louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05567068: Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis
Official title: Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception.

Exclusion Criteria:

* Breastfeeding
* Significant liver and kidney function abnormalities
* Colorectal cancer patients
* Patients with severe UC
* Patients taking rectal or systemic steroids
* Patients taking immunosuppressives or biological therapies

Primary outcomes:
measure: Improvement in health related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: changes in serum and fecal inflammatory biomarkers
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References:
Clinical trial NCT00057668: Preventing Behavior Problems in Children With ADHD
Official title: Prevention of Behavioral Deficits in Young ADHD Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Lehigh University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the effectiveness of a combination of treatments in preventing behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD) in young children.

Detailed description: Participants are randomly assigned to either a Multi-Setting Early Intervention group or to a Community Intervention group. The Early Intervention group receives parent training and assessment-based behavioral and academic intervention for 1 year, followed by either a high or a low intensity maintenance intervention for an additional 18 months. The Community Intervention group members receive psychotropic medication, special education services, and monthly sessions to obtain information about child development and medical functioning for 2 years. Participants are assessed on six occasions over 4 years. Parents and teachers assess children's behavior, academic performance, and archival data, including medical and school records.

Eligibility criteria: Inclusion Criteria:

* Attention Deficit Hyperactivity Disorder (ADHD) diagnosis
* Preschool, nursery school, or group daycare enrollment at least 2 days per week
* Parents who can communicate in English

Exclusion Criteria:

* Plans to move out of the area in the near future
* Mental retardation, neurological damage, significant motor or physical impairments, or autism or other pervasive developmental disorder
* Inattentive ADHD or conduct disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University College of Education
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05057468: Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Official title: Cyclosporine As a Second-line Treatment of Primary Autoimmune Hemolytic Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Autoimmune Hemolytic Anemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 30
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: the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This study compares cyclosporin versus rituximab in steroid-refractory anemia.

Detailed description: Auto-immune hemolytic anemia (AIHA) is a heterogeneous syndrome in adults. This disease is associated with significant morbidity-mortality. First-line treatment with prolonged corticosteroid is well identified but there is not enough data about cyclosporine treatment in case of resistance or dependence on steroids.

the cyclosporine showed efficacy in many immune cytopenic diseases in the light of numerous case reports and retrospective data. This drug is cheap, licensed in immunologic diseases, and does not expose to major infections. So, we compare cyclosporin versus rituximab in steroid-refractory anemia.

Eligibility criteria: Inclusion Criteria:

* Patients aged more than 18 years old from any sex with a diagnosis of primary warm autoimmune hemolytic anemia (AIHA) based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test who have disease progression or failure after treatment with steroid therapy, or who are intolerant to treatment, or who refuse standard treatment.
* No evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions.

Exclusion Criteria:

* any contraindications to the drugs of the study.
* any identified secondary cause of the AIHA.
* pregnant or lactating women.

Primary outcomes:
measure: the proportion of complete response
timeFrame: 3months
measure: the proportion of partial response
timeFrame: 3months
Secondary outcomes:
measure: rate of adverse events
timeFrame: 3months
Other outcomes:
Locations:
city: Assiut,
country: Egypt
facility: Assiut university hospital
state: Assiut
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
References:
Clinical trial NCT05446168: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Official title: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: short chain fatty acid
butyrate
tributyrin
functional neuroimaging
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 18
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Small exploratory open-label pilot study to assess the short-chain fatty acid (SCFA) prodrug tributyrin as a potential therapy for persons with Parkinson disease

Detailed description: The overarching goal of this small exploratory open-label pilot study is to explore metabolic (glucose metabolism, butyrate) and cognition (MoCa) before and after open-label treatment with the short-chain fatty acid (SCFA) prodrug tributyrin in a small pilot study in PD and normal control older adults. Positive findings in this small exploratory pilot trial may support target engagement study of SCFA supplementation in normal adults and PD.

Eligibility criteria: Inclusion Criteria:

* Healthy control volunteers over 45 years of age
* People with Parkinson Disease over 45 years of age

Exclusion Criteria:

* Subjects with contra-indications to MR imaging, including pacemakers or claustrophobia;
* Evidence of large vessel stroke or mass lesion on MRI
* Regular use of anti-cholinergic, benzodiazepines or neuroleptic drugs
* History of significant GI disease
* Significant metabolic or uncontrolled medical comorbidity
* Poorly controlled diabetes
* Pregnancy or breast feeding
* Dementia requiring informed assent
* Suicidal ideation

Primary outcomes:
measure: Whole Brain Butyrate PET Radiotracer Binding
timeFrame: Pre and Post approximately 30 days of intervention
measure: Glucose Metabolism
timeFrame: Pre and Post approximately 30 days of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System Functional Neuroimaging, Cognitive and Mobility Laboratory
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nicolaas I Bohnen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00090168: Cholesterol Lowering Level of MK0653A+Simvastatin in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease (0653A-806)(COMPLETED)
Official title: A Multicenter Study to Assess the Cholesterol Lowering Level of Switching to an Investigational Drug Compared to Doubling the Dose of an Investigational Drug in Patients With Hypercholesterolemia and Atherosclerotic or Coronary Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Atherosclerotic Disease
Coronary Disease
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 435
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: A 6-week treatment study to compare the reduction in cholesterol of two drugs MK0653A+Simvastatin for high cholesterol, in patients with hypercholesterolemia and atherosclerotic or coronary vascular disease.


Eligibility criteria: - Men and women greater than or equal to 18 years of age with elevated cholesterol levels and coronary heart disease (CHD), or atherosclerotic vascular disease may be eligible to participate in this study.

Primary outcomes:
measure: LDL-C lowering
Secondary outcomes:
measure: Total cholesterol (TC) lowering
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Barrios V, Amabile N, Paganelli F, Chen JW, Allen C, Johnson-Levonas AO, Massaad R, Vandormael K. Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease. Int J Clin Pract. 2005 Dec;59(12):1377-86. doi: 10.1111/j.1368-5031.2005.00714.x.
Clinical trial NCT01269268: Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
Official title: Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Active Tuberculosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 270
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: active TB patients group : from the referred center TB care clinic healthy control : from the community sample

Brief summary: There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.


Eligibility criteria: Inclusion Criteria:

* active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings
* healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients

Exclusion Criteria:

* pregnant woman
* positive result of human immunodeficiency virus examination

Primary outcomes:
measure: Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00727168: Screening for Glaucoma in Namil Area, South Korea
Official title: Epidemiologic Study for the Prevalence of Glaucoma in Namil Area, Geumsan City, South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Intraocular Pressure
Optic Nerve Head
Visual Field
Keywords: prevalence study
glaucoma
Lead sponsor: Korean Glaucoma Society
Sponsor class: NETWORK
First posted: 2008-08-01
Enrollment: 1532
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All residents aged over 40 in Namil area in Geumsan city

Brief summary: The purpose of this study is to study the prevalence of glaucoma in Korea, the investigators selected Namil area in Geumsan city, located in central Korea. The residents aged over 40 in this area are to be recruited to full ophthalmologic examination to detect and classify the glaucoma.

Detailed description: Screening includes following examinations; Questionaire and Consent form, Visual acuity test, Auto-refraction, IOL Master measurement, Pachymetry, FDT Perimetry, Fundus Photography, Slit lamp examination, Goldmann applanation Tonometry, Gonioscopy, and Binocular optic disc evaluation. For the cases showing any abnormality in FDT perimetry, optic disc morphology, or intraocular pressure, Humphrey automated visual field test is to be performed as an extended examination. Finally, optic nerve head evaluation by OCT or GDx analyzer is to be used as a confirmation test, as well as additional Humphrey visual field test.

Eligibility criteria: Inclusion Criteria:

* All residents aged over 40 in Namil area

Exclusion Criteria:

* Individuals registered but not actually living in this area

Primary outcomes:
measure: Prevalence of glaucoma in Namil area
timeFrame: cross-sectional
Secondary outcomes:
measure: Clinical factors associated with the glaucoma
timeFrame: cross-sectional
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yongdong Severance Hospital
Study officials:
affiliation: Korean Glaucoma Society
name: Gong-je Seong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YY, Lee JH, Ahn MD, Kim CY; Namil Study Group, Korean Glaucoma Society. Angle closure in the Namil study in central South Korea. Arch Ophthalmol. 2012 Sep;130(9):1177-83. doi: 10.1001/archophthalmol.2012.1470.
Clinical trial NCT05087472: Prevalence of Psychiatric Disorders in the Refugee Population of Turkey
Official title: Prevalence of Psychiatric Disorders in the Refugee Population of Turkey
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Psychiatric Disorder
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients in a primary care clinic who have official refugee status

Brief summary: The investigators are planning to diagnose psychiatric disorders in willing participants from the refugee population in Turkey.


Eligibility criteria: Inclusion Criteria:

* Having official refugee status in Turkey, willing to participate in the study

Exclusion Criteria:

* Having any disability that prevents answering interviewers' questions

Primary outcomes:
measure: Any diagnosed psychiatric disorder using the Mini-International Neuropsychiatric Interview
timeFrame: Through study completion, on average five months
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kütahya Health Sciences University
Study officials:
References:
Clinical trial NCT02942472: Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles
Official title: Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles:Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: clinical pregnancy rate after embryo transfer
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 94
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prospective observational study

Brief summary: Position of the tip of the inner catheter and air bubbles detection (at time,5min 10min)during embryo transfer influence the pregnancy rate in ICSI cycles .

Detailed description: The aim of this study is to assess the relationship between the position of the tip of the inner catheter, the position of the air bubbles (at time , 5 min ,10 min )after embryo transfer and pregnancy rate outcome in ICSI cycles. Most IVF teams consider not touching the endometrium and the uterine fundus with replacement of the embryos in the lumen of the endometrial cavity the most important factors for successful embryo transfer, it is highly recommended to use agents that can facilitate a smooth embryo transfer and reduce unintended stimulation of the fundus, for example the application of soft-tipped catheters, which can improve pregnancy rate.

The advantage of using the air and liquid content for catheter loading is to prevent the embryo from adhering to the wall of the catheter at the time of injection.The presence of two air bubbles on both sides of the medium that contains the embryo prevents the transfer of the embryo within the catheter and beside, in the transfer under ultrasonographic guidance, the air bubbles are often considered a marker for the embryo's position in the uterus.

Eligibility criteria: Inclusion Criteria:

* BMI \< 30 kg/ m2.
* Between 20 and 35years old.
* FSH levels on cycle day 3 of \<12 mIU/mL.
* Both ovaries present deprived of morphological abnormalities and adequately visualized in Transvaginal ultrasound.
* Grade one or two embryo quality.

Exclusion Criteria:

* Hydrosalpinx.
* Intrauterine lesion.
* Patients undergoing ET after cryopreservation.
* Blood present on the catheter during the transfer procedure.
* A difficult transfer or with a suspicion of touching the fundus.
* Endometrial thickness less than 8mm.
* Known allergic reaction against one of the ingredient of the medications used during the study.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: one and half year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05997472: The Effect of Using Walking Aid On TUG Test
Official title: The Effect of The Use of Walking Aid On Timed Up and Go Test In Patients With Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Locomotion Disorder, Neurologic
Keywords: stroke
Timed Up and Go Test
balance
locomotion
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Stroke patients older than 18 years of age at least 6 weeks after stroke

Brief summary: The Timed Up and Go Test is a measurement tool that allows the participant to use assistive devices and walking aids during the test that evaluates functional mobility. This study was conducted to determine the effect of using walking aids on the Timed Up and Go test and it's correlation with balance in stroke patients.

Detailed description: Cross-sectional, observational study

Eligibility criteria: Inclusion Criteria:

* Mini Mental State Test \>24
* Stroke patients who can walk 10 meters with or without walking aid

Exclusion Criteria:

* Individuals dependent on bed or wheelchair
* Individuals with musculoskeletal disease that may adversely affect mobility and balance.
* Individuals who have had any operation in the last 6 months

Primary outcomes:
measure: Timed Up and Go Test
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Balikesi̇r
country: Turkey
facility: Bandirma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: BANDIRMA ONYEDİ EYLÜL UNIVERSITY
name: EBRU KAYA MUTLU
role: STUDY_CHAIR
References:
Clinical trial NCT00313872: Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
Official title: Phase III Randomized Trial of Taxotere/Cisplatin Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Metastases
Keywords: gastric cancer
chemotherapy
irinotecan
docetaxel
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2006-04-12
Enrollment: 200
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: To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.

Detailed description: Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed metastatic adenocarcinoma of the stomach
2. Age ≥ 18
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
4. Life expectancy of at least 3 months
5. Adequate renal, liver, bone marrow functions
6. Adjuvant chemotherapy more than 12 months from the date of study entry
7. Written informed consent

Exclusion Criteria:

1. Active infection requiring antibiotics
2. Pregnant, lactating women
3. Brain metastasis
4. Systemic illness not appropriate for chemotherapy
5. Radiotherapy within 2 weeks before the study entry
6. Allergy to drugs used in the trial

Primary outcomes:
measure: Second progress-free survival
timeFrame: 2years
Secondary outcomes:
measure: Toxicity, overall survival
timeFrame: 2years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ki Kang, MD
role: PRINCIPAL_INVESTIGATOR
References: