louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03524703: Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion
Official title: Short-term Effect of Chewing Gum in Patients With Mild-moderate Dysphagia After Anterior Cervical Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Keywords: dysphagia
anterior cervical fusion
chewing gum
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to estimate the effect of chewing gum after anterior cervical fusion surgery on decreasing the severity of dysphagia in patients with mild-moderate dysphagia.

Detailed description: Postoperative dysphagia is the most common complication of anterior cervical fusion surgery. Previous studies showed that chewing gum helped to improve swallow frequency and latency. However, its short-term effect on alleviating dysphagia symptom after anterior cervical surgery is still unknown. A randomized, parallel controlled, superiority trial is performed in patients with postoperative mild-moderate dysphagia. Dysphagia severity will be assessed using dysphagia short questionnaire (DSQ) score in the chewing gum group and control group during 7 days after surgery, and the changes in DSQ score between two groups will be compared, to estimate the effect of chewing gum on alleviating dysphagia symptom.

Eligibility criteria: Inclusion Criteria:

* age from 18 years to 80 years.
* underwent anterior cervical fusion surgery for degenerative cervical disease.
* diagnosed with mild or moderate postoperative dysphagia 1 day after surgery using Bazaz scale.

Exclusion Criteria:

* Patients underwent revision procedures or procedures treating conditions other than degenerative cervical disease.
* Patients with preoperative dysphagia.
* Patients unable to chew, or unable to follow the directions for chewing gum.
* Patients unable to attend follow-up visits or finish the dysphagia questionnaires.

Primary outcomes:
measure: Dysphagia Short Questionnaire (DSQ) score
timeFrame: Change from the 1st day after surgery to the 7th day after surgery.
Secondary outcomes:
measure: Bazaz grading system
timeFrame: Change from the 1st day after surgery to the 7th day after surgery.
measure: Prevertebral soft tissue swelling
timeFrame: The 3rd days after surgery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yunbing Chang, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00194103: Effectiveness of Extended Telephone Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.


Eligibility criteria: Inclusion Criteria:

* enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry
* qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);
* willingness to participate in research and be randomized;
* 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);
* able to provide the names of several informants who will know his/her whereabouts during the follow-up period

Exclusion Criteria:

* acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);
* IV heroin use during the past year;
* anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.

Primary outcomes:
measure: TimeLineFollowBack
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James McKay, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695703: Point Prevalence of Side Strain in Fast Bowlers and Effectiveness of Core Strength Training.
Official title: Point Prevalence of Side Strain in Fast Bowlers and Effectiveness of Core Strength Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport Injury
Sports Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 36
Sex: MALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out the prevalence of side strain in fast bowlers and determine the effectiveness of core strength training in treating side strain

Detailed description: A fast bowler needs to have strong core muscles in order to prevent side strain, which can hider the performance. Variation in deliveries , bowling speed and bowling action can be compromised due to side strain injuries specifically in fast bowlers.

A strong and stable core helps to maintain balance and provide strength while performing repetitive movements such as bowling. Core strengthening program should include exercises that are sports specific, conditioning exercises that focus on anterior and posterior musculature of the trunk and hip.

The aim of this study is to find out the prevalence of side strain in fast bowlers and to incorporate strengthening exercises for core muscles to evaluate its effectiveness for side strain.

Eligibility criteria: Inclusion Criteria:

* Male fast bowlers
* Age 14 to 40 years

Exclusion Criteria:

* Athletes who have undergone any surgery
* Anyone with history of chest pain due to cardiopulmonary disorders

Primary outcomes:
measure: Core Muscle Strength Test
timeFrame: 6 weeks
measure: Sahrmann Core Stability Test
timeFrame: 6 weeks
Secondary outcomes:
measure: Ultrasonographical assessment of side strain
timeFrame: 6 weeks
measure: Cornell Musculoskeletal Discomfort Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gujar Khan
country: Pakistan
facility: Sawar Muhammad Hussain Shaheed Sports Stadium, Gujar Khan
state: Punjab
Study officials:
affiliation: Riphah University
name: Saad Rauf, Ph.D*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02209103: The Sleep Improving Effects of Orange Phenolics
Official title: Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyphenols
Sleep
Fatigue
Keywords: Polyphenols
Orange
Sleep
Fatigue
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest.

Participants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires.

The study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Non-smoking
* Healthy
* Lightly disturbed sleep for at least six months, on a regular basis

Exclusion Criteria:

* Severe sleep disorders (sleep apnea, restless legs syndrome)
* An apparent cause for the sleep disorders (pain, etc.)
* Clinically significant abnormal liver functioning
* Clinically significant abnormal serum creatinine
* BMI lower than 18 or higher than 30 kg/m2
* Use of concomitant medications or supplements

Primary outcomes:
measure: Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
timeFrame: 9 test nights (up to 9 days)
Secondary outcomes:
measure: Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
timeFrame: up to 9 days. Questionnaires are filled out the morning after every test night
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC)
Study officials:
affiliation: Department: lung diseases MUMC
name: Chris Van der Grinten
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04495803: Augmented CBGT for Perinatal Anxiety During a Global Pandemic (COVID-19)
Official title: Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Anxiety
Covid19
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.


Eligibility criteria: Inclusion Criteria:

* Females, aged 18-45 years
* Pregnant or up to six months postpartum
* Primary diagnosis of an anxiety disorder, as per the MINI for DSM-5, with or without comorbid depression
* No concurrent psychological treatment
* Not taking psychoactive medication or medication is stable in dose and type for at least 8 weeks prior to the study (as per Canadian Psychiatric Guidelines) and throughout study duration (participants will not be excluded from treatment if medication/dose changes during the study duration, however, they must notify the study team immediately)
* Fluent in English in order to understand the consent and group material

Exclusion Criteria:

* Severe depression/suicidality
* Primary diagnosis other than an anxiety disorder
* Psychotic or current substance/alcohol use disorder

Primary outcomes:
measure: State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
timeFrame: 8 weeks
Secondary outcomes:
measure: Intolerance of Uncertainty Scale (IUS)
timeFrame: 8 weeks
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: 8 weeks
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 8 weeks
measure: COVID-19 Stress Scales (CSS)
timeFrame: 8 weeks
measure: Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)
timeFrame: 8 weeks
measure: Postpartum Specific Anxiety Scale (PSAS)
timeFrame: 8 weeks
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: 8 weeks
measure: Parenting Sense of Competence Scale (PSOC)
timeFrame: 8 weeks
measure: Abbreviated Dyadic Adjustment Scale (ADAS)
timeFrame: 8 weeks
measure: Social Provisions Scale (SPS)
timeFrame: 8 weeks
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: 8 weeks
measure: Postpartum Bonding Questionnaire (PBQ)
timeFrame: 8 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 8 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
References:
Clinical trial NCT02033603: Adductor Canal Versus Femoral Nerve Block for Analgesia Post Total Knee Arthroscopy
Official title: A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Femoral Nerve Block for Analgesia Post Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty
Total knee replacement
Femoral Nerve Block
Adductor Canal Block
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee arthroplasty or replacement (TKA) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. It is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. The current practice is to perform a femoral nerve block (FNB) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). This provides effective analgesia. However, it also results in weakness of the quadriceps and may result in falls post-operatively.

Adductor canal block (ACB) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to FNB, hence potentially reducing the risk of falls post-operatively.

Investigators aim to study if the analgesia provided by ACB is as good as FNB while preserving quadriceps strength.


Eligibility criteria: Inclusion Criteria:

* ages 45-85
* American Society of Anaesthesiologists physical status 1-3
* BMI 18-35 kg/m2

Exclusion Criteria:

* inability to give consent, communicate, cooperate
* Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
* Patients with allergy to local anaesthetics or any drugs included in the study
* Patients with lower limb surgery in the preceding year
* Patients with pre-existing neurological deficits
* Patients who are unsuitable for general anaesthetics (eg difficult airway)

Primary outcomes:
measure: Morphine consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Pain scores
timeFrame: 1, 6, 12, 24, 48
measure: Morphine consumption
timeFrame: 48 hours
measure: Side effects of opioids- sedation, nausea and vomiting
timeFrame: 48 hours
measure: Quadriceps strength, ability to mobilise
timeFrame: 24, 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Yean Chin Lim, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03048903: The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function Failure
Official title: The Effect of Rhubarb on Sepsis and Post-traumatic Gastrointestinal Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sepsis
Keywords: Gastrointestinal dysfunction
sepsis
trauma
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2017-02-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly divided into two groups ,using rheum palmatum or placebo
Primary purpose: TREATMENT

Brief summary: Random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group.

Detailed description: Patients were randomly divided into two groups, using rhubarb powder or placebo. Rhubarb is commercially certified rhubarb(Rheum palmatum, Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh, Two days before 6g, three times / day, oral or nasal feeding, two days later reduced to 3g, three times / day, oral or nasal feeding; Another group of patients taking placebo, with the same dose of Rhubarb; The overall course of the two drugs was a week.

Eligibility criteria: Inclusion Criteria:

1. Age:18-65 year old;
2. Diagnosis: sepsis with gastrointestinal dysfunction (II-III grade AGI); gastrointestinal dysfunction after trauma (II-III AGI);
3. Complete gastrointestinal tract anatomic structure（including the ileum and colon stoma）

Exclusion Criteria:

1. Hemodynamic instability;
2. Underlying diseases: cardiac function III\~IV, chronic liver dysfunction Child-Pugh score \>9 points;
3. Less than 5 days after surgery for stomach and small intestine，less than 7 days after Colonic surgery, Postoperative gastrointestinal leakage;
4. Abdominal Compartment Syndrome;
5. mechanical ileus
6. active gastrointestinal hemorrhage

Primary outcomes:
measure: The remission rate of gastrointestinal dysfunction
timeFrame: 2 weeks
Secondary outcomes:
measure: The ratios of L/M in human urine samples
timeFrame: 7 days
measure: citrulline
timeFrame: 7 days
measure: D- lactic acid
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai ChangZheng Hospital
state: Shanghai
Study officials:
References:
citation: Kubica P, Kot-Wasik A, Wasik A, Namiesnik J, Landowski P. Modern approach for determination of lactulose, mannitol and sucrose in human urine using HPLC-MS/MS for the studies of intestinal and upper digestive tract permeability. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Oct 15;907:34-40. doi: 10.1016/j.jchromb.2012.08.031. Epub 2012 Sep 4.
Clinical trial NCT02658903: Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Official title: Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Urinary Infections
Keywords: Foley
Infection
Hospital acquired
catheter associated
urinary
Lead sponsor: Oxys Medical AG
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

Detailed description: This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.

The endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of \>95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Eligibility criteria: Inclusion Criteria:

* Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.

Exclusion Criteria:

* Need for antibiotic treatment for any infections
* Urological intervention or need for catheter change within study duration of 4 weeks

Primary outcomes:
measure: Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.
timeFrame: 4 weeks
Secondary outcomes:
measure: Significant bacteriuria assessed by weekly bacterial cultures.
timeFrame: every week during 4 weeks
measure: Clinically symptomatic catheter associated lower urinary infections.
timeFrame: 4 weeks
measure: occurence of adverse events
timeFrame: within 4 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: Universitätsklinik Balgrist Zürich
name: Thomas Kessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00968903: Effects of Methylprednisolone After Total Hip Arthroplasty
Official title: Effects of Pre-operative Methylprednisolone (125mg iv) After Total Hip Arthroplasty: A Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: LOS
Postoperative Pain
Postoperative Nausea and Vomiting
Sleeping Quality
Fatigue
Inflammatory Response
Keywords: Hip arthroplasty
Methylprednisolone
Post-operative pain
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2009-08-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty.

The hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.

Detailed description: In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. The investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Elective total hip arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics or methylprednisolone
* Age \< 18 years
* Daily use of opioids or glucocorticoids
* Pregnancy or breastfeeding (fertile women)

Primary outcomes:
measure: Time to fulfill discharge criteria
timeFrame: At discharge (mean 1-2 days)
Secondary outcomes:
measure: Hand muscle strength
timeFrame: 24 hours
measure: Sleeping quality on the visual analog scale
timeFrame: up to four days
measure: Inflammatory response measured as CRP in blood sample
timeFrame: 24 hours postoperatively
measure: Fatigue measured on a 10 point numeric range scale
timeFrame: up to four days
measure: Additional analgetics, antinausea agents and sleeping medicine.
timeFrame: up to four days
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 30 days
measure: Postoperative pain scores on the visual analog scale
timeFrame: up 30 days
measure: Postoperative nausea and vomiting (PONV) on 4 point numeric range scale
timeFrame: up to 4 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
Study officials:
References: