louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05544630: Effect of Aging on Postural Stability
Official title: Effect of Aging on Postural Stability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Effect of Aging on Postural Stability
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy ageing people not complaining imbalance not diabetic or hypertensive

Brief summary: Postural control of human body is a complex process involving visual , vestibular, somatosensory system and their central processing , add the vestibular system through its multiple connection coordinates movements of the head with movement of the eyes (to maintain clear vision ), trunk , and limbs (to maintain cephalic and postural stability ) via vestibulo-ocular and vestibulo-spinal reflexes respectively Global postural control shows alterations with aging increasing the chance of falls in the population aged 60 years or older, In older adults, poor postural balance can indicate an impaired ability to recover from small postural perturbations and be predictive of future falls


Eligibility criteria: Inclusion Criteria:

* Age: from 60 years to 80 years old.
* Sex: males and females
* All subject had no audio vestibular disease's.
* No evidence of cognitive dysfunction.
* No evidence of musculo-skeletal abnormalities.
* No motion intolerance.
* No history of any disease required to give treatment that could affect results

Exclusion Criteria:

* Old age person with cognitive dysfunction.
* Old age person with musculo-skeletal disorder.
* Adult person below age 60 years old.
* Old age person with neurological disease, motion intolerance, visual disorder, diabetes mellitus and hypertension.

Primary outcomes:
measure: Percentage of change in balance function
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospital
Study officials:
References:
citation: Baudry S. Aging Changes the Contribution of Spinal and Corticospinal Pathways to Control Balance. Exerc Sport Sci Rev. 2016 Jul;44(3):104-9. doi: 10.1249/JES.0000000000000080. No abstract available.
citation: Haas BM, Burden AM. Validity of weight distribution and sway measurements of the Balance Performance Monitor. Physiother Res Int. 2000;5(1):19-32. doi: 10.1002/pri.181.
citation: Henry M, Baudry S. Age-related changes in leg proprioception: implications for postural control. J Neurophysiol. 2019 Aug 1;122(2):525-538. doi: 10.1152/jn.00067.2019. Epub 2019 Jun 5.
citation: Hu M, Chen T, Dong H, Wang W, Xu K, Lin P. [Clinical values of the sensory organization test in vestibular diseases]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2015 Sep;50(9):712-7. Chinese.
Clinical trial NCT01465230: Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Official title: Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic lymphocytic leukemia
maintenance therapy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2011-11-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).


Eligibility criteria: Inclusion Criteria:

* Previous induction treatment with bendamustine and rituximab
* 18 or more years of age
* chronic lymphocytic leukemia
* ECOG performance status less than or equal to 2
* Absolute neutrophile count more than 1,000
* Platelet count more than 70,000

Exclusion Criteria:

* Serious medical condition that would prevent treatment with lenalidomide
* Evidence of tumor lysis syndrome
* Any prior treatment with lenalidomide

Primary outcomes:
measure: Response Rate
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Terri L Parker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02613130: A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Malodor
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess changes in oral malodor and other factors in response to using a two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have an average hedonic score of at least 6.5;
* Have at least 16 gradable teeth;
* Have at least 10 bleeding sites;
* Have a Lobene composite stain score of ≥1 on at least 1 tooth;
* Have at least one test tooth with recession and a score of 6 or greater on the nine-point comfort/discomfort sensitivity scale;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to refrain from tongue brushing for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study;
* Agree to abstain from eating, drinking, chewing gum, using tobacco products, and any oral hygiene at least eight hours prior to evaluation of oral malodor; and
* Agree to refrain from using deodorant, body lotion/powder/spray, hair products, perfume/cologne, lipstick/gloss, or any other scented products on the mornings of the evaluation days prior to their visit to the clinic.

Exclusion Criteria:

* Oral malodor of systemic origin as determined by health history or examination;
* Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
* Active treatment for periodontitis;
* Removable oral appliances;
* Fixed facial or lingual orthodontic appliances;
* Antibiotic use within four weeks of the Screening visit;
* Any disease or condition that might interfere with the safe participation in the study; and
* Inability to undergo study procedures.

Primary outcomes:
measure: Breath odor
timeFrame: Baseline
measure: Breath odor
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Whittier
country: United States
facility: University Health Resources Group
state: California
Study officials:
References:
Clinical trial NCT05898230: Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Official title: Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Disease
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have been implanted with the Carbomedics OptiForm Mitral Heart Valve

Brief summary: The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.

The study is designed as a post-market, retrospective, single arm and multicentric data collection

Detailed description: This study is conducted to evaluate the medium and long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.

Valve-related SAEs such as prosthetic valve dysfunction, death, valve-related bleeding events, valve thrombosis and thromboembolic events, endocarditis and reintervention will be studied to describe the safety profile of the valve. Data of approximately 400 subjects will be collected in two clinical sites in China.

Eligibility criteria: Inclusion Criteria:

* Subject who has been treated with the Carbomedics OptiForm Mitral Heart Valve.
* Subject (or representative or family member) who can understand the objective of the study and is willing to provide verbal informed consent and the available medical information.

Exclusion Criteria:

* Subject (or legal representative or family member) who do not provide their verbal consent to the data collection, or who are unable to provide follow-up information

Primary outcomes:
measure: Prosthetic Valve Dysfunction
timeFrame: up to 7-8 year
measure: Mortality
timeFrame: up to 7-8 year
measure: Valve-related bleeding
timeFrame: up to 7-8 year
measure: Valve thrombosis
timeFrame: up to 7-8 year
measure: Thromboembolism
timeFrame: up to 7-8 year
measure: Endocarditis
timeFrame: up to 7-8 year
measure: Valve-Related Reintervention
timeFrame: up to 7-8 year
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The second Xiangya Hospital of Central South University
city: Chendu
country: China
facility: West China hospital of Sichuan University
Study officials:
affiliation: Corcym S.r.l
name: Sara Gaggianesi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01170130: Lidocaine Usage for Pupil Dilatation (Mydriasis)
Official title: Efficiency and Safety of Lidocaine Usage for Pupil Dilatation (Mydriasis) During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Mydriasis
Lidocaine
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine 1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective mydriasis during phacoemulsification surgery.

Detailed description: Former studied done on the effect of Intracameral lidocaine 1% compared to topical mydriatic agents for achieving effective mydriasis during phacoemulsification surgery have compared 2 different groups of patients, ie; One group received topical agents and the other received intracameral lidocaine. The resultant pupil size was recorded and evaluated in the 2 groups. Our purpose is to compare the effect of these agents on the same group of people.

Patients recruited will be invited first for evaluation at least 1 week before the surgery. During this evaluation 1 dose (drop) of topical cyclopentolate 1% and Phenylephrine 10% will be instilled to the evaluated eye 3 times at 10 minutes intervals. After 1 hour from the last instillation pupil diameter will be recorded. In the second part of this study during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds. the resultant values will be evaluated/compared.

Eligibility criteria: Inclusion Criteria:

* cataract
* men and women
* can read and sign informed consent form

Exclusion Criteria:

* sensitivity to Lidocaine
* sensitivity to Ephrine
* any other ocular surgeries
* diseases like Adie's pupil, Horner syndrome

Primary outcomes:
measure: Pupil size after mydriatics
timeFrame: no longer then 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Carmel Medical Center
name: Orna Geyer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05766930: The Novel Electrolyzed Water Spray Treatment the Genital Itching
Official title: A Novel Electrolyzed Water Spray Reduces the Itching Scores of Patients With Genital Itching: A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genital Inflammation
Itching
Keywords: Electrolyzed water device
Hydroxyl radical
Tap water
Spray
Genital itching
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open label, single arm and before and after treatment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether spraying the genitalia of patients by use of the novel electrolyzed water spray will produce improvement in the condition of genitalia itching.

Detailed description: In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U).

This is an open-label, single-arm, and before and after treatment comparison study. This study uses this novel electrolyzed water device and the water spray to treat genital itching.

Eligibility criteria: Inclusion Criteria:

Patients with genital itching.

Exclusion Criteria:

Severe genital itching. 80 years or older.

Primary outcomes:
measure: An itching scale made by modifying a pain scale (NPRS)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: QingDao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
Clinical trial NCT04301830: Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery
Official title: Postoperative Changes in Optic Nerve Sheath Diameter in Patients Undergoing Spinal Anesthesia for Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Hypotension
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cesarean section under spinal anesthesia.

Brief summary: This is observational study. The investigator will measure optic nerve sheath diameter by ultrasound on the eye after cesarean section under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients has ophthalmic diseases
* Patients has previous history of ophthalmic surgery.
* Patients has neurological disorders.
* Patients has history of head surgery.

Primary outcomes:
measure: Change optic nerve sheath diameter
timeFrame: 0,1,6,24 and 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Watanabe A, Horikoshi T, Uchida M, Ishigame K, Kinouchi H. Decreased diameter of the optic nerve sheath associated with CSF hypovolemia. AJNR Am J Neuroradiol. 2008 May;29(5):863-4. doi: 10.3174/ajnr.A1027. Epub 2008 Feb 29.
citation: Bauerle J, Gizewski ER, Stockhausen Kv, Rosengarten B, Berghoff M, Grams AE, Kaps M, Nedelmann M. Sonographic assessment of the optic nerve sheath and transorbital monitoring of treatment effects in a patient with spontaneous intracranial hypotension: case report. J Neuroimaging. 2013 Apr;23(2):237-9. doi: 10.1111/j.1552-6569.2011.00640.x. Epub 2011 Sep 1.
Clinical trial NCT05010330: Identify Prognostic Biomarkers of Lung Cancer
Official title: Multi-omics Combined With Clinical Data Analysis to Identify Prognostic Biomarkers of Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lung Adenocarcinoma
Lung Squamous Cell Carcinoma
Non Small Cell Lung Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals aged between 18 and 80 years old. Patients with diagnosis of lung cancer or healthy controls without any history of tumor will be eligible for our enrollment.

Brief summary: Multi-omics and Clinical Data Analysis is potential to predict the prognosis of lung cancer patients.

Detailed description: Lung cancer is the leading cause of cancer-related death in China. In order to improve prognosis of lung cancer as well as provide new therapeutic targets, the identification of effective biomarkers for the prognosis of lung cancer is of great significance. It has been reported that some small molecules such as lncRNA, circRNA and polypeptides in human plasm have good prospects in diagnosing or evaluating the stage of diseases. In this study, we planned to use multi-omics combined with clinical data to discovery some small molecules that are potential to predict the prognosis of lung cancer patients. In addition, we want to construct a new risk score model that provide a candidate model for prognostic evaluation of lung cancer. And we hope our study can provide insights for precision immunotherapy of lung cancer by exploring the differences in clinical characteristics, tumor mutation burden, and tumor immune cell infiltration between different risk score groups.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with lung cancer;
* Untreated lung cancer patients;
* No history of chronic or serious diseases, such as cardiovascular disease, liver disease, kidney disease, respiratory disease, blood disease, lymphatic disease, endocrine disease, immune disease, mental disease, neuromuscular disease, gastrointestinal system disease, etc.

Exclusion Criteria:

* Patients with other tumors;
* Lung cancer patients who had been treated;
* Abnormal liver and kidney function;
* Acute and chronic infectious diseases

Primary outcomes:
measure: Identify some prognostic biomarkers in lung cancer.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University school of medicine
Study officials:
affiliation: RenJi Hospital
name: Huijing Huang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Yang M, Ng DM, Haleem M, Yi T, Hu S, Zhu H, Zhao G, Liao Q. Multi-omics Data Analyses Construct TME and Identify the Immune-Related Prognosis Signatures in Human LUAD. Mol Ther Nucleic Acids. 2020 Sep 4;21:860-873. doi: 10.1016/j.omtn.2020.07.024. Epub 2020 Jul 23.
Clinical trial NCT04053530: Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: RCCT
Official title: Evaluation of the Marginal Integrity of Recent Bulk Fill Flowable Composite vs Glass Ionomer for Carious Cervical Restorations: Randomized Controlled Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries Class v
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel groups
Primary purpose: TREATMENT

Brief summary: The study will be conducted to assess the marginal integrity of different types of restorations (ketac ™ N100 - ketac™ Universal and bulk fill flowable composite) in class v restoration using USPHS criteria.


Eligibility criteria: Inclusion Criteria:

1. Presence of at least one carious buccal cervical lesion.
2. The absence of tooth mobility.
3. Presence of contact with opposite teeth without any abnormal occlusion stress for the selected teeth.
4. Accessible isolation and observable and easily accessible gingival margins during tooth restoration.

Exclusion Criteria:

1. Patients with poor oral hygiene.
2. The presence of any para functional habit.
3. Abnormal occlusion.
4. Any regurgitation problem.
5. Subjects with compromised medical history.
6. Pulpitis, non-vital or endodontically treated teeth.

Primary outcomes:
measure: is marginal integrity of restoration.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: