louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05999890: Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol
Official title: A Comparative Study Between Intranasal Tapentadol Versus Intravenous Paracetamol for Post-operative Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anaesthesia'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Limb Fracture
Lead sponsor: Kempegowda Institute of Medical Sciences, Bangalore
Sponsor class: OTHER_GOV
First posted: 2023-08-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a single blind randomized controlled trial comparing the intranasal tapentadol with intravenous paracetamol for post operative analgesia
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by Visual analog scale(VAS)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. Paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of NSAIDs. Tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. This dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects

Detailed description: Inclusion criteria Age: From 18.00 Year(s) to 60.00 years Gender: Both American Society of Anesthesiologists (ASA) physical status: 1 \& 2, posted for elective lower limb orthopedic surgeries Exclusion criteria

1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. Patient on chronic opioid use Outcome Comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. The secondary outcome is to compare the need for the rescue analgesia between the groups

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1 \& 2
2. Posted for elective lower limb orthopaedic surgeries

Exclusion Criteria:

1. Sepsis at the site of injection
2. Coagulopathy
3. Patients with history of renal, hepatic, cardiovascular disease
4. Patient on chronic opioid use

Primary outcomes:
measure: Pain as measured with Visual analogue scale
timeFrame: Every 12 hours after the intervention till about 72 hours after the intervention
Secondary outcomes:
measure: The need for rescue analgesia
timeFrame: In the first 72 hours after the initiation of the intervention
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Kempegowda Institute of Medical Sciences
state: Karnataka
Study officials:
References:
Clinical trial NCT01841190: Prognostic Evaluation Of Severe Sepsis And Septic Shock. Procalcitonin Versus Delta Sofa
Official title: PROGNOSTIC EVALUATION OF SEVERE SEPSIS AND SEPTIC SHOCK. PROCALCITONIN VERSUS DELTA SOFA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Sepsis
Septic Shock
Keywords: Prognosis
Sepsis
Septic shock
Procalcitonin
SOFA
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with severe sepsis and septic shock admitted to a multidisciplinary ICU

Brief summary: The purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa.

Detailed description: This is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary ICU of a tertiary hospital.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted to the ICU
* severe sepsis and septic shock

Exclusion Criteria:

* Children
* Pregnant.

Primary outcomes:
measure: MORTALITY
timeFrame: 28 DAYS
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: Maranhao
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: MA
Study officials:
References:
citation: de Azevedo JR, Torres OJ, Beraldi RA, Ribas CA, Malafaia O. Prognostic evaluation of severe sepsis and septic shock: procalcitonin clearance vs Delta Sequential Organ Failure Assessment. J Crit Care. 2015 Feb;30(1):219.e9-12. doi: 10.1016/j.jcrc.2014.08.018. Epub 2014 Sep 10.
Clinical trial NCT06166290: Comparing CO2 Laser and Electrosurgical Treatments for Perianal Condyloma
Official title: CO2 LASER Vaporization vs Electrosurgical Fulguration for the Surgical Management of Perianal Condyloma: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perianal Wart
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perianal condyloma are skin- colored and fleshy lesions caused by various variants of Human Papilloma Virus (HPV), most commonly 6 and 11. The treatment modalities available include topical options like podophyllin, imiquimod cream, trichloroacetic acid and cryotherapy, injectable options like interferon and 5-fluoroucil, and surgical options like excision, fulguration, cryotherapy, and laser removal. However, the treatment is usually short-lived, and the patients are subjected to multiple repeat procedures because of high recurrence and low clearance rates. Surgical management has the highest clearance rate. There are several surgical modalities including excision, electrosurgical fulguration (ESF), and LASER vaporization. LASER techniques work directly to destroy/transect the lesion, cause necrosis of infected keratinocytes and induce local inflammation. LASER treatment is also reported to have minimal local surrounding tissue injury and sphincter injury, and less pain and discomfort. For this reason, LASER therapy has been increasingly used to remove anogenital warts, and is a standard of care treatment of condyloma. We hypothesize that LASER vaporization is effective to treat perianal condyloma and may have clinical benefits over ESF. We will compare postoperative outcomes such as pain, healing, cosmesis and recurrence following either treatment method.


Eligibility criteria: Inclusion Criteria: Adults (\>18) treated in our CRS department for perianal condyloma, not previously treated surgically, English speaking patients.

Exclusion Criteria: \<18, intra-anal condyloma, previously treated for condyloma, other skin diseases in the perianal region, limited English proficiency.

* Adults unable to consent- exclude
* Individuals who are not yet adults (infants, children, teenagers)- exclude
* Pregnant women- exclude
* Prisoners- exclude

Primary outcomes:
measure: Recurrence of Anal Condyloma
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of Postoperative Pain and associated outcomes
timeFrame: 6 months
measure: Incidence of Treatment-Emergent complications
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02709590: Diclofenac Potassium With Lidocaine Cream in Reducing Pain During HSG
Official title: Randomized Clinical Trial of Oral Diclofenac Potassium With Cervical Lidocaine Cream in Reducing Pain During HSG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Relief With HSG
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 140
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.


Eligibility criteria: Inclusion Criteria:

* any patient came for HSG

Exclusion Criteria:

* any patient has contraindication to HSG

Primary outcomes:
measure: Mean pain score during hysterosalpigography by visual analog scale
timeFrame: intraoperative
Secondary outcomes:
measure: Mean pain score after hysterosalpigography
timeFrame: 30 minutes
measure: side effects of medication
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT05141890: Probiotics for Inflammation in Pediatric Chronic Pain
Official title: Probiotics for Inflammation in Pediatric Chronic Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Body Mass Index >=85th Percentile
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 39
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To examine benefits of a probiotic for youth with chronic pain and a Body Mass Index \>=85th percentile.

Detailed description: The purpose of the current study: (1) examine whether a 7-11 week supplement of a single-strain probiotic (Lactobascillus Plantarum, Lp299v) reduces systemic inflammation; (2) determine whether reductions in systemic inflammation will correlate with reductions in pain, disability, mood impairment and changes in mechanical pain threshold and mechanical pain sensitization; (3) Explore whether reductions in systemic inflammation will correlate with reductions in other outcomes.

Eligibility criteria: Inclusion Criteria:

1. Male or female biological sex
2. 13-17 years of age
3. Body Mass Index ≥85th percentile for sex and age

Exclusion Criteria:

1. Probiotic (or prebiotic) supplement use or antibiotic use within the past month
2. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
3. Patients who have had a poor response to blood draw or immunizations in the past
4. Chronic use of medications known to alter gastrointestinal function or inflammation (e.g. metformin, non-steroidal anti-inflammatory medications)
5. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
6. Use of illicit drugs
7. Females who are pregnant or lactating

Primary outcomes:
measure: Change in systemic inflammation - CRP
timeFrame: 7-11 weeks
Secondary outcomes:
measure: Change in Worst Pain intensity
timeFrame: 7-11 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT03750890: Visual Study of Molecular Genotype in Glioma Evolution
Official title: A New Strategy for the Visulation of Molecular Genotype in Glioma Evolution Based on the Radiomics and Microomics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma of Brain
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients who were suspected of having brain gliomas on the basis of clinical findings and who were previously diagnosed with brain gliomas underwent MRI.

Brief summary: The key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. Based on the previous research, this project intends to establish a multi-dimensional database of glioma from clinical, radiomics and microomics levels. The investigators aim to filter out the specific molecular markers in the progression of glioma and explore the intrinsic connection of radiomics features and microomics molecular markers by using bioinformatics integration analysis and artificial intelligence multiple kernel learning. Thus, the investigators could determine the specific molecular mechanism in the progression of glioma, and establish a visually quantitative assessment system of pre-operative precisive grading, molecular typing discrimination and prognosis prediction. The completion of this project is of great significance for improving molecular diagnostic level of glioma, guiding individualized diagnosis and treatment decisions, and improving the survival rate of patients.


Eligibility criteria: Inclusion Criteria:

1. postoperative pathological and genetic test confirmed brain glioma;
2. The preoperative Clear and complete multimodal imaging data were collected within 10 days.

Exclusion Criteria:

1. patients who underwent surgery more than 4 weeks after MRI;
2. patients with motion artifacts.

Primary outcomes:
measure: radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）
timeFrame: through study completion, an average of 3 years
measure: microomics molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features)
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhenxiong Wang
state: Choose A State Or Province
Study officials:
References:
Clinical trial NCT03298490: Reliability, Validity Of The Turkish Version Of The Back Performance Scale
Official title: Reliability, Validity Of The Turkish Version Of The Back Performance Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Keywords: validity
reliability
low back pain
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic back pain between the ages of 18-65

Brief summary: In this study, we performed the validity and reliability of the Turkish version of Back Performance Scale.

Detailed description: Low back pain (LBP) is defined as the pain that occurs in the area between the lower border of the scapula and the buttocks and sometimes radiates to the lower extremities. In the community, lower back pain is the second most common health problem after cold. 15% of LBP cases are chronic. Appropriate use of assessment questionnaires is one of the most important steps in the evaluation of the functional level of the patient and in deciding on an effective treatment protocol. The purpose of study is to determine the Turkish version, validity and reliability of Back Performance Scale. 180 patients with chronic low back pain were included in the study. Test-retest and internal consistency analysis were conducted to determine the reliability of the questionnaire. Test-retest results evaluated using the Intraclass Correlation Coefficient method.

Eligibility criteria: Inclusion Criteria:

* Having a low back pain
* Literate persons

Exclusion Criteria:

* Cancer disease
* Trauma
* Pregnant

Primary outcomes:
measure: Roland Morris disability questionnaire
timeFrame: 10 minute
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 10 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: gazi üniversity
name: seyit çıtaker
role: STUDY_CHAIR
References:
Clinical trial NCT02662790: Dexamethasone on Fetal and Uteroplacental Doppler
Official title: Effects of Antenatal Dexamethasone Administration on Fetal and Uteroplacental Doppler Waveforms in Women at Risk for Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Birth
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study aims to investigate the effects of dexamethasone exerted on fetal and uteroplacental circulation as measured by Doppler ultrasonography in pregnancies at risk for preterm birth after 24 hours of its administration.


Eligibility criteria: Inclusion Criteria:

* Patients at risk of preterm labor to be included were those with preterm uterine contractions, placenta previa, and mild preeclampsia

Exclusion Criteria:

* Patients who were actively in labor, presented with premature rupture of membranes, intrauterine growth restriction (IUGR), those who had received corticosteroids in their pregnancies and/or fetuses with suspected structural abnormalities

Primary outcomes:
measure: mean of Doppler Resistance index (RI)
timeFrame: 24 hours
Secondary outcomes:
measure: mean of Doppler Pulsatility index (PI)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT02056990: Screening of Athletes
Official title: Screening of Athletes for Prevention of Injury and Optimisation of Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Individual Differences
Motor Activities
Keywords: Athletes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes will be selected from a list offered by the Flemish Atlethics League. This incorporates a group of athletes with potential to become Elite Athletes of the highest international level

Brief summary: Athletes have to participate in screenings in order to reduce injuries. Up-to-now most screenings are purely clinically based. Literature, however, indicates the importance of knowledge on deviant movement patterns as possible risk factors for injuries. From this perspective, the current project aims to measure movement patterns, gait and running in young athletes to optimise training and prevent injuries.

2D- and 3d registration methods, force plate data and pressure plate data will be used to document the performance of the athletes.


Eligibility criteria: Inclusion Criteria:

1. Selected by the Flemish Athletics League
2. Level: B1, B2 en C
3. Age categories: 16-22 years
4. No injuries at lower back and lower extremities in the past 6 months
5. Signing informed consent

Exclusion Criteria:

1. Not selected by the Flemish Athletics League
2. Injuries at lower quadrant

Primary outcomes:
measure: Kinematic and kinetic data
timeFrame: March - June 2014 (3 months)
Secondary outcomes:
measure: 2 D parameters
timeFrame: March - June 2014 (3 months)
Other outcomes:
measure: Sports activities,personal demographics, injury history
timeFrame: March - June 2014 (3 months)
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/UZLeuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Filip F Staes, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04539990: A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD
Official title: A Behavioral Intervention for Ameliorating Sleep Problems in Children With ASD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Sleep
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study will test the effectiveness of a behavioral intervention program that targets sleep problems in 1.5-5-year-old children with ASD. Sleep patterns will be measured using questionnaires and sleep diaries that will be completed by the parents as well as by Fitbit sensors that will be placed on the child's wrist or back of the arm. The study will also explore whether specific child (e.g., severity of cognitive abilities) or parent characteristics (e.g., parent stress levels) impact the effectiveness of the intervention. In addition, we will examine whether changes in sleep disturbances are associated with changes in the family's quality of life.


Eligibility criteria: Inclusion Criteria:

Parents of 1.5-5-year-old children with autism will be asked to fill the Child Sleep Habits Questionnaire (CSHQ). Those who report high scores on the following 3 CSHQ subscales will be invited to participate: bedtime resistance, sleep onset delay, and night-wakings.

Exclusion Criteria:

None

Primary outcomes:
measure: Child Sleep Habits Questionnaire
timeFrame: 8 weeks after program begins
measure: Night time sleep as measured by Fitbit sensor
timeFrame: 8 weeks after program begins
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: