louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01052818: Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Tumor Cells
Keywords: Non small-cell lung cancer
Circulating tumor cells
Carcinoembryonic antigen
Cytokeratin
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2010-01-20
Enrollment: 200
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: Advanced non small-cell lung cancer

Brief summary: The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

Detailed description: In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

Eligibility criteria: Inclusion Criteria:

* Histopathologic diagnosis of non small-cell lung cancer
* Clinical stage IV
* ECOG functional status 0 or 1
* No renal function alteration (GFR \>50%)
* No hepatic function alteration (ALT and AST less than 2 times its normal value)
* Leucocytes more than 2,000/mcl
* Hemoglobin more than 10mg/dL
* Platelets more than 100,000/mcl

Exclusion Criteria:

Non-advanced disease

Primary outcomes:
measure: Response rate, progression-free survival and over-all survival
timeFrame: 4 years
Secondary outcomes:
measure: Quantification of CTCs
timeFrame: 4 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Cancerologia
state: Distrito Federal
Study officials:
affiliation: National Counsil of Science and Technology
name: Oscar Arrieta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arrieta O, Pineda B, Muniz-Hernandez S, Flores D, Ordonez G, Borbolla-Escoboza JR, Orta D. Molecular detection and prognostic value of epithelial markers mRNA expression in peripheral blood of advanced non-small cell lung cancer patients. Cancer Biomark. 2014;14(4):215-23. doi: 10.3233/CBM-140394.
Clinical trial NCT04460118: Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
Official title: Clinical and Radiographic Outcomes in Arthroscopic "Inlay"Bristow Surgery With Screw Fixation vs Suture-button Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder; Dislocation, Chronic
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing the "Inlay" Bristow surgery in our hospital between June 2015 and February 2018.

Brief summary: Retrospective comparative case-cohort study to investigate the efficacy of the modified arthroscopic Bristow-Latarjet surgery and to compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Detailed description: Background：Some studies have advocated the use of suture-button fixation during Bristow-latarjet surgery to reduce complications associated with screw fixation. However, these studies are not comparative studies, and their data are relatively incomplete.

Purpose: To compare the clinical and radiographic outcomes using screw fixation vs suture-button fixation.

Study Design: Retrospective comparative case-cohort study Methods: Patients who underwent the modified arthroscopic Bristow-Latarjet surgery between June 2015 and February 2018 were selected. Shoulders were separated into two groups based on surgical fixation method. Radiological results on 3D CT scan and clinical results were assessed preoperatively, immediately after operation, and postoperatively at 3 months, 6 months, 1 year and during the final follow-up.

Eligibility criteria: Inclusion Criteria:

1. a glenoid defect ≥10%
2. contact sport athletes with a glenoid defect \< 10%
3. failure after Bankart repair.

Exclusion Criteria:

1. epilepsy
2. multidirectional shoulder instability
3. concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps
4. Follow-up was less than 2 years or incomplete follow-up data.

Primary outcomes:
measure: VAS for pain score
timeFrame: 2 years after surgery
measure: ASES score
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Active shoulder ranges of motion
timeFrame: 2 years after surgery
measure: Bone block position
timeFrame: immediately after surgery.
measure: Bone union
timeFrame: 3 months after surgery, 6 months after surgery, 1 year after surgery and 2 years after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: PekingUTH
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Guoqing Cui, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01618318: Glasgow Asthma and Allergy Study
Official title: Cross Sectional Study to Evaluate and Associate Clinical and Laboratory Features of People With Allergic and Non-allergic Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Allergy
Keywords: Asthma
Allergy
Diagnosis
Correlation study
Lead sponsor: National Services for Health Improvement Ltd
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2012-06-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with asthma, non smoker, aged 18 and over.

Brief summary: In the past, doctors separated people with asthma into two groups, those with "allergic asthma" (about 2/3rds of people) and those with "non-allergic asthma". These labels are not much used now as the treatments for all people with asthma don't depend on this classification. However, new treatments for asthma may become available and the classification may again become important. It could be useful for clinicians to know how to identify which patients are likely to benefit from particular treatments.

Additionally, some new blood tests are becoming available and some of these might help to categorise the type of asthma people have. What the study hopes to do is to identify patient features which make a diagnosis of "allergic asthma" more likely and to see which new blood tests are most likely to be helpful in confirming this diagnosis.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 years old and over with a diagnosis of asthma and having received at least two prescriptions for any asthma medication in the last 12 months, who have signed an informed consent form prior to initiation of any study-related procedure

Exclusion Criteria:

* under 18 years
* current smokers
* unwilling or unable to give informed consent
* a clinical diagnosis of COPD
* a history of anaphylaxis (skin prick test)
* participated in any clinical study in the last 12 months

Primary outcomes:
measure: Serum periostin level
timeFrame: 1 day
Secondary outcomes:
measure: skin prick test
timeFrame: 1 day
measure: Serum total IgE
timeFrame: 1 day
measure: Blood eosinophil count
timeFrame: 1 day
measure: Blood neutrophil count
timeFrame: 1 day
measure: Blood CD4 cells that are positive for CRTh2
timeFrame: 1 day
measure: Blood eosinophils expressing CRTh2
timeFrame: 1 day
measure: Spirometry
timeFrame: 1 day
Other outcomes:
Locations:
city: Dartford
country: United Kingdom
facility: NSHI Ltd
state: Kent
Study officials:
affiliation: NSHI Ltd
name: John A Haughney, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486418: European Serrated Adenoma Classification Score
Official title: Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Neoplasms
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing routine colonoscopy

Brief summary: The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.

In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).


Eligibility criteria: Inclusion Criteria:

* indication for colonoscopy
* patients \>= 18 years

Exclusion Criteria:

* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin

Primary outcomes:
measure: Optical diagnosis of each colorectal polyp
timeFrame: Participants will be followed for the duration of the study an expected average of 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der TU München
state: Bayern
Study officials:
References:
Clinical trial NCT00515918: The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Deficiency
Keywords: Iron deficiency
brain
cognition
behavior
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2007-08-14
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this project to examine brain functions and behavior related to ID including sensory ,motor, cognitive and social /emotional functioning, and address unanswered questions about brain and behavior impacts of different timing of ID(pre- and /or postnatal ID) in infants.

Detailed description: Iron deficiency (ID) is the most common single nutrient disorder in the world. Pregnant women and children before pre-school age are at highest risk. Data from animal models provide evidence that early ID affected developing brain in specific regions and functions by varies processes include myelination, dopamine neurotransmitter system, and neurometabolism. These impacts appeared differential at different time of brain development and different brain regions, depending on the timing of ID. The reversibility of these effects also appeared to depend on the timing of ID. This project uses innovative neuropsychologic/ neurophysiologic and behavioral techniques, such as event-related potentials(ERP), ABR and VEP, to study brain functions and behavior related to ID including sensory ,motor, cognitive and social /emotional functioning, and address unanswered questions about brain and behavior impacts of different timing of ID(pre- and /or postnatal ID) in the human infants. This research has the potential to understand reversibility of effects depending on timing of ID and treatment as well as basic understanding of mechanism of impact of ID in human developing brain. It may also have important implications with regard to policy of interventions for different timing of ID, and improve children early development and the quality of population.

Eligibility criteria: Inclusion Criteria:

* Full- term infants

Exclusion Criteria:

* Prematures,
* Perinatal high risk infants(asphyxia,infection etc.),
* Maternal alcohol,
* Smoking,
* Drug abuse,
* Inherited diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University School of Medicine, Children's Hosp
name: Zhengyan Zhao, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06167018: Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).
Official title: Nurse-administered, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult IBS patients with symptoms refractory to standard treatment.

Brief summary: Adult IBS patients with symptoms refractory to standard medical treatment received nurse-administered, gut-directed hypnotherapy. The primary outcome measure was change in gastro-intestinal symptom severity.

Detailed description: IBS patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, were consecutively included in the study. The patients received gut-directed hypnotherapy given by a nurse trained in Cognitive Behavioral Therapy (CBT) and hypnotherapy. Between 2005 and 2015 patients received 8-12 sessions in an individual manner for 12 weeks. From 2016 the treatment was given in a group format. Effects of treatment were measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Eligibility criteria: Inclusion Criteria: IBS diagnosis. -

Exclusion Criteria: Organic GI disease.

-

Primary outcomes:
measure: Change in gastrointestinal symptom severity
timeFrame: Baseline (week 0), during treatment (week 6), at treatment completion (week 8), follow-up (6 months, 1 and 2 years after treatment initiation)
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Magnus Simrén
Study officials:
affiliation: Göteborg University
name: Magnus Simrén, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02579018: Heart Rate Sensing and Response in Persons With Anorexia Nervosa
Official title: Heart Rate Sensing and Response in Persons With Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Exercise
Healthy Adults
Physical Activity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: There are two major goals of this investigation. First, to develop pilot data to justify a larger randomized clinical trial of an intervention designed to train interoceptive signals (IS) and interoceptive responsivity (IR) in persons with Anorexia Nervosa (AN). Second, the investigators will determine whether persons with AN have similar or different IS and IR for heart rate while exercising as compared to age and gender matched controls.

Detailed description: The purpose of this pilot investigation is to assess AN interoceptive sensitivity and responsivity as it pertains to heart rate during exercise. Thirty adults, 18 years and older will be recruited for a cross-sectional comparison of IS and IR in the context of exercise.

Eligibility criteria: Inclusion Criteria: Study participants will include adults with anorexia spectrum disorders and healthy age and gender matched controls. There will be two control groups, one that includes regularly exercising age and gender matched persons and one where controls do not engage in regular exercise.

For those with AN, the following INCLUSION criteria must be met:

* Age ≥ 18 years old
* BMI 25 kg/m2 or less
* Diagnosis of anorexia spectrum disorder
* Medications: Stable use of all medications ≥ three months

For age and gender matched controls, the following INCLUSION criteria must be met:

* Age ≥ 18 years old
* BMI 25 kg/m2 or less
* No diagnosis of anorexia spectrum disorder
* Medications: Stable use of all medications ≥ three months
* Age (+/- 2 years) and gender matched to study participant

Exclusion Criteria:

* History of diabetes, heart disease or taking medications for those conditions
* History of hypertension (high blood pressure) not controlled with medication
* Orthopedic limitations, musculoskeletal disease and/or injury
* Inability to consent
* Lack of transportation to the Duke Center for Living campus

Primary outcomes:
measure: Mean percentage of time in prescribed heart rate range during four bouts of interval exercise training
timeFrame: Baseline only
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medicine - Duke Molecular Physiology Institute
state: North Carolina
Study officials:
affiliation: Director, Duke Center for Eating Disorders
name: Nancy L Zucker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05739318: the Diameter of Double-lumen Tube Measured by Different Methods
Official title: The Accuracy of the Diameter of Double-lumen Tube Measured by Different Methods as a Guide to the Size Selection of Double-lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Procedural Complication
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2023-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.

Detailed description: The comparison of the diameter of double-lumen tube at the cuff of endotracheal and endobronchial during the cuff was collapse or inflated as a guide for the selection of the size of double-lumen tube.

Eligibility criteria: Inclusion Criteria:

BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia

Exclusion Criteria:

Age younger than 18 yr or older than 70 yr

* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation function

Primary outcomes:
measure: Incidence of complications
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The first hospital of Qinhuangdao
state: Hebei
Study officials:
References:
Clinical trial NCT01130818: First-in-Human Single Ascending Dose of GLPG0492
Official title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Bioavailability (solid vs solution, fasting vs fed)
Young healthy subjects
Elderly healthy subjects
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)
* BMI between 18-30 kg/m², inclusive
* non-smoker

Exclusion Criteria:

* elevated PSA
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of single ascending doses in healthy young and elderly subjects.
timeFrame: up to 10 days postdose
Secondary outcomes:
measure: Pharmacokinetics of single oral doses (solution) in young and elderly subjects.
timeFrame: up to 10 days postdose
measure: Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food.
timeFrame: up to 10 days postdose
measure: Determine the maximum tolerated dose in young subjects.
timeFrame: Up to 10 days postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Florence Namour, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Sofie Mesens, MD
role: PRINCIPAL_INVESTIGATOR
References: