louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03950726: Ileocolic Resection for Complex Crohn's Disease
Official title: Minimally Invasive Open Technique for Ileo-colic Resection in Complex Cases of Terminal Ileum Crohn's Disease. Case Series.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease of Ileum
Keywords: Crohn Disease
Ileocolic resection
Appendectomy
Single-port incision
McBurney
Laparoscopy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with complex terminal ileum Crohn's disease candidate for ileocolic resection who underwent to previous open appendectomy.

Brief summary: Laparoscopic ileocolic resection is the preferred surgical approach for patients with ileocecal Crohn's disease (CD). Objective of this study was to evaluate the efficacy of a minimally invasive gas-less ileocolic resection in complex cases of CD through a Mc Burney incision, in patients who already had a previous appendectomy.

Detailed description: From January 2016 to December 2017, all consecutive CD patients with primary or recurrent complex disease referred for IC resection were evaluated for the study purpose.Complex disease patients presenting McBurney incision for a previous open appendectomy were included in the group of study. This group was compared with a control group of CD patients with the same clinical characteristics of ileocolic disease who underwent standard laparoscopic IC resection, pooled out from the database of IC resections for CD of the Minimally Invasive and Gastrointestinal Surgery Unit of Tor Vergata Hospital, Rome, Italy. Data on demographics, BMI, type and behavior of CD, presence of disease apart from ileocecal site, previous surgery, recurrence, current medical treatment, thickening of the mesentery, preoperative imaging results (MR enterography or small intestine contrast ultrasound), operative time, blood loss, conversion to laparoscopy and conversion to open rates, complications, adherence rate to ERAS protocols and length of hospital stay were collected for the study purpose.

Eligibility criteria: Inclusion Criteria:

* diagnosed Crohn's disease
* previous appendectomy trough a mcburney incision

Exclusion Criteria:

* patients with major comorbidities
* age\>75
* previous midline laparotomy

Primary outcomes:
measure: Mean operative time
timeFrame: 75-156 minutes
measure: Mean blood loss during surgical procedure
timeFrame: 2 hours
measure: Mean post-operative hospital stay
timeFrame: 3-7 days
Secondary outcomes:
measure: post-operative complications
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01064726: A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
Official title: A Double Blind (3rd Party Open), 3-Way Crossover Study To Explore The Reproducibility Of Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis (Out Of Season) And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects with seasonal allergic rhinitis (out of season).
* Sensitive to ragweed skin prick test and screening nasal allergen challenge.

Exclusion Criteria:

* Subjects with significant concomitant diseases.
* Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening.
* Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.

Primary outcomes:
measure: Nasal inflammatory markers
timeFrame: 8h 45 min post dose
measure: Acoustic rhinometry
timeFrame: 8h 45 min post dose
measure: Nasal symptom scores
timeFrame: 8h 45 min post dose
Secondary outcomes:
measure: Spirometry
timeFrame: 8h 45 min post dose
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03823326: Paediatric Oximetry Algorithms - Normative Data Collection
Official title: Paediatric Oximetry Algorithms - Normative Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes in Children
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children aged 1 month - 16 years who are undergoing an overnight pulse oximetry investigation.

Brief summary: To undertake normative data collection of existing clinical algorithms using existing oximetry technology.

Detailed description: Paediatric patients who are undergoing routine diagnostic pulse oximetry, will be approached to also wear an additional oximeter at the same time so that comparisons between two oximeters and their clinical algorithms can be compared.

Eligibility criteria: Inclusion Criteria:

* All children who have been referred for a clinical overnight pulse oximetry test

Exclusion Criteria:

* Families who do not understand written English if an interpreter is not present for clinical reasons
* Times when the kit is already being used for another recruit
* If children do not attend with the legal guardian and so informed consent cannot be signed
* Patient is deemed too unwell by clinical team to be approached about the research

Primary outcomes:
measure: Oximetry Raw data
timeFrame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection.
measure: Pulse Rate Raw data
timeFrame: Overnight (8-10 hours) of pulse oximetry data is collected from participants and then they have completed the study. It is a single time frame of data collection
Secondary outcomes:
Other outcomes:
measure: Age
timeFrame: Taken at time of consent
measure: Gender
timeFrame: Taken at time of consent
Locations:
city: Sheffield
country: United Kingdom
facility: Clinical Research Facility
state: South Yorkshire
Study officials:
affiliation: Sheffield Children's Hospital
name: Heather E Elphick, MbChBMDMRCPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05606926: Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
Official title: Effect of Whole Body Vibration With Weighted Vest on Motor Function in Children With Spastic Diplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
balance
muscle strength
spastic diplegia
HUMAC balance system
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Whole body vibration has been widely used in rehabilitation of individuals with disabilities as well as children with cerebral palsy. Previous studies have demonstrated the efficacy of Whole body vibration on balance, gross motor function, spasticity and bone density in children with cerebral palsy. However, adding extra weight during Whole body vibration for children with cerebral palsy as a means of enhancing the potential effects of Whole body vibration is unknown. Therefore, the aim of this study is to examine the effect of Whole body vibration with weighted vest on trunk control, balance and gross motor function in children with spastic diplegia.


Eligibility criteria: Inclusion Criteria:

* Their age will range from 8-12 years, from both sexes.
* Level II and III of gross motor functional classification system
* Grade 1 and 1+ spasticity according to the Modified Ashworth Scale
* Ability to understand and follow simple verbal instruc

Exclusion Criteria:

* Uncontrolled epilepsy.
* Mental retardation or autistic features.
* Medication changes that could affect muscle strength or tone
* Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination),
* Structural or fixed soft tissue deformities of the lower and/or upper extremities.
* Neurological or orthopedic surgery in the past 12 months in the lower and/or upper extremities.
* Botox injection in the lower and/or upper extremities in the past 6 months.

Primary outcomes:
measure: Trunk control
timeFrame: three months
measure: Gross motor function
timeFrame: three months
measure: balance
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo university, faculty of physical therapy
name: HOSAM A ALMOHANDES, B.S.C
role: STUDY_DIRECTOR
affiliation: Cairo university, faculty of physical therapy
name: Nahla M Ibrahim, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT06282757: Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP
Official title: The Effect of Physiotherapists' Placebo or Nocebo Communication About Virtual Reality on Treatment Beliefs in Patients With CMP
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Communication
Chronic Pain
Lead sponsor: HAN University of Applied Sciences
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP

Study design: Web-based randomized controlled trial.

Study population: 100 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).


Eligibility criteria: Inclusion Criteria:

* aged ≥ 18
* access to the internet
* provide informed consent
* suffers from CMP

Exclusion Criteria:

* lacked comprehension of the Dutch language
* had experience with therapeutic VR

Primary outcomes:
measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediately after the intervention
measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Change in openness to VR measured using a single question
timeFrame: Baseline and immediately after the intervention
measure: Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline and immediately after the intervention
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: HAN University of Applied Sciences
state: Overijssel
Study officials:
affiliation: HAN University of Applied Sciences
name: Bart Staal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811757: Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps
Official title: Clinical Outcomes After Arthroscopic Tenotomy or Tenodesis of the Long Head of the Biceps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroscopic Rotator Cuff
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 100
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: Degenerative changes of the long head of the biceps brachii (LHB) are frequent and often associated with cuff tendinopathy. The function of the LHB in the shoulder is still controversial and uncertain, whereas its function in the elbow is certain. The biceps brachii is a flexor of the elbow and supinator of the forearm. Suppression of the pathologic long head of the biceps permits pain relief and is very reliable in the literature. Two options are available for the remaining tendon : simple tenotomy or tenodesis which consists to reattach the tendon to the humerus. Our hypothesis is that there is no difference in strength or endurance of the biceps brachii after tenotomy or tenodesis of the LHB. The aim of this study was to compare the strength and the endurance of the biceps brachii during supination and flexion after tenotomy or tenodesis of the LHB.

the investigators proposed a prospective and randomized study. All the patients treated in our department for an arthroscopic rotator cuff repair were included in this study after signed consent. Participants will complete isokinetic strength and endurance testing for elbow flexion and supination on the operative and nonoperative sides a minimum of 1 year after biceps tenotomy or tenodesis. The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and SSV at 6 weeks, 3 months, 6 months and one year.


Eligibility criteria: Inclusion Criteria:

* surgery tenotomy or tenodesis type of the long head of the biceps (broken tendinopathy or not rotator cuff escaping a well conducted medical treatment and under a repair or cap pathology of the long head of the biceps during the arthroscopy)
* Patients treated in the orthopedic service of the Reims University Hospital
* Patients agreeing to participate in the research and who signed the informed consent
* Major patients.

Exclusion Criteria:

* prior Shoulder Surgery
* surgery scheduled contralateral shoulder
* patient protected by law

Primary outcomes:
measure: Max Peak Torque supination
timeFrame: 1 year
measure: Max peak Torque Flexion
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Chu Reims
state: Reims
Study officials:
References:
Clinical trial NCT05842057: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
Official title: Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Erectile Dysfunction Following Radical Prostatectomy
Keywords: Prostatectomy
Allograft Membrane
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2023-05-03
Enrollment: 240
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.


Eligibility criteria: Inclusion Criteria:

1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).

Exclusion Criteria:

1. Men requiring any use of pads for urinary leakage.
2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
3. Men with baseline EPIC26 scores \< 60.
4. Previous treatment for prostate cancer.
5. Previous history of pelvic radiation.
6. Patients with impaired decision-making capacity.

Primary outcomes:
measure: Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score
timeFrame: Baseline, 12 Months Post-RARP
Secondary outcomes:
measure: Change in Erectile Function Recovery as Measured by SHIM Score
timeFrame: Baseline, 12 Months Post-RARP
measure: Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
measure: Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
measure: Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
measure: Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
measure: Change in Rate of Urinary Control
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
measure: Change in Biochemical Failure
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
measure: Number of Treatment-Related Adverse Events
timeFrame: Up to 12 months post-RARP
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sanoj Punnen, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772057: Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
Official title: Early Primary Prophylaxis With Beta-Blockers In Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2008-10-15
Enrollment: 164
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background and Aims: The efficacy of portal pressure reduction by beta blockers for the management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The present randomized controlled trial aims to address these issues. The investigators also assessed the utility of serial HVPG measurements in these patients.

Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history of variceal bleed, were randomized to receive propranolol or placebo. These patients were further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement. Propranolol was titrated to reduce heart-rate to 55/min.


Eligibility criteria: Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis was made
* Age was between 18 and 70 years
* Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al).

Exclusion Criteria:

* Presence of previous variceal bleeding
* Previous medical, surgical or endoscopic treatment for portal hypertension
* Child-Pugh score \>13
* Neoplastic disease of any site
* Splenic or portal vein thrombosis
* Concurrent illnesses expected to decrease life expectancy to less than one year
* Pregnancy
* Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate \<50 beats per minute, arterial hypotension with systolic blood pressure \<90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment)
* Concurrent anti-viral treatment during the study period
* Inability to perform follow-up
* Failure to give consent to participate in the study.

Primary outcomes:
measure: The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)
timeFrame: 24 months
Secondary outcomes:
measure: Secondary endpoints were variceal bleeding, death, adverse effects of beta blockers, and hemodynamic response to beta-blocker in patients who underwent serial HVPG
timeFrame: 24 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology, G B Pant Hospital
state: Delhi
Study officials:
affiliation: G B Pant Hospital
name: Shiv K Sarin, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883857: Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume
Official title: Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Cardiac Surgery
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 49
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: Patients scheduled for cardiac surgery

Brief summary: The purpose of this study is to evaluate a new monitor that measures cardiac output (amount of blood pumped by the heart). The system that is being tested in this study, called Endotracheal Cardiac Output Monitor (ECOM), uses electricity (impedance cardiography) to measure cardiac output and is not harmful to the patient.

This study will test the accuracy and efficacy of the ECOM system in anesthetized and sedated patients who, in the normal course of clinical care in the OR or ICU, are having cardiac output measured. The investigators propose that unlike the standard system for cardiac output measurement, the ConMed ECOM System should result in a simplified, inexpensive, continuous, less-invasive, and accurate method of measuring cardiac output. Such a technique could allow the rapid diagnosis of instability in the cardiovascular system for critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Able to give informed consent
* Patients requiring all of the following:

  * an oral ET tube
  * an arterial catheter
  * measurement of CO

Exclusion Criteria:

* Patients not competent to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Aman Mahajan, MD, PhD
role: STUDY_DIRECTOR
References: