louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03299855: MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
Official title: MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Keywords: oncogeriatric
MMS
MoCA
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: UCOG (Unite de coordination en Onco-Gériatrie)
First posted: 2017-10-03
Enrollment: 104
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Passation of MMS and MoCA tests associated to passation of neuropsychological test
Primary purpose: OTHER

Brief summary: This study concerns elderly patients with cancer with onco-geriatric assessment.

This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.


Eligibility criteria: Inclusion Criteria:

* Patient aged over 70 years
* Patient with cancer (solid tumor or haemopathy) for whom a first line treatment is envisaged (whatever it is). Surgery and radiotherapy are allowed before entry into the study.
* Patient candidate for oncogeriatric assessment
* Patient agree to participate in the study
* Using the French language

Exclusion Criteria:

* Primary central nervous system or cerebral metastasis
* Evolutionary psychiatric pathology known (e.g. schizophrenia)
* Severe Visual and / or Auditory Impairment
* Patients unable to respond to cognitive tests
* Patient (s) deprived of liberty, under guardianship or curatorship
* Refusal of participation

Primary outcomes:
measure: Evaluate the sensitivity of MoCA test
timeFrame: Up 2 months after inclusion, before initiation of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU
city: Cherbourg
country: France
facility: CH
city: Compiègne
country: France
facility: Ch Compiegne
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Lô
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Centre François Baclesse
name: florence JOLY, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462355: Tobacco Smoking Among Crosslinked-keratoconus Patients
Official title: Tobacco Smoking Among Crosslinked-keratoconus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffering from Keratoconus and needing Cross-linking therapy

Brief summary: Certain studies reported that cigarette by-products may make the cornea more rigid, suggesting that it could lead to "natural" CXL of collagen fibers, hence a protective effect for KC. Others have reported that cigarette smoking causes no significant changes in the corneal biomechanics. The aim of this study was to assess a possible link between keratoconus (KC) occurrence and patients' smoking habits.

Detailed description: a telephone Survey was performed among 80 KC patients who were treated from March 2014 until September 2017 by accelerated crosslinking (A-CXL) within the ophthalmology department. From the 80 people we phoned, 62 answered. Our questions were regarding family history, allergic history, and smoking habits. Family history was considered positive if a first-degree or second-degree relative had been diagnosed with KC. Allergies toward any kind of external factors were marked as positive. Patients' smoking habits were recorded and classified into regular, occasional, ex-smoker and non-smoker. The results were confronted to those of the general population by indirect standardization over age and sex according to the "Baromètre Santé 2010" INPES survey (French Nation Institute for Prevention and Health Education).

Eligibility criteria: Inclusion Criteria:

* patients suffering from Keratoconus and needing Cross-linking therapy

Exclusion Criteria:

* none

Primary outcomes:
measure: Percentage of smokers
timeFrame: After 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00889655: A Trial Comparing Bowel Preparation and Patient Tolerability of Miralax Versus Golytely
Official title: A Prospective, Randomized Controlled Trial Comparing the Efficacy and Patient Tolerability of MiraLAX (PEG 3350) vs Golytely as Bowel Preparation for Screening Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonoscopy
Keywords: efficacy of bowel cleansing
patient tolerability
Golytely
MiraLax
colonoscopy preparation
bowel preparation
screening colonoscopy
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 432
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prior to colonoscopies, the colon is cleansed using a laxative. Golytely is approved by the FDA for this purpose. Another laxative, called MiraLax, is approved by the FDA to relieve constipation, but it is not approved specifically for preparation for a colonoscopy. Nonetheless, it is commonly used in clinical practice for this purpose, just as is Golytely. The purpose of this study is to compare Golytely and MiraLax in two ways: to see whether one is better tolerated by patients than the other and to see whether one more effectively cleanses the bowel than the other. The investigators' hypothesis is that these 2 bowel preparation methods are equally effective in bowel cleansing, but that patients prefer Miralax to Golytely.


Eligibility criteria: Inclusion Criteria:

* average risk screening for colon cancer

Exclusion Criteria:

* subjects with a history of constipation

Primary outcomes:
measure: bowel cleanliness as rated by the boston bowel prep survey
timeFrame: measured at the time of colonoscopy
Secondary outcomes:
measure: patient tolerability
timeFrame: measured at check in to colonoscopy
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
Study officials:
References:
citation: Enestvedt BK, Fennerty MB, Eisen GM. Randomised clinical trial: MiraLAX vs. Golytely - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2011 Jan;33(1):33-40. doi: 10.1111/j.1365-2036.2010.04493.x. Epub 2010 Oct 25.
Clinical trial NCT06392555: Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
Official title: Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: BrightHeart
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ultrasound examinations conducted during the second trimester of the pregnancy, containing interpretable 4-chamber, LVOT and ROVT standard views of the fetal heart

Brief summary: Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.


Eligibility criteria: Inclusion Criteria:

* ultrasound examinations conducted during the second trimester of the pregnancy
* fetus between 18 and 24 weeks of gestational age
* mothers 18 years old or older

Exclusion Criteria:

* exams corresponding to multiple pregnancy
* fetal heterotaxy
* exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views

Primary outcomes:
measure: AUC of the ROC curve for the presence of any suspicious finding
timeFrame: 1 month
Secondary outcomes:
measure: AUC of the ROC curve for the presence of each suspicious finding
timeFrame: 1 month
measure: Sensitivity and specificity for both reading conditions for the presence of any suspicious finding
timeFrame: 1 month
measure: Sensitivity and specificity for both reading conditions for the presence of each suspicious finding
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: MFM Associates, PLLC
state: New York
Study officials:
affiliation: Chief Technical Officer
name: Christophe Gardella, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06330155: A Genetic Study for Alzheimer Dementia: Case-control Study
Official title: A Genetic Study for Alzheimer Dementia: Case-control Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer Dementia (AD)
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 Alzheimer's dementia patients 10 healthy subjects

Brief summary: The purpose of this study is to find out the difference in genetic test results between Alzheimer's dementia patients and healthy subjects.

The investigators want to identify genes that are importantly related to Alzheimer's dementia.


Eligibility criteria: 1. Inclusion Criteria: Alzheimer's dementia patient

   * Adult patients over 60 years old
   * Patients with a Alzheimer's dementia patient
   * Total Korean version of mini-mental state examination (K-MMSE) score less than 24
   * Total Clinical Dementia Rating (CDR) over 0.5
2. Inclusion Criteria: healthy subjects

   * Adult healthy over 60 years old
   * Total Korean version of mini-mental state examination (K-MMSE) over 24
   * Total Clinical Dementia Rating (CDR) is 0
3. Exclusion Criteria:

   * Those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition
   * In the case of a person with impaired consent (MMSE less than 10 points), if not accompanied by a guardian
   * Other cases where the researcher determines that participation in this clinical trial is not appropriate (Patients who are participating in other studies or have participated in other studies within the past 30 days can also participate in this study.)

Primary outcomes:
measure: genetic analysis
timeFrame: Baseline
Secondary outcomes:
measure: Measurement of Korean version of mini-mental state examination (K-MMSE)
timeFrame: screening, Baseline
measure: Measurement of Clinical Dementia Rating (CDR)
timeFrame: screening, Baseline
measure: Measurement of Geriatric Depression Scale (GDSd)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: CHA Bundang Medical Center
name: MinYoung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362555: The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain
Official title: The Effect of Nuchal Ligament Calcification on Cervical Function in Patients With Neck Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Keywords: Ossification of nuchal ligament
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patient with chronic neck pain

Brief summary: Ossification of nuchal ligament often observed in patient with chronic neck pain, previous study showed ossification of nuchal ligament was associated with cervical spondylosis and radiculopathy. Patient with chronic neck pain was divided into two groups according to the presence of ossification of nuchal ligament on cervical radiographic images.

This study is to evaluate and compare the neck function including range of motion, neck strength and pressure pain threshold, radiography characteristics and functional disability between two groups.


Eligibility criteria: Inclusion Criteria:

* Patient with neck pain and stiffness last for more than 1 month

Exclusion Criteria:

* cervical trauma or fracture in 3 months
* evidence of cervical spine instability
* rheumatoid cervical spondylopathy
* previous cervical surgery
* head and neck cancer
* previous radiotherapy over neck and surrounding
* those complicated with myelopathy
* contraindication to radiography like pregnant woman

Primary outcomes:
measure: Degrees of cervical range of motion
timeFrame: 1 day ( first visit)
measure: Angles of cervical lordotic curve at C2-C7 on cervical x-ray
timeFrame: within one week after first visit
measure: Scores of functional disability as a measure of effects of neck pain on daily living
timeFrame: 1 day ( first visit)
measure: The values of neck flexor, extensor, lateral bending and rotation strength
timeFrame: 1 day ( first visit)
measure: The values of pressure pain threshold as a measure of participants' pain sensitivity
timeFrame: 1 day ( first visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital Taiwan
Study officials:
References:
Clinical trial NCT05362955: 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Official title: 5-fluorouracil Following Cervical Intraepithelial Neoplasia Treatment Among HIV-positive Women in East Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: CIN 2/3
HIV Infections
Keywords: cervical cancer
CIN 2/3
5-Fluorouracil
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).


Eligibility criteria: Subjects must meet all of the inclusion criteria to participate in this study.

Inclusion Criteria:

1. HIV-positive women
2. Age 18 years - 49 years at enrollment
3. Documentation of a biopsy-confirmed CIN2 or CIN3
4. Within 4-12 weeks after primary treatment for CIN2 or CIN3
5. Negative pregnancy test at screening and agreement to use dual form of contraception (hormonal birth control, intrauterine device, or tubal ligation - plus condoms) during the study duration, if of childbearing age.
6. Agree to use dual contraception if of childbearing age (hormonal method, intrauterine or implant device, or tubal ligation - plus condoms) for duration of study
7. Ability to understand and willingness to sign (or assent when applicable) informed consent

Exclusion Criteria:

1. HIV-negative women
2. Pregnant or planning pregnancy within the next 6 months or breastfeeding
3. Unwilling or unable to use birth control during participation in the study
4. History of invasive cervical cancer
5. Untreated vaginal or vulvar dysplasia
6. Known allergy to 5-Fluorouracil
7. History of total hysterectomy
8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient
9. Current use of chemotherapeutic medication or high dose steroids (10 mg prednisone per day or more (or equivalent steroids)

Primary outcomes:
measure: Safety of intravaginal 5-FU
timeFrame: Up to 5 months
Secondary outcomes:
measure: Tolerability of intravaginal 5-FU
timeFrame: Up to 5 months
measure: Adherence of intravaginal 5-FU
timeFrame: Up to 5 months
measure: Acceptability of intravaginal 5-FU
timeFrame: Up to 20 weeks
measure: Uptake of intravaginal 5-FU
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Study officials:
affiliation: Assistant Professor, Obstetrics and Gynecology
name: Chemtai Mungo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05512455: Accuracy of Various Virtual Articulator Mounting Procedures: An in Vivo Study
Official title: Comparison of the Precision of the Virtual Articulators Using Various Virtual Articulator Mounting Procedures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occlusion
Keywords: virtual articulator ,occlusion
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 10 females and 10 males

Brief summary: the aim of this study was to evaluate the accuracy of the various virtual articulator mounting procedures.

Detailed description: The purpose of the present study was to evaluate the accuracy of various virtual articulator mounting procedures. For this purpose, 7 kinds of virtual mounting procedures were investigated:(1) indirect virtual mounting in MS VA by using an average facebow; (2) virtual mounting in MS VA by using average values; (3) virtual mounting in MS VA by using professional facial scanner; (4) virtual mounting in MS VA by using smartphone facial scanner; (5) virtual mounting in MS VA by using CBCT located in Bergstrom's point; (6) virtual mounting in MS VA by using CBCT located in the medial poles of the condyles; (7) virtual mounting in CA VA by using JMA，as the group to compare with the other mounting procedures. The null hypothesis is that no difference would be found in the static measurements taken virtually when comparing these 7 procedures for virtual mounting.

Eligibility criteria: Inclusion Criteria:

* 1.without any symptoms and signs of the temporomandibular joint 2.Willing to participate and to sign a written informed consent form 3.in good health and had no past history of any serious illness

Exclusion Criteria:

* emporomandibular or craniocervical disorders

Primary outcomes:
measure: the accuracy of different virtual articulator mounting procedures
timeFrame: immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University
state: Fujian
Study officials:
affiliation: Fujian Medical University
name: Hao Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397955: Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan
Official title: Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Keywords: Julina
Postmenopausal osteoporosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 148
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of this study is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.

Brief summary: This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.


Eligibility criteria: Inclusion Criteria:

* Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

* Patients who are contraindicated based on the product label

Primary outcomes:
measure: Incidence of adverse drug reactions and serious adverse events in subject who received Julina
timeFrame: After Julina administration, upto 3 years
Secondary outcomes:
measure: Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina
timeFrame: At baseline and after Julina administration, upto 3 years
measure: Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse
timeFrame: At baseline and at end of Julina treatment, upto 3 years
Other outcomes:
Locations:
city: Many Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: