and December 2014

Sociodemographic criteria:

* Adult patients (aged between 18 and 75, inclusive)
* Social security coverage

Exclusion Criteria:

Sociodemographic criteria:

* Patients under the age of 18
* Pregnancy or breastfeeding
* Legal guardianship or incarceration

Primary outcomes:
measure: identify the population of patients having been hospitalized for less than 24 hours.
timeFrame: during 1 year (from december 2013 to december 2014)
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: REGIMBEAU Jean-Marc, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04545086: Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.
Official title: Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging
Keywords: Anxiety, Video Based Education, Music Therapy, Experience, Cooperation, Magnetic Resonance Imaging
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned randomly to three groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study to assess the Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation among Patients undergoing Magnetic Resonance Imaging. This is a Experimental Multiple Interventions Pre test - Post test Design. Three groups namely, Video Based Education group, Music Therapy Group and control groups are there in study.There will be significant difference in the Mean Anxiety Scores, Experience level, and Co-operation level of patients undergoing MRI in Video Based Education , Music Therapy group and Control Group


Eligibility criteria: Inclusion Criteria:

* undergoing MRI with or without contrast
* having age between 18- 60 years.
* alert, oriented
* able to comprehend, speak and listen English or Hindi.
* patients without hearing and visual impairment.
* available during period of data collection

Exclusion Criteria:

* unconscious
* critically ill and sedated.
* visiting Radiology Department for other procedures such as Computed Tomography scan, and MRI brain
* having pain score of 3-10 on universal pain assessment scale..

Primary outcomes:
measure: to assess the effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Cooperation among patients undergoing Magnetic Resonance Imaging
timeFrame: 45 minutes to 1 hour.
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Deepika Bist
Study officials:
References:
Clinical trial NCT04452786: Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Official title: Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endoscopic Sleeve Gastroplasty
Laparoscopic Sleeve Gastrectomy
Gut Hormones
Glucose Metabolism Disorders
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion
* BMI\<45

Exclusion Criteria:

* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations

Primary outcomes:
measure: Changes in ghrelin (pg/ml)
timeFrame: 240 minutes
Secondary outcomes:
measure: Changes in gut hormone response before and after sugery (pmol/L)
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Endocrinology, Hvidovre University Hospital
state: Hvidovre
Study officials:
References:
Clinical trial NCT02739386: Study of Autoimmune Disease Complications Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases
Official title: Evaluation of Hospitalization for Complications of Autoimmune Disease Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases Treated in Routine Clinical Practices in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-04-15
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with an underlying autoimmune disease treated with ipilimumab for advanced melanoma.

Brief summary: The research questions to be addressed by this study are as follows:

1. What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma?
2. Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?


Eligibility criteria: Inclusion Criteria:

* Received ipilimumab therapy between 03/01/2011 and 6/30/2014
* Aged 18 years or older at index date (initiation of ipilimumab)
* Diagnosed with melanoma before index
* Documented history of an autoimmune disease
* Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index
* Have at least 3 months of continuous pharmaceutical and medical benefit enrollment following and including the index date

Exclusion Criteria:

* Diagnosed with melanoma but NO record of exposure to ipilimumab
* No exposure to nivolumab (Opdivo ®) at any time

Primary outcomes:
measure: Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
timeFrame: Approximately 40 months
measure: Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab
timeFrame: Approximately 40 months
Secondary outcomes:
measure: Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment
timeFrame: Approximately 40 months
measure: Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment
timeFrame: Approximately 40 months
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bristol-Myers Squibb
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01859286: Improving Signout Accuracy and Information Delivery in the Emergency Department
Official title: Improving Transfer of Care Accuracy and Information Delivery in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Errors Related to Emergency Department Sign Out
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 321
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ED Physicians. We looked at the amount of errors due to signout that ED Physicians commit with standard signout procedure and then with a revised signed out process

Brief summary: The investigators sought to determine if implementing a standardized sign out process would reduce the amount of medical errors related to patient sign out. The standardized process included the following interventions: implementation of a data resident to review patients lab values, vital signs, radiologist results, and orders in real time, conducting sign out in a standardized location and using the attending physician as an "interruption manager." The investigators defined medical errors related to sign out as any piece of information was incorrectly reported or omitted during sign out that caused a change in treatment or disposition discussed during sign out. The investigators hypothesis was that implementing a standardized sign out process would lead to a decrease in the amount of sign out related errors.


Eligibility criteria: Inclusion Criteria:

* ED transfers of care occurring at 0700 or 1900.

Exclusion Criteria:

* Attending only handovers (1500, 2300)
* Handovers including midlevel providers (Thursday 0700, 1300).

Primary outcomes:
measure: Sign out related errors
timeFrame: 4 months
Secondary outcomes:
measure: perception of sign out
timeFrame: 1 year after implementation of revised sign out process
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital - Texas Medical Center
state: Texas
Study officials:
affiliation: UT Houston Health Sciences Center at Houston Department of Emergency Medicine
name: Nnaemeka G Okafor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03555786: MEV for Retroclavicular Approach to Infraclavicular Block
Official title: Minimum Effective Volume of Bupivacaine for Retroclavicular Approach Brachial Plexus Block
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bupivacaine
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-06-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.

Brief summary: In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Detailed description: A "biased coin up-and-down sequential design" will be applied to assess the minimum effective volume in 90% of patients for the retroclavicular brachial plexus block. The first subject received 25 ml 0.5% bupivacaine . Each subsequent patient received a dose that depended on the response of the previous one. If the previous block is successful, the block will be performed either by a reduction of the volume by 2.5 ml with a probability ß = 0.11 or by a same dose of the previous one with a probability 1-ß = 0.89 in the next patient.

Eligibility criteria: Inclusion Criteria:

* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

* patients \<18 years old
* \>65 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* inability to provide written informed consent
* refusal of regional anesthesia
* pregnancy
* contraindication for regional anesthesia

Primary outcomes:
measure: The minimum effective volume of bupivacaine 0.5% resulting in successful block in 90% of patients (MEV90)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05864586: Developing E-liquid Product Standards (Sweet Spot Study)
Official title: Nicotine Concentration and Forms: Differential Appeal to Smokers Versus Non-Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine
Nicotine Vaping
E-cigarette Use
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The Sweet Spot Study aims to evaluate the effect of e-liquids with nicotine varying in freebase (FB) levels and concentrations on the appeal of electronic cigarettes (ECs) in young adult EC users with minimal/no history of smoking and older adult smokers.


Eligibility criteria: Inclusion criteria:

1. Young adult e-cigarette user or older adult smoker
2. Willing to abstain from all nicotine product use for 12 hours prior to the study visit
3. Read and speak English

Exclusion criteria:

1. Currently attempting to quit nicotine products
2. Currently pregnant, planning to become pregnant, or breastfeeding
3. Current or past use of tobacco products other than e-cigarettes or cigarettes
4. Self-reported diagnosis of lung disease
5. Self-reported new or unstable cardiovascular disease

Primary outcomes:
measure: Behavioral Intentions for Continued Use
timeFrame: The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours.
measure: Intensity of Sensory Attributes
timeFrame: The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours.
measure: Degree of Liking or Disliking of Sensations
timeFrame: The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours.
Secondary outcomes:
measure: Subjective Appeal
timeFrame: The outcome measure was assessed immediately after each vaping session. During each vaping session, participants took two puffs of each of the 10 study conditions within a single study visit lasting up to 3 hours.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Theodore L Wagener, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02215486: The Effect of Head Massage Therapy on the Regulation of the Autonomic Nervous System
Official title: Head Massage Intervention to Decrease Physiological Signs of Stress as Assessed by Changes in the Autonomic Nervous System Functions in Healthy Volunteers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Effect of Head Massage Therapy on the Autonomic Nervous System
Keywords: Head massage therapy
Massage therapy
Autonomic nervous system (ANS)
Heart rate variability (HRV)
Pre-ejection period (PEP)
Lead sponsor: Children's & Women's Health Centre of British Columbia
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The autonomic nervous system (ANS) unconsciously regulates the activities of vital organ systems such as the respiratory, circulatory, and urinary systems. It consists of two major components, the parasympathetic nervous system (PNS) and the sympathetic nervous system (SNS), which together are in charge of keeping our body in homeostasis. Homeostasis is the state of chemical and metabolic balance within an organism; it is disturbed in situations of uncontrolled stress.

Massage has been shown to decrease SNS and stimulate PNS; but most studies focused on full body massage, with limited assessment of ANS function, and lacked control groups.

The effects of head massage therapy (HMT) on regulating the activity of the ANS have not been studied before. In this pilot study, we propose that by randomizing 10 participants to sessions of HMT and 'Simple Relaxation' (no HMT), and by using a non-invasive method of measuring the ANS activity (spectral analysis of Heart Rate Variability \[HRV\] as well as Pre-ejection Period (PEP)), we will be able to investigate the effects of 10 minutes of HMT in comparison with the period of no HMT administered. We expect HMT to reduce stress, with a better and balanced profile of autonomic nervous system after receiving massage.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy individuals

Exclusion Criteria:

* Use of anti-depressants or drugs that affect the cardiovascular system or ANS
* Smoking more than 10 cigarettes/day
* Inability to provide consent
* Inability to speak and/or understand English

Primary outcomes:
measure: Heart Rate Variability (HRV) parameters
timeFrame: Within 1 day
measure: Pre-ejection period (PEP)
timeFrame: Within 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital
state: British Columbia
Study officials:
affiliation: Children's & Women's Health Centre of British Columbia
name: Jean-Paul Collet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of British Columbia
name: Mir Sohail Fazeli, M.D.
role: PRINCIPAL_INVESTIGATOR
References: