louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02288143: COmbining Oral Letrozole and Clomiphene for Ovarian Stimulation
Official title: Evaluation of a Simplified Low-cost and Friendly Controlled Ovarian Stimulation Combining Oral Letrozole and Clomiphene Citrate: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and low-dose hMG on the number of oocytes retrieved.


Eligibility criteria: Inclusion Criteria:

* Women scheduled to controlled ovarian stimulation for oocyte retrieval.
* Body mass index: 18-35 Kg/m2.
* Ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle \>10mm and serum estradiol ≥ 40 pg/L).
* Signing an informed consent.

Exclusion Criteria:

* No exclusion criteria.

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 12 days
Secondary outcomes:
measure: Number of embryos
timeFrame: 17 days
measure: Ovarian hyper-stimulation syndrome
timeFrame: 1 month
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Setor de Reproducao Humana do HC-FMRP-USP
state: Sao Paulo
Study officials:
References:
citation: Figueiredo JB, Nastri CO, Vieira AD, Martins WP. Clomiphene combined with gonadotropins and GnRH antagonist versus conventional controlled ovarian hyperstimulation without clomiphene in women undergoing assisted reproductive techniques: systematic review and meta-analysis. Arch Gynecol Obstet. 2013 Apr;287(4):779-90. doi: 10.1007/s00404-012-2672-0. Epub 2012 Dec 19.
citation: Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013.
citation: Martins WP, Vieira AD, Figueiredo JB, Nastri CO. FSH replaced by low-dose hCG in the late follicular phase versus continued FSH for assisted reproductive techniques. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.
citation: Seko LM, Moroni RM, Leitao VM, Teixeira DM, Nastri CO, Martins WP. Melatonin supplementation during controlled ovarian stimulation for women undergoing assisted reproductive technology: systematic review and meta-analysis of randomized controlled trials. Fertil Steril. 2014 Jan;101(1):154-161.e4. doi: 10.1016/j.fertnstert.2013.09.036. Epub 2013 Oct 29.
citation: Nastri CO, Teixeira DM, Moroni RM, Leitao VM, Martins WP. Ovarian hyperstimulation syndrome: pathophysiology, staging, prediction and prevention. Ultrasound Obstet Gynecol. 2015 Apr;45(4):377-93. doi: 10.1002/uog.14684. Epub 2015 Mar 1.
Clinical trial NCT01255943: Testing Spread and Implementation of Novel Methicillin Resistant Staphylococcal Aureus (MRSA)-Reducing Practices
Official title: Testing Spread and Implementation of Novel MRSA-Reducing Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Stream Infections
MRSA Infections
Keywords: MRSA
bloodstream infections
hemodialysis
Lead sponsor: MaineHealth
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Indiana University School of Medicine
First posted: 2010-12-08
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prevalent hemodialysis patients at two outpatient dialysis units

Brief summary: The purpose of this study is to implement strategies for improved efficiency and waste reduction ("Toyota Lean") and positive deviance, a social behavioral change process, utilizing frontline healthcare personnel to reduce infection bloodstream infection and MRSA infection in outpatient dialysis care. In two outpatient dialysis units, dialysis unit healthcare staff will be educated in Toyota lean techniques and conduct periodic "discovery and action" dialogues to identify and implement care process changes to reduce infection. Outcomes to be monitored will include incidence of bloodstream infections and MRSA infections of all types. Data will be assessed at quarterly intervals using interrupted time series analysis.


Eligibility criteria: Inclusion Criteria: all hemodialysis patients at two outpatient dialysis units

Exclusion Criteria:peritoneal dialysis patients

Primary outcomes:
measure: Incidence of bloodstream infections
timeFrame: 14 months
Secondary outcomes:
measure: Incidence of MRSA infections
timeFrame: 14 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Mark G Parker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686643: Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension
Official title: A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 306
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 3 study to evaluate efficacy and safety of AGSAVI

Detailed description: A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of AGSAVI for Inadequately Controlled with AGLS

Eligibility criteria: Inclusion Criteria:

* Hypertension patient who satisfied below condition at Visit 1.

  * patient who takes antihypertensive drug

    * 140mmHg \<= sitSBP \<= 200mmHg
  * patient who doesn't take antihypertensive drug

    * 160mmHg \<= sitSBP \<= 200mmHg
* Hypertension patient who satisfied below condition at Visit 2.

  * 140mmHg \<= sitSBP \<= 200mmHg at Visit 2
  * 130mmHg \<= sitSBP \<= 200mmHg at Visit 2(In high-risk patients)

Exclusion Criteria:

* Patient who have received 4 or more antihypertensive drug
* Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 2 times of BP measuring at Visit 1
* Patient with sitDBP \>= 120mmHg at Visit 1 or 2
* Patient with secondary hypertension

Primary outcomes:
measure: Change from baseline in sitSBP at week 10
timeFrame: 10 weeks
Secondary outcomes:
measure: Change from baseline in sitting diastolic blood pressure at week 4 and week 10
timeFrame: week 4 and week 10
measure: Change from baseline in sitting systolic blood pressure at week 4
timeFrame: week 4
measure: •Proportion of subjects achieving Blood Pressure control
timeFrame: week 4 and week 10
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00312143: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Official title: A Prospective, Open Label, Multicenter Study to Assess the Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: De Novo Kidney Transplant Recipients
Keywords: De novo Kidney Transplant recipients, enteric-coated mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in kidney transplant recipients.


Eligibility criteria: Inclusion criteria

1. Males and females aged 18 to 75 years.
2. Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
3. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
4. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion criteria:

1. Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
2. Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
3. Patients with low platelet count (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at screening or baseline.
4. Patients who have received an investigational drug within four weeks prior to study entry.
5. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
6. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.

Additional protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: patient and graft survival
measure: acute rejection incidence
measure: graft function at 6 months post transplant.
Secondary outcomes:
measure: influence of age, gender, and post-transplantation complications on the main clinical outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT05909943: Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders
Official title: Efficacy and Safety of Ruxolitinib in Neuromyelitis Optica Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Neuromyelitis Optica Spectrum Disorder Relapse
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Rucotinib is an oral inhibitor of JAK1 and JAK2 tyrosine kinases. It may benefit some patients with NMOSD due to the important role of JAK/STAT signaling pathway in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.


Eligibility criteria: Inclusion Criteria:

Male or female patients ≥ 18 years old; Diagnosis of NMO or NMO spectrum disorder according to the 2015 International diagnostic criteria for neuromyelitis optic; Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months; EDSS \<= 6.0; Rituximab should be used for at least 3 months if the condition is stable; Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc); Participation in another interventional trial within the last 3 months; Patients taking oral immunosuppressants such as azathioprine; Tumor disease currently or within last 5 years; Pregnant, breastfeeding, or child-bearing potential during the course of the study; Clinically relevant anemia, thrombocytopenia and dysfunction of the heart, liver, kidney or bone marrow.

Primary outcomes:
measure: time to the first protocol-defined relapse
timeFrame: From baseline to one year after.
Secondary outcomes:
measure: Worsening in EDSS
timeFrame: Worsening from baseline in EDSS to 52 weeks
measure: Incidence of treatment-emergent adverse events [safety and tolerability]
timeFrame: From baseline to 52 weeks
Other outcomes:
measure: Counts of peripheral blood B cell subsets
timeFrame: From baseline to 52 weeks
measure: Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Optic nerve,brain and spinal cord Magnetic Resonance Imaging (MRI)
timeFrame: From baseline to 52 weeks
measure: Determination of serum AQP4 antibodies
timeFrame: From baseline to 52 weeks
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04417543: Effect of Memantine on Cognitive Impairment in Patients With Epilepsy
Official title: Effect of Memantine on Cognitive Impairment in Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 patients divided into two groups each group 50patients
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of memantine on improving the cognitive impairment in patient with epilepsy

Detailed description: Epilepsy is a complex disorder, which involves much more than seizures, encompassing a range of associated comorbid health conditions that can have significant health and quality-of-life implications. Of these comorbidities, cognitive impairment is one of the most common and distressing aspects of epilepsy.

Excito-toxicity, mediated by glutamate acting on N-methyl-D-aspartate (NMDA) receptors in the hippocampus, can cause memory dysfunction in epilepsy .

Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor . It also has antioxidant property and increases production of brain derived neurotropic factor (BDNF)

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic epilepsy.
* Normal brain imaging (CT brain).
* Patients on anti epileptic drugs more than 6 months.
* No more than two fits per month.
* Score of Mini mental state examination (10-24), mild and moderate cognitive impairment.
* No other medical disorders.

Exclusion Criteria:

* Progressive neurological diseases.
* Abnormal brain imaging (CT brain).
* More than two fits per month.
* Patients with severe cognitive impairment, score of MMSE less than10.
* Patients with severe medical disorders

Primary outcomes:
measure: Memory Assessment Scale (MAS)
timeFrame: 1.5years
measure: Wechsler Adult Intelligence Scale (WAIS)
timeFrame: 1.5years
measure: Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: 1.5years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Salma Mohmed Fahmy
Study officials:
References:
citation: Bell B, Lin JJ, Seidenberg M, Hermann B. The neurobiology of cognitive disorders in temporal lobe epilepsy. Nat Rev Neurol. 2011 Mar;7(3):154-64. doi: 10.1038/nrneurol.2011.3. Epub 2011 Feb 8.
citation: Aggleton JP. Multiple anatomical systems embedded within the primate medial temporal lobe: implications for hippocampal function. Neurosci Biobehav Rev. 2012 Aug;36(7):1579-96. doi: 10.1016/j.neubiorev.2011.09.005. Epub 2011 Sep 24.
citation: Alvarez PS, Simao F, Hemb M, Xavier LL, Nunes ML. Effects of undernourishment, recurrent seizures and enriched environment during early life in hippocampal morphology. Int J Dev Neurosci. 2014 Apr;33:81-7. doi: 10.1016/j.ijdevneu.2013.12.004. Epub 2013 Dec 21.
Clinical trial NCT02119143: Micronutrient Supplementation and Incidence of Common Cold
Official title: Influence of Micronutrient Supplementation on Duty Days Lost Due to Flu/Common Cold, Immune System, Oxidative Stress and Wellbeing in a Cohort of Middle Management Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System Diseases
Keywords: common cold, immunity, oxidative stress
Lead sponsor: Green Beat
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2014-04-21
Enrollment: 82
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of a dietary supplement - a cocktail of vitamins and minerals - on the incidence of common cold in a cohort of middle management employees.The primary outcome is defined as the number of duty days lost due to common cold/flu. Further, immune parameters and markers of redox biology/oxidative stress will be determined. The wellbeing in the cohort will be evaluated via questionnaires.

Detailed description: randomized, double-blinded, placebo controlled trial 82 Subjects, men and women, 25 - 50 yrs, non-smokers, employees of middle management, 24 weeks of supplementation/placebo, 4 wk wash-out of all supplements and dietetic products, undersupply of fruit, vegetables (\< 4 portions/day) and whole grain food (\< 5x/wk)

Eligibility criteria: Inclusion Criteria:

* pre or peri-menopausal
* non-smokers
* sedentary or moderately trained
* BMI: \>20 and \< 35kg/m2
* undersupply of fruits, vegetables and whole grain food, fibres
* contraceptives
* wash-out

Exclusion Criteria:

* post-menopausal
* smokers
* trained people
* BMI out of inclusion range
* adequate intake of vegetables, fruits and whole grain food, fibres
* no adherence to wash-out

Primary outcomes:
measure: Incidence of common cold
timeFrame: 24 weeks
Secondary outcomes:
measure: change in immune markers
timeFrame: 24 weeks
Other outcomes:
measure: change in redox biology
timeFrame: 24 weeks
Locations:
city: Graz
country: Austria
facility: Institute of Pathophysiology and Immunology
state: Styria
Study officials:
affiliation: Green Beat and Medical University of Graz
name: Manfred Lamprecht, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06744543: Clinical Decision Support to Identify Pediatric Patients With Undiagnosed Genetic Disease
Official title: Randomized Controlled Trial to Assess EHR Prediction Model to Identify Pediatric Patients With Undiagnosed Genetic Disease"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Genetic Disease
Pediatrics
Predictive Model
Clinical Decision Support
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 allocation by predicted probability to either the intervention group, receiving a SIGHT-prompted provider message, or the control group, receiving standard care without the SIGHT-prompted message. The randomization process will be integrated into the routine clinical workflow, with SIGHT scores generated before regularly scheduled patient visits in pediatric primary care at VUMC.
Primary purpose: SCREENING

Brief summary: This study will evaluate the effectiveness of SIGHT as a clinical support system to prompt provider/patient discussion and shared decision making regarding the need for genetic testing in the form of a chromosomal microarray. Identifying patients at high predicted probability of needing a test in clinical settings will be examined to determine if it decreases the duration of time to testing and increases diagnostic yield. SIGHT requires only data already collected in routine clinical encounters and is calculated prior to a clinical visit at VUMC.


Eligibility criteria: Inclusion Criteria:

* All patients \> 1 year old, \< 20 years of age with a scheduled visit to the VUMC pediatric primary care.

Exclusion Criteria:

* Patients who have been programmatically excluded due to having already received a chromosomal microarray at VUMC and patients \> 20 years of age or \< 1 year of age.

Primary outcomes:
measure: Number of Diagnoses in the intervention arm compared to the control arm
timeFrame: 2 years
Secondary outcomes:
measure: Time to test
timeFrame: 2 years
measure: Abnormal CMA
timeFrame: 2 years
measure: Rate of genetic testing
timeFrame: 2 years
measure: Diagnosis via any test (molecular confirmation)
timeFrame: 2 years
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Douglas Ruderfer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morley TJ, Han L, Castro VM, Morra J, Perlis RH, Cox NJ, Bastarache L, Ruderfer DM. Phenotypic signatures in clinical data enable systematic identification of patients for genetic testing. Nat Med. 2021 Jun;27(6):1097-1104. doi: 10.1038/s41591-021-01356-z. Epub 2021 Jun 3.