louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03704961: Effect of Auditory Distractions on Pediatric Postoperative Pain
Official title: Professor (Head of the Departmant of Nursing)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 3
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to determine the effect of different auditorial methods of attention distraction on postoperative pain and anxiety in children. Three group pre and post-test randomized clinical trial.The data were collected using the Socio-demographic Data Form for Child and Parent, Visual Analogue Scale, Wong-Baker Faces Pain Scale and State-Trait Anxiety Inventory for Children. The investigators found that listening to classical music, Turkish music and audiobook methods played an effective role in decreasing postoperative pain and anxiety state in children in the three groups in the study. As a result, investigators showed that different auditorial attention distraction methods had a decreasing effect on postoperative pain and anxiety in children.


Eligibility criteria: Inclusion Criteria:

* patients aged between 7-14 years old,
* staying in a single room,
* those for whom a surgical procedure for inguinal or abdominal region had been planned,
* in the first hour of postoperative period,
* free of any problem that prevents expression of the post-operative pain,
* free of hearing problems,
* having undergone same analgesia protocol; were included in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: one hour after the patients were taken to the patient's room after the surgery
measure: Wong-Baker Faces Pain Scale
timeFrame: one hour after the patients were taken to the patient's room after the surgery
measure: State-Trait Anxiety Inventory for Children
timeFrame: one hour after the patients were taken to the patient's room after the surgery
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Immediately after the listening was over
measure: Wong-Baker Faces Pain Scale
timeFrame: Immediately after the listening was over
measure: State-Trait Anxiety Inventory for Children
timeFrame: Immediately after the listening was over
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00744861: Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Official title: EXO-SPINE: A Prospective, Multi-center, Double-blind, Randomized, Placebo Controlled Pivotal Study of Ultrasound as Adjunctive Therapy for Increasing Posterolateral Fusion Success Following Single Level Posterior Instrumented Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Keywords: Lumbar Fusion
exospine
Exo-Spine
LIPUS
Exogen
Lead sponsor: Bioventus LLC
Sponsor class: INDUSTRY
First posted: 2008-09-01
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.

Detailed description: The purpose of this study is to determine whether using active low intensity pulsed ultrasound as adjunct therapy following single level posterior instrumented lumbar surgery increases the posterolateral success rate when compared to inactive (placebo) therapy.

Eligibility criteria: Inclusion Criteria:

* The subject has a documented diagnosis of degenerative disc disease with up to Grade I spondylolisthesis at the target level
* Requires spinal fusion of a single level disc space (L2 to S1) with the use of local bone graft.
* Requires a posterolateral fusion procedure with or without an interbody fusion procedure using a posterior approach
* The subject has failed non-operative treatment lasting at least 6 months.

Exclusion Criteria:

* Requires spinal fusion at more than one lumbar level.
* Is pregnant, is lactating or plans to become pregnant before discontinuation of study treatment

Primary outcomes:
measure: Number of Participants With Posterolateral Fusion Success at the Treated Level
timeFrame: 12 months post treatment start
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: William Beaumont Hospitals
name: Jeffrey Fischgrund, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01033461: Combination of Probiotic and Calcium in Healthy Adults
Official title: The Effect of the Probiotic L. Paracasei LPC 37 Alone or in Combination With a Calcium Supplement in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: probiotic
lactobacillus paracasei
calcium
faecal microbiota
cholesterol metabolism
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone or in combination with a calcium supplement of the human microbiota and further physiological parameters.

Detailed description: Animal studies suggest that calcium beneficially influence the microbiota in the gut. This effect of calcium is due to the formation of amorphous calcium phosphate, which has the ability to bind bile acids and other cytotoxic substances in the gut. The precipitation of the cytotoxic substances leads to a less aggressive environment in the gut and might be stimulate the adhesion of the microbiota.

Thirty-two healthy men and women participated in a placebo-controlled, double-blind and cross over human study. The participants were randomly divided into two groups. All probands consumed a probiotic drink for four weeks (10e+10 CFU/d). Additionally, one group consumed a pentacalcium phosphate-enriched bread (1 g Ca/d) and the other group consumed a bread without pentacalcium phosphate. After a two-week wash-out and a two-week placebo period the invention changed for another four weeks (cross over). At the end of each intervention and placebo period, subjects consumed a defined diet for three days. Furthermore, there was a three-day quantitative stool and urine collection and a fasting venous blood sample was taken.

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* blood cholesterol concentration \> 5 mmol/l

Exclusion Criteria:

* pregnancy, lactation
* intake of dietary supplements
* intake of prebiotics and probiotics
* chronic diseases

Primary outcomes:
measure: faecal microbiota, cholesterol metabolism
timeFrame: 4 weeks
Secondary outcomes:
measure: mineral status, immunological parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutrional Physiology
name: Gerhard Jahreis, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trautvetter U, Ditscheid B, Kiehntopf M, Jahreis G. A combination of calcium phosphate and probiotics beneficially influences intestinal lactobacilli and cholesterol metabolism in humans. Clin Nutr. 2012 Apr;31(2):230-7. doi: 10.1016/j.clnu.2011.09.013. Epub 2011 Oct 20.
Clinical trial NCT00657683: A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
Official title: A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Invasive Group B Streptococcus (GBS) Disease
Keywords: GBS
GBS prevention
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.


Eligibility criteria: Inclusion Criteria:

* healthy females 18 through 40 years of age;
* have provided written informed consent after the nature of the study has been explained;
* are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period);
* are in good health as determined by: medical history, physical assessment, clinical judgment of the investigator

Exclusion Criteria:

* unwilling or unable to give written informed consent to participate in the study;
* pregnant (serum pregnancy test)
* unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization
* nursing (breastfeeding) mothers

Primary outcomes:
measure: To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events.
timeFrame: 1 month
Secondary outcomes:
measure: To study the magnitude and durability of GBS-specific antibody responses over 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ligornetto
country: Switzerland
facility: Institute for Pharmacokinetic and Analytical Studies, I.P.A.S. S.A.
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT01854983: Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer
Official title: Clinical Trial to Access Significance of Fluorescence Colposcopy With Autofluorescence Imaging for the Screening of Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: fluorescence colposcopy
cervical cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
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: tertiary center

Brief summary: Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

Detailed description: 1. Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.
2. Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.
3. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.
4. After 1\~2weeks follow up the subjective at opd and confirm biopsy result.

Eligibility criteria: Inclusion Criteria:

1. age : 20-65 years
2. abnormal cervical papanicolaou smear , no other specific cervical disease
3. subject to colposcopic biopsy or LEEP
4. signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents

Exclusion Criteria:

1. pregnant women
2. porphyria
3. severe cervical bleeding
4. genital chlamydia, gonorrhea infection
5. other drug user with possible interaction (e.g. photosensitizer)
6. no informed consent

Primary outcomes:
measure: fluorescence colposcopic result
timeFrame: 2weeks after fluorescence colposcopy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jeong-Yeol Park, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05554783: Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.
Official title: Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shock
Hypovolemia
Hemodynamic Instability
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Intensive Care Unit of University Clinical Centre in Gdańsk

Brief summary: Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device.

Detailed description: It is a prospective observational study. Patients admitted to Intensive Care Unit of University Clinical Centre of Gdańsk, receiving advanced hemodynamic monitoring with PiCCO method will be enrolled. After blood pressure measurement, PiCCO will be calibrated with transpulmonary thermodilution with 10 - 20 ml of cold saline. Readings will be noted. The patient will be positioned in Trendelenburg position with it's head 15 degrees down. The increase of blood pressure after positioning in relation to the values obtained before the trial will be correlated to the parameters that asses patent's volaemia. After 5 minutes patient will be back to supine position and hemodynamic parameters will be recorded for another 5 minute.

Eligibility criteria: Inclusion Criteria:

* hemodynamic instability
* mechanical ventilation

Exclusion Criteria:

* increased intracranial pressure
* increased intraabdominal pressure
* lower limbs sequential compression system
* agitation
* patients exposed to pain stimulus before the test
* aortic aneurysm
* left to right cardiac shunt
* severe valvular insufficiency

Primary outcomes:
measure: Correlation of SVV with increase in blood pressure
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk - Department of Anesthesiology and Intensive Care
state: Pomorskie
Study officials:
affiliation: Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy
name: Jan Stefaniak, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy
name: Radosław Owczuk, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04085783: PRP in Recurrent Implantation Failure
Official title: PRP in Recurrent Implantation Failure , Hope or Hype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Implantation Failure
Keywords: Recurrent implantation failure
implantation
IVF
platelet rich plasma (PRP)
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The endometrial function and endometrial receptivity have been accepted to be major limiting factors in the establishment of pregnancy. In spite of improved almost all aspects of IVF: ovarian stimulation, embryo culture and transfer, the pregnancy rates still not satisfactory. The bottleneck is the process of implantation.

Recurrent implantation failure (RIF) is one of the nightmares in reproductive medicine and despite several strategies that have been described for management; there is no universal agreement yet.

Recently, intrauterine infusion of platelet-rich plasma (PRP) is described to promote endometrial growth and receptivity, PRP has been investigated as a therapeutic approach for several medical disorders in dermatology and rheumatology, but its use in IVF is still limited.

Objective:

To evaluate the effectiveness of intrauterine perfusion of autologous platelet-rich plasma in the improvement of pregnancy rate in RIF patients.

Detailed description: After ethical committee approval was obtained, 150 infertile women with history of RIF gave their written consent to be included in this study. All were recruited from the outpatient clinic of Al-Baraka fertility hospital - with age below 40 yrs, body mass index (BMI) below 30 kg/m2, whose uteri were morphologically normal as confirmed by HSG and U/S to limit additional factors that may affect the results of the study - Divided into 2 comparable groups; all participants underwent antagonist protocol, oocytes retrieval, fertilization and embryo transfer; In the study group, intrauterine infusion of 0.5 to 1 ml of platelet-rich plasma (PRP) was performed 48 hrs before blastocyst transfer, pregnancy tests were done 12 days after ET.

Eligibility criteria: Inclusion Criteria:

* female infertile patients with history of recurrent implantation failure
* age below 40 yrs.,
* body mass index (BMI) below 30 kg/m2.

Exclusion Criteria:

* haematological and immunological disorders
* hormonal disorders,
* chromosomal and genetic abnormalities and uterine abnormalities (acquired or congenital) as confirmed by HSG and U/S to limit additional factors that may affect the results of the study

Primary outcomes:
measure: Number of Participants with positive pregnancy test
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Al-BARAKA FERTILITY HOSPITAL
state: Adliya
Study officials:
References:
Clinical trial NCT02618083: Prognostic Value of Hemodynamic Disturbances in Rhegmatogenous Retinal Detachment (CRADO-RED)
Official title: Prognostic Value of Hemodynamic Disturbances of the Central Retinal Artery in Color Doppler Ultrasound in Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinal Detachment
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-12-01
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Retinal detachments correspond to a separation of the neuroepithelium from the pigment epithelium. They can be exudative (sometimes in conjunction with a tumor), tractional, traumatic (postoperative) or rhegmatogenous (in relation to a tear).

Ultrasound, requested when the fundus is difficult to achieve and shows a hyperechoic mobile membrane. It can also measure the hemodynamic parameters of retinal arteries.

A preliminary study showed a correlation between systolic velocity in the central retinal artery and postoperative visual acuity.

The aim of this study is to confirm those preliminary data.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* rhegmatogenous retinal detachment, relapsing or not, including pseudophakic retinal detachment or aphakic retinal detachment, if the retinal detachment occurs more than three months after phacoemulsification

Exclusion Criteria:

* traumatic retinal detachment
* bilateral retinal detachment
* less than 3 months after phakoemulsification
* predictable follow-up of less than 6 months
* patient under of legal protection
* patient's opposition to participate
* absence of affiliation to the social security
* eye's axial length\> 25.5 mm
* preoperative visual acuity greater than 70/100
* no surgery

Primary outcomes:
measure: Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth week of follow-up
timeFrame: Six weeks
Secondary outcomes:
measure: Visual acuity measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale before surgery and at the sixth :month of follow-up
timeFrame: Six months
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT00431483: Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
Official title: Clinical and Economic Impact of Interventions by a Clinical Pharmacist on Antibiotic Use on Surgical Wards
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infections
Keywords: antibacterial agents
surgery
pharmacist
economics, pharmaceutical
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2007-02-05
Enrollment: 779
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to establish the impact of a pharmacist's recommendations regarding choice, dosing and duration of antibiotic therapy on quality and cost of antibiotic treatment on surgical wards.

Detailed description: Inappropriate or incorrect use of antibacterials exerts selection pressure on pathogens potentiating emergence of resistance, puts patients at risk for unnecessary adverse drug reactions and potentially prolongs the length of stay in hospital thus increasing healthcare costs.

In an effort to improve the quality of antibiotic drug therapy on surgical wards of a large university hospital, specific consulting by a clinical pharmacist was established.

The objective of this study is to assess the impact of pharmaceutical consulting on the quality and costs of antibiotic use in surgical wards.

Comparison:

Within a control period the current pattern of antibiotic use is monitored. During the intervention period, the impact of the interventions made by the clinical pharmacist on antibiotic use is examined. One ward serves as a parallel control group; no intervention is being made on this ward throughout this study.

Eligibility criteria: Inclusion Criteria:

* female and male patients receiving antibiotics for a proven or suspected infection on designated surgical wards

Exclusion Criteria:

* patients under 18
* patients unable or unwilling to consent to their data being evaluated
* patients receiving antibiotics perioperatively as prophylaxis
* patients receiving antibiotics for less than 48hrs

Primary outcomes:
measure: overall duration of antibiotic therapy during study period
timeFrame: Feb 2008
Secondary outcomes:
measure: iv to oral switch
timeFrame: Feb 2008
measure: compliance of treatment with hospital formulary for antibiotic therapy
timeFrame: Feb 2008
measure: cost of antibiotic therapy
timeFrame: Feb 2008
measure: number and duration of therapy with antibiotics with redundant spectra
timeFrame: Feb 2008
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Luwig Maximilians University - Klinikum Grosshadern
state: Bavaria
Study officials:
affiliation: Klinikum Grosshadern
name: Karl-Walter Jauch, Prof. Dr.
role: STUDY_DIRECTOR
References: