louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02839824: Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting
Official title: Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting (CALICOL Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation for Colonoscopy
Keywords: bowel cleansing
bowel preparation
Lead sponsor: Casen Recordati S.L.
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have been performed a colonoscopy and who have received a bowel cleansing agent according to the investigator criteria

Brief summary: Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient adherence to investigational products increases in the context of clinical trials. By the same token, efficacy of interventions may be overestimated in clinical trials.

For this reason, an observational study to collect data on the effectiveness of several colonic preparations when these are used under usual clinical practice is proposed.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Subjects who have been performed a colonoscopy

Exclusion Criteria:

* Subjects being previously performed colon surgery.
* Subjects suffering from active inflammatory bowel disease at the time of performing colonoscopy.
* Subjects with extreme limitations due to disease.
* Subjects in who Boston Bowel Preparation Scale (BBPS) is not available
* Subjects who have undergone a colonoscopy during their participation in another clinical study.

Primary outcomes:
measure: Percentage of patients with adequate colon cleansing
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Percentage of patients with adequate colon cleansing of different administration schedules
timeFrame: Through study completion, an average of 6 months
measure: Identify factors influencing bowel cleansing quality
timeFrame: Through study completion, an average of 6 months
measure: Influence of total volume of liquid ingestion in the effectiveness of bowel cleansing agents
timeFrame: Through study completion, an average of 6 months
measure: Patients' tolerance
timeFrame: Through study completion, an average of 6 months
measure: Quality of bowel cleansing comparison among different bowel cleansing agents
timeFrame: Through study completion, an average of 6 months
measure: Subjects' satisfaction
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Clínica de Medicina Integral Diagonal
state: Barcelona
Study officials:
affiliation: Clínica de Medicina Integral Diagonal, Gastroenterology department
name: Ana Bargalló, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01327924: Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
Official title: Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Genetic Disorder
Turner Syndrome
Foetal Growth Problem
Small for Gestational Age
Chronic Kidney Disease
Chronic Renal Insufficiency
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-04-04
Enrollment: 77
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Growth hormone treatment naïve children for whom a prescription of Norditropin NordiFlex® is initiated according to the SPC (Summary of Product Characteristics)

Brief summary: This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.


Eligibility criteria: Inclusion Criteria:

* Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
* Subjects who receive Norditropin NordiFlex® according to the SPC

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Child and/or parent unable to give consent or fill out the questionnaires
* The receipt of any investigational medicinal product within 3 months prior to this study
* Suffer from a life-threatening disease

Primary outcomes:
measure: Usability of growth hormone injection device assessed by a quantitative scale
timeFrame: after 3 months of growth hormone treatment
Secondary outcomes:
measure: Number of adverse events
timeFrame: from 0 - 3 months of growth hormone treatment
measure: Number of technical complaints
timeFrame: from 0 to 3 months of growth hormone treatment
Other outcomes:
Locations:
city: Paris La défense cedex
country: France
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01962324: Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer
Official title: Phase 2 Study of High Risk Prostatae Cancer Treated With Dose-escalated Simultaneous Integrated Boost to Prostate and Lymph Node GTV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Lymphatic Metastasis
Keywords: Quality of Life
Radiotherapy
Radiotherapy, dose-escalation
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 85
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single arm phase 2 study to study the outcome of dose-escalation with simultaneous integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is that we will have fewer relapses in this very high risk patient group compared to matched historical controls with acceptable side effects.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed high risk prostate cancer with a risk of lymphatic spread \>15% according to the MSKCC nomogram (1) http://nomograms.mskcc.org/Prostate/PreTreatment.aspx
* Written informed consent
* \> 18 years
* Fiducial gold markers implanted in the prostate (min 3)

Exclusion Criteria:

* • Non MR-safe implants or other contraindication to MRI

  * WHO PS\>1
  * Previous pelvic irradiation
  * TURP within 6 months
  * IPSS \>19
  * Metastatic disease in skeleton, parenchymal organs or lymph nodes outside the pelvis
  * Creatinin clearance \< 30ml/min according to http://www.fass.se/LIF/produktfakta/kreatinin.jsp

Primary outcomes:
measure: PSA progression free survival
timeFrame: 36 months
Secondary outcomes:
measure: Genitourinary Quality of Life
timeFrame: 0 6 12 36 60 months
measure: Gastrointestinal Quality of Life
timeFrame: 0 6 12 36 60 months
measure: Overall Quality of Life
timeFrame: 0 6 12 36 60 months
measure: Sexual Quality of Life
timeFrame: 0 6 12 36 60 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University, Cancercenter
Study officials:
affiliation: Umea University
name: Camilla Thellenberg Karlsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03773224: Role of Wound Irrigation After Appendectomy
Official title: A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 179
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical site infection is a common problem after open appendectomy. Irrigation of the surgical wound by topical antibiotics has been devised as a measure to reduce the incidence of wound infection. The present trial aims to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution in prevention of superficial surgical site infection after open appendectomy for acute uncomplicated appendicitis.


Eligibility criteria: Inclusion Criteria:

* Adult patients of both genders aging between 18 and 65 years who present with acute appendicitis.
* Patients with perforated appendicitis will be also included.

Exclusion Criteria:

* Patients with appendicular mass, appendicular abscess, generalized peritonitis.
* Patients with other causes of acute abdomen as revealed intraoperatively.
* Patients taking long course of steroid therapy or immunosuppressive treatment,
* Patients unwilling to participate in the trial.

Primary outcomes:
measure: Surgical site infection
timeFrame: 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile
role: STUDY_CHAIR
References:
Clinical trial NCT05322824: Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
Official title: Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Function
Stenosis
Keywords: Cognitive Function
Intracranial / Carotid Stenosis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intracranial / carotid stenosis aged ≥ 40 years

Brief summary: Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 40 years
* ≥ 50% stenosis in unilateral intracranial / carotid artery
* Written informed consent available

Exclusion Criteria:

* Previous history of major head trauma and any intracranial surgery
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* Severe loss of vision, hearing, or communicative ability

Exit Criteria:

* Not meet the inclusion criteria
* For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
* Any adverse or serious adverse events during the study period judged by investigator

Primary outcomes:
measure: Changes in the scores of Mini-mental State Examination
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 2 years
measure: Changes in cerebral glymphatic function
timeFrame: 2 years
measure: Changes in the scores of Montreal Cognitive Assessment
timeFrame: 2 years
measure: Changes in cerebral blood flow in the territory of the culprit artery
timeFrame: 2 years
measure: Changes in the scores of Colour Trail Test
timeFrame: 2 years
measure: Changes in the scores of Hopkins Verbal Learning Test
timeFrame: 2 years
measure: Changes in the scores of clock drawing test
timeFrame: 2 years
measure: Changes in the scores of Animal Fluency Test
timeFrame: 2 years
measure: Changes in the scores of Olfactory stick test
timeFrame: 2 years
measure: Changes in metabonomics
timeFrame: 2 years
Other outcomes:
Locations:
city: HangZhou
country: China
facility: Second Affilated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT01233024: Satiety Response of Four Dietary Fibers
Official title: Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Adult
Women
Dietary Fiber
Satiety Response
Food Intake
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.

The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.


Eligibility criteria: Inclusion Criteria:

* Healthy women
* Age 18-40 years
* Nonsmoking
* Not taking weight loss medications
* Non-dieting (weight has not changed more than 11 pounds over three months)
* BMI between 18.5 and 29
* Spoken and written English literacy

Exclusion Criteria:

* Do not regularly consume breakfast
* Food allergies to wheat, soy, peanut, or dairy
* BMI less than 25 or greater than 29 upon admission to study
* Cancer diagnosis in past 5 years
* History of heart disease, kidney disease, diabetes, or eating disorder
* History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition
* History of drug or alcohol abuse in past 6 months
* Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
* Concurrent or recent (within 30 days) intervention study participation
* Pregnant or lactating
* Irregular menstrual cycle
* Vegetarians
* People who eat more than approximately 15 grams of fiber per day

Primary outcomes:
measure: Satiety response using visual analogue scales
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Secondary outcomes:
measure: Food intake
timeFrame: 180 minutes postprandially and over 24 hours
measure: Breath hydrogen response
timeFrame: 0 and 180 minutes
measure: Gastrointestinal tolerance using visual analogue scales (VAS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00511524: An Imaging Study to Investigate the Distribution of GW842166X in the Brain.
Official title: An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [11C]GW842166 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Inflammatory
Keywords: brain,
inflammation,
CB2,
PET
analgesia,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 6
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought that for the anti-inflammatory action the drug is required to cross inot the brain from the blood. This study aims to look at if the drug crosses into the brain once given orally using an imaging technique called positron emission tomography.


Eligibility criteria: Inclusion Criteria:

* Male aged 50 to 80yrs inclusive at the screening visit.
* subjects with negative HIV and hepatitis B and C test results within 3 months of study start.

Exclusion Criteria:

* A negative Allens test on arm to be used for arterial cannulation.
* Any contraindications to MRI scanning.
* History or presence of hepatic or renal disease.
* Previous involvement in PET or radiological investigations.
* Family history of cancer.
* History of claustrophobia
* Presence of a cardiac pacemaker or any other electronic device or ferromagnetic metal

Primary outcomes:
measure: Rate at which the drug crosses from plasma to brain (ki)using images from the scan
timeFrame: throughout the study
Secondary outcomes:
measure: Safety of drug
timeFrame: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04340024: Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients
Official title: Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Cancer
Prostate Cancer
Other Cancer
Keywords: Radiotherapy
Biomarkers
Genomics
Immunomics
Precision medicine
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: Duke-NUS Graduate Medical School
name: Ferring Pharmaceuticals
name: ImmunoSCAPE
name: Decipher Biosciences
First posted: 2020-04-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from patients of the study team when they attend their regular clinic visits or when they are admitted to the hospital. These are patients from NCCS.

Brief summary: Patients with cancers that are sensitive to radiotherapy treatment and/or patients who have experienced severe acute/ late side effects to radiotherapy will be recruited to the study. Blood and/or matched tumour-normal tissue pairs will be collected. Blood and/or tissue samples will be processed and studied for genetic and biochemical markers that have potential to be used for predicting sensitivity to radiation.


Eligibility criteria: Inclusion Criteria:

* Patients with severe side effects from radiotherapy
* Patients with a type of cancer that is associated with sensitivity to radiotherapy

Exclusion Criteria:

* Age of patient must be between 21 (inclusive) and 99 (exclusive)

Primary outcomes:
measure: To identify genes or molecular pathways that are associated with radiation sensitivity in blood and tissue samples
timeFrame: Blood is taken at informed consent; tissue is from archived sample
measure: Change in immune profile of blood and tissue after radiation
timeFrame: Blood is taken at informed consent; tissue is from archived sample
measure: To identify proteins that are associated with radiation sensitivity in tissue samples
timeFrame: Tissue is from archived sample
measure: To identify RNA expression pathways that are associated with radiation sensitivity in blood and tissue samples
timeFrame: Blood is taken at informed consent; tissue is from archived sample
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Melvin Chua, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02472496: Korean Coronary Overlapping Stenting Registy
Official title: Korean Coronary Overlapping Stenting Registy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with coronary lesion treated with overlapping drug-eluting stents

Brief summary: The Korean Coronary Overlapping Stenting Registry is a multicenter database which includes percutaneous intervention using drug-eluting stents from cardiovascular centers in eight affiliated hospitals of The Catholic University of Korea

Detailed description: The Korean Coronary Overlapping Stenting Registry is a multi-center, real-world of drug-eluting stent overlap.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Drug-eluting stent overlap

Exclusion Criteria:

* Overlap with previous stent
* Cardiogenic shock

Primary outcomes:
measure: Incidence of the composite outcomes of cardiac death, myocardial infarction, and target lesion revascularization
timeFrame: 3 years
Secondary outcomes:
measure: Cardiac death
timeFrame: 3 years
measure: Myocardial infarction
timeFrame: 3 years
measure: Target lesion revascularization
timeFrame: 3 years
measure: stent thrombosis
timeFrame: 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea cardiovascular center
Study officials:
affiliation: The Catholic University of Korea
name: Dong-Bin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raber L, Juni P, Loffel L, Wandel S, Cook S, Wenaweser P, Togni M, Vogel R, Seiler C, Eberli F, Luscher T, Meier B, Windecker S. Impact of stent overlap on angiographic and long-term clinical outcome in patients undergoing drug-eluting stent implantation. J Am Coll Cardiol. 2010 Mar 23;55(12):1178-1188. doi: 10.1016/j.jacc.2009.11.052.