louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00188604: The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer
Official title: A Randomized Phase II Placebo-controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lymphedema
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-09-16
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient's quality of life and to assess the incidence of adverse effects of selenium therapy.


Eligibility criteria: Inclusion Criteria:

* patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy)
* patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy
* ECOG performance 0-2
* informed consent

Exclusion Criteria:

* active cellulitis/skin infection of the limb
* venous thrombosis of the upper limbs
* active malignancy
* any other medical condition or congenital or traumatic injury involving either limb
* patients already on selenium medication
* patients participating in another clinical study related to lymphedema

Primary outcomes:
measure: To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer.
Secondary outcomes:
measure: To assess the toxicity of selenium.
measure: To assess the association of selenium, quality of life and limb function.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Wilfred Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04061304: A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
Official title: A Clinical Trial Into the Efficacy of rTMS Treatment for Treating Anorexia Nervosa and Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Keywords: rTMS
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) in treating individuals with Anorexia Nervosa and Bulimia Nervosa. The main objective of this study is to determine the short and long-term efficacy of repetitive transcranial magnetic stimulation (rTMS) in reducing eating disorder symptoms (i.e. binging, purging, restricting, intense fear of gaining wait, etc;) in Anorexia Nervosa and Bulimia Nervosa.

The investigators will also be comparing the brain activity patterns of individuals with Anorexia Nervosa and Bulimia Nervosa to healthy controls using electroencephalography (EEG). Further, the investigators would like to examine if the activation patterns in these patients change after receiving rTMS.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of Anorexia Nervosa or Bulimia Nervosa, must pass rTMS screening questionnaire

Exclusion Criteria:

* Diagnosis of another psychiatric disorder, except MDD.
* Any rTMS counter-indications:
* History of seizures
* Metal in head
* Currently pregnant
* Having received rTMS for any reason in the past as this would interfere with participant blinding.

Primary outcomes:
measure: Weekly Binge/Purge Frequency on Eating Disorder Examination
timeFrame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Secondary outcomes:
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
measure: Change in Beck Depression Inventory (BDI)
timeFrame: baseline, after week 1, week 2, and week 3 of treatment, 3 months post treatment, and 6 months post treatment.
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Mandana Modirrousta, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00839904: Physical Activity and Health of Children With Cancer in Remission
Official title: The Effect of Physical Activity on the Mental and Physical Health of Children With Cancer in Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Cancer
Exercise
Keywords: children
cancer
exercise
fitness
body composition
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Israel Cancer Association
First posted: 2009-02-10
Enrollment: 22
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical activity is a well-known and powerful tool in medicine,having preventive, palliative, and curative properties. This has not been sufficiently examined in children in remission from cancer. In this study, children in remission from cancer will be divided into exercise and control groups. The interventional group will perform two supervised, 60-minute weekly exercise sessions. Outcome measures of the exercise intervention will be quality of life, mood, cardiorespiratory fitness, body composition and bone mineral density.


Eligibility criteria: Inclusion Criteria:

* children aged 6-16
* remission from cancer
* \>6 months after completion of all therapy

Exclusion Criteria:

* informed consent not given in writing
* refusal of tests: blood, fitness, questionnaires or DEXA
* locomotive handicaps
* extreme fatigue, nausea, dyspnea
* concurrent acute illness
* recent (less than 3 months) hospitalization
* documented (echocardiographic or nuclear medicine) decrease in cardiac function
* abnormal blood tests: Hb \< 10 gr/dl, neutropenia \< 500/mm3, thrombocytopenia \< 50,000/mm3
* additional chronic health conditions unrelated to cancer (e.g. celiac disease, cerebral palsy, Down's syndrome)

Primary outcomes:
measure: health-related quality of life
timeFrame: 6months
measure: mood
timeFrame: 6months
measure: cardiorespiratory fitness
timeFrame: 6months
measure: body fat percentage
timeFrame: 6months
measure: bone mineral density
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05739604: Serum Free Amino Acid Concentrations in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
Official title: Serum Free Amino Acid Concentrations in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy (CRRT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Amino Acid Catabolism Disorder
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 26
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: All patients hospitalized in ICU who met inclusion criteria.

Brief summary: Sepsis is a life-threatening condition associated with high morbidity and mortality. The breakdown of proteins mainly from skeletal muscles leads to the release of free amino acids (FAAs). The serum FAA pool has been repeatedly assessed and found to be significantly altered in patients with sepsis/septic shock. Sepsis is well known to be the most common factor contributing to the development of acute kidney injury in critically ill patients.

The investigators want to establish the baseline profile of FAAs and their derivatives in patients with sepsis/septic shock undergoing continuous renal replacement therapy due to sepsis-associated acute kidney injury. Secondly, the investigators want to compare the FAA profiles of the survivors and nonsurvivors.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* present AKI
* requiring renal replacement therapy
* hospitalized at the ICU.

Exclusion Criteria:

* acute kidney disease requiring renal replacement therapy prior to admission to the ICU
* chronic kidney disease requiring renal replacement therapy prior to admission to the ICU
* history of past CRRT.

Primary outcomes:
measure: Evaluation the baseline profile of FAAs and their derivatives in serum in a group of patients undergoing continuous renal replacement therapy (CRRT) due to sepsis associated acute kidney injury (SA-AKI) in the Intensive care unit (ICU)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Comparison the free amino acids (FAA) profile of survivors and nonsurvivors
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
state: Pomorskie
Study officials:
affiliation: Medical University of Gdansk
name: Radosław Owczuk, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00245804: Developmental Dyslexia and Functional Maturation of Auditory Cortex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Reading Disorder
Dyslexia
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with developmental reading disorders from 8 to 25 jears. Control groupes with healthy people in de same age

Brief summary: Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different in developmental dyslexia and controls.


Eligibility criteria: Inclusion Criteria:

Age (8-10 years ; 11-17 years ; 18-25 years developmental reading disorders (developmental dyslexia) criteria according to Critchley (1970) PIQ \> 85 No auditory deficit No psychosis -

Exclusion Criteria:

PIQ \< 85 Epilepsy ADHD Stroke, head injury

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Tours
name: Caroline Hommet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02684604: Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility
Official title: Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 88
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: female healthy participants who attend the outpatient clinic

Brief summary: Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.

Detailed description: Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.

Following admission, all patients underwent complete clinical examination and detailed medical history was obtained.

A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).

Eligibility criteria: Inclusion Criteria:

1. regular cycles.
2. normal thyroid function, prolactin and androgen levels.
3. normal semen analysis of the partner.
4. normal hysterosalpingography.
5. normal transvaginal ultrasound examination.

Exclusion Criteria:

1. possible uterine malformations or pathologies.
2. presence of infections, including hepatitis, human immunodeﬁciency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.
3. presence of anti-sperm antibodies in serum.
4. Male factor infertility.

Primary outcomes:
measure: Quantitative Helicobacter Pylori IgG Assay in Serum
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04342104: NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure
Official title: NIV and CPAP Failure Predictors in COVID-19 Associated Respiratory Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Covid-19
Keywords: noninvasive ventilation
CPAP
Covid-19
Respiratory failure
HACOR score
Lead sponsor: Hospital General Universitario Morales Meseguer
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 100
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 with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision

Brief summary: Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.

Propose adaptations to HACOR score based on the "state of art" of COVID-19

Detailed description: Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure.

Propose adaptations to HACOR score based on the "state of art" of COVID-19

- this adaptations may include radiologic aggravation and monitoring of CRF, ferritin, LDH, d-dimers, NT-proBNP, troponin I, GOT, GPT, blood count

Eligibility criteria: Inclusion Criteria:

* Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision

Exclusion Criteria:

* Patients with imediate indication to invasive mechanical ventilation
* Patients with any formal contraindication to noninvasive respiratory support

Primary outcomes:
measure: HACOR score efficacy
timeFrame: 1 hour after initation of CPAP or NIV
measure: HACOR score addaptation
timeFrame: 1 - 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
Study officials:
affiliation: Hospital General Universitario Morales Meseguer
name: Miguel Guia
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Morales Meseguer
name: Antonio Esquinas
role: STUDY_DIRECTOR
References:
Clinical trial NCT00924404: Xylitol Versus Saline in Chronic Sinusitis
Official title: Randomized Controlled Trial of Xylitol Versus Saline Rinse For Chronic Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Keywords: Xylitol vs. Saline
nasal washes
sinusitis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 53
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: Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

Detailed description: In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol nasal rinse with saline rinse which is the current standard, on outcomes such as quality of life and exacerbations.

Eligibility criteria: We now have two arms to this study.

Group I: Immunocompetent subjects with chronic rhinosinusitis

Inclusion Criteria:

* 56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

  * Anterior and/or posterior mucopurulent drainage
  * Nasal obstruction
  * Facial pain, pressure, and/or fullness
  * Decreased sense of smell
* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion Criteria:

* Cystic fibrosis
* Fungal sinusitis
* Immunocompromised status (use of long term oral steroids (\> 30 days), AIDS, active malignancy or chemotherapy)
* Known Ciliary disorders
* Sinonasal tumors
* Pregnancy

Group 2: CRS with antibody deficiency

* 56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

  * Anterior and/or posterior mucopurulent drainage
  * Nasal obstruction
  * Facial pain, pressure, and/or fullness
  * Decreased sense of smell
* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion criteria:

Cystic Fibrosis Sinonasal tumors Pregnancy

Primary outcomes:
measure: SNOT-20 Scores at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Number of Antibiotic Courses During the Study Period
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Lakshmi Durairaj, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04426604: Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
Official title: Validity of Fluorescence-Based Devices Versus Visual-Tactile Method in Detection of Secondary Caries Around Resin Composite Restorations: Invivo Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Secondary Caries Around Resin Composite Restorations
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will be conducted to evaluate the clinical performance and validity of both light-induced fluorescence intraoral camera and laser-induced fluorescence device in comparison to visual-tactile assessment method in detection of secondary caries around margins of resin composite restorations.

Detailed description: Each patient should have at least one resin composite restoration. The restoration will be evaluated by all diagnostic methods. Each examiner will independently record the dental findings using all methods, the visual- tactile assessment method and both fluorescent-aided identification methods. The visual-tactile assessment method includes the use of mirror, probe under good illumination condition, while the fluorescent-aided identification methods will be performed by both light-induced fluorescence intraoral camera and laser-induced fluorescence device. Then Diagnostic performance for caries detection was evaluated, assessing the validity of each diagnostic method in diagnosing secondary caries around margins of resin composite restorations

Eligibility criteria: Inclusion Criteria:

* Patients should be over 18 years of age.
* Patients should have an acceptable oral hygiene level.
* Patients should have at least one resin composite restoration.

Exclusion Criteria:

* Patients with a compromised medical history.
* Patients with active severe periodontal disease.

Primary outcomes:
measure: Validity of Fluorescence-based Devices versus Visual-tactile method
timeFrame: Through study completion, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References: