louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03403218: Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test
Official title: Translation and Validation of the Spanish Version of the BESTest and Mini-BESTest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: balance, risk of falling
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
Collaborators: name: Instituto Aragones de Ciencias de la Salud
First posted: 2018-01-18
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group assignment. cross-sectional survey.
Primary purpose: BASIC_SCIENCE

Brief summary: This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population.

Detailed description: To translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish. Check its metric properties in relation to other balance tests.

Eligibility criteria: Inclusion Criteria: healthy subjects without diagnosed balance problems.

-

Exclusion Criteria:

* Diagnosed balance problems.
* One falling in the last three months.

Primary outcomes:
measure: Concurrent validity of Best test- 1
timeFrame: 1 month
Secondary outcomes:
measure: Psychometric properties of Spanish version of BESTest.
timeFrame: 1 year
measure: Psychometric properties of Spanish version of mini-BESTest.
timeFrame: 1 year
Other outcomes:
measure: concurrent validity of mini-BESTest
timeFrame: 1 month
Locations:
city: Zaragoza
country: Spain
facility: Facultad de Ciencias de la Salud
Study officials:
affiliation: Instituto de Investigacion Sanitaria de Aragon
name: Angel Mr Lanas-Arbeloa
role: STUDY_CHAIR
References:
citation: Dominguez-Olivan P, Gasch-Gallen A, Aguas-Garcia E, Bengoetxea A. Validity and reliability testing of the Spanish version of the BESTest and mini-BESTest in healthy community-dwelling elderly. BMC Geriatr. 2020 Nov 4;20(1):444. doi: 10.1186/s12877-020-01724-3.
Clinical trial NCT02898818: Vaginal and Oral Microbiome Crosstalk
Official title: EMMI - Emättimen Mikrobiomi - Emättimen ja Suun Limakalvojen Vuorovaikutus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Vaginal Discharge
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Oulu University Hospital
First posted: 2016-09-13
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients coming to Turku University Hospital Dermato-Venereology Department for venereal disease tests with or without vaginal discharge. Patients coming to Turku University Hospital Gynaecology Department by remission because of atypical papa smear test result or (controls) for some other reason. Patients coming to family planning clinics in The wellbeing services county of Southwest Finland.

Brief summary: To study the vaginal and oral microbiome by swab samples. On selected cases, also papa smear will be studied.

Detailed description: To study the vaginal and oral microbiome by swab samples and on selected groups, by papa smear test, to find out the constitution of normal and vaginal microbiome and the cross-talk between oral and vaginal mucosa. To find out about the impact of human papilloma virus on the microbiome and vice versa.

Eligibility criteria: Inclusion Criteria:

* patients coming to Turku University Hospital Dermato-Venereology or Gynaecology Departments or to family planning clinics in The wellbeing services county of Southwest Finland for previously mentioned reasons

Exclusion Criteria:

* those not meeting the criteria

Primary outcomes:
measure: microbiome, papa smear
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: specialist
name: Niina K Hieta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01827618: Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
Official title: An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Invasive Bladder Cancer Stage II
Keywords: bladder
Cancer
Cystectomy
Rapamycin
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 29
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: This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.

Detailed description: This is a presurgical clinical trial which aims to understand the biologic activity of TORC1 inhibition and safety in patients with bladder cancer. In this presurgical setting, paired PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and correlation of biomarkers with clinical activity.

Eligibility criteria: Inclusion Criteria:

1. Have invasive (≥T1) bladder cancer
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. In their treating physician's opinion is a good candidate for radical cystectomy
4. In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy
5. Be able to give informed consent
6. Be age 18 or older
7. Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin \>9.5 gm/dl or platelets more than 100,000 cells/mm3).
8. Have adequate end-organ function (GFR \>30, bilirubin \<1.5, SGOT \< 3x ULN)
9. Have a life expectancy \> one year
10. Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment
11. Not have received chemotherapy or radiotherapy in the prior 30 days

Exclusion Criteria:

1. Immunosuppressed state (e.g. HIV, use of chronic steroids)
2. Fixed disease (clinical T4)
3. Active, uncontrolled infections
4. Hepatic impairment (SGOT \>3x ULN)
5. Unhealed wounds
6. Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.

Primary outcomes:
measure: Tissue pharmacodynamic (PD) response to TORC1 inhibition
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health Science Center San Antonio
state: Texas
Study officials:
affiliation: UT Health Science Center San Antonio
name: Robert S Svatek, MD,MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03000218: Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems
Official title: Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Overweight
Abnormal Liver Function Tests
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration

Detailed description: This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled, multiple drug administration design. The purpose of this study is as follows; To evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid administration

Eligibility criteria: Inclusion Criteria:

* Healthy Subjects aged 18 - 50 years
* A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2.
* A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator

Primary outcomes:
measure: Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
timeFrame: Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h
measure: Change from Baseline Low-density lipoprotein cholesterol at 8 weeks
timeFrame: Day 1, 29, 57, 71 predose (0h)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae-Yong Chung, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240418: Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
Official title: Initiative in LYon for Lung cAncer Screening Development - Prevalence Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Screening
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 4595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Civil Hospices of Lyon is the second largest university hospital in France, with 23000 staff.

Brief summary: Screening at-risk subjects with low-dose computed tomography (CT) efficiently reduces lung cancer specific mortality. However screening efficiency relies on the at-risk population's criteria definition and its participation rate to the screening. In France, there are concerns regarding the participation rates to national cancer screening that are quite low (around 50% and 32% of the eligible population for breast cancer and colorectal cancer respectively). Before organizing national lung cancer screening it is then crucial to determine the factors impacting the at-risk subjects willingness to participate in lung cancer screening.

The Lyon University Hospital is the second biggest hospital in France with more than 23,000 employees distributed among more than 160 professions representing every level of education or working conditions. Its population is heterogeneous and wide enough to perform a prevalence study assessing the willingness to participate among the at-risk population.

ILYAD is a prospective study performed by anonymous questionnaires that will be submitted to the 23,000 employees of the Lyon University Hospital. The study main objective is to evaluate the at-risk population presence in the Lyon University Hospital population, as defined by NELSON criteria and selection criteria for lung cancer screening (PLCOm2012 scoring), and its willingness to participate to a lung-cancer screening with low-dose CT. This might help further efficient national lung cancer screening campaign organization.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Employee from the Lyon University Hospital (receiving salary from the Lyon University Hospital)
* Person who has willingness to respond the survey

Exclusion Criteria:

* Employees not hired by the Lyon University Hospital
* Employees who have not willingness to participate in the survey

Primary outcomes:
measure: Number of employees belonging to the at-risk population for lung cancer and consequently eligible to lung cancer screening.
timeFrame: Day 0 (at inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02231541: Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
Official title: Effectiveness of Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromylgia
Magnetic Fields
Pain
Visual Analogue scale
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.


Eligibility criteria: Inclusion Criteria:

* Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
* Subjects aged between 18 and 60 years

Exclusion Criteria:

* Pregnant patients
* Patients with pacemaker or other metal implants
* Systemic infectious disorders
* Neoplastic disorders
* Epilepsy
* Severe heart disease

Primary outcomes:
measure: Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change of Fibromylgia Impact Questionnaire (FIQ) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of Fibromylgia Assessment Status (FAS) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Umberto I Hospital, Sapienza University of Rome
name: Vincenzo Maria Saraceni
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolucci T, Piccinini G, Iosa M, Piermattei C, de Angelis S, Grasso MR, Zangrando F, Saraceni VM. Efficacy of extremely low-frequency magnetic field in fibromyalgia pain: A pilot study. J Rehabil Res Dev. 2016;53(6):1023-1034. doi: 10.1682/JRRD.2015.04.0061.
Clinical trial NCT00822341: Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
Official title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Single Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TG-0054 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: GPCR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female 18 to 45 years of age inclusive
* Body mass index (BMI) in the range of 19.0 to 30.0 kg/m² and body weight ≥ 50 kg inclusive
* Good physical and mental health status determined on the basis of the medical history and a general clinical examination
* Subjects must have used a consistent form of acceptable oral birth control or the double barrier method (intrauterine device (IUD) plus condom, spermicidal gel plus condom) for at least 3 months prior to study initiation

Exclusion Criteria:

* Any medical condition (other than a self-limited illness) that requires ongoing and current medical attention
* History of any other hematologic disorders including thromboembolic disease or anemia
* Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
* Subjects who currently smoke (intake nicotine or nicotine-containing products) or have given up smoking for less than 6 months before the first administration of study drug
* Subjects who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody or who are Human Immunodeficiency Virus (HIV) antibody positive

Primary outcomes:
measure: To assess the safety and tolerability for a single IV dose of TG-0054
measure: To determine the maximum tolerated dose (MTD) of TG-0054
Secondary outcomes:
measure: To assess the plasma pharmacokinetics (PK) profile of TG-0054
measure: To assess the pharmacodynamic (PD) effects of TG-0054 via CD34+stem cell, CD133+ progenitor cell counts; white blood cell (WBC), red blood cell (RBC), platelet, and differential counts
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center
state: Maryland
Study officials:
affiliation: PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center
name: Ronald Goldwater, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04823741: Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma
Official title: Molecular, Pathologic Intra Tumoral Heterogeneity in Malignant Pleural Mesothelioma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mesothelioma, Malignant
Gene Abnormality
Pleural Mesothelioma
Keywords: malignant pleural mesothelioma
intra tumoral heterogeneity
genetic abnormalities
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient with suspected malignant pleural mesothelioma requiring surgical biopsy for diagnosis

Brief summary: Malignant pleural mesothelioma (MPM) is a rare pleural cancer, which could be primary or secondary to an asbestos exposure. To enhance our knowledge of this rare disease, an exploration of genetic and tumor mechanism is mandatory. One of the principal difficulty is to harvest sufficient tumour pieces to perform multi-omics analysis. The goal of the SCITH-MESO study is to harvest larges pieces of tumour during a routine surgical procedure of MPM diagnosis by mean of pleural biopsies during VATS surgery. Operating samples will increase a tissue bank collection (CRB).


Eligibility criteria: Inclusion Criteria:

* age \>18
* suspected MPM requiring VATS biopsy after multidisciplinary oncologic board validation
* patient able to understand study objectives and able to give an informed consent
* patient affiliated to an healthcare society.

Exclusion Criteria:

* pregnancy
* mental disease, psychiatric disorder
* patient under protection regimen

Primary outcomes:
measure: For patients with MPM, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
timeFrame: day 1 (day of chirurgie)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Département de chirurgie thoracique
Study officials:
References:
Clinical trial NCT03591341: Melatonin Degradation Rate in Human Milk
Official title: Melatonin Degradation Rate in Human Milk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Infant
Lactation
Keywords: melatonin
breast milk
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women who are breast feeding

Brief summary: Our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants. Prior to testing this, we need to learn the pharmacokinetics of melatonin in vitro.

In this preliminary research we would like to check the levels of melatonin in breast milk pumped during the night, and evaluate the rate of degradation of the melatonin to determine the half life of melatonin in pumped breast milk (in vitro).

Detailed description: The study includes 10 nursing women. Each woman will bring a frozen 5 ml sample of breast milk that was pumped at 03:00 AM. The samples will be collected at the NICU department of Carmel Medical Center and will be stored at deep freeze (-20°C). The samples will be numerically coded and will be kept anonimously. After defrosting the samples, melatonin concentration will be checked in the hospital laboratory every hour, for 4 hours. If meltonin levels will be detectable after 4 hours, continous measurements will be done at 8 hours and at 12 hours after defrosting. The samples will be tested with IBL Melatonin ELISA kit. For control we will use breast milk that was pumped at 10:00 am (when melatonin excretion is minimal). At the end of the analysis the samples will be thrown away.

Eligibility criteria: Inclusion Criteria:

1. Women that are breast feeding and will pump and freeze a milk sample at 03:00 AM
2. Women at least one week after delivery

Exclusion Criteria:

1. A sample that will not be freezed right after the pump
2. Women that are taking hypnotic drugs
3. Women that are taking melatonin

Primary outcomes:
measure: melatonin stability in human milk
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: michal molad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen Engler A, Hadash A, Shehadeh N, Pillar G. Breastfeeding may improve nocturnal sleep and reduce infantile colic: potential role of breast milk melatonin. Eur J Pediatr. 2012 Apr;171(4):729-32. doi: 10.1007/s00431-011-1659-3. Epub 2011 Dec 29.
citation: Katzer D, Pauli L, Mueller A, Reutter H, Reinsberg J, Fimmers R, Bartmann P, Bagci S. Melatonin Concentrations and Antioxidative Capacity of Human Breast Milk According to Gestational Age and the Time of Day. J Hum Lact. 2016 Nov;32(4):NP105-NP110. doi: 10.1177/0890334415625217. Epub 2016 Jul 10.