louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01263327: Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
Official title: An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Cancer
Keywords: human papillomavirus vaccine
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
First posted: 2010-12-20
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.


Eligibility criteria: Inclusion Criteria:

* Written informed consent from the subject prior to enrolment;
* Female between, and including, 18 and 55 years of age at the time of enrolment;
* Subjects must be free of obvious health problems;
* Not pregnant and having no plan for pregnancy;

Exclusion Criteria:

* Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
* Previous vaccination against HPV;
* Having severe allergic history or other immunodeficiency;
* Chemotherapy and other immunosuppressive agents using;

Primary outcomes:
measure: Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination.
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dongtai
country: China
facility: Jiangsu Provincial Centre for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Centre for Disease Control and Prevention
name: Yue-mei Hu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu YM, Huang SJ, Chu K, Wu T, Wang ZZ, Yang CL, Cai JP, Jiang HM, Wang YJ, Guo M, Liu XH, Huang HJ, Zhu FC, Zhang J, Xia NS. Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial. Hum Vaccin Immunother. 2014;10(2):469-75. doi: 10.4161/hv.26846. Epub 2013 Oct 25.
Clinical trial NCT03460327: Bariatric Surgery and Pharmacokinetics of Candesartan
Official title: Bariatric Surgery and Pharmacokinetics Candesartan: BAR-MEDS Candesartan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Candesartan
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on candesartan are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Candesartan concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06832527: Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries
Official title: Use of Virtual Reality to Improve Sensorimotor Function in Patients with Traumatic Wrist and Hand Injuries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wrist Injury
Keywords: wrist injury
proprioception
virtual reality
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 79
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: The goal of this randomized clinical trial is to compare how the incorporation of Virtual Reality could influence in proprioception, kinesiophobia, functionality and catastrophism in people that are undergoing a rehabilitation treatment after a wrist fracture. The principal questions it aims to answer are:

* Evaluate the effect of using virtual reality added to standard rehabilitation of wrist injuries in proprioception impairment.
* Evaluate the effect of using virtual reality on psychological factors as kinesiophobia and catastrofism.
* Evaluate the effect of using virtual reality in functionality on wrist-injured patients.

Intervention will be:

* Control group: participants of this group will receive conventional rehabilitation of the wrist, plus a specific proprioceptive exercise program.
* Experimental group: participants of this group will receive the same treatment as the control group but adding virtual reality games at the end of the session.

Researchers will compare control and experimental group to see if an implantation of Virtual Reality could had benefits on function, kinesiophobia, catastrofism and proprioception.


Eligibility criteria: Inclusion Criteria:

* Adult (equal or more than 18 y/o).
* Suffering wrist injury
* Agree and sign informed consent.

Exclusion Criteria:

* Not had suffered a wrist injury
* Suffer from any mental, cognitive, neurological or musculoskeletal disorder
* Have cervical pathology/impairment
* Have visual or balance problems

Primary outcomes:
measure: Proprioception
timeFrame: Baseline, 1 and 3 months
Secondary outcomes:
measure: Kinesiophobia
timeFrame: Baseline, 1 and 3 months
measure: Catastrophism
timeFrame: Baseline, 1 and 3 months
measure: Function
timeFrame: Baseline, 1 and 3 months
measure: Hand and Wrist function
timeFrame: Baseline, 1 and 3 months
measure: Range of motion
timeFrame: Baseline, 1 and 3 months
measure: Force Sense
timeFrame: Baseline, 1 and 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03526627: Advanced Care Management in Patients With Advanced Heart Failure
Official title: Advanced Care Management in Patients With Advanced Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Heart Failure
Keywords: advanced care management, advanced heart failure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 227
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with advanced heart disease and received medical treatment now.

Brief summary: The purpose of this study is to explore the trajectory of advanced management care in patients with heart failure over a period of 9 months, then comparing the medical treatment accepted by patients after 2 years later and compliance with the preferences of patients and their families.

Detailed description: this study is to observe the trajectory of the advanced care management on patients with advanced heart failure and follow the difference between the actual medical treatment accepted by patients on 2years later and the preference of the patient and their families.

the advance care management in this study is mean the patients who know about the preference of medical treatment, communication, and prognosis of illness. we also measure the sense of coherence, self-efficacy and their quality of life to compare their relationship of the advanced care management.

Eligibility criteria: Inclusion Criteria:

* diagnosed with AHA stage D, or NYHA class function 4, or LVEF\<=30%.
* has one or more than one symptoms such as dyspnea, lower legs edema, weakness.
* ever admission to the hospital (include emergency room or the general room)

Exclusion Criteria:

* with other end-stage diseases such cancer, dementia, COPD, ESRD...etc.
* had other physical, cognitive, or psychological condition which may influence their answer.

Primary outcomes:
measure: advanced care management
timeFrame: 3 months for each interval and 4 times on each patient (total 9 months on this study)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng
Study officials:
affiliation: National Taiwan University Hospital
name: Kai-di Kao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818727: Bone Density of Newborn Infants to Mothers Treated With Selective Serotonin Reuptake Inhibitor (SSRI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Density
Keywords: Bone density
SSRI
newborn infants
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy term newborn infants to mothers treated with SSRI and healthy controls. bone density mesurment will be applied on the 1-7 days of life.

Brief summary: SSRI treatment in adults was found to decrease bone density. The use of SSRI among pregnant women with depression or anxiety is extendent and raising. The effect of bone density of the infants was not yet evaluated.


Eligibility criteria: Inclusion Criteria:

* Term newborn infants to mothers treated with SSRI and healthy controls

Exclusion Criteria:

* Preterms, major congenital malformations.

Primary outcomes:
measure: bone density
timeFrame: 1 month
measure: bone density
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01615627: Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Official title: Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Keywords: Subcutaneous Treprostinil
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.


Eligibility criteria: Inclusion Criteria:

* PAH by standard criteria
* Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month
* Pain at infusion site (defined as \> 8 on McGill Pain Questionnaire)

Exclusion Criteria:

* Known pregnancy or breastfeeding

Primary outcomes:
measure: Daily Pain Diary
timeFrame: 2 weeks
Secondary outcomes:
measure: McGill Pain Questionnaire
timeFrame: 2 weeks
measure: CAMPHOR quality of life questionnaire
timeFrame: 2 weeks
measure: 6 minute walk distance
timeFrame: 2 weeks
measure: NT-proBNP level
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: David Langleben, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06595927: Clinical Signs and Changes in Cervical Muscles Activity Evaluated by Magnetic Resonance Imaging During an Endurance Test
Official title: Comparison and Correlation of Clinical Signs with Changes in the Activity of the Cervical Muscles Evaluated by Muscle Functional Magnetic Resonance Imaging During the Cervical Cervical Extensor Endurance Test
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Motor Activity
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: University of Liege
First posted: 2024-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this present study is to compare the radio-clinic correlation between the ability to hold the head and neck (by inertial sensor) and the changes in neck muscles activity (by functional magnetic resonance imaging) during the cervical extensor endurance test between an asymptomatic population and one suffering from chronic neck pain.


Eligibility criteria: Inclusion Criteria:

* Neck Disability Index score \> 8/50 for the symptomatic group OR \< 4/50 for the asymptomatic group
* numerical rating scale \< 7/10 for the symptomatic group
* suffering from idiopathic or traumatic chronic neck pain for the neck pain group OR being free of neck pain which required therapeutic, medical or medicinal treatment in the last 12 months.

Exclusion Criteria:

* fibromyalgia, cervical radiculopathy, previous cervical surgery

Primary outcomes:
measure: Change of Cervical muscles metabolism by the transverse relaxation time (T2) values in milliseconds
timeFrame: At baseline and after the endurance test, to assess the change of T2 values
measure: Head and neck movements in degrees or millimetres during the cervical extensor endurance test.
timeFrame: At baseline (just after the first MRI)
Secondary outcomes:
measure: Tandem stand balance test in seconds
timeFrame: During the 7 days following the MRI
measure: Cervical joint position sense error test in millimetres
timeFrame: During the 7 days following the MRI
measure: Head lift test in seconds
timeFrame: During the 7 days following the MRI
measure: Cranio-cervical flexion test in mmHg
timeFrame: During the 7 days following the MRI
measure: Endurance in cranio-cervical flexion test (in percent)
timeFrame: During the 7 days following the MRI
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liege
Study officials:
affiliation: University of Liege
name: Marc MV Vanderthommen, Professor
role: STUDY_CHAIR
References:
citation: Cagnie B, O'Leary S, Elliott J, Peeters I, Parlevliet T, Danneels L. Pain-induced changes in the activity of the cervical extensor muscles evaluated by muscle functional magnetic resonance imaging. Clin J Pain. 2011 Jun;27(5):392-7. doi: 10.1097/AJP.0b013e31820e11a2.
Clinical trial NCT00397527: Acceptability Dermacyd Wipes - Lactoserum - Hygiene
Official title: Safety Dermatological Evaluation: Acceptability With Gynecological Follow up of Dermacyd Wipes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes


Eligibility criteria: The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women;
* Use of antiinflammatory or immunosuppression drugs;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynaecological disease which may interfer in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history.

Primary outcomes:
measure: Adverse events and their association with the treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05626127: MRI-based Clinico-radiomics Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma
Official title: Evaluation of a MRI-based Clinico-radiomics Model in Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma Patients: a Prospective Diagnostic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hilar Cholangiocarcinoma
Keywords: Hilar Cholangiocarcinoma
Lymph Node Metastasis
Radiomics
Machine-learning
Prognosis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had resectable hilar cholangiocarcinoma and completed the upper abdomen MRI examination before surgery.

Brief summary: This is a prospective, observational diagnostic study aiming to assess multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma.

Detailed description: A preoperative tool capable of predicting lymph node metastasis status in hilar cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a machine-learning algorithms of multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma. This study will investigate the relationship between radiomic depth information and tumor biological characteristics. The study includes the construction of capable MRI-based clinico-radiomics prediction model and the validation of the prediction model.

Eligibility criteria: Inclusion Criteria:

1. The patient must sign an informed consent form;
2. Age 18-75 years old, both male and female;
3. ECOG performance status score (PS score) 0-2;
4. Hilar cholangiocarcinoma with resectable tumor lesions;
5. Complete the upper abdomen MRI examination before treatment;

Exclusion Criteria:

1. Accompanied with other primary malignant tumors;
2. Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
3. Incomplete imaging or medical history data.

Primary outcomes:
measure: Lymph node metastasis status
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
name: Chao Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666327: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
Official title: An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Keywords: Crohn's Disease
Ulcerative Colitis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.

Detailed description: This is an open-label, non-randomised, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis).

Eligibility criteria: Inclusion Criteria:

* A body mass index (BMI) ranging from 16 to 34 kg/m2
* Subjects who were diagnosed as Crohn's Disease or Ulcerative Colitis at least 6 months prior to Screening, clinically confirmed either by radiological, endoscopic or histological examination.
* Subjects who have had at least one flare within 18 months prior to Screening.
* Confirmed medical records of inflammatory lesions in intestinal tract

Exclusion Criteria:

* Present or past history of clinically significant gastrointestinal surgery.
* Present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon.
* Known hypersensitivity to any formulation excipients.

Primary outcomes:
measure: Safety and tolerability of single dose of MT-1303 assessed by number of participants with adverse events
timeFrame: 1month
measure: Peak plasma concentration (Cmax) of MT-1303 and its metabolite
timeFrame: 15 time points up to 1 month
measure: Area under the plasma concentration versus time curve (AUC) of MT-1303 and its metabolite
timeFrame: 15 time points up to 1 month
Secondary outcomes:
measure: Pharmacodynamic effect of MT-1303 on lymphocyte count
timeFrame: 16 time points up to 1 month
measure: Exploratory parameter : C-reactive protein (CRP)
timeFrame: 4 time points up to 1 week
measure: Exploratory parameter :Erythrocyte sedimentation (ESR)
timeFrame: 4 time points up to 1 week
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
References: