louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00337545: Phase II Trial of RAD001 in Refractory Colorectal Cancer
Official title: Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Metastatic
Refractory
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-06-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single center open-label study of an oral agent (RAD001) in subjects with metastatic colorectal cancer refractory to at least 2 standard chemo/biologic regimens.

Detailed description: Study is completed and closed.

Eligibility criteria: Inclusion Criteria:

* Metastatic colorectal cancer refractory to at least 2 chemo/biologic regimens
* Measurable disease
* ECOG 0-2

Exclusion Criteria:

* CNS disease
* Chemotherapy or radiotherapy \< 4 weeks prior
* Active bleeding diathesis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Cancer Institute
name: Philip Gold, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01585545: Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
Official title: Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lung Cancer
Keywords: CT
PET CT
MRI
cancer genomics
Radiomics
Radiogenomics
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with non-small cell lung cancer

Brief summary: The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.

Detailed description: To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients

Eligibility criteria: Inclusion Criteria:

* Suspected lung cancer on chest CT or histologically proven NSCLC
* Participant is being considered for the conventional/neoadjuvant/targeted chemotherapy or surgery
* At least one measurable primary or other intrathoracic lesion \>= 2cm, according to RECIST
* Performance status of 0 to 2 on the ECOG scale
* Age 20 years or older
* Able to tolerable PET/CT and CT imaging required by protocol
* Able to undergo percutaneous needle biopsy before and after chemotherapy
* Able to give study-specific informed consent

Exclusion Criteria:

* Poorly controlled diabetes
* Contraindication for CT contrast agent

Primary outcomes:
measure: Functional and genomic profiling of lung cancer
timeFrame: five years
Secondary outcomes:
measure: Relationship between genomic and multiparametric imaging profiling
timeFrame: five years
measure: Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection.
timeFrame: five years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ho Yun Lee, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01810445: Endoscopic Subsurface Optical Imaging for Cancer Detection
Official title: Endoscopic Subsurface Optical Imaging for Cancer Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Bladder Cancer
Laser
Optical
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients already scheduled to undergo a bladder surgery at UCDMC.

Brief summary: The purpose of this pilot study is to develop the methodology for an innovative subsurface imaging technology that was designed at Lawrence Livermore National Laboratory. It will allow the non-invasive analysis and imaging of tissues and chemical distributions in the body at an imaging depth of up to 1 centimeter with spatial resolution on the order of 1 mm.

Detailed description: This is a pilot, feasibility study to determine if the subsurface imaging technology warrants advancement to a larger clinical trial.

Eligibility criteria: Inclusion Criteria:

* Patient must be scheduled for a bladder procedure (TURBT or Cystectomy) at the University of California Davis Medical Center.

Exclusion Criteria:

* Non bladder surgical procedures at University of California Davis Medical Center.

Primary outcomes:
measure: Accuracy of the subsurface laser to determine cancer cells versus normal cells when viewed endoscopically during a surgical procedure.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Stavros Demos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969045: Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy
Official title: Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Administration of Local Anaesthetics With a Special Atomizing Set Durching Fexible Bronchoscopy
Keywords: felxible bronchoscopy
anaesthetics
transcutaneous pCO2
capillary pCO2
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this prospective study is to examine the benefits und risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.


Eligibility criteria: Inclusion Criteria:

* bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (suspected lung cancer, interstitial lung disease, unexplained pulmonary opacities)
* hospitalized patients
* patients aged 18 years or above
* written informed consent prior to study participation

Exclusion Criteria:

* known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 \> 55 mmHg) or pCO2 \> 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
* women, who are pregnant or breastfeeding
* alcohol or drug abuse
* expected non-compliance
* patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
* Participation on another clinical trial within the last 3 months
* subjects who are committed to an institution and/or penitentiary by judicial or official order.
* employees of the investigator cooperation companies.

Primary outcomes:
measure: Amount of anaesthetics during fexible bronchoscopy
timeFrame: one hour
Secondary outcomes:
measure: pCO2
timeFrame: two hours
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Cardiology, Pneumology, Vascular Medicine and Intensive Care Medicine, RWTH Aachen University Hospital
name: Tobias Müller, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01140945: Association Study Between Periodontal Disease and Male Infertility
Official title: Periodontal Status of Males Attending in Vitro Fertilization Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Sub-fertility
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-06-10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males attending in vitro fertiliztion clinic

Brief summary: The aim of the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.

Detailed description: An association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. Anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of Gingivitis and Periodontitis.

However, its possible association with male infertility have not yet been investigated.

Eligibility criteria: Inclusion Criteria:

* Consent to participate in study

Exclusion Criteria:

* Systemic uncontrolled disease

Primary outcomes:
measure: Positive association between periodontitis and infertility
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah medical organization
Study officials:
References:
citation: Klinger A, Hain B, Yaffe H, Schonberger O. Periodontal status of males attending an in vitro fertilization clinic. J Clin Periodontol. 2011 Jun;38(6):542-6. doi: 10.1111/j.1600-051X.2011.01720.x. Epub 2011 Mar 28.
Clinical trial NCT04688645: Balanced Crystalloid Solutions for Acute Pancreatitis
Official title: Treatment With Balanced Crystalloid Solutions in the Early Phase of Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pancreatitis
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
Collaborators: name: University of Rijeka
First posted: 2020-12-30
Enrollment: 276
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: Patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. The intervention group will receive a balanced crystalloid (Plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. The control group will receive normal saline at the same rate.


Eligibility criteria: Inclusion Criteria:

- patients diagnosed with acute pancreatitis based on the revised Atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis

Exclusion Criteria:

* chronic pancreatitis
* liver cirrhosis (Child-Pugh B and C)
* chronic hearth failure (NYHA\>II)
* acute coronary syndrome
* cardiovascular intervention within 60 days before randomization
* chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease
* chronic kidney disease (eGFR \<30 ml/min/1.73 m2)
* concomitant biliary infection (cholecystitis, cholangitis)
* severe autoimmune disease
* chronic active infection (TBC, AIDS)
* metastatic malignant disease
* primary pancreatic neoplasm
* patients transferred from other hospitals
* pregnancy and ongoing breastfeeding
* not willing to participate

Primary outcomes:
measure: Number of Participants with New Onset Systemic inflammatory response syndrome (SIRS)
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Number of participants with organ failure (transitory and persistent)
timeFrame: 30 days
measure: Number of participants with local complications
timeFrame: 30 days
measure: Number od participants with systemic complications
timeFrame: 30 days
measure: Number of participants with infected pancreatic necrosis
timeFrame: 30 days
measure: Number of participants needing endoscopic / percutaneous / surgical interventions
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Rijeka
country: Croatia
facility: University Hospital Rijeka
Study officials:
References:
Clinical trial NCT05102045: The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
Official title: The Effects of Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise on Cognition, Balance and Functional Brain Networks in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Repetitive Transcranial Magnetic Stimulation
Cognitive Function
Aerobic Exercise
Functional MRI
Resting State Networks
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: The purpose of this study was to investigate the effects of high-frequency repetitive Transcranial Magnetic Stimulation (rTMS) in Alzheimer's Disease (AD).

Methods: Twenty-seven AD patients aged ≥60 years were included in the study and divided into 3 groups (rTMS, Aerobic Exercise (AE) and control). All groups received pharmacological treatment. rTMS group (n=10) received 20 Hz rTMS treatment on bilateral dorsolateral prefrontal cortex, 5 days a week over 2 weeks, and AE group (n=10) received the moderate-intensity aerobic exercise for 50 min sessions, 5 days a week over 2 weeks. Control group (n=10) was only treated pharmacologically. Neuropsychiatric and behavioral status, cognition, balance, functional mobility, and quality of life, and functional brain changes were evaluated before and after the treatment.


Eligibility criteria: Inclusion Criteria:

* having clinical AD diagnosis according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) criteria
* being 60 years and older
* having Clinical Dementia Rating Scale (CDR) scores 1 or 2
* living independently

Exclusion Criteria:

* not being able to walk independently,
* having physical disabilities,
* having a history of alcohol / substance abuse,
* having head trauma
* having epileptic seizures

Primary outcomes:
measure: Functional Magnetic Resonance Imaging
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Neuropsychometric test battery
timeFrame: 4 weeks after baseline
measure: Mini Mental State Examination Test
timeFrame: 4 weeks after baseline
measure: Neuropsychiatric Inventory Questionnaire
timeFrame: 4 weeks after baseline
measure: Berg Balance Scale
timeFrame: 4 weeks after baseline
measure: Timed Up and Go Test
timeFrame: 4 weeks after baseline
measure: Quality of Life in Alzheimer's Disease Scale
timeFrame: 4 weeks after baseline
measure: Frontal Behavioral Inventory
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
References:
Clinical trial NCT06669845: Prospective Study of the Variation in the Angle of Anteflexion of the Uterus Before and After Micturition in Nulliparous Women With Uterine Anteversion.
Official title: Prospective Study of the Variation in the Angle of Anteflexion of the Uterus Before and After Micturition in Nulliparous Women With Uterine Anteversion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Anteflexion
Keywords: Uterine anteflexion
Nulliparous women
Full bladder
Ultrasound measurements
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A monocentric, prospective, comparative, and descriptive clinical study examining the uterine anteflexion angle before and after bladder emptying in nulliparous women with uterine anteversion. The study aims to assess how bladder fullness affects the anteflexion angle, which may impact the ease of intrauterine device (IUD) insertion. The primary objective is to determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion. Ultrasound measurements will be taken before and after bladder emptying. A secondary objective is to determine the prevalence of uterine anteversion in nulliparous women.


Eligibility criteria: Inclusion Criteria:

* Women aged 18 and over;
* Nulliparous ;
* Feeling the need to urinate;
* Affiliated to a Social Security scheme.

Exclusion Criteria:

* Pregnant women;
* Desire of pregnancy with conception in progress;
* Primary amenorrhea ;
* Menopause ;
* Previous surgical termination of pregnancy;
* Previous medical abortion;
* Previous hysterectomy ;
* Previous conization;
* Absence of uterus;
* Irrepressible need to urinate;
* Inability or refusal to participate in the study.

Primary outcomes:
measure: To determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT02941445: Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Body Weight
Keywords: DPP4-inhibitors
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.


Eligibility criteria: Inclusion Criteria:

* 18 years old to menopause
* polycystic ovary syndrome (NICHD criteria)
* BMI of 30kg/m2 or higher

Exclusion Criteria:

* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* personal or family history of multiple endocrine neoplasia type 2
* significant cardiovascular, kidney or hepatic disease
* the use of statins, within 90 days prior to study entry

Primary outcomes:
measure: Change in body weight.
timeFrame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.
Secondary outcomes:
measure: Change in body mass indey (BMI).
timeFrame: Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Centre Ljubljana
name: Andrej Janež, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02223845: Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.
Official title: Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Music, Anxiety, IVF
Lead sponsor: University of Southampton
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.

Detailed description: An assessor-blinded randomized case control study in an IVF center, England UK will randomise women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior to, and immediately following a post-treatment observation period. Total scores will be compared.

Eligibility criteria: Inclusion Criteria:

Eligible participants were women aged between 25-40 years, undergoing IVF or ICSI with fresh or frozen embryos to completion from February 2013 to December 2013.

Exclusion Criteria:

Women unable to consent or with hearing impairment were excluded.

Primary outcomes:
measure: Anxiety level
timeFrame: 20 minutes
Secondary outcomes:
measure: Background anxiety
timeFrame: 20 minutes prior to ET
measure: Quality of life scores
timeFrame: 20 minutes prior to ET
measure: Ongoing pregnancy rate
timeFrame: At 2 weeks and 6 weeks after ET
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Complete Fertility
state: Hampshire
Study officials:
References: