louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01427777: 3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
Official title: The Thirty-six-Month Immunogenicity Evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anogenital Human Papilloma Virus Infection
Lead sponsor: Guangxi Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2011-09-02
Enrollment: 300
Sex: ALL
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in V501-030 in Per-protocol population

Brief summary: The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.

Detailed description: All eligible subjects will be enrolled for one visit. A medical history and physical examination will be conducted on all subjects. A 10 mL blood specimen will be collected. All Sera should be shipped to PPD Vaccines and Biologics Laboratory in the US. The serum specimen will be tested at PPD Laboratory with competitive Luminex immunoassay (cLIA) and multiplexed HPV immunoassay. The purpose of the quadrivalent HPV cLIA and multiplex is to detect neutralizing antibody and total IgG to HPV virus-like particles (VLPs), serotypes 6, 11, 16, 18, respectively.

Eligibility criteria: Inclusion Criteria:

* Healthy Chinese subject who participated in V501-030 in Per-protocol population.
* Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
* Subject is willing to give consent/assent.

Exclusion Criteria:

* Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
* Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
* Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Liuzhou
country: China
facility: Liuzhou CDC
state: Guangxi
Study officials:
affiliation: Guangxi CDC
name: Rongcheng Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang T, Liu Y, Li Y, Liao Y, Shou Q, Zheng M, Liao X, Li R. Evaluation on the persistence of anti-HPV immune responses to the quadrivalent HPV vaccine in Chinese females and males: Up to 3.5 years of follow-up. Vaccine. 2018 Mar 7;36(11):1368-1374. doi: 10.1016/j.vaccine.2018.02.006. Epub 2018 Feb 7.
Clinical trial NCT05763277: Ate-Bev Early Response Prediction Model in Advanced HCC
Official title: Developing Atezolizumab-Bevacizumab Treatment Response Early Prediction Model in Advanced Hepatocellular Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Atezolizumab-bevacizumab
Response Evaluation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy in a single tertiary hospital are included.

Brief summary: The prognosis of hepatocellular carcinoma is poor compared to other carcinomas. Many drugs have recently been developed, and recently, atezolizumab-bevacizumab treatment was superior to sorafenib, the conventional treatment for advanced hepatocellular carcinoma. However, there is no information on the evaluation on the evaluation of treatment response for atezolizumab-bevacizumab combination therapy compared to atezolizumab alone or bevacizumab alone. Therefore, this study aimed to create a predictive model that can detect treatment response at an early stage.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy
* Patients willing to participate in this study

Exclusion Criteria:

* Individuals with a history of severe contrast allergy
* Individuals with severe comorbidities (according to the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction.)

Primary outcomes:
measure: progression free survival
timeFrame: the follow up will be continued until June 22th 2025.
Secondary outcomes:
measure: Overall survival
timeFrame: the follow up will be continued until June 22th 2025.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01120977: Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study
Official title: Reference Values for Body Composition Parameters and IGF-I in the Adult NordiNet® International Outcome Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Deficiency
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects are healthy persons in the age 20-70 years, both males and females will be recruited from the city Aarhus in Denmark.

Brief summary: The treatment of Growth Hormone deficiency (GHD) patients with GH, often induce fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness. The objective of this study is to create bioelectric impedance/arm muscle area (BIA/AMA) reference data, as a measurement of hydration status, of healthy persons of both genders in the age 20-70 years.

Detailed description: The treatment of Growth Hormone deficiency (GHD) patients with GH, has since 1994 been approved in several countries. The approval is based on studies that show positive effect on body composition, physiology, lipid profile, bone density and life quality. One often observed side effect is fluid retention; this effect is dose dependent and temporary. The symptoms are swelling of soft tissue and joint stiffness.

By comparing the body bioelectric impedance (BIA) with an Arm Muscle Area (AMA) measurement, it is possible to determine the hydrations status of a person. This measurement is a simple and non invasive method to evaluate the GH dosages applied in the treatment of GHD persons.

The objective of this study is to create BIA/AMA reference data of healthy persons of both genders in the age 20-70 years.

Eligibility criteria: Inclusion Criteria:

* Healthy persons,
* Age 20- 70 years.

Exclusion Criteria:

* Cardiac implanter (pacemaker),
* Heart insufficiency, chronic venuos insufficiency,
* Use of diuretics, desmopressin, neuroleptica, antidepressants, corticosteroids, fludrocotidon,
* Obesity (BMI \> 30),
* Knowledge of changes in electrolyte or water homeostasis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus university hospital NBG
Study officials:
affiliation: University of Aarhus
name: Jens O Jørgnsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556577: Weight Cycle Post Intervention
Official title: Weight Cycle Impacted by Health Lifestyle Post Pharmacotherapy Intervention
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Weight Gain
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

Brief summary: The aim of this follow-up (FU) study is to examine trajectory of body weight impacted by self-reported diet patterns and physical activities in 6 months at 3 monthly intervals from treatment cessation among patients who completed a pharmacotherapy trial. In addition, patient self-reported diet patterns and physical activities at respective time points will be described.

Detailed description: This is a real-world prospective observational study with primary data collection. All participants with a background be recommended to adopt lifestyle intervention as chronic weight management in China clinical practice. This FU study will enroll patients who completed SURMOUNT-CN trials, with planed study duration of 6 months. No investigational medicine is applied in this prospective follow-up study.

Patients are requested to report body weight, waist circumferences, blood pressure, diet, physical activities, and laboratory results if available, at 3 monthly intervals during the 6-month follow-up period. Patients are also asked if they receive any Anti-Obesity medication (AOM) or participate in any interventional clinical trials indicated for weight management during study period. Summary statistics will be respectively applied to examine changes from trial baseline (time at trial randomization, week 0) and study baseline (time at 52 weeks from trial randomization, week 52) to each scheduled follow-up (at week 65 and week 78) by study arms in SURMOUNT-CN trial.

Eligibility criteria: Inclusion Criteria:

* All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

Exclusion Criteria:

* Those in the SURMOUNT-CN trial who denied to participant.

Primary outcomes:
measure: the change in body weight
timeFrame: at week 65 and week 78 from study baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00220077: Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal Cancer
Official title: Determination of the Role of Microarray for Prognosis and Prediction to Chemotherapy Sensitivity in Patients With Operable, Locally Advanced and Metastatic Oesophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oesophageal Cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Knowledge of the impact of gene expression profiling could allow optimisation of chemotherapy regimens for individual patients. It could ensure that patients do not receive a particular form of chemotherapy if it is unlikely to benefit them, and in these circumstances an alternative form of chemotherapy that may prove beneficial could be selected. This information will therefore allow chemotherapy to be tailored to the individual tumour. It may help identify those patients with a poorer prognosis who could be selected for further therapy post surgery or a different treatment strategy at the outset.


Eligibility criteria: Inclusion Criteria:

* Any patient with histologically proven operable ,locally advanced and metastatic oesophageal or gastric carcinoma.

Exclusion Criteria:

* Second malignancy

Primary outcomes:
measure: To determine whether specific gene expression profiles are associated with response in oesophago-gastric cancer.
Secondary outcomes:
measure: Evaluation of the association of gene expression profiling and progression free survival and overall survival in patients with oesophago-gastric cancer.
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: David Cunningham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501977: Retrospective Analysis of Factors Affecting Chronic Postoperative Pain After Thoracotomy
Official title: Retrospective Analysis of Factors Affecting Chronic Postoperative Pain After Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain Syndrome
Thoracotomy
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent elective thoracotomy ASA 1, 2 and 3, 18 years of age and older in Ankara University İbn-i Sina Hospital, Thoracic Surgery operating room between 01.01.2016 and 31.12.2020 were included in the study.

Brief summary: The aim of this retrospective study is to determine the factors affecting the development of chronic pain in patients with thoracotomy in the Thoracic Surgery Operating Rooms of İbn-i Sina Hospital. By identifying these factors, it is aimed to apply the necessary treatments to prevent the development of chronic pain and to improve patient outcomes.

Detailed description: The study included 229 patients ASA 1, 2 and 3, 18 years of age and older, who underwent elective thoracotomy in Ankara University İbn-i Sina Hospital, Thoracic Surgery operating room between 01.01.2016 and 31.12.2020. The medical files and electronic records of the patients were scanned from the system. Age, gender, weight, ASA score, smoking, comorbidities (hypertension, diabetes), drug use, malignancy, chemotherapy history, radiotherapy history, intraoperative and postoperative analgesia method, duration of acute pain, type of surgery, duration of surgery, duration of anesthesia, rib resection, number of chest tubes and duration time, time to apply to the pain clinic, and the analgesic method applied were recorded.

Eligibility criteria: Inclusion Criteria:

* asa 1,2 and 3
* 18 year of age and older
* underwent elective thoracotomy

Exclusion Criteria:

* ASA 4 and 5, emergency or trauma thoracotomy, patients with malignancy infiltrating the chest wall, more than one thoracotomy performed, patients whose cardiovascular or cerebrovascular or musculoskeletal system was affected at a level that would affect their daily activities after surgery, and patients with insufficient data for various reasons

Primary outcomes:
measure: number of patients who had chronic pain after thoracotomy
timeFrame: 3 months
Secondary outcomes:
measure: type of analgesic
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Cigdem Yildirim Guclu
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIM GUCLU
role: STUDY_DIRECTOR
References:
Clinical trial NCT01209377: Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
Official title: Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: standard
fixed
no focus
EMDR treatment with bilateral stimulation via eye movement
EMDR treatment with fixed eyes
Trauma exposition without external stimulus
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University of Giessen
First posted: 2010-09-27
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation reaction, and the duality of alertness focus during trauma exposition causes a distraction of the traumatic topic.

Within a randomized controlled study 120 patients will be treated during 8 therapeutical sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after treatment (max 8 sessions of psychotherapy).

The following hypothesis are investigated in the study:

1. EMDR treatment with bilateral stimulation through eye movements will be followed significant larger reduction in CAPS compared with EMDR treatment without bilateral stimulation (specific treatment effect of eye movements)
2. EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared with EMDR without external focus (specific treatment effect of distraction)


Eligibility criteria: Inclusion Criteria:

* the participant is able to reduce stress symptoms
* no actual contact to offender

Exclusion Criteria:

* drug or alcohol addiction
* inability to tell about the traumatic events
* cardiac problems

Primary outcomes:
measure: CAPS-2: Clinical Administered PTSD Scale
timeFrame: 30 minutes
Secondary outcomes:
measure: IES - Impact of Events Scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Martin Sack, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01332877: Breakfast Size and Weight Loss in Overweight/Obese Adults
Official title: The Effect of Breakfast Enriched With Protein and Carbohydrates on Weight Loss, Hunger, Satiety and Ghrelin in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
Weight loss
Ghrelin
Satiety
Hunger
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: EFFECT OF HIGH CARBOHYDRATE AND HIGH PROTEIN BREAKFAST ON WEIGHT LOSS, GHRELIN, HUNGER AND CRAVING SCORES IN OBESE MEN AND WOMEN. D Jakubowicz, M Boaz, J Wainstein, O Froy

Background: Obesity underlying endocrine, metabolic and eating behaviour features promotes weight gain, increase of hunger, and carbohydrate (Carb) craving. Restrictive diets either in calories or Carb produce withdrawal effect, that further exacerbate Carb craving resulting in rapid return of obesity. Meal timing and composition has shown to play a pivotal role in appetite regulation through several hormonal systems such as ghrelin. The investigators hypothesized that to be successful; a weight loss strategy must change the hormonal environment to increase satiety while reducing hunger and craving.

Objectives: To assess weight loss, satiety, hunger, cravings and ghrelin response to two isocaloric diets. Additionally, these outcomes were measured in response to meal challenge.

Methods: In this randomized, treatment controlled clinical trial, 146 obese, sedentary adults with impaired glucose tolerance will be assigned to Low carb diet (LCHbd) or an isocaloric diet with a high carb, high protein breakfast (HCPbd),1400 kcal for women and 1600 kcal for men. LCHbd breakfast will provide 300 kcal with carb: protein: fat of 13:40:48. HCPbd breakfast will provide 600 kcal with 50:20:30. From baseline until week 16 participants will take part in a supervised weight loss diet, followed until week 32 by a maintenance period. Anthropometric measures, OGTT for glucose and insulin, VAS-measured hunger and satiety and Food Craving Inventory Analysis will be performed at baseline, week 16 and week 32.


Eligibility criteria: Inclusion Criteria:

* adult
* male and female
* obese
* sedentary
* glucose intolerant/insulin resistant

Exclusion Criteria:

* pregnant/lactating
* malignancy
* taking weight loss medications
* know eating disorder

Primary outcomes:
measure: Weight loss
timeFrame: 32 weeks
Secondary outcomes:
measure: Hunger
timeFrame: 32 weeks
measure: Satiety
timeFrame: 32 weeks
measure: plasma ghrelin
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
Clinical trial NCT01379677: Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
Official title: Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Myocardial perfusion imaging
Rubidium
Technetium
Lead sponsor: Advanced Accelerator Applications
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 135
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).


Eligibility criteria: Inclusion Criteria:

* Referred for scintigraphy to assess myocardial ischaemia
* Ability to give informed written consent.

Exclusion Criteria:

* Impaired capacity to consent
* Pregnancy, or breastfeeding
* Allergy to iv contrast
* Renal failure
* Severe Uncontrolled asthma
* Claustrophobia

Primary outcomes:
measure: The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
timeFrame: Up to 2 days
Secondary outcomes:
measure: Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
timeFrame: Up to 2 days
measure: Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
timeFrame: Up to 2 days
measure: Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.
timeFrame: Up to 2 days
measure: Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospital London NHS Foundation Trust
Study officials:
affiliation: University College Hospital London NHS Foundation Trust
name: Leon Menezes, Dr.
role: PRINCIPAL_INVESTIGATOR
References: