louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06174584: Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children
Official title: Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Rectal Prolapse
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children

Detailed description: Sclerotherapy is the least invasive procedure used in management of grade I/II rectal prolapse, with a success rate of around 80%, and generally considered as the first choice for uncomplicated and recurrent prolapse. Several sclerosing agents such as 15% hypertonic saline, 5% Phenol in almond oil and cow milk have been used and reported in the literature. Present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in the management of children with grade I/II rectal prolapse.

All the details will be entered on the proforma which will include resolvement of rectal prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal stenosis.

Eligibility criteria: Inclusion Criteria:

* All children with Grade I and II rectal prolapse
* Age \<12 years
* Both genders

Exclusion Criteria:

* Rectal prolapse secondary to causes like ulcerative colitis and crohn's disease
* Past surgical history on the pelvic floor,
* Neurological diseases like rectal polyps, congenital megacolon, Hirschsprung disease, sacrococcygeal teratoma, neural tube defects, cauda equina syndrome
* Where parents are not willing to participate in the study

Primary outcomes:
measure: recurrence (as described by parent s during follow up)
timeFrame: 1 year
measure: Number of participants with fecal incontinence (as described by parents during follow up)
timeFrame: 1 year
measure: Number of participants with anal stenosis (on clinical examination)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University/PIMS
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Mansoor Ahmed, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708084: Randomized Phase II Trial on Safety and Neutralizing Activity of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin (HRIG) and Rabies Vaccine in Children and Adolescents
Official title: A Single-blind, Randomized, Monocentric Phase II Trial to Explore the Safety and Rabies-neutralizing Activity of Combined Administration of CL184 and Rabies Vaccine Versus Human Rabies Immune Globulin Plus Rabies Vaccine in Simulated Rabies Post-exposure Prophylaxis in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rabies
Keywords: Rabies post-exposure prophylaxis
Monoclonal antibody
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) in combination with rabies vaccine in healthy children and adolescents.


Eligibility criteria: Inclusion Criteria:

* Subjects free of obvious health-problems or with stable conditions
* Male or female subject aged ≥5 to ≤18 years
* Subject is living, studying, or working close to the study referral site
* Parent or legal representative signed written informed consent; in addition for subjects ≥12 years: signed assent form

Exclusion Criteria:

* Prior history of rabies exposure or immunization (rabies vaccine and/or immune globulin)
* Acute infection or disease within the last 2 weeks
* History and/or family history of clinically significant immunodeficiency or auto-immune disease
* Any history of known or suspected anaphylaxis or hypersensitivity reaction
* Planned immunization with live vaccines during the next 3 months
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Primary outcomes:
measure: Safety and tolerability
timeFrame: 42 days
Secondary outcomes:
measure: Rabies virus neutralizing activity
timeFrame: 42 days
Other outcomes:
Locations:
city: Alabang, Muntinlupa, Metro Manila
country: Philippines
facility: Research Institute for Tropical Medicine
Study officials:
affiliation: Research Institute for Tropical Medicine, Alabang, Muntinlupa, Metro Manila, Philippines
name: Beatriz P. Quiambao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871984: Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis
Official title: Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Stone
Ureteral Stone
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-05-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled for ureteroscopy on renal or ureteral stones, which have been previously confirmed by tomography

Brief summary: Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.

The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.

The costs and complications will also be studied.


Eligibility criteria: Inclusion Criteria:

* renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
* treatment with rigid or flexible ureteroscopy
* laser lithotripsy during the procedure
* bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)

Exclusion Criteria:

* non-use of laser for stone lithotripsy
* pregnant women
* under 18 years old
* refusal to give informed consent
* urinary malformation

Primary outcomes:
measure: Stone free rate
timeFrame: Three months after surgery
Secondary outcomes:
measure: Perioperative complications
timeFrame: During the intervention
measure: Operating time
timeFrame: Immediately after the intervention
measure: Postoperative complications
timeFrame: Up to three months after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Panthier F, Doizi S, Corrales M, Traxer O. Pulsed lasers and endocorporeal laser lithotripsy. Prog Urol. 2021 Jun-Jul;31(8-9):451-457. doi: 10.1016/j.purol.2020.11.008. Epub 2021 Jan 28.
citation: Martov AG, Ergakov DV, Guseinov MA, Andronov AS, Dutov SV, Vinnichenko VA, Kovalenko AA. [Initial experience in clinical application of thulium laser contact lithotripsy for transurethral treatment of urolithiasis]. Urologiia. 2018 Mar;(1):112-120. Russian.
citation: Rapoport LM, Vinarov AZ, Sorokin NI, Dymov AM, Enikeev DV, Tsarichenko DG, Lekarev VY, Klimov RE, Andreeva VA, Kovalenko AA. [Experimental verification of thulium lithotripsy]. Urologiia. 2018 Dec;(5):74-80. Russian.
Clinical trial NCT03750084: Anaesthesia and mHealth
Official title: Anaesthesia and mHealth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Cell Phone
Mobile Applications
Keywords: Anesthesia
Cell Phone
Mobile Applications
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Active diploma-holding Anesthesiologists working in Belgium

Brief summary: This survey aims to better define the wishes/needs of the Belgian Anaesthesiologists within the field of mobile technology, namely, what would help improve the daily anaesthesia practice.

Detailed description: This study consists of a simple online survey that takes approximately 3 minutes to complete.

The study aims to assess the confidence of the belgian anaesthesiologists on smartphone applications and dedicated smartphone peripherals, on how these can be used in daily practice, as well as what their wishes for further developments are.

Eligibility criteria: Inclusion Criteria:

* Active diploma-holding Anesthesiologist working in Belgium

Exclusion Criteria:

* None

Primary outcomes:
measure: Questionnaire about the Confidence (scale 0-5) on Mobile Apps and Peripheral Devices in Anesthesiology
timeFrame: One single time-point assessment (time of filling in the questionnaire) during 3 months (time during which the filling-in of the questionnaire is possible)
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Hugo Carvalho, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Carvalho H, Verdonck M, Forget P, Poelaert J. Acceptance of mHealth among health professionals: a case study on anesthesia practitioners. BMC Anesthesiol. 2020 Mar 3;20(1):55. doi: 10.1186/s12871-020-00958-3.
Clinical trial NCT00810784: Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients
Official title: Evaluation of Venous Thromboembolism (VTE) Prophylaxis in Medically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: Venous Thromboembolism
Prevention
Quality Improvement
Education
Compliance with VTE prophylaxis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-12-18
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data was collected on consecutive patients ≥18 years with a hospital length of stay of \>48 hours admitted to the cardiology, pulmonary, or general medical services. Admission dates were a sample of two different two-week blocks (January 1-14, 2006 and April 1-14, 2006). These blocks were chosen to be consistent with dates of analysis in the pre-intervention cohort. Patients receiving therapeutic anticoagulation were excluded.

Brief summary: VTE prophylaxis is not as routinely employed in medically ill patients as compared to surgical patients. This retrospective chart review project will evaluate the effectiveness of VTE prophylaxis in medically ill patients at the University of Utah Hospitals and Clinics compared to current literature. The study will ultimately serve as a quality improvement project to help improve patient care.


Eligibility criteria: Inclusion Criteria:

* Hospitalized at the University of Utah on one our medical services.

Exclusion Criteria:

* Patients received therapeutic anticoagulation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Matthew Rondina, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stinnett JM, Pendleton R, Skordos L, Wheeler M, Rodgers GM. Venous thromboembolism prophylaxis in medically ill patients and the development of strategies to improve prophylaxis rates. Am J Hematol. 2005 Mar;78(3):167-72. doi: 10.1002/ajh.20281.
Clinical trial NCT03397784: IVC Variation After VT Challenge to Predict Fluid Responsiveness
Official title: Can Respiratory Variation in Inferior Vena Cava Diameter After Tidal Volume Challenge Predict Fluid Responsiveness in Cardiac Surgical Patients With Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Fluid Challenge
Fluid Responsiveness
Mechanical Ventilation
Keywords: Tidal volume challenge
Fluid responsiveness
Preload responsiveness
Functional hemodynamic monitoring
Cardiac surgery
inferior vena cava variation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after cardiac surgery

Brief summary: The purpose of the study was to evaluate the efficacy of using the respiratory variation in inferior vena cava diameters as an index of fluid responsiveness after tidal volume challenge in mechanically ventilated patients after cardiac surgery.

Detailed description: The "tidal volume challenge" is a novel test to predict fluid responsiveness in patents in shock, ventilated using low tidal volume without spontaneous breathing activity. The test involves transiently increasing tidal volume from 8 ml/kg PBW to 12 ml/kg PBW for one minute and observing the change in PPV or SVV. The aim of this study was to evaluate whether the respiratory variation in inferior vena cava diameter after tidal volume challenge can predict fluid responsiveness in cardiac surgical patients with mechanical ventilation

Eligibility criteria: Inclusion Criteria:

* acute circulatory failure (low blood pressure or urine output, tachycardia, or mottling)
* clinical signs of organ hypoperfusion (renal dysfunction or hyperlactatemia)

Exclusion Criteria:

* a contraindication to elevation of tidal volume
* evidence of cardiac arrhythmia
* left ventricular ejection fraction less than 50%
* echocardiographic examination that showed the existence of severe tricuspid or mitral regurgitation or right heart dysfunction
* intracardiac shunt
* pulmonary hypertension
* severe chronic obstructive pulmonary disease
* a contraindication to the passive leg raising (PLR) test
* air leakage through chest drains
* abdominal compartment syndrome
* portal hypertension
* pregnancy
* inability to perform ultrasonography

Primary outcomes:
measure: fluid responsiveness
timeFrame: after fluid challenge (30min)
Secondary outcomes:
measure: inferior vena cava variation
timeFrame: After tidal volume challenge (1 minute) and fluid challenge (30 minute)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
affiliation: Fudan University
name: Tu Guo-wei, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786679: Non-operative Treatment in Sweden of Proximal Humeral Fractures
Official title: Non-operative Treatment in Sweden of Proximal Humeral Fratures, a Randomised Multicenter Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Proximal Humeral Fracture
Keywords: Non-operative treatment, orthosis, healing, rehabilitation
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2018-12-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: Proximal humeral fractures are common especially in the elderly population. The majority of these fractures are minimally displaced and may be treated non-operatively. There is however a controversy about which fractures that need surgery and randomised trials have not been able to show a clinically important advantage in patient reported outcome measures for those operated. The trend is therefore that also displaced and comminute fractures are treated non-operatively. There is however very little scientific support for how the non-operative treatment should be designed and performed. Therefore this prospective multicenter study is aiming at investigating the benefit of a four week immobilisation orthosis as compared to early range of motion exercises for those patients not assigned for surgery one week after the trauma.


Eligibility criteria: Inclusion Criteria:

* A proximal humeral fracture verified on radiology no older than 7-10 days.

Exclusion Criteria:

* Surgically treated proximal humeral fracture
* Fracture only involving the greater tuberosity
* Previous surgery in the fractured shoulder
* Ongoing malignancy in the fractured shoulder
* Neurologic disease
* Radiating pain from the neck in the affected arm
* Associated vascular or nerve injuries
* Dementia
* Alcohol abuse
* Unwilling to participate in the trial

Primary outcomes:
measure: Union of fracture
timeFrame: Followed 12 months
Secondary outcomes:
measure: Oxford shoulder score
timeFrame: 12 months
measure: Numerical pain reporting scale
timeFrame: 12 months
measure: Quick DASH
timeFrame: 12 months
measure: Global assessment of improvement
timeFrame: 12 months
measure: Shoulder range of motion
timeFrame: 12 months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Lars Adolfsson
Study officials:
affiliation: Linkoeping University
name: Lars E Adolfsson, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Linkoeping University
name: Hanna C Björnsson Hallgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT00261079: Fexofenadine in Pruritic Skin Disease
Official title: The Evaluation of Efficacy and Safety of Fexofenadine 180mg Tablets for 7 Days in the Treatment of Pruritic Skin Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pruritus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-02
Enrollment: 435
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

* To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease

Secondary objective:

* To evaluate patient's satisfaction of Allegra treatment


Eligibility criteria: The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* All patients diagnosed with atopic dermatitis, contact dermatitis

Exclusion Criteria:

* Other skin disease except atopic dermatitis, contact dermatitis.
* Subjects taken steroid within 4 weeks and antihistamine within 1 week before screening day.
* Pruritus localized only head and face
* Subjects with severe hepatic, renal, heart dysfunction.
* Subjects with history of alcohol and drug abuse.
* Pregnant and lactating women.

Primary outcomes:
measure: The change of physician's assessment on pruritic score before and after 7-day treatment.
Secondary outcomes:
measure: Patient visual analogue scale change and Overall satisfaction.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Handok
Study officials:
affiliation: Handok Inc.
name: Hyou-Young Rhim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06189079: Arterial Embolization for the Treatment of Bone Metastases: Prospective Observational Study
Official title: Embolizzazione Arteriosa Per il Trattamento Delle Metastasi Ossee: Studio Osservazionale Prospettico
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Metastases
Keywords: Arterial embolization
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent arterial embolization in the treatment of bone metastases

Brief summary: To date, arterial embolization constitutes one of the most popular methods in minimally invasive treatment of bone metastases, allowing good results in terms of pain reduction, local control of disease and reduction of peri-operative bleeding, with low invasiveness.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex of age or older who are candidates for embolization therapy
* Life expectancy \> 3 months
* Single metastatic or oligometastatic.
* Plurimetastatic if a particular site is causing painful symptoms or at risk for pathologic rupture

Exclusion Criteria:

* Patients with life expectancy \<3 months or severe functional status impairment (ASA 4)
* Patients with hypovascular metastasis documented by angiography or MRI perfusion study with MDC.
* Patients with coagulation deficiency or plateletopenic patients.
* Patients with documented active infection.

Primary outcomes:
measure: Reduction of pain (VAS score)
timeFrame: 1 year
measure: Improvement in quality of life (EORTC QLQ - BM22)
timeFrame: 1 year
measure: Improvement in quality of life (EORTC QLQ-C15-PAL questionnaire)
timeFrame: 1 year
Secondary outcomes:
measure: Volume reduction in cm
timeFrame: 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: Emilia Romagna
Study officials:
References: