louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05794126: A Clinical Comparison of Two Soft Multifocal Contact Lenses
Official title: A Clinical Comparison of Two Soft Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 47
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.

Detailed description: The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

1. They were at least 42 years of age and had capacity to volunteer.
2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
3. They had had a full eye examination within the past two years (by self-report).
4. They were willing and able to follow the protocol.
5. They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
6. They had refractive astigmatism of no greater than -0.75DC.
7. They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.

Exclusion Criteria:

Subjects were not eligible to take part in the study if:

1. They had an ocular disorder which would normally contra-indicate contact lens wear.
2. They had a systemic disorder which would normally contra-indicate contact lens wear.
3. They were using any topical medication such as eye drops or ointment.
4. They were aphakic.
5. They had had corneal refractive surgery.
6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
7. They were pregnant or lactating.
8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

Primary outcomes:
measure: Subjective Overall Score
timeFrame: 15 Minutes
Secondary outcomes:
measure: Subjective Comfort
timeFrame: 15 Minutes
measure: Subjective Vision
timeFrame: 15 Minutes
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: Eurolens Research
name: Philip Morgan, PhD, MCOptom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00081926: Gleevec Trial in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Myelogenous Leukemia
Keywords: CML
Chronic Myelogenous Leukemia
RIGHT Trial
US177
CSTI571
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-04-29
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the molecular response to high dose Gleevec in newly diagnosed patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase. This study will evaluate the ability of Gleevec to reduce the amount of abnormal protein that occurs in patients with CML.

Patients who are eligible to participate will be treated for 18 months. This trial will include male or female patients 18 years or older who are newly diagnosed (within 6 months) with CML.


Eligibility criteria: Inclusion Criteria:

Participants must meet all of the following criteria:

* Male or Female patients 18 years and older.
* Patient with a diagnosis of chronic myelogenous leukemia in chronic phase
* Within 6 months of initial diagnosis.
* Received any treatment for CML for less than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide.

Exclusion Criteria:

* Late chronic phase, accelerated phase or blastic phase
* Taking any other investigational agents within 28 days of starting the study
* If sibling donors have been identified and where allogeneic bone marrow transplantation will be the first line treatment.
* Another primary malignancy /cancer unless it is not considered clinically significant or does not require active intervention.
* If patients have heart problems or complications
* Pregnant or breast-feeding females
* Severe and/or uncontrolled disease such as diabetes, chronic renal disease, etc.
* Chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
* Diagnosis of human immunodeficiency virus (HIV) infection.
* Received any treatment for CML for longer than 1 month prior to study entry with the exception of hydroxyurea and/or anagrelide.
* Patient previously received radiotherapy to greater than 25% of the bone marrow.
* Patient had a major surgery within 4 weeks prior to study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis RIGHT Trial Hotline
state: New Jersey
Study officials:
References:
citation: Cortes JE, Kantarjian HM, Goldberg SL, Powell BL, Giles FJ, Wetzler M, Akard L, Burke JM, Kerr R, Saleh M, Salvado A, McDougall K, Albitar M, Radich J; Rationale and Insight for Gleevec High-Dose Therapy (RIGHT) Trial Study Group. High-dose imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: high rates of rapid cytogenetic and molecular responses. J Clin Oncol. 2009 Oct 1;27(28):4754-9. doi: 10.1200/JCO.2008.20.3869. Epub 2009 Aug 31.
Clinical trial NCT00763126: Does Having a Spouse Present During Epidural Analgesia Affect Stress Levels in the Parturient and Her Spouse?
Official title: The Effect of the Presence of a Spouse on the Parturient's and Her Spouse's Stress Level During Epidural Analgesia During Labor as Measured by Salivary Amylase
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Keywords: parturient
epidural analgesia
labor
spouse
Stress levels
Salivary amylase
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is unclear the effect of a spouse's presence on the partureint's and the spouse's stress level during the performance of epidural analgesia during labor.

Couples will be randomized to two groups: one group where the spouse is present during the performance of epidural analgesia and the second where the spouse is not present.

Before and after epidural anlgesia, both the spouse and parturient will be have their blood pressure and pulse checked. In addition, both will have their salivary amylase measured.

Salivary amylase is an enzyme whic has been foud to correlate directly with stress levels. To check this enzyme, a sample of saliva is given.


Eligibility criteria: Inclusion Criteria:

* Healthy term parturients

Exclusion Criteria:

* Diabetes
* Preterm labor
* Mouth pathologies

Primary outcomes:
measure: Stress levels
timeFrame: 1 year
Secondary outcomes:
measure: hemodynamic parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Sharon Orbach-Zinger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06329726: Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
Official title: Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson disease
Deep Brain Stimulation
Cognitive dysfunction
Mood
Anxiety
Quality of life
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of Parkinson's disease

Brief summary: The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.

PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.

Researchers will compare data collected from patients with DBS versus patients with best medical therapy.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease patients candidates for DBS of the subthalamic nucleus
* Parkinson's disease patients with best medical treatment

Exclusion Criteria:

* patients unable to complete study assessments

Primary outcomes:
measure: Long-term characterization of DBS-STN on cognitive outcomes
timeFrame: Annual assessments up to 5 years
measure: Beck Depression Inventory
timeFrame: Annual assessments up to 5 years
measure: State-Trait Anxiety Inventory
timeFrame: Annual assessments up to 5 years
measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson
timeFrame: Annual assessments up to 5 years
measure: Pittsburgh Sleep Quality Index
timeFrame: Annual assessments up to 5 years
measure: Parkinson's Disease Questionnaire-8
timeFrame: Annual assessments up to 5 years
measure: Minnesota Multiphasic Personality Inventory 2-RF
timeFrame: Annual assessments up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Francesca Mameli, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06189326: Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma
Official title: Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Glaucoma
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The high success rate of the non-penetrating deep sclerectomy (NPDS) procedure in adult glaucomatous patients motivated some glaucoma specialists to try it as an alternative procedure in childhood PCG. In deep sclerectomy, the surgeon fashions a partial-thickness scleral flap and excises the outer parts of both Schlemm's canal and trabecular meshwork without opening the eye, leaving a thin trabeculo-descemetic membrane. This membrane will guard against early postoperative hypotony due to the non-penetrating nature of the procedure.

The aim of this study is to assess the safety and efficacy outcomes of non-penetrating deep sclerectomy versus combined trabeculotomy-trabeculectomy in the treatment of congenital primary glaucoma


Eligibility criteria: Inclusion Criteria:

* patients with PCG younger than 6 years old with a HCD between 12-14 mm ware

Exclusion Criteria:

* patients with anterior segment anomalies,
* secondary glaucoma
* previous anterior segment surgeries
* patients more than 6 years old

Primary outcomes:
measure: Intra Occular Pressure
timeFrame: Base line
measure: Intra Occular Pressure
timeFrame: Post 1 week
measure: Intra Occular Pressure
timeFrame: Post 1 month
measure: Intra Occular Pressure
timeFrame: Post 3 month
measure: Intra Occular Pressure
timeFrame: Post 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT06722326: Hydrogen-rich Water and Appetite in Obesity
Official title: The Effects of 8-week Hydrogen-rich Water Consumption on Body Composition, Appetite and Obesity-specific Quality of Life, and Circulating Glucagon-like Peptide-1 in Obese Men and Women (Hydrappet): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: dihydrogen
appetite
LDL cholesterol
supplementation
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal of this study is to investigate how dihydrogen supplementation impacts body composition, appetite, quality of life specific to obesity, and levels of the hormone GLP-1 in men and women with obesity. This randomized controlled trial aims to explore whether dihydrogen can improve these health indicators.

Detailed description: The primary aim of this randomized controlled trial is to evaluate the effects of dihydrogen supplementation on body composition indices, appetite, obesity-specific quality of life, and circulating GLP-1 levels in obese men and women

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Body fat \> 30% in women and \> 25% in men
* Not physically active
* Informed consent signed

Exclusion Criteria:

* Major chronic disease and acute injuries
* History of dietary supplement use during the past 4 weeks
* History of obesity pharmaceuticals use during the past 8 weeks
* No consent to randomization
* Participation in other studies

Primary outcomes:
measure: Appetite
timeFrame: Change from baseline appetite at 8 weeks
Secondary outcomes:
measure: Obesity-related quality or life
timeFrame: Change from baseline total scores for obesity-related quality of life at 8 weeks
measure: Body fat
timeFrame: Change from baseline body fat at 8 weeks
measure: Serum GLP-1
timeFrame: Change from baseline GLP-1 at 8 weeks
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab
state: Vojvodina
Study officials:
References:
citation: Korovljev D, Ostojic J, Todorovic N, Ostojic SM. Molecular hydrogen modulates brain glutamate/GABA-glutamine cycle in overweight humans. Arch Med Sci. 2023 Jul 13;19(4):1151-1153. doi: 10.5114/aoms/162938. eCollection 2023.
Clinical trial NCT06873126: Two Group Experimental Trial Promoting Sports and Exercise Among Female University Students in Saudi Arabia
Official title: A Two-group Experimental Trial to Promote Sports and Exercise Among Female University Students in Saudi Arabia: the Relationship Between Mental Health and Adherence to Phyicsal Activity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Mental Health
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2025-03-12
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study provides insights into the use of awareness counselling sessions for physical activity promotion, which may have a significant impact on physical activity education, promotion, practice and policy making and will be more effective to ensure adherence to activity among young adults.


Eligibility criteria: Inclusion Criteria:

* Participants scoring between 0 to 10 (normal) and 11 to 16 (mild) and 16 to 20 (moderate) in DASS-21 depression subscale
* voluntary participants
* physical activity level lightly active

Exclusion Criteria:

* University students diagnosed with psychiatric disorders and taking therapy or family history of mental illness
* Students with comorbid conditions such as chronic pain, respiratory disorders, musculoskeletal diseases, cardiac diseases, neurological diseases or any disabilities and pregnancy

Primary outcomes:
measure: daily moderate- to vigorous-intensity physical activity (MVPA), physical activity level (PAL) evaluated using IPAQ-SF
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jazan
country: Saudi Arabia
facility: Jazan University
Study officials:
References:
Clinical trial NCT02388126: Prostate Magnetic Resonance Imaging in Patient With Previous Negative Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-03-13
Enrollment: 150
Sex: MALE
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: DIAGNOSTIC

Brief summary: Prostate cancer has been the most common neoplastic disease in men in Finland over the last ten years. Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer. However, PSA has a limited sensitivity and specificity for prostate cancer detection. Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS) guided biopsy. Because of the low accuracy of TRUS a systematic biopsy is usually performed instead of targeted TRUS biopsy. While, as many as 47% of the ultra-sound guided biopsies may be false negative and biopsies carry a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities.

This study will enroll 150 men with previous negative biopsies and clinical suspicion of prostate cancer due to serum level of PSA higher than 2.5 ng/ml or abnormal digital rectal examination (DRE) or patients in active surveillance due to low risk prostate carcinoma. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. In addition to routine 12-core TRUS biopsies, targeted TRUS guided biopsy based on MRI findings will be performed.


Eligibility criteria: Inclusion Criteria:

* Language spoken: Finnish or Swedish
* Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
* Previous diagnosis of prostate carcinoma and patient on active surveillance
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Language spoken: Finnish or Swedish
* Clinical suspicion of prostate cancer and/or previous negative prostate biopsies and MRI target
* Previous diagnosis of prostate carcinoma and patient on active surveillance
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Primary outcomes:
measure: Diagnostic accuracy of multiparametric MRI in prostate cancer diagnosis
timeFrame: 3 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Peter J Boström, Adj. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00101426: Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy
Keywords: Diabetic sensorimotor polyneuropathy
Diabetic Neuropathy
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2005-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.


Eligibility criteria: Inclusion Criteria:

* Patients with the following may enter:

Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test.

* 18 to 70 years old of either sex and any race
* Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry
* Healthy in general
* No hospitalizations for diabetic control or episodes of ketoacidosis for three months prior to screening
* Female patients of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria:

* Known non-diabetic causes of neuropathic symptoms
* Diabetic patients with no neuropathy or severe neuropathy
* Used any Aldose Reductase Inhibitors within one year of screening
* Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease
* A history of systemic carcinoma within five years of screening
* A history of epilepsy or serious head injury
* A history or evidence of drug or alcohol abuse
* Test positive at screening for hepatitis B surface antigen or hepatitis C antibody or have a history of a positive result, or patients with evidence of significant hepatic insufficiency
* A history of known or suspected diagnosis of AIDS, or have tested seropositive for HIV antibody or antigen previously

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
References:
citation: Bril V, Hirose T, Tomioka S, Buchanan R; Ranirestat Study Group. Ranirestat for the management of diabetic sensorimotor polyneuropathy. Diabetes Care. 2009 Jul;32(7):1256-60. doi: 10.2337/dc08-2110. Epub 2009 Apr 14.