louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04829903: Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin
Official title: Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin: Results From a Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Obesity
Adolescent Obesity
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 116
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin

Detailed description: To observe the efficacy, effect on glycemic control, impact on BMI and incidence of adverse effects of Dulaglutide and to compare it to Liraglutide in individuals aged thirteen to eighteen who have Type 2 diabetes mellitus and are obese.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Obese
* Taking metformin
* Male or female

Exclusion Criteria:

* Non obese
* Not taking metformin
* Taking other injectable diabetic medications

Primary outcomes:
measure: Glycemic level
timeFrame: 24 weeks for the duration of the study
measure: BMI
timeFrame: 24 weeks for the duration of the study
measure: Adverse effects
timeFrame: 24 weeks for the duration of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Zainab Khan
state: Punjab
Study officials:
affiliation: Al Ain University
name: Nadia Hussain, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459003: Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer
Official title: Evaluation of Beauty Care Before Chemotherapy in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluation of beauty care in women receiving adjuvant chemotherapy for breast cancer


Eligibility criteria: Inclusion Criteria:

* breast cancer with no metastasis receiving adjuvant chemotherapy

Exclusion Criteria:

Primary outcomes:
measure: quality of life questionnaire
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Mahasti Saghatchian, MD
role: STUDY_CHAIR
References:
citation: Saghatchian M, Lacas B, Charles C, Ghouadni A, Clain GT, Boinon D, Delaloge S, Vaz-Luis I, Dauchy S, Amiel P. BEAUTY and the breast: is adjuvant chemotherapy the right time for a beauty boost? Lessons learned from a large randomized controlled trial. Qual Life Res. 2022 Mar;31(3):723-732. doi: 10.1007/s11136-021-02947-6. Epub 2021 Jul 29.
Clinical trial NCT01297803: Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery
Official title: Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Glaucoma Patients Scheduled for Trabeculectomy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-02-17
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Application of antimetabolite agents such as mitomycin_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin_c can be applied remain a concern before or after sclera flap dissection. Mitomycin_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.


Eligibility criteria: Inclusion Criteria:

* Age Range between 18 to 80 years old
* Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.

Exclusion Criteria:

* Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).

Primary outcomes:
measure: corneal endothelial cell density
timeFrame: six month
measure: corneal endothelial cell polymorphism
timeFrame: 6 months
measure: corneal endothelial cell polymegathism
timeFrame: 6 months
Secondary outcomes:
measure: IOP (intra ocular pressure)
timeFrame: six months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad medical center
Study officials:
References:
Clinical trial NCT00539903: Physical Activity and Immigrant Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Activity Level
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
First posted: 2007-10-05
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is today a growing need for culturally adapted initiatives among immigrants to prevent and treat T2D. Others have failed to increase the level of physical activity in this sedate group. The investigators believe this is due to missing assistance and lack of influence from the Pakistani milieu. To improve this, a culturally adapted physical activity will be established in this project in close cooperation with the Pakistanis themselves.

Through this program it is the investigators' goal to increase their physical activity level and prevent lifestyle diseases among Pakistanis in Oslo with a high risk of developing these diseases.


Eligibility criteria: Inclusion Criteria:

* Pakistani background
* 25-55 year old
* Physically inactive

Exclusion Criteria:

* Diabetes
* heart condition
* medication that could affect the results

Primary outcomes:
measure: Physical activity level
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian school of sport sciences
Study officials:
affiliation: Norwegian School of Sport Sciences
name: Eivind Andersen, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen E, Burton NW, Anderssen SA. Physical activity levels six months after a randomised controlled physical activity intervention for Pakistani immigrant men living in Norway. Int J Behav Nutr Phys Act. 2012 Apr 26;9:47. doi: 10.1186/1479-5868-9-47.
Clinical trial NCT01837303: chemQbiosciences:Manual Liquid Based Cytology
Official title: chemQbiosciences:Manual Liquid Based Cytology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dysplasia
Cervical Cancer
Keywords: Cervical dysplasia
Cervical cancer
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 76 healthy women presenting for standard pap smear screening

Brief summary: Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. Clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Hypothesis: Manual liquid based cytology is equivalent to conventional liquid based cytology.

Detailed description: Purpose: To assess equivalence between low cost manual liquid based cytology (pap smear) and standard Thin prep cytology screening.

Participants: 100-120 healthy women presenting for standard pap smear screening

Procedures (methods): After routine care pap smear, another pap smear will be performed and placed in the study medium. The study pap medium will be processed using the manufacturers instructions and then clinical care pap and study pap will be reviewed by a single pathologist to assess for equivalent findings.

Eligibility criteria: Inclusion Criteria:

* Female ages 18 years or older
* English speaking
* Presenting for pap smear examination

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Compare cytologic outcomes using manual liquid based cytology to conventional
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Lisa Rahangdale, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588403: TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients
Official title: Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nasopharyngeal carcinoma patients staged T1-4N0-3M0

Brief summary: Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma


Eligibility criteria: Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
3. Performance status: KPS\>70
4. With normal liver function test (ALT, AST \<1.5ULN)
5. Renal: creatinine clearance \>60ml/min
6. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
7. Written informed consent

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age \>65 or \<18
3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
5. Patient is pregnant or lactating
6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

   -

Primary outcomes:
measure: QoL(quality of life)
timeFrame: 2 years
Secondary outcomes:
measure: PFS (progression free survival)
timeFrame: 2 years
measure: OS (overall survival)
timeFrame: 2 years
measure: LRRFS(Locoregional failure-free survival)
timeFrame: 2 years
measure: Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
References:
Clinical trial NCT06207903: Navigating the Clinical Research Process for Mild Cognitive Impairment
Official title: Investigating Participation Behavior: An Observational Study in Mild Cognitive Impairment Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mild cognitive impairment patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This trial will admit a wide range of data on the clinical trial experience of mild cognitive impairment patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future mild cognitive impairment patients.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of mild cognitive impairment
* Participant must be 18 years of age or older
* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Participant is actively receiving study therapy in another
* Inability to provide written informed consent

Primary outcomes:
measure: Rate of patients who decide to enroll in a mild cognitive impairment clinical research.
timeFrame: 3 months
measure: Number of mild cognitive impairment study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313.
citation: Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27.
citation: Chou YH, Sundman M, Ton That V, Green J, Trapani C. Cortical excitability and plasticity in Alzheimer's disease and mild cognitive impairment: A systematic review and meta-analysis of transcranial magnetic stimulation studies. Ageing Res Rev. 2022 Aug;79:101660. doi: 10.1016/j.arr.2022.101660. Epub 2022 Jun 6.
Clinical trial NCT05796843: 360 Degrees Virtual Reality-based Mirror Therapy for Stroke Patients
Official title: 360 Degrees Virtual Reality-based Mirror Therapy for Upper Extremity Rehabilitation Among Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke Rehabilitation
Mirror Movement Therapy
Keywords: Stroke
Stroke Rehabilitation
Mirror Movement Therapy
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the effects of 360 degree virtual reality-based mirror therapy (360MT) to traditional mirror therapy (TMT) and conventional physical therapy (control group) on upper extremity function among stroke patients.

The main questions it aims to answer are:

* Would 360MT be more effective when treated for 4 weeks in outcome measure ments including: Fugl-Meyer Assessment for upper extremity (FMA-UE); manual function test (MFT); and box \& block test (BBT)?
* How would particants' experience be in terms of satisfactory and enjoyment during 360MT?

The study will have three groups of participants who will be involved in different tasks:

* 360MT group: will receive mirror therapy using a virtual reality device (HMD) and perform tasks with their paralyzed hand. Sessions will last 30 minutes, 3 times a week for 4 weeks.
* TMT group: will receive mirror therapy using an acrylic mirror and perform finger, wrist, elbow exercises using their paralyzed limb. Sessions will last 30 minutes, 3 times a week for 4 weeks.
* Control group: will receive conventional physical therapy consisting of exercises for the upper extremity, 60 minutes per day, 5 sessions a week, for 4 weeks.


Eligibility criteria: Inclusion Criteria:

* who have not passed 12 months since onset;
* who can understand and follow instructions;
* who have ≥21 scores in Korean version of Mini-Mental State Examination (MMSE-K);
* who have mild to moderate motor impairment according to the Fugl Meyer Assessment (FMA) scores

Exclusion Criteria:

* patients who have any kinds of mental disorder and/or Alzheimer's disease;
* who have orthopedic and/or musculoskeletal injury;
* who have apraxia; and
* who have previous experiences of participating in investigations and/or mirror therapy.

Primary outcomes:
measure: Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: Changes from baseline after 4 weeks of intervention
Secondary outcomes:
measure: Manual Function Test (MFT)
timeFrame: Changes from baseline after 4 weeks of intervention
measure: Box & Block Test (BBT)
timeFrame: Changes from baseline after 4 weeks of intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Myeonji Choonhae Hospital
Study officials:
affiliation: Sahmyook University
name: Sungbae Jo, PhD candidate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05737043: Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios
Official title: Comparison of the Modified Myocardial Performance Index and Epicardial Thickness in Cases With Idiopathic Polyhydramnios and in Healthy Normal Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Diagnose
Fetal Cardiac Disorder
Keywords: polyhidramnios, epicard, myocardial performance index
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: In cases diagnosed as idiopathic polyhydramnios and healthy pregnancy between 24-40 weeks (total number of cases (100-120)), prospective fetal echocardiography will be performed to evaluate MPI and EFT.

Detailed description: : gestational week, maternal age, amniotic fluid index measurement, modified myocardial performance in fetal echo and epicardial thickness of all cases will be evaluated. week of pregnancy, body mass index, fetal biometry, umbilical artery doppler, middle cerebral artery doppler measurements will be taken. Birth weight and fetal intensive care hospitalizations at the birth week of all cases will be recorded. All data will be evaluated with the appropriate statistical method.

Eligibility criteria: Inclusion Criteria: 24-40 weeks gestational age, polyhydramnios and healthy pregnancy -

Exclusion Criteria: multıpl pregnancy, fetal anomaly, growth restriction, maternal chronic disease

-

Primary outcomes:
measure: neonatal and fetal outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
Study officials:
References:
Clinical trial NCT03272243: Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures
Official title: Short Segment Posterior Fixation With Index Level Screws Versus Long Segment Posterior Fixation for Thoracolumbar Spine Fracture: Angle of Correction and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SPINAL Fracture
Keywords: thoracolumbar fracture
short segment fixation
long segment fixation
index level
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study included 91 patients, who had single level thoracolumbar fracture with Cobb's angle ≤ 25⁰, underwent posterior fixation. Forty four patients underwent short segment fixation with screws into the index level, and 47 patients underwent long segment fixation with skipped index level. The angle of correction, pain, and neurological state were regularly assessed


Eligibility criteria: Inclusion Criteria:

* wedge fracture or burst fracture with Thoraco-Lumbar Injury Classification and Severity (TLICS) score ≥ 4
* Single level fracture
* Less than 50% of spinal canal compromised
* Mild kyphosis or scoliosis
* Cobb's angle ≤ 25˚
* with or without neurological deficit

Exclusion Criteria:

* patients with multiple level fractures
* patients with more than 50% spinal canal compromise
* patients who needed anterior approach to decompress the canal
* patients who have fracture dislocation and / or marked kyphosis and scoliosis with Cobb's angle \>25⁰
* patients who needed 360⁰ fixation with long segment fixation to maintain the angle of correction.

Primary outcomes:
measure: Change in pain
timeFrame: 3rd, 6th, 9th, 12th months
measure: Change in disability
timeFrame: 3rd, 6th, 9th, 12th months
measure: Change in angle of correction
timeFrame: 3rd, 6th, 9th, 12th months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor of Neurosurgery
name: Walid A Abdel Ghany, M.D., Ph.D
role: STUDY_DIRECTOR
References: