louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01389986: Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer
Official title: Effects of Gum Chewing on Recovery of Bowel Function Following Abdominal Surgery for Endometrial and Ovarian Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Paralytic Ileus
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Following extensive abdominal surgery for the treatment of endometrial or ovarian cancer, paralytic ileus frequently develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.

The objectives of this study are to evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complications, and patients' satisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing staging or cytoreductive surgery for primary endometrial or ovarian cancer at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

* Perioperative hyperalimentation
* Recent chemotherapy (within 3 weeks before surgery)
* Previous bowel surgery
* Inflammatory bowel diseases
* Previous abdominal or pelvic radiation
* Need for immediate postoperative endotracheal intubation
* Need for postoperative admission to intensive care unit
* Undergoing emergency surgery with oral intake of fluid or food within 4 hours before surgery

Primary outcomes:
measure: Time to first flatus
timeFrame: Up to 7 days after surgery
Secondary outcomes:
measure: Incidence and severity of postoperative nausea, vomiting,and abdominal discomfort
timeFrame: Up to 7 days after surgery
measure: Incidence of postoperative complications
timeFrame: Up to 7 days after surgery
measure: Time to first regular diet
timeFrame: Up to 7 days after surgery
measure: Time to first defecation
timeFrame: Up to 7 days after surgery
measure: Postoperative analgesics requirement
timeFrame: Up to 7 days after surgery
measure: Hospital stay
timeFrame: On the day of hospital discharge, an expected average of 7 days
measure: Patients' satisfaction
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Kittipat Charoenkwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01267786: The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery
Official title: The Effect of Volatile Anesthetics Sevoflurane and Desflurane on Liver, Renal and Cardiovascular Systems During Liver Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Apoptosis
Liver Surgery
Keywords: Oxidotic stress
Lead sponsor: Aretaieio Hospital
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing liver surgery

Exclusion Criteria:

* ASA IV, Cardiovascular diseases

Primary outcomes:
measure: Oxidotic stress after hepatectomy.
timeFrame: 5 d postop.
Secondary outcomes:
measure: Liver and renal dysfunction
timeFrame: 5 d
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital
state: Attica
Study officials:
affiliation: Areataieio Hospital
name: Georgios P Fragulidis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04324086: Effect of Removal of Intracanal Medication on Post Operative Pain
Official title: Post Operative Pain After Removal of Calcium Hydroxide With Different Activation Techniques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of the Elements
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recruited patients with necrotic pulp after application of Calcium hydroxide are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

Detailed description: The investigator will recruit patients who are found eligible to the criteria, Calcium hydroxide will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.

After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

Eligibility criteria: Inclusion Criteria:

* Medically free patients.
* Patient's age between 20-50 years.
* Both sexes.
* Necrotic pulp as indicated by thermal or electric pulp testing.
* No history of previous endodontic treatment of the tooth.
* Enough crown structure for adequate isolation.

Exclusion Criteria:

* Pregnancy or lactation
* Medically compromised patients
* Previous endodontic therapy of the affected tooth.
* Teeth diagnosed with vital pulp.
* Teeth with periodontal pocket more than 3mm deep.
* Teeth with abnormal anatomy or calcified canals.
* Teeth with caries below the bony level (non-restorable tooth).
* Immature teeth with open apices.

Primary outcomes:
measure: change in post operative pain (Visual Analogue Scale)
timeFrame: Intrappointment at 4,24,48,72 and 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Oral and dental medicine, Minia University
Study officials:
References:
citation: Sadaf D, Ahmad MZ. Factors associated with postoperative pain in endodontic therapy. Int J Biomed Sci. 2014 Dec;10(4):243-7.
citation: Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
citation: Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.
Clinical trial NCT03388086: Efficacy of Two Onabotulinum Toxin Doses
Official title: Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder
Overactive Detrusor
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2018-01-02
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with Onabotulinum toxin for neurogenic detrusor overactivity as a result of spinal cord injury

Brief summary: The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.


Eligibility criteria: Inclusion Criteria:

* neurogenic detrusor overactivity
* spinal cord injury
* Onabotulinum toxin injections into the detrusor from 2000-2017

Exclusion Criteria:

* missing urodynamic values before or after Onabotulinum toxin injections

Primary outcomes:
measure: change in detrusor pressure post-injection
timeFrame: within 3 months before injection; within 2 months after injection
Secondary outcomes:
measure: maximum bladder volume
timeFrame: within 3 months before injection; within 2 months after injection
measure: bladder compliance
timeFrame: within 3 months before injection; within 2 months after injection
measure: reflexive bladder volume
timeFrame: within 3 months before injection; within 2 months after injection
measure: complications
timeFrame: within 2 months after injection
measure: presence of urinary incontinence
timeFrame: within 3 months before injection; within 2 months after injection
Other outcomes:
measure: lesion level
timeFrame: at the time of spinal cord injury
measure: lesion severity
timeFrame: at the time of spinal cord injury
measure: method of bladder evacuation
timeFrame: within 2 months after injection
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT05149222: "REACT-FM-EXT": Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia: An Extension Study
Official title: "REACT-FM-EXT": Real-World Evidence From Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia: An Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Swing Therapeutics, Inc.
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a virtual, single-arm, pragmatic, non-significant risk study.

Study participants will receive 12 weeks of Digital Acceptance and Commitment Therapy (ACT) in addition to their standard care for fibromyalgia
Primary purpose: TREATMENT

Brief summary: This is an extension study of REACT-FM. The primary objective of the study is to assess the response to digital therapy in the treatment of fibromyalgia over an additional 9 months.


Eligibility criteria: Inclusion Criteria:

* Participant has completed participation in the REACT-FM study.
* Participant has completed 41 sessions within Tempo in the REACT-FM study and is willing and able to comply with all protocol-specified requirements.
* Participant has provided informed consent to participate.
* Participant continues to meet original safety criteria for the REACT-FM study.

Exclusion Criteria:

* None

Primary outcomes:
measure: The primary efficacy endpoint is the response rate to Patient Global Impression of Change (PGIC).
timeFrame: 9 months
Secondary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
timeFrame: Enrollment to Month 9
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) symptoms domain score
timeFrame: Enrollment to Month 9
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) function domain score
timeFrame: Enrollment to Month 9
measure: Revised Fibromyalgia Impact Questionnaire (FIQ-R) impact domain score
timeFrame: Enrollment to Month 9
measure: Participant's self-reported average weekly pain score, recorded on an NRS scale
timeFrame: Enrollment to Month 9
measure: Participant's self-reported average weekly pain interference score, recorded on an NRS
timeFrame: Enrollment to Month 9
measure: Participant's self-reported weekly sleep interference score, recorded on an NRS scale
timeFrame: Enrollment to Month 9
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Swing Therapeutics
state: California
Study officials:
affiliation: Swing Therapeutics
name: Brian Keefe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04167722: How Does Prostate Cancer Metastasize? Studying the Role of Secreted Packages (Exosomes) From Fat Tissue in Lean and Obese Patients
Official title: The EXOPRO Study: How Does Prostate Cancer Metastasize? Understanding the Role of Exosomal Communication in Lean vs Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Obesity
Keywords: Prostate Cancer
Obesity
Exosomes
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Experimental Cancer Medicine Centres
First posted: 2019-11-19
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese vs lean patients

Brief summary: The investigators will be collecting prostate and fat tissue from participants undergoing radical prostatectomy to culture and study in the laboratory.

Detailed description: Both obesity and prostate cancer are major health problems in the UK, affecting 1 in 3 and 1 in 8 men respectively. Moreover, obesity increases the risk of developing aggressive disease and the risk of prostate cancer spreading. How this happens is not known. The investigators want to understand how fat cells communicate with prostate cancer cells. Investigators will be collecting prostate and fat tissue from radical prostatectomy participants for culture, in particular to look at exosome communication.

Eligibility criteria: Inclusion Criteria:

* All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

* Patients unable to consent

Primary outcomes:
measure: Determine functional differences of peri-prostatic adipose tissue from lean vs obese patients on prostate cancer cell lines
timeFrame: Through to study completion, on average 3 years
measure: Identification of exosomal small RNAs transferred between human adipose tissue to prostate cancer cells lines
timeFrame: Through to study completion, on average 3 years
measure: Assess how exosomal small RNAs from lean vs obese patients affect cancer regulation
timeFrame: Through to study completion, on average 3 years
measure: Attempt to replicate functional changes observed
timeFrame: Through to study completion, on average 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Charlotte Bevan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College Healthcare NHS Trust
name: Mathias Winkler, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690622: Effect of Topical Dexmedetomidine on Intraocular Pressure
Official title: The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Intraocular Pressure
Lead sponsor: Beirut Eye Specialist Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised control trial
Primary purpose: TREATMENT

Brief summary: Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.


Eligibility criteria: Inclusion Criteria:

* Patients with healthy eyes and no history of glaucoma

Exclusion Criteria:

* history of glaucoma, IOP \> 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery

Primary outcomes:
measure: Intraocular pressure change
timeFrame: at presentation, 30 minutes, 4 hours and 24 hours after instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Beirut Eye Specialist Hospital
Study officials:
References:
citation: Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
citation: Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
citation: Kim NY, Yoo YC, Park H, Choi YD, Kim CY, Bai SJ. The effect of dexmedetomidine on intraocular pressure increase in patients during robot-assisted laparoscopic radical prostatectomy in the steep Trendelenburg position. J Endourol. 2015 Mar;29(3):310-6. doi: 10.1089/end.2014.0381. Epub 2014 Oct 14.
citation: Zhou C, Zhu Y, Liu Z, Ruan L. The Effects of Intravenous Dexmedetomidine Injections on IOP in General Anesthesia Intubation: A Meta-Analysis. Biomed Res Int. 2017;2017:6186832. doi: 10.1155/2017/6186832. Epub 2017 Feb 2.
citation: Vartiainen J, MacDonald E, Urtti A, Rouhiainen H, Virtanen R. Dexmedetomidine-induced ocular hypotension in rabbits with normal or elevated intraocular pressures. Invest Ophthalmol Vis Sci. 1992 May;33(6):2019-23.
citation: Fakhoury H, Abdelmassih Y, El-Khoury S, Amro M, Zaarour K, Cherfan C, Tomey K, Khoueir Z. Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: A Randomized Controlled Trial. J Curr Glaucoma Pract. 2021 May-Aug;15(2):58-63. doi: 10.5005/jp-journals-10078-1310.
Clinical trial NCT02467322: To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.
Official title: To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompensated Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .


Eligibility criteria: Inclusion Criteria:

1. All Cirrhotics decompensated with ascites admitted in the hospital.
2. Grade II/III ascites
3. Need for paracentesis.

Exclusion Criteria:

1. Age \<12 or \> 75 years
2. Hepatocellular carcinoma
3. Non cirrhotic ascites such as malignancy or tubercular peritonitis
4. Serum Cr \>1.5mg%
5. Refractory septic shock
6. Grade III/IV hepatic encephalopathy
7. Abdominal wall cellulitis
8. Active variceal bleed
9. Respiratory, cardiac and renal failure
10. Refusal to participate in the study

Primary outcomes:
measure: Incidence of PICD (Paracentesis Induced Circulatory Dysfunction).
timeFrame: 1 Year
Secondary outcomes:
measure: Survival
timeFrame: 28 days
measure: Total number of patients develop Hepatorenal Syndrome.
timeFrame: 1 Year
measure: Total number of patients develop hyponatremia.
timeFrame: 1 Year
measure: Changes in plasma Renin activity.
timeFrame: 1 Year
measure: Changes in aldosterone with volume of ascitic fluid tap.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT05121922: Sense of Coherence and Empowerment at Patients With MUPS
Official title: Sense of Coherence and Empowerment at Patients With Medically Unexplained Physical Symptoms in General Practice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Medically Unexplained Symptoms
Sense of Coherence
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a study on Metacognitive therapy in general practice in Norway. The intervention is a small pilot study to examine whether Metacognitive therapy is feasible in an ordinary general practice. Will the physicians be capable to learn and provide the therapy method for their patients with MUPS and is is possible to implement this in an ordinary general practice routine? Both physicians and their patients will be asked to respond to a questionnaire on perceived utility of the treatment.

Detailed description: Metacognitive therapy is different from Cognitive therapy in the sense that it adresses the individual's attention towards potential worries and threats and also the management performed by the patient to avoid these. Also the individual's capacity to produce empowerment to manage these threats are of interest in the talks with the health care provider. - In this study, General Practitioners with specific training in Metacognitive therapy will be asked to recruit 2-3 patients with Medically Unexplained Physical Symptoms each and invite them to a series of Metacognitive Therapy. The patients and physicians will then provide their assessments of the treatment on a number of questionnaires. To explore the Sense of coherence and Empowerment among patients with Medically Unexplained Symptoms, the physicians will be asked to recruit six patients each to respond to a questionnaire.

Eligibility criteria: Inclusion Criteria:

* MUPS: Medically Unexplained Physical Symptoms
* somatic and mental examination sufficiently accomplished
* ongoing symptoms
* more than three months of disabeling symptoms

Exclusion Criteria:

* not capable to respond on a written questionnaire in Norwegian

Primary outcomes:
measure: Feasibility in daily practice
timeFrame: One year
Secondary outcomes:
measure: Effect of metacognitive therapy
timeFrame: One year
measure: Effect of metacognitive therapy
timeFrame: One year
measure: Effect of metacognitive therapy
timeFrame: One year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Jørund Straand, PhD
role: STUDY_CHAIR
References: