louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03868176: Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors
Official title: Phase II, Open-label, Randomized, Non-comparative Study Evaluating the Impact of Short Message Service (SMS) on Compliance With Surveillance of Patients With Germ-cell Tumors. (TEXTIS Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Follow-up
Compliance, Patient
Text Messaging
Germ Cell Tumor
Keywords: surveillance
compliance
germ cell tumors
short message service
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 235
Sex: MALE
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: 235 patients, with 157 in the experimental arm, with SMS sending and 78 patients in the control arm, without sending SMS.

Brief summary: This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.


Eligibility criteria: Inclusion Criteria:

* Patient with germ cell tumor.
* Patient with a mobile phone.
* Patient on surveillance.

Exclusion Criteria:

* Testicular cancer without germ cell component.
* Prior history of other malignancy except for: cutaneous cancers excluding melanoma, superficial bladder tumor, localized prostate cancer with undetectable PSA.
* Cognitive condition that would preclude patient's understanding and completion of study procedures.

Primary outcomes:
measure: Rate of patients who report optimal compliance to surveillance
timeFrame: 1 year
Secondary outcomes:
measure: Rate of patients who report intermediate compliance to surveillance
timeFrame: 1 year
measure: Rate of patients who report a non compliance to surveillance
timeFrame: 1 year
measure: Patient satisfaction of sending SMS, in experimental arm
timeFrame: 1 year
measure: biological recurrence rate
timeFrame: 1 year
measure: Radiological recurrence rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besancon
state: Franche-Comté
Study officials:
References:
Clinical trial NCT06154876: Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
Official title: Effect Of Cough Assist Device On Hemodynamic Status And Oxygen Saturation For Ventilated Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia Childhood
Intensive Care Unit
Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: Statement of the problem:

•Is there an effect of the cough assist device on Hemodynamic status and oxygen saturation for ventilated children? Null hypothesis There will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.

Detailed description: Subjects:

The study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. Sample size estimation will be carried out to determine the recruited number of children, selected randomly from Cairo University pediatric specialized hospital, Cairo to participate in the study.

Study design:

Randomized controlled clinical trial. Children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.

Children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired Tidal Volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention

Eligibility criteria: Inclusion Criteria:

1. Children of both sexes, with age ranged from 4-9 years old.
2. Children will diagnosed with pneumonia.
3. Children will intubated on mechanical ventilation.
4. All children should be vitally stable during the study period.

Exclusion criteria:

Exclusion Criteria:

1. Hemodynamically unstable child.
2. Child with diaphragmatic hernia.
3. Child with pneumothorax (if chest tube is present).
4. Child with raised intracranial pressure.
5. Child with recent upper Gastrointestinal surgery

Primary outcomes:
measure: Assessment of oxygen saturation
timeFrame: 14 days for each participant or time of weaning
measure: Assessment of expired Tidal Volume
timeFrame: 14 days for each participant or time of weaning
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Nour Reda
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382576: Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity
Official title: Women With Polycystic Ovary Syndrome Have Increased Plasma Chitotriosidase Activity: A Pathophysiological Link Between Inflammation and Impaired Insulin Sensitivity?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
chitotriosidase activity
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 34 women with PCOS and 44 healty women as control group.

Brief summary: In the present study, serum chitotriosidase activity and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS).

Detailed description: ChT activity is increased in patients with PCOS in concordance with insulin resistance. These findings may reflect the pronounced risk for metabolic syndrome and atherosclerotic diseases in this particular patient group.

Eligibility criteria: Inclusion Criteria:

* Absence of significant abnormalities on physical examination except hirsutism
* no lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
* normal thyroid function and prolactin level
* absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

Exclusion Criteria:

* Pregnant
* ovarian tumors
* congenital adrenal hyperplasia or BMI greater than 30 kg/m2

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Etlik
Study officials:
affiliation: No organizational affiliation
name: Aydogan Aydogdu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03963076: Efficacy of Nasal Spray Hypertonic Puressentiel on Symptoms of Allergic Rhinitis
Official title: Evaluation of the Efficiency of Nasal Spray Hypertonic Puressentiel on Symptoms of Patients With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: Puressentiel
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Montpellier
First posted: 2019-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective multicentric study
Primary purpose: TREATMENT

Brief summary: Prospective multicentric study.

60 subjects with allergic rhinitis will be enrolled to test the efficacy of nasal hypertonic spray Puressentiel on symptoms of allergic rhinitis and nasal peak flow.

Subjects with allergic rhinitis and nasal obstruction will use during 30 days the nasal spray (2 nebulisations /day in each nostril) during 30 days.

Rhinitis symptoms questionnaire and nasal inspiratory peak flow will be evaluated before and after 30 days of exposure.

Detailed description: Objective: evaluate the efficiency of a nasal hypertonic spray Puressentiel in subjects with allergic rhinitis and nasal obstruction.

Inclusion criteria: subjects with allergic obstructive rhinitis without treatment or remaining symptomatic despite treatment.

Duration of exposure: 2 nasal sprays per day (morning and evening) during 30 months.

Primary criteria of efficacy: Rhinitis questionnaire.

Secondary criteria: Inspiratory nasal peak flow

Eligibility criteria: Inclusion Criteria:

* allergic rhinitis with nasal obstruction

Exclusion Criteria:

* pregnant patients
* patients with severe asthma

Primary outcomes:
measure: Rhinitis auto questionnaire symptoms
timeFrame: Measurement at Day 0
measure: Rhinitis auto questionnaire symptoms
timeFrame: Measurement at Day 30
Secondary outcomes:
measure: Nasal inspiratory peak flow
timeFrame: Measurement at Day 0 and Day 30
measure: Nasal inspiratory peak flow
timeFrame: Measurement at Day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: Caroline Bonnard
Study officials:
References:
Clinical trial NCT05988476: Investıgatıon of The Effıciency of Pulsed Electromagnetıc Field Therapy and Stretching Exercises
Official title: Investigation of The Efficiency of Pulsed Electromagnetic Field Treatment and Stretching Exercise In Experimental Skeletal Muscle Injury Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Injury
Pulsed Electromagnetic Therapy
Muscle Stretching Exercise
Keywords: Muscle Injury
TGF-Beta 1
Fibrosis
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.

Detailed description: Purpose: The aim of this study was to evaluate the efficacy of stretching exercise and the pulsed electromagnetic field (PEMF) method in the treatment of muscle injury (INJ).

Methods: In this study, a total of 69 Wistar Albino rats were used, five of which were in the preliminary study. The preliminary study was planned to determine the ideal PEMF treatment time. In the study, animals were divided into 5 groups (Control, INJ, INJ+Exercise, INJ+PEMF, INJ+Exercise+PEMF). Experimental animals were sacrificed on the 7th and 14th days to see the effects of the treatments. At the end of the experiment, genetic, histopathological, and immunohistochemical evaluations were made in the muscle tissue.

Eligibility criteria: Inclusion Criteria:

* Healthy young wistar albino rats

Exclusion Criteria:

* not having any injury

Primary outcomes:
measure: Mononuclear cell infiltration, Atrophy and necrosis, Pyknotic nucleus assesment at the end of two weeks
timeFrame: two week
measure: VEGF and FGF assesment at the end of two weeks
timeFrame: two week
measure: TGF-β1, eNOS assesment at the end of two weeks
timeFrame: two week
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: SuleymanDU
Study officials:
References:
Clinical trial NCT02241876: THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS
Official title: EVALUATION OF THE USE OF N-ACETYLCYSTEINE ATTENUATING CISPLATIN-INDUCED TOXICITIES BY OXIDATIVE STRESS IN HEAD AND NECK CANCER PATIENTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Head and Neck Neoplasms
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Head and neck cancer corresponds to tumors located in the upper aerodigestive tract, such as the oral cavity, pharynx and larynx. The most effective treatment consists of high dose of cisplatin chemotherapy and radiotherapy, however, their use is limited due to toxicities caused mainly by oxidative stress. The objective of this study will be evaluate the use of n-acetylcysteine attenuating cisplatin-induced toxicities by oxidative stress in head and neck cancer patients. This is a randomized double-blind placebo-controlled clinical trial with consecutive sampling that will be conducted at Oncology Department of Clinic Hospital / University of Campinas (UNICAMP). Head and neck cancer patients who will begin cisplatin antineoplastic treatment (80-100mg/m2 on days 1, 22 and 43) and concurrent radiotherapy will be included in this research. They will be studied in 2 groups (n-acetylcysteine and placebo). All patients will be evaluated in relation to cisplatin induced hematologic and gastrointestinal disorders, nephrotoxicity, ototoxicity, and hepatotoxicity; plasmatic and cellular oxidative stress; quality of life; and pharmacoeconomic evaluation. Results will be statistically analysed using Chi-square, Fisher, Mann-Whitney, and ANOVA for repeated measures tests (p\<0.05.)


Eligibility criteria: Inclusion Criteria:

* head and neck cancer
* anticancer treatment - cisplatin (80 to 100 mg/m²) plus radiotherapy
* patients without previous treatment of head and neck cancer (surgery, chemotherapy and radiotherapy)

Exclusion Criteria:

* severe psychiatric diseases
* impossibility of verbal communication
* without caregivers or companions

Primary outcomes:
measure: Hematologic, Nephro, and Hepato Toxicity - Degree of toxicity by Common Toxicity Criteria for Adverse Effects (CTCAE - version 4.0)
timeFrame: 120 hours
measure: Gastrointestinal Toxicity - Degree of toxicity by CTCAE (version 4.0)
timeFrame: 1 day
measure: audiometric testing
timeFrame: 1 day
measure: Nephrotoxicity
timeFrame: 1 day
Secondary outcomes:
measure: Quality of Life
timeFrame: 21 days
measure: Cellular and plasma oxidative stress biomarkers
timeFrame: 1 day
measure: Effectiveness of anticancer therapy
timeFrame: 1 day
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: State University of Campinas - UNICAMP, Hospital das Clinicas
state: São Paulo
Study officials:
References:
Clinical trial NCT01208376: Prevalence of Liver Fibrosis and Progression of Liver Fibrosis
Official title: Prevalence of Liver Fibrosis and Progression of Liver Fibrosis in HIV-infected, Hepatitis C (HCV) and Hepatitis B (HBV) Seronegative Patients With Chronic Alanine Aminotransferase (ALT) Elevation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection and Chronic Alanine Aminotransferase Elevation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss HIV Cohort Study
First posted: 2010-09-23
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected, hepatitis B and C seronegative Patients With Chronic alanine aminotransferase (ALT) Elevation

Brief summary: Little is known about the clinical significance of chronic alanine aminotransferase (ALT) elevation in HIV-infected patients without hepatitis B and C coinfection. Study aim is first to evaluate the prevalence of liver fibrosis and cirrhosis in HIV-infected patients with chronic ALT elevation and no chronic viral hepatitis using non-invasive diagnostic tests and second to find associated factors with significant fibrosis and cirrhosis. In a second longitudinal part we intend to assess fibrosis progression within 1 and 3 years.


Eligibility criteria: Inclusion criteria: Case patients:

* HIV-1 infection
* no hepatitis B and C coinfection
* chronic alanine aminotransferase (ALT) elevation after 1.1.2007
* signed informed consent
* no other common cause of liver disease

Control patients:

* HIV-infection
* no hepatitis B and C coinfection
* no ALT elevation after 1.1.2002, the date when ALT values were regularly collected in the Swiss HIV Cohort Study (SHCS)
* no known chronic liver disease

Exclusion criteria: please see inclusion criteria

Primary outcomes:
measure: Liverfibrosis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT06993376: PENG Block vs ESPB in Elderly Undergoing Hip Surgeries
Official title: Comparison Between the Ultrasound Guided Pericapsular Nerve Group Block and Erector Spinae Plane Block on Motor Power Postoperative in Elderly Patients Undergoing Total Hip Replacement Surgeries; A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia for Hip Surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 56
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To our knowledge, the comparison between the ultrasound-guided lumbar erector spinae plane block and the pericapsular nerve group block has not been investigated before in previous literature.


Eligibility criteria: Inclusion Criteria:

* Both genders Type of surgery; unilateral elective total hip replacement. Physical status ASA I, II Age more than or equal 65 Years. Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

Exclusion Criteria:

* Patient refusal. Patients with known sensitivity or contraindication to drugs used in the study (local anesthetics \& opioids).

History of psychological disorders and/or chronic pain. Pre- existing peripheral neuropathies Coagulopathy. Infection of the skin at the site of needle puncture area.

Primary outcomes:
measure: Motor power
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01425827: Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Reduction
Function Improvement
Keywords: duloxetine
osteoarthritis
pain
function
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 288
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options have had limited symptomatic effect and are associated with significant side effects. Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to have, besides its antidepressant properties, a centrally acting analgesic effect.

The aim of the present study was to investigate the efficacy of duloxetine in reducing pain in older adults with knee OA.

288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary knee OA attending the outpatient clinic of our institution were enrolled in this study. All patients underwent a physical examination and where questioned about the number of flares. Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The primary outcome measure was pain reduction. Secondary outcome measures included improvements in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded. Safety and tolerability were also assessed. Data was collected at baseline and at monthly intervals for 4 months. All staff involved in data collection was blinded to the treatment assignment groups.


Eligibility criteria: Inclusion Criteria:

* primary knee osteoarthritis

Exclusion Criteria:

* inflammatory conditions
* autoimmune disorders
* psychiatric illness
* morbid obesity

Primary outcomes:
measure: Pain reduction
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, University of Alexandria
Study officials:
affiliation: University of Alexandria
name: Anna Abou-Raya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abou-Raya S, Abou-Raya A, Helmii M. Duloxetine for the management of pain in older adults with knee osteoarthritis: randomised placebo-controlled trial. Age Ageing. 2012 Sep;41(5):646-52. doi: 10.1093/ageing/afs072. Epub 2012 Jun 27.