louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01698411: Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders
Official title: Study of the Influence of Sleep on Hemodynamic Parameters in Patients With Sleep Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Sleep
Insomnia
Keywords: hypertension
sleep
insomnia
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-10-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: adult with chronic complain of insomnia

Brief summary: Several epidemiological studies in large cohorts suggest a strong association between sleep duration, complaint of insomnia and risk of hypertension.These findings suggest an important role of sleep quality in development of hypertension. Principal limitations of these studies are the cross-sectional study design, self-report sleep duration and poor measurement of blood pressure. The investigators propose to study an insomniac population with complete evaluation of quality and quantity of sleep, associated to complete hemodynamic measurement of hypertension.

Detailed description: Hypertension and sleep disorders is a cross sectional study realised in an adult cohort with chronic complain of insomnia. In our study, sleep duration is evaluated by complete evaluation of quality and quantity of sleep: one night PSG, associated with sleep agenda during 3 weeks, actigraphy, and several sleep questionnaires. We join to this sleep evaluation, a complete hemodynamic evaluation with: path way velocity and central BP obtained by tonometry, ambulatory BP measurement (ABBM), and self- BP measurement.

The primary objective of this epidemiological study is to show an increase risk of hypertension when sleep duration is less than 7 hours, with objective measurement of sleep duration and hypertension.

Secondary objectives are to evaluate role of complain of insomnia in the risk of hypertension, and to determine cardiovascular risk in insomnia with hemodynamic explorations.

Eligibility criteria: Inclusion Criteria:

* adult with insomnia (6 months or more)

Exclusion Criteria:

* sleep disorders with obstructive apnea

Primary outcomes:
measure: hypertension
timeFrame: one year
Secondary outcomes:
measure: hemodynamic measures
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: centre du sommeil et de la vigilance, Hotel Dieu
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: jacques blacher, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07021911: Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Official title: Concomitant Radiotherapy and New Drugs in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Radiotherapy; Complications
Keywords: breast cancer
radiotherapy
stereotactic radiotherapy (SABR)
side effects
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from stage IV breast cancer undergoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors)

Brief summary: The primary objective of the study is to describe the tolerance profile of radiation treatments performed during systemic treatment with new drugs (molecular targeted therapies, immunotherapy, others).

Detailed description: Patients suffering from stage IV breast cancer undergoing a systemic treatment including: molecular targeted therapy, conjugated antibodies (ADCs), monoclonal antibodies, tyrosine kinase inhibitors (TKI), immunotherapy (ICIs), who are candidates for a radiation treatment (both palliative or curative), after being informed about the study and giving written informed consent, will be considered eligible for this observational study. This study aims to prospectively analyze the tolerance profile of radiation treatments performed during new generation systemic therapy.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from stage IV breast cancer
* Ongoing systemic treatment including: molecular targeted therapy, conjugated antibodies, monoclonal antibodies, tyrosine kinase inhibitors, immunotherapy (immunocheckpoint inhibitors)
* Candidates for radiation treatment (both palliative and curative).

Exclusion Criteria:

* Previous radiation treatment on the same site
* Absolute contraindications to radiotherapy
* Systemic treatment administered as part of a clinical trial

Primary outcomes:
measure: Toxicity of Radiotherapy Treatments
timeFrame: Baseline, at 3, 6 month, one year from the end of radiation treatment, then yearly up to 3 years
Secondary outcomes:
measure: Response to Radiotherapy treatments with curative intent
timeFrame: evaluated at 3 months, 6 months, 1 year from treatments
measure: Pain response to Radiotherapy treatments with palliative intent
timeFrame: evaluated at 3 and 6 months after treatments
measure: Progression free survival (PFS)
timeFrame: every 3 months after radiation treatments
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Radiation Oncology Department Fondazione Policlinico Campus BioMedico
Study officials:
References:
Clinical trial NCT00273611: Vitamin D Levels and Vitamin D Education in Geriatric Patients
Official title: Characterization of Vitamin D Levels and Affect of Pharmacist-initiated Vitamin D Education in Geriatric Outpatients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Insufficiency
Vitamin D Deficiency
Keywords: vitamin D deficiency
geriatric patients
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2006-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Vitamin D is important to maintain good health. Although it is found in foods and vitamins, many people still have low vitamin D levels. One purpose of this study is to describe vitamin D levels from patients at the University of Colorado Seniors Clinic. Another goal of the study is to find out if education by a pharmacist can increase vitamin D levels in patients who have low vitamin D levels.


Eligibility criteria: Inclusion Criteria:

* Patient at the University of Colorado Hospital Seniors Clinic with an appointment in December 2005 or January 2006
* Age 65-89 years

Exclusion Criteria:

* History of dementia or memory loss
* Severe illness or life expectancy less than 6 months
* Assistance with medications from an assisted living facility
* History of celiac Sprue, Crohn's disease, or chronic pancreatitis
* High calcium levels, high parathyroid hormone levels, low phosphorus levels, or very high vitamin D levels
* Taking prescription vitamin D

Primary outcomes:
measure: 25(OH) vitamin D level
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital Seniors Clinic
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sunny Linnebur, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vande Griend JP, Linnebur SA, Ruscin JM, Vondracek SF, Wolfe P, McDermott MT. Vitamin D intervention by pharmacists in geriatric outpatients. J Am Pharm Assoc (2003). 2008 Jul-Aug;48(4):501-7. doi: 10.1331/JAPhA.2008.07056.
Clinical trial NCT00611611: BLYS and IFN in SLE
Official title: BLyS and IFN Responses to Antigen Challenge in Human SLE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Hospital for Special Surgery, New York
First posted: 2008-02-11
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lupus and healthy controls

Brief summary: This protocol tests whether changes in BLyS or IFN can be detected in a normal immune response to a vaccine and, if so, whether the response differs between those with lupus and healthy controls.


Eligibility criteria: Inclusion Criteria:

* ACR lupus criteria
* 18\<age\<65

Exclusion Criteria:

* chronic infection or cancer
* pregnancy

Primary outcomes:
measure: change in specific antibodies in response to vaccine
timeFrame: 2 weeks
Secondary outcomes:
measure: change in BLyS after vaccination
timeFrame: 2 weeks
measure: change in IFN after vaccination
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Robert H Carter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03613311: Evident, Occult and no Demonstrated USI and UDS Findings in Women With ≥Stage II Cystocele
Official title: Prevalence Rates of Evident, Occult and no Demonstrated Urodynamic Stress Incontinence and Their Clinical and Urodynamic Findings in Women With ≥Stage II Cystocele
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urodynamic Stress Incontinence in Severe Cystocele Women
Keywords: Cystocele
Urodynamic stress incontinence
Pad test
Urodynamic study
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 480
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with cystocele more than stage II

Brief summary: Prevalence rates of urodynamic urinary incontinence (USI) subtypes and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation, especially for occult USI. Misdiagnosis of occult USI before cystocele repair might lead to occurrence of de novo stress urinary incontinence after cystocele repair. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Detailed description: Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction. The recruited patients with cystocele were classified into three groups (i.e.,evident USI, occult USI and no demonstrated USI) according to pad weight results before and after prolapse reduction.

Eligibility criteria: Inclusion Criteria:

1. Age \>20y/o
2. Cystocele \> stage II
3. Complete urodynamic study

Exclusion Criteria:

1. Pregnancy
2. Urinary tract infection
3. Previous pelvic reconstruction surgery

Primary outcomes:
measure: Evident USI
timeFrame: Between November 2011 and January 2017
measure: Occult USI
timeFrame: Between November 2011 and January 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03532711: Potential Predictive Biomarkers in Patients Undergoing First-line Chemotherapy for Metastatic Colorectal Cancer
Official title: A Study to Characterize and Evaluate Biomarkers of Chemotherapy in Patients With Metastatic Colorectal Cancer In The First-line Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Chemotherapy Effect
Biomarker
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed metastatic colorectal cancer

Brief summary: Chemoresistance remains an obstacle in treating people with metastatic colorectal cancer (mCRC). Studying samples of blood and tumor tissue in the laboratory from patients with mCRC receiving chemotherapy may help doctors understand the effect of chemotherapy on biomarkers. It may also help doctors predict how patients will respond to treatment. In this study, we aimed to evaluate biomarkers in chemotherapy regimens for first-line chemotherapy for mCRC.


Eligibility criteria: Inclusion Criteria Histologically confirmed metastatic colorectal cancer Unresectable metastatic disease must be confirmed histologically if \> 2 years since primary diagnosis Measurable metastatic disease \> 1 cm by spiral CT scan or \> 2 cm by other methods Scheduled to receive first-line chemotherapy for metastatic disease Chemotherapy must include fluorouracil, capecitabine, irinotecan hydrochloride, or oxaliplatin Exclusion Criteria Inadequate or unusable tissue as the only tissue available Brain metastases or meningeal disease Contraindication to chemotherapy Pregnant or nursing Other severe pathology that is likely to worsen during therapy Dementia or severely impaired mental condition Geographical or psychological reasons that would preclude treatment

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 6 months
measure: Progression Free Survival (PFS)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06600711: Nitazoxanide for Treatment of Cryptosporidium in Children
Official title: Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cryptosporidiosis
Keywords: Nitazoxanide
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2024-09-19
Enrollment: 480
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:

* Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?
* Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool?

Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.

Participants will:

* Take NTZ or placebo for 3 days
* Receive regular visits from field research assistants
* Provide blood and urine samples


Eligibility criteria: Inclusion Criteria:

* tests positive for Cryptosporidium by stool point-of-care test, with or without active diarrhea
* family plans on remaining in the area for next 6 months

Exclusion Criteria:

* history of hypersensitivity to nitazoxanide.
* taking warfarin. Tizoxanide, the metabolite of nitazoxanide is highly bound to plasma proteins and may compete with binding sites of other highly plasma bound drugs with narrow therapeutic indices, including warfarin.
* history of renal insufficiency or a baseline serum creatinine = 40 µmol/L. Renal clearance of the drug has not been studied.
* history of hepatic dysfunction or serum aspartate aminotransferase (AST) ;
* 50 U/L, serum alanine transaminase (ATL) ;
* 50 U/L, or serum bilirubin ;
* 23 µmol/L. Hepatic clearance of the drug has not been studied.

Primary outcomes:
measure: Days of Cryptosporidium-associated diarrhea
timeFrame: 7 days
measure: Time to clearance of Cryptosporidium from stool
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events, total and stratified by age
timeFrame: 6 months
measure: Time-to-first Cryptosporidium infection in sibling
timeFrame: 6 months
measure: Change in weight from baseline to 6 months post-treatment
timeFrame: Baseline, 6 months
measure: Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment
timeFrame: Baseline, 6 months
measure: Change in height-for-age adjusted z-score from baseline to 6 months post treatment
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Poonum Korpe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07006311: Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol
Official title: Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol: A Single-center Pilot Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Lesions
Robotic Assisted Bronchoscopy
Propofol
Bronchoscopy
Bronchoscopy Biopsy
Keywords: Robotic-assisted bronchoscopy
robotic assisted bronchoscopy
diagnosis of lung lesions
moderate sedation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.


Eligibility criteria: Inclusion Criteria:

* informed consent signed by the subject
* aged at least 18 years
* scheduled for bronchoscopy with moderate sedation and tracheal intubation in order to obtain at least 1 specimens of the lung via transbronchial biopsy
* necessary periinterventional laboratory examinations needed for the bronchoscopy
* judgement of the subject

Exclusion Criteria:

* endobronchial lesion causing lobar atelectasis
* inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders or severe neurosis)
* pregnant or lactating women

Primary outcomes:
measure: Confirmation of tool-in-lesion
timeFrame: during the intervention
measure: Acquisition of at least one histological sample
timeFrame: during the intervention
measure: histopathological classification of the pulmonary lesion
timeFrame: From enrollment to the end of treatment at 8 days.
Secondary outcomes:
measure: Procedure duration
timeFrame: during the intervention
measure: Diagnostic yield of biopsies
timeFrame: From enrollment to the end of treatment at 8 days.
measure: diagnostic accuracy for malignancy
timeFrame: From enrollment to the end of treatment of 3 months
measure: cost analysis
timeFrame: From enrollment to the end of treatment at 8 days.
measure: Safety profile
timeFrame: From enrollment to the end of treatment at 8 days.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06183411: Theory of Mind in Children With DCD
Official title: Theory of Mind in Children With DCD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Coordination Disorder
Keywords: Child
Development
Theory of mind
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor).

During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).


Eligibility criteria: Inclusion Criteria:

* Age of child: from six to 12 years old
* Confirmed diagnosis of DCD by a multidisciplinary team (including a physician)
* Child lives in Flanders or the Netherlands
* Child has Dutch as the mother tongue

Exclusion Criteria:

* Diagnosis of autism spectrum disorder (ASD)
* Blood related siblings of the child
* Parent/legal guardian does not have an adequate level of Dutch
* (IQ lower than 70) OR (no IQ information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))

Primary outcomes:
measure: Theory of Mind
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Universiteit Gent - Vakgroep revalidatiewetenschappen
Study officials:
References: