louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00757445: Treatment Results on Patients With Debridement and Prosthesis Retention in the Hip
Official title: Treatment Results on Patients With Debridement and Prosthesis Retention in the Hip 1997-2007
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Debridement With Prosthesis Retention
Keywords: Antibiotic therapy
Microbiological diagnosis
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2008-09-23
Enrollment: 105
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with prosthesis infection in hip

Brief summary: This study presents the investigators results on patients treated for infection in the implemented hip prosthesis. Debridement and prosthesis retention is the method, followed by antibiotic treatment. The investigators present treatment results, predisposing factors and microbiological data.


Eligibility criteria: Inclusion Criteria:

* Infection in prothesis in hip treated with debridement and prosthesis retention

Exclusion Criteria:

* Other technique

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF
state: Agder
Study officials:
affiliation: Sorlandet Hospital HF
name: Bjoern Waagsboe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210145: Socio-aesthetic Intervention on Body Image and Quality of Life in Women With Breast Cancer.
Official title: Impact of a Socio-aesthetic Intervention on Body Image and Quality of Life in Patients With Mastectomy or Tumorectomy for Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Aesthetic care,
Mastectomy,
Breast cancer,
Quality of life,
Body image,
Psychological adjustment
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer

Brief summary: The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast cancer.Two groups of randomized subjects were constituted. Patients of the experimental group received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the control group not. Body image, quality of life and diverse other personality variables were assessed at three different times: surgical operation day before, exit day before of hospitalization and three months afterwards. Our general hypothesis is that subjects who receive aesthetic care report levels significantly higher of corporal satisfaction and of quality of life at the end of the hospitalization and three months later than patients of the control group.


Eligibility criteria: Inclusion criteria:

First diagnosis of cancer and first surgical treatment for cancer Diagnosis of breast cancer

Exclusion criteria:

Psychiatric antecedents Inclusion in another psychosocial research

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Study officials:
affiliation: Institut Bergonié
name: Fabrice LAKDJA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03638245: Evaluation of the Fetal MPI in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome.
Official title: Evaluation of the Fetal Myocardial Performance Index in Abnormal Cardiotocography Cases in 3rd Trimester of Pregnancy and Fetal Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echocardiography
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 148
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women in 3rd trimester attending for CTG

Brief summary: The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

Detailed description: The study will focus in evaluation of fetal cardiac function by using myocardial performance index in fetuses with abnormal cardiotocography in 3rd trimester.

Study Hypothesis:

In women with non reassuring fetal cardiotocography, myocardial performance index may predict fetal distress accurately.

Study Question:

In pregnant women in the third trimester with abnormal cardiotocography, Does myocardial performance index predict fetal distress accurately?

Study Objectives:

This study aims to assess the accuracy of myocardial performance index in predicting fetal distress in pregnant women with non reassuring cardiotocography in third trimester.

Eligibility criteria: Inclusion Criteria:

1. Women between 30-40 weeks gestational age.
2. Women pregnant in singleton fetus.

Exclusion Criteria:

1. Multiple pregnancies.
2. Fetal congenital malformation.

Primary outcomes:
measure: Evaluation of the Fetal Myocardial Performance Index.
timeFrame: 3rd Trimester CTG, immediately followed by Fetal Echocardiography at the same set
Secondary outcomes:
measure: Neonatal outcome observation
timeFrame: Immediately postnatal (first five minutes after delivery)
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Mohamed H Nasr El din, MD
role: STUDY_CHAIR
affiliation: Assistant Professor
name: Amr MA El Helaly, MD
role: STUDY_DIRECTOR
affiliation: Lecturer
name: Noha AA Sakna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03783845: The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients
Official title: The Effects of Non -Surgical Periodontal Therapy on Glycemic Control and Periodontal Health in Diabetic Patients With Periodontitis (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis, Generalized
Lead sponsor: Taibah University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?

Detailed description: The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.

Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group

Eligibility criteria: Inclusion Criteria:

Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis

Exclusion Criteria:

Pregnancy

* Alcoholism and smoking
* Presence of any systemic disorders other than hypertension and diabetes
* Diabetic major complications

Primary outcomes:
measure: glycosylated haemoglobin (HbA1c)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05999045: Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)
Official title: Investigation of the Validity And Reliability of the Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voice Fatigue
Keywords: Singing voice
Professional voice users
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who sings in a professional or unprofessional choir

Brief summary: The aim of the study is to translate and culturally adapt the Turkish version of the EASE (EASE-TR) scale and investigate its validity and reliability.

Detailed description: The study consists of two phases. In the first phase of the study, the scale will be translated and culturally adapted into Turkish. The second phase involves assessing participants and validating the translated scale. In this phase, participants will complete the EASE-TR and the severity part of the Vocal Tract Discomfort Scale (VTDS) before and after a 1-hour performance. One hundred choir member between the ages of 18 and 65 will be included in the study.

Both construct and criterion validity procedures will be used.Within the scope of construct validity, the "Known Groups Validity" method will be used based on variables such as experience duration, vocal training status, and the presence or absence of current vocal complaints. A comparison of pre- and post-performance EASE-TR scores will be conducted. Regarding criterion validity, the correlation between EASE scores and the severity part of the VTDS will be examined. For reliability, Cronbach's alpha and test-retest reliability will be calculated. The questionnaire will be administered a second time to 30 participants after 14 days in order to measure test-retest reliability.

Eligibility criteria: Inclusion Criteria:

* Having Turkish as mother tongue
* Singing in choir at least 6 months
* Performing at least for an hour

Exclusion Criteria:

* Having previously received voice therapy or undergone voice surgery
* Having a systematic/or neurological disorder that may affect voice quality

Primary outcomes:
measure: Change in Evaluation of the Ability to Sing Easily (EASE) Turkish Version score
timeFrame: 1-hour singing activity
Secondary outcomes:
measure: Vocal Tract Discomfort Scale (VTDS)
timeFrame: 1-hour singing activity
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT04697745: Dexamethasone and Dexmedetomidine as an Adjuvant to Spinal Anesthesia for Elective Caesarean Sections
Official title: Comparison Between Analgesic Effect of Dexamethasone and Dexmedetomidine as an Adjuvant to Bupivacaine for Spinal Anesthesia for Elective Caesarean Sections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
* Elective cesarean section under spinal anaesthesia
* Gestational age \> 37 weeks
* BMI less than 30 kg/m2

Exclusion Criteria:

* Patient refusal
* unable to give consent
* age \< 18 or \> 40
* BMI more than 30 kg/m2
* known allergy to the study medication
* coagulopathies or on anticoagulant medications
* diabetic neuropathy
* patients with psychiatric disorders

Primary outcomes:
measure: analgesic effect
timeFrame: Up to 24 hours after surgery
Secondary outcomes:
measure: intraoperative complications
timeFrame: during surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01268345: AST Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: blood glucose
Lead sponsor: Andon Medical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2010-12-30
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Blood glucose monitoring system are tested in the alternative site to validate the accuracy of the blood glucose.


Eligibility criteria: Inclusion Criteria:

* people ( disbetes people)with at least 8 hours of limosis

Exclusion Criteria:

* After meal(when doing the test)
* take Hypoglycemic Drugs(when doing the test)
* with insulin(when doing the test)
* after strenuous exercise(when doing the test)
* Pregnant women
* neonates
* patients in a hyperglycemic-hyperosmolur state, with or without ketosis.
* patients who are dehydrated, hypertensive, hypotensive or in shock.

Primary outcomes:
measure: blood glucose value
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Hexi Ruijing metabolism hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT03596398: Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients
Official title: Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fabry Disease
Keywords: Fabry disease
Young stroke
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2018-07-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young stroke

Brief summary: Epidemiological Study of Fabry Disease in Taiwan Young Stroke Patients

Detailed description: This is a cross-sectional, population-based study. No randomization procedure will be executed in this study. Approximately 1000 subjects over a 36-month period. The aim of this screening study is to identify the Fabry disease as the cause in patients with young stroke.

To measure the level of α-Gal A activity, male subjects will initially provide a DBS sample and female subjects will start with a test by whole blood sample.

The prevalence of Fabry disease among patients with young stroke will be estimated by a confirmative diagnosis in gene testing.

Eligibility criteria: Inclusion Criteria:

* Patients aged 20 or over
* Patients aged under 56 years old, not included 56
* Patients with acute stroke
* Patients and/or their legal representatives are willing to provide written informed consent

Exclusion Criteria:

* Patients with a confirmed diagnosis of Fabry disease

Primary outcomes:
measure: Fabry disease
timeFrame: 3 years later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05949398: Evaluation of the Prevalence of Oral HPV Infection in Patients Who Are Positive to the PAP-test
Official title: Evaluation of the Prevalence and Type of Oral HPV Infection in Patients Who Are Positive to the PAP-test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HPV Infection
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women older than 18 years of age who are PAP-test positive.

Brief summary: The present cross-sectional study aims to assess the prevalence and type distribution of oral HPV infection in PAP-test-positive women aged ≥18 years. The means used in the present study will be the use of anamnestic questionnaires and exfoliative cytology tests at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

Detailed description: The present cross-sectional study aims to evaluate the prevalence and distribution of the type of oral HPV infection in PAP-test positive women.

aged ≥18 years. Sociodemographic and anamnestic data will be collected by questionnaire administration. Data collected will be age, marital status, number of sexual partners, HPV vaccination, oral sex, contraceptive use, systemic diseases, smoking, alcohol consumption, etc.. Next, patients will undergo oral cavity inspection and exfoliative cytology testing at predetermined oral mucosal sites (lingual belly and dorsum, palate, and buccal mucosa).

Sample taken sent for cytological analysis to determine the presence of viral DNAand possible typing.

Eligibility criteria: Inclusion Criteria:

* Female patients with positive PAP test;
* Age ≥ 18 years

Exclusion Criteria:

* Female patients with negative PAP test
* Uncooperative patients
* Patients with mental deficits
* Age\<18 years

Primary outcomes:
measure: Prevalence and type of oral HPV infection in PAP-test positive patients
timeFrame: 1 Month
measure: To assess whether there are any factors that may or may not promote the occurrence of oral HPV lesions in PAP-test positive patients,
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02963298: CRRT for Glutamate Elimination After Cardiac Arrest
Official title: Pilot Trial Concerning Glutamate Elimination With CRRT for Neurological Outcome After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reperfusion Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 42
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: Glutamate is known to be a mediator for apoptosis after brain hypoxia e.g. due to cardiac arrest. This pilot trial evaluates the possibility of elimination of Glutamate by CRRT after cardiac arrest.


Eligibility criteria: Inclusion Criteria:

* post cardiac arrest

Exclusion Criteria:

* hemodynamic instable
* in-hospital cardiac arrest

Primary outcomes:
measure: Glutamate blood concentration in intervention arm over the time
timeFrame: 72 hours
Secondary outcomes:
measure: number of participants with abnormal outcome parameters
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christian Storm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nee J, Jorres A, Krannich A, Leithner C, Schroeder T, Munk AL, Enghard P, Moore C, Steppan S, Storm C. Elimination of glutamate using CRRT for 72 h in patients with post-cardiac arrest syndrome: A randomized clinical pilot trial. Resuscitation. 2019 Nov;144:54-59. doi: 10.1016/j.resuscitation.2019.09.020. Epub 2019 Sep 23.
Clinical trial NCT01550198: Early Detection of Neonatal Shock
Official title: Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Impact of Advanced Hemodynamic Monitoring
Keywords: newborn
shock
hemodynamics
cardiac output
blood pressure
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2012-03-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates admitted to a neonatal intensive care unit

Brief summary: The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring results in an earlier detection of circulatory failure in newborn infants


Eligibility criteria: Inclusion Criteria:

* Birth weight \>700 grams
* Arterial catheter in place
* Central venous catheter in place
* Informed consent from parents/legal representatives

Exclusion Criteria:

* Life-threatening congenital defects
* Congenital heart defects, except patent ductus arteriosus and patent foramen ovale

Primary outcomes:
measure: Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, Department of Neonatology
Study officials:
affiliation: Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
name: Willem de Boode, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05083598: Wearable Health Technology for Perioperative Risk Assessment
Official title: Wearable Health Technology for Perioperative Risk Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2021-10-19
Enrollment: 31
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 70 or older undergoing major non cardiac surgery, with expected surgical duration \> 2 hours.

Brief summary: Accurate and timely preoperative identification of high-risk patients provides opportunities to better inform and manage them. Current predictors for perioperative complications are either resource consuming or have low accuracy. The primary objective of the study is to assess if Wearable Devices may be an alternative to assess cardiopulmonary function, with low risks and lower costs.


Eligibility criteria: Inclusion Criteria:

* Age 70 or more
* Undergoing major non cardiac surgery
* Expected surgical duration \> 2 hours.

Exclusion Criteria:

* Patients unable to express consent
* Patients undergoing urgent/emergent surgery
* Patients in which surgery is planned within less than two weeks
* Patients with limited physical activity due to limited mobility related with neurological or orthopedic disease
* Acute cardiovascular event
* Surgery conducted in locoregional anesthesia only

Primary outcomes:
measure: Assess whether wearable devices (WD) can identify patients at risk for postoperative complications.
timeFrame: 12 months
Secondary outcomes:
measure: To compare performance of WD data with 6MWT, MET scale, CFS and ASA score in identifying reduced functional capacity
timeFrame: 24 months
measure: A sub analysis of WD data during 6MWT will be conducted
timeFrame: 24 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
References: