louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04140409: Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation
Official title: Sandostatin (Octreotide LAR) May Lead to Clinical Improvement Through Receptor Occupation Optimisation A Prospective Interventional Trial of Patients With Neuro-endocrine Tumors With Carcinoid Syndrome Receiving Octreotide LAR
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Neuroendocrine Tumors
Carcinoid Syndrome
Keywords: NET
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-centric prospective interventional study in which patients with a symptomatic GEP-NET will receive octreotide LAR every 2, 3 or 4 weeks. The basal dose and the dose adaptation will be left at the discretion of the investigator depending on the rate of symptom control. Dose increase up to doses of 60 mg octreotide every 4 weeks, or increase of frequency up to 30 mg every 2 weeks can be done to obtain control of carcinoid symptoms, defined by at least a 50% decrease of the mean number of bowel movements per day and the total number of flushes over 7 days AND a maximum frequency of less than 4 bowel movements a day. If only one symptom is present, analysis will be done for that symptom only: refer to table in statistical analysis The concentration of serum octreotide level will be realized with LCMS/MS following the method of Capron \& Wallemacq. Each blood sample should be taken 4 times per year just before the next injection of Octreotide LAR.


Eligibility criteria: Inclusion Criteria:

* Written informed consent GEP NET Ki 67 ≤ 10 %
* Histologically or cytologically confirmed GEP NET
* Appearance of carcinoid syndrome maximum 6 months before the inclusion
* Evaluable or measurable disease (RECIST 1.1) WHO ECOG performance status 0-2
* Positive somatostatin receptor scintigraphy
* \>18 years
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Uncontrolled concurrent disease which prevents the adequate management and follow-up of the NET.
* Previous malignancy in the last past 3 years except malignancies estimated as completely cured.
* Current pregnancy or breast feeding
* Concomitant anti-tumoral treatment, except external beam radiotherapy

Primary outcomes:
measure: Treatment succes vs treatment failure
timeFrame: 2 years
Secondary outcomes:
measure: Symptoms
timeFrame: 2 years
measure: Rate of diarrhea and flushes
timeFrame: 2 years
measure: Impact of increased dose
timeFrame: 2 years
measure: Changes in Quality of life
timeFrame: 2 years
measure: Effect on tumor control
timeFrame: 2 years
measure: Toxicities
timeFrame: 2 years
measure: Correlation dose/frequency
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Cliniques Universitaires St-Luc
name: Ivan Borbath, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06421909: Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman
Official title: Effect of Mindfulness-based Educational Intervention on Anxiety, Depression, Stress and Quality of Life on Menopausal Woman.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Mindfulness-based educational intervention is a structured program that incorporates principles of mindfulness to help individuals develop greater awareness and acceptance of their thoughts, feelings, and bodily sensations. The intervention typically includes mindfulness meditation practices, cognitive-behavioral techniques, and educational components about stress management and emotional regulation. By fostering a non-judgmental and present-focused attitude, participants learn to manage their symptoms more effectively and improve their overall quality of life.

Detailed description: Menopause is a significant transitional phase in a woman's life, often accompanied by various physical, emotional, and psychological challenges. Common issues during menopause include anxiety, depression, stress, and a decreased quality of life. Addressing these concerns holistically is crucial for improving overall well-being. Mindfulness-based educational interventions have gained recognition for their effectiveness in enhancing mental health and quality of life by promoting awareness and acceptance of present experiences. This study investigates the impact of a mindfulness-based educational intervention on anxiety, depression, stress, and quality of life in menopausal women.

Eligibility criteria: Inclusion Criteria:

* in age of menopause

Exclusion Criteria:

* age of menarche
* older than 70 years old

Primary outcomes:
measure: menopausal women who participate in the mindfulness-based educational intervention will experience significant reductions in anxiety inventory score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
timeFrame: three months
Secondary outcomes:
measure: menopausal women who participate in the mindfulness-based educational intervention will experience reductions in stress scale score ( total score range from 10 to 50, a lower score of less than 20) than those who not entered
timeFrame: three months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
state: Al Iskandariyah
Study officials:
References:
Clinical trial NCT06107309: Suppressive Antibiotic Therapy for Endocarditis
Official title: Suppressive Antibiotic Therapy for Prosthetic Valve or Implantable Device Related Infectious Endocarditis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endocarditis
Keywords: Endocarditis
Antibiotic therapy
Suppressive antibiotics
Long term treatment
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023

Brief summary: Endocarditis are deadly infections, which nowadays occurs mainly among older patients with multiple comorbidities. The incidence is notably high among patients with valvular prosthetic or implantable devices. Management of such situation usually requires intravenous antibiotic therapy along with removal of the infected prosthetic or device. However, such invasive procedures and revision surgeries may be judged unreasonable among these patients, who are then exposed to a high risk of infectious relapse when curative antibiotics are discontinued.

In these situation, a long-course antibiotic therapy may be used in order to maintain lasting infection control, to limit the risks of relapse of infection due to the infected device retention, and ultimately to prolong survival. This strategy is already suggested in case of infected prosthesis joint retention (IDSA 2013), and has been proposed for implantable device retention by the American Heart Rhythm Society in 2017, but data regarding its modalities and outcomes are scare.

The objectives of this study are to describe the survival of patient under long-term antibiotic therapy for endocarditis, at 6-months and 1 year after initiation. Secondary outcomes includes modalities of the suppressive treatment prescribed, its security (secondary effects, tolerance) and to precise causes of death.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject having benefited from suppressive antibiotic therapy after collegial decision in CPR Endocarditis during the period from January 1, 2016 to January 31, 2023
* Subject not opposing the reuse of their data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Death or loss of sight of the patient before initiation of suppressive antibiotic therapy.

Primary outcomes:
measure: Survival of the patient who benefited from suppressive antibiotic therapy
timeFrame: Survival at 6 months, 1 year, 3 years after infection
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06655909: Serum Ferritin Concentration in Kenyan Women and Their Preschool Children at Which the Body Begins to Upregulate Iron Absorption From the Diet
Official title: Defining the Serum Ferritin Concentration in Kenyan Women and Their Preschool Children at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption From the Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Mothers
Preschool Children
Keywords: iron absorption
serum ferritin
maize porridge
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Jomo Kenyatta University of Agriculture and Technology
First posted: 2024-10-24
Enrollment: 275
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Using standardized methods, the investigators will perform stable iron isotope absorption studies in young Kenyan women and their preschool children (2-5y of age) with varying iron status to measure iron absorption from maize meal containing labeled ferrous sulfate. Using these data, this study aim is to define the ferritin in these young women and children at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women and children.

Detailed description: In this experimental study in southern Kenya, the investigators will take a baseline venous blood sample to measure iron and inflammation biomarkers in generally healthy young women (n=125) and in their preschool children. The investigators will then administer, after an overnight fast, a standardized test meal porridge made from refined maize and bottled water containing the stable iron isotope 57Fe. Fourteen days later, the investigators will take a second venous blood sample for determination of erythrocyte incorporation of the 57Fe to measure iron absorption from the labeled test meal.

Eligibility criteria: Inclusion Criteria:

* \< 75 kg
* BMI between 17 - 27.5 kg/m2
* No acute illness (self-reported)
* No metabolic or gastrointestinal disorders (self-reported)
* No use of medication affecting iron absorption or metabolism during the study
* No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during study
* Mother of a preschool age child (2-5 years)
* Child has normal Z-scores for WAZ, HAZ and WHZ (-3 - +3)

Primary outcomes:
measure: Fractional iron absorption
timeFrame: Study day 14
Secondary outcomes:
measure: Serum ferritin
timeFrame: Study day 1
measure: soluble transferrin receptor
timeFrame: Study day 1
measure: C-reactive protein
timeFrame: Study day 1
measure: alpha(1)-acid-glycoprotein
timeFrame: Study day 1
Other outcomes:
Locations:
city: Msambweni
country: Kenya
facility: ETH/JKUAT Research Station
Study officials:
References:
Clinical trial NCT05153109: Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preescholers
Official title: Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preschoolers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Disease
Keywords: clinical interview
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2021-12-10
Enrollment: 156
Sex: ALL
Minimum age (years): 0
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All parents who have a child in the according age group.

Brief summary: The Kleinkind-DIPS (Diagnostisches Interview bei psychischen Störungen für Kleinkinder) is a structured interview to assess a variety of the most frequent psychological problems in babies and preschoolers, e.g. feeding or sleeping problems, anxiety disorders. It is administered by a trained clinician with one of the primary carers. In this study, its acceptance, reliability and validity will be tested in a clinical and non-clinical sample.

Detailed description: The Kleinkind- DIPS (Diagnostisches Interview bei psychischen Störungen für Kleinkinder) is a structured interview to assess a variety of the most frequent psychological of the most frequent psychological problems in babies and preschoolers, e.g. feeding or sleeping problems, anxiety disorders. It is administered by a trained clinician with one of the primary carers. In this study, its acceptance, reliability and validity will be tested in a clinical and non-clinical sample. Parts of the interview are adapted from the Kinder-DIPS, for which information on acceptance, reliability and validity are available. The aim of the present study is to test the interviews acceptance, reliability and validity in both a clinical and a non-clinical sample.

Eligibility criteria: Inclusion Criteria: sufficient knowledge of the German language -

Exclusion Criteria:

-

Primary outcomes:
measure: Kleinkind-DIPS
timeFrame: within one week of the other measures
Secondary outcomes:
measure: Fragebogen zum Schreien, Füttern, Schlafen (SFS)
timeFrame: within one week of the other measures; only for parents of children aged 18 months or younger
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: within one week of the other measures;
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: within one week of the other measures; only for parents of children aged 18 months or older
measure: Parental sense of control (PSCO)
timeFrame: within one week of the other measures;
Other outcomes:
measure: Acceptance of the Interview
timeFrame: within one week after being interviewed
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilian University of Munich
state: Bavaria
city: Bochum
country: Germany
facility: Ruhr-University
state: North-Rhine Westphalia
Study officials:
affiliation: Ruhr University of Bochum
name: Silvia Schneider, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02137109: Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri
Official title: Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Pediatric
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-05-13
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric MS patients who have received at least 1 dose of natalizumab prior to the age of 18 years where the first dose was administered prior to 31 March 2015.

Brief summary: The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.

Detailed description: All available retrospective and prospective data from pediatric MS participants who have received at least 1 dose of natalizumab before turning 18 years old and before 31Mar2015 will be used in this study. Prospective data are defined as data to be collected in the future, i.e., from new participants not included in the first data transfer or additional data from existing participants that were not included in the first data transfer. Existing biospecimen samples will be evaluated but not collected as part of this study.

Eligibility criteria: Key Inclusion Criteria:

* All available retrospective and prospective data from pediatric MS patients who have received at least 1 dose of natalizumab before turning 18 years old and before 31 March 2015.
* In addition, patients must be registered in TOUCH (US patients only), enrolled in a Biogen sponsored postmarketing observational study (e.g., TOP (NCT00493298) or TYGRIS (NCT00477113,NCT00483847)), or in a country-specific TYSABRI registry.
* Adequate data received by Biogen by 30 September 2015 will be used for this meta-analysis including data collected after a patient may have turned 18 years old.

Key Exclusion Criteria:

* Data received by Biogen after 30 September 2015 will not be included in the statistical analyses

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Primary outcomes:
measure: Incidence of all serious adverse events (SAEs)
timeFrame: Up to 19 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00699309: A Clinical Investigation of the Taperloc® Microplasty™ Hip System
Official title: A Prospective, Non-controlled, Clinical Investigation of the Taperloc® Microplasty™ Hip System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis
Keywords: Total Hip Replacement
Total Hip Arthroplasty
Minimally Invasive
Microplasty
Hip Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 98
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 requiring relief from painful or disabling joint disease.

Brief summary: The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Taperloc® Microplasty™ Hip System.


Eligibility criteria: Inclusion Criteria:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis.
* Correction of functional deformity.
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
* Revision of previously failed femoral head resurfacing component

Exclusion Criteria:

Absolute contraindications include:

* infection,
* sepsis, and
* osteomyelitis.

Relative contraindications include:

* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* osteoporosis,
* metabolic disorders which may impair bone formation,
* osteomalacia,
* distant foci of infections which may spread to the implant site,
* rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
* vascular insufficiency, muscular atrophy, or neuromuscular disease.

Primary outcomes:
measure: Harris Hip Score
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of revision or removals
timeFrame: 5 Years
Other outcomes:
Locations:
city: Beaufort
country: United States
facility: Low Country Bone & Joint Specialists
state: South Carolina
city: Greenville
country: United States
facility: Piedmont Orthopedics
state: South Carolina
city: Plano
country: United States
facility: Texas Center for Joint Replacement
state: Texas
city: Sterling
country: United States
facility: Arthritis & Sports Orthopaedics
state: Virginia
Study officials:
affiliation: Director, Clinical Research, Biomet Orthopedics, LLC
name: Russell Schenck, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01428609: Blood Mercury Levels Following Retrograde Amalgam Surgeries
Official title: Blood Mercury Levels Following Retrograde Amalgam Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Mercury Concentration
Keywords: Amalgam
Mercury
Endodontics
Apicoectomy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Isfahan University of Medical Sciences
First posted: 2011-09-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to determine the blood's mercury level of patients who had amalgam root end filling surgeries. It is to be examined if the mercury concentration in blood is elevated by using amalgam retroseal.

Detailed description: * A total of 14 patients who needs surgical root canal therapy (SRCT) participated in this clinical study.
* The Isfahan University Human Subjects Review Committee approved the protocol of the study.
* All patients filled in the consent form.
* Apicoectomy with retrograde amalgam filling performed for all participant.
* Blood samples were collected in three period of time immediately before and immediately after each surgery and also one week later.
* Each time 10 ml blood was drawn from each patient.
* Analysis of total mercury in blood samples was performed using cold-vapor atomic absorption spectrometry

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* without physician-diagnosed psychological, behavioral, neurological, immunosuppressive, or renal disorders
* having a tooth that required apical surgery

Exclusion Criteria:

* using tobacco and alcohol one week before surgery and during the study
* dealing with mercury in their job like dentists, stonemason, mine workers

Primary outcomes:
measure: Blood mercury concentration
timeFrame: within the 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: School of Dentistry, Isfahan University of Medical Sciences
Study officials:
affiliation: Department of Endodontics and Torabinejad Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences
name: Masoud Saatchi, DDS, MS
role: STUDY_CHAIR
References: