louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04258826: A Study to Evaluate LY3154207 on the Brain of Healthy Participants
Official title: A Single-Dose Study Using Functional Magnetic Resonance Imaging to Evaluate the Effect of LY3154207 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-02-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn more about how LY3154207 affects the brain of healthy participants by using magnetic resonance imaging. The study will last up to about nine weeks for each participant and may include up to four visits to the study center.


Eligibility criteria: Inclusion Criteria:

-Overtly healthy males and non-childbearing females, as determined through medical history and physical examination

Exclusion Criteria:

* Have known or ongoing psychiatric disorders
* Have contraindications to magnetic resonance imaging (MRI)

Primary outcomes:
measure: Change from Baseline in Intrinsic Functional Connectivity Among Resting-State Networks of the Brain
timeFrame: Day 1, Approximately Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01892826: Frozen Blastocyst Transfer in Natural Cycle
Official title: Cryopreserved Thawed Blastocyst Transfer in Natural Cycle With or Without hCG Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: FET
Blastocyst
natural cycle
hCG
Spontaneous LH pic
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 120
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rational of the study is to assess the pregnancy rate after the transfer of frozen blastocyst in natural cycle controlled by external administration of hCG.


Eligibility criteria: Inclusion Criteria:

* age \< 40
* BMI:18-29 kg/m2
* day 5 frozen embryo
* previously IVF/ICSI

Exclusion Criteria:

* OOCYTE DONATION CYCLES

Primary outcomes:
measure: Implantation rate
timeFrame: 2 years
Secondary outcomes:
measure: ongoing pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00001126: Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
Official title: A Phase I/II Evaluation of Cidofovir Therapy For Recurrent Laryngeal Papillomatosis in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Papilloma
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see what dose of the drug cidofovir is safe to treat laryngeal papillomatosis (warts in the throat which occur over and over) in children.

Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This study tests the safety of giving this drug to children.

Detailed description: Your child will be assigned randomly (like tossing a coin) to receive either cidofovir or placebo (an inactive substance). Neither you nor your doctor will know which your child is receiving. Your child will undergo a total of 6 bronchoscopic procedures, which involves placing a tube down your child's throat so that the warts can be seen and treated. The warts will be removed by laser or other procedures and the study drug injected. Study drug will be injected at the sites of all newly removed warts and warts which were removed during earlier study visits. This procedure will be performed every other week. Blood and urine tests will also be performed at this time. Your child will be under general anesthesia during each procedure and will be in the surgery unit for about 6 to 8 hours. Your child will also have to be seen by the doctor 2 days after the procedure. Your child will be followed for a total of 5 years to make sure he/she develops normally and to monitor any side effects of cidofovir. Follow-up visits will take place at Months 3, 6, and then once every 6 months through Year 5. If necessary, laser or other procedures will be performed at these visits to remove any warts.

Eligibility criteria: Inclusion Criteria:

Your child may be eligible for this study if he/she:

* Has active laryngeal papillomatosis (warts in the throat) that requires 8 or more surgeries per year.
* Developed this infection before the age of 16.
* Is between the ages of 2 and 17 years with consent of parent or guardian.

Exclusion Criteria:

Your child will not be eligible for this study if he/she:

* Has a history of a prior malignancy (cancer), kidney disease, or immune system deficiency.
* Is HIV-positive.
* Is allergic to probenecid.
* Has received radiation therapy to the throat area or has received certain medications.
* Is pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: NIAID/DMID/CASG Central Unit
state: Alabama
Study officials:
References:
Clinical trial NCT01084226: Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects
Official title: Dietary Intervention Trial of Alkylresorcinols and Plant Sterols in High-Fibre Rye Bread and Their Effects on Serum Lipids in Normo- and Mildly Hypercholesterolemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterol
Keywords: Rye fiber
Alkylresorcinols
Plant sterols
Cholesterol
Antioxidant
Effects of plant sterols in rye bread on serum lipids
Effects of alkylresorcinols in rye fiber on LDL particles
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Samfundet Folkhälsan
name: Sigrid Jusélius Foundation
name: Fazer
First posted: 2010-03-10
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the antioxidative effects of alkylresorcinols (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols, incorporated in the rye bread, on serum total and LDL cholesterol concentration.


Eligibility criteria: Inclusion Criteria:

* healthy
* volunteer
* hemoglobin above 125 mmol/L in females, above 135 mmol/L in males

Exclusion Criteria:

* taking drugs affecting plasma lipids or gastrointestinal track
* severe illness
* use of antibiotics within 3 months before entering the study
* use of vitamin pills or fish oil 1 month before entering the study
* pregnancy or lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Folkhälsan Research Center
Study officials:
affiliation: Department of Medicine, University of Helsinki, Helsinki, Finland
name: Matti J Tikkanen, M.D.. Prof.
role: STUDY_DIRECTOR
References:
citation: Soderholm PP, Alfthan G, Tikkanen MJ, Adlercreutz H. Rye bread intake improves oxidation resistance of LDL in healthy humans. Atherosclerosis. 2012 Apr;221(2):583-6. doi: 10.1016/j.atherosclerosis.2012.01.030. Epub 2012 Jan 25.
citation: Soderholm PP, Alfthan G, Koskela AH, Adlercreutz H, Tikkanen MJ. The effect of high-fiber rye bread enriched with nonesterified plant sterols on major serum lipids and apolipoproteins in normocholesterolemic individuals. Nutr Metab Cardiovasc Dis. 2012 Jul;22(7):575-82. doi: 10.1016/j.numecd.2010.09.011. Epub 2011 Jan 6.
Clinical trial NCT03383926: Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
Official title: Prospective Study About the Efficacy of the Longo's Intervention for the Treatment of Hemorrhoids and Rectal Mucosal Prolapse.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Rectal Mucosa Prolapse
Keywords: Longo
Hemorrhoids
Rectal
Prolapse
Anal
Lead sponsor: Hospital de Mataró
Sponsor class: OTHER
First posted: 2017-12-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the surgery, Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).
Primary purpose: TREATMENT

Brief summary: The aim of this study is to define the significance of the distance of the staple line to the dentate line of the anal canal in the efficacy of the Longo's intervention.

Detailed description: Is going to be carried out with patients from 18 to 70 years old with hemorrhoids in a level III and IV in the Lord scale.

In the surgery Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).

Eligibility criteria: Inclusion Criteria:

* Women and men from 18 to 70 years old
* Hemorrhoids in level III and IV in the Lord scale
* Surgery without income and conventional hospitalization

Exclusion Criteria:

* Previous hemorrhoidal intervention
* Actual anal pathology

Primary outcomes:
measure: Efficacy of the Longo's intervention (distance in the staple line till the dentate line of the anal canal in cm)
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
Study officials:
affiliation: Hospital de Mataró
name: Lluis Hidalgo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hidalgo-Grau LA, Piedrafita-Serra E, Ruiz-Edo N, Llorca-Cardenosa S, Heredia-Budo A, Estrada-Ferrer O, Sunol-Sala X. Prospective Randomized Study on Stapled Anopexy Height and Its Influence on Recurrence for Hemorrhoidal Disease Treatment. World J Surg. 2020 Nov;44(11):3936-3942. doi: 10.1007/s00268-020-05676-y.
Clinical trial NCT04487626: Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring
Official title: Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Disease
Keywords: artificial intelligence, deep learning, bowel preparation
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2020-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to develop and validate the accuracy and reliability of an artificial intelligence(AI) system for bowel preparation quality scoring based of Boston Bowel preparation Scoring(BBPS). Then evaluate whether this AI system can help endoscopists to improve the quality of colonoscopy in clinical practice.

Detailed description: Bowel preparation is one of the most important factors which decide the quality of colonoscopy. Adequate bowel preparation is essential to guarantee a clear vision of colonic mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs). Therefore, the quality of bowel preparation should be evaluated accurately and objectively. However, current bowel preparation quality scales depend on memories and subjective decision of endoscopists. Recently, articifial intelligence system based on deep learning algorithm has been used widely in medical fields. But, few studies have been reported to evaluate the performance of AI system based on deep learning in bowel preparation quality scoring. This study aims to develop and train an AI system to assess bowel preparation quality using the BBPS, and validate the AI system to improve the quality of colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Patients aged 20-80 years undergoing elective colonoscopy

Exclusion Criteria:

* Patients received colon or rectal surgery

Primary outcomes:
measure: accuracy of bowel preparation score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01034826: Progression to Impaired Glucose Tolerance and Type 2 Diabetes in the Korean People-based KNDP Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impaired Glucose Tolerance
Diabetes
Keywords: NGT, IGT, diabetes
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who vist the endocrinology department due to impaired fasting glucose or impaired glucose tolerance, or both.

Brief summary: Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and diabetes. Previously, prospective studies have shown higher progression rates from IGT to diabetes in other country. But There is no prospective-multicenter based reports in Korea. Therefore, the purpose of this study is to estimate the progression rates to impair glucose regulation and diabetes in the Korean population-based Korea national Diabetes program.


Eligibility criteria: Inclusion Criteria:

* fastic serum glucose \>100 and/or pp2 serum glucose \<200

Exclusion Criteria:

* known diabetes
* organ failure(For example, liver, kidney)
* known malignancy

Primary outcomes:
measure: fasting serum glucose, fasting plasma insulin,post prandial serum glucose, post prandial plasma insulin, hbA1c
timeFrame: 0.1.3.5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Choi KM, Hwang SY, Hong HC, Yang SJ, Choi HY, Yoo HJ, Lee KW, Nam MS, Park YS, Woo JT, Kim YS, Choi DS, Youn BS, Baik SH. C1q/TNF-related protein-3 (CTRP-3) and pigment epithelium-derived factor (PEDF) concentrations in patients with type 2 diabetes and metabolic syndrome. Diabetes. 2012 Nov;61(11):2932-6. doi: 10.2337/db12-0217. Epub 2012 Jul 26.
Clinical trial NCT04409626: Hyponatraemia and Mortality in Schizophrenic and Bipolar Patients: Protocol for a Bayesian Causal Inference Study
Official title: Is Hyponatraemia a Risk Factor for Mortality in Schizophrenic and Bipolar Patients? Protocol for a Bayesian Causal Inference Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyponatremia
SIADH
Keywords: Causality
Bayesian analysis
Antipsychotics
Psychotropics
Polypharmacy
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 31740
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases:

* Died in our catchment area between 1 January 2011 and 1 July 2016.

Controls:

* 5 controls per case found by risk-set sampling with replacement, matched on date of birth +/- 180 days.

Brief summary: This study seeks to investigate if hyponatraemia be a direct contributor to death in schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.


Eligibility criteria: Source population:

* Danish residents
* At least one International Classification of Diseases version 10 (ICD-10) F2 or F31 diagnosis from a hospital in Region Zealand and the Capital Region (Denmark)

No exclusion criteria.

Primary outcomes:
measure: Mortality
timeFrame: 1 January 2011 through 1 July 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00503126: Bivalirudin as a Procedural Anticoagulant in Pediatrics
Official title: Bivalirudin (Angiomax®) As A Procedural Anticoagulant In The Pediatric Population Undergoing Intravascular Procedures For Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiology
Keywords: pediatrics
bivalirudin
Lead sponsor: The Medicines Company
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 110
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pharmacokinetics and safety of weight based bivalirudin in children


Eligibility criteria: Inclusion Criteria:

* Male and non-pregnant females, with an age range of birth to 16 years of age.
* Expected to undergo a percutaneous intravascular procedure for the management of congenital heart disease.
* Written informed consent from a legal guardian/parent.
* Life expectancy of at least 15 days at study entry.
* Assent of the patient if older than 8 years, whenever possible.

Exclusion Criteria:

* History of intracerebral bleed (neonates confirmed by an ultrasound head scan prior to procedure), or cerebral arteriovenous malformation or any prior bleed with neurological deficit.
* Gastrointestinal or genitourinary bleeding within the last 2 weeks excluding normal menstrual cycles.
* Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
* Known congenital or acquired bleeding or clotting disorder.
* Patients undergoing renal dialysis.\*
* Weight \< 2.5 kg.
* Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
* Known allergy to bivalirudin or hirudin-derived drugs, or known sensitivity to any component of bivalirudin (Angiomax®).
* Any condition that in the investigator's opinion would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
* Participation in another investigational therapeutic drug or therapeutic device trial within 30 days of starting study.
* Patients who have been receiving warfarin (Coumadin®) therapy and whose INR is \> 1.5.
* Patients who cannot be discontinued from UFH at least 30 minutes prior to study drug bolus.
* Patients who have received a dose of LMWH within 8 hours prior to study drug bolus.
* Patients previously enrolled in the study.

Primary outcomes:
measure: PK/PD and safety
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Forbes TJ, Hijazi ZM, Young G, Ringewald JM, Aquino PM, Vincent RN, Qureshi AM, Rome JJ, Rhodes JF Jr, Jones TK, Moskowitz WB, Holzer RJ, Zamora R. Pediatric catheterization laboratory anticoagulation with bivalirudin. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):671-9. doi: 10.1002/ccd.22817. Epub 2011 Jan 4.
Clinical trial NCT00588926: Changes of the Neuronal Activity in the Subthalamic Nucleus Under Remifentanil Sedation During Stereotactic Electrode Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Movement Disorders
Effect of Remifentanil
Keywords: Deep Brain Stimulation
Movement Disorders
Remifentanil
Sedation
Basal Ganglia electrical activity
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-01-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Deep brain stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who has to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the basal ganglia.

The purpose of this study is to detect possible changes in the electrical activity of the basal ganglia related to remifentanil sedation. electrical activity of single neurons will be recorded before, during and after sedation.


Eligibility criteria: Inclusion Criteria:

* Patients with movement disorder, who are candidates for implantation of deep brain stimulation electrode.

Exclusion Criteria:

* Suspected difficult intubation
* history of sleep apnea
* known allergy for remifentanil

Primary outcomes:
measure: Electrical activity in the basal ganglia
timeFrame: During the experiment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Dan Eimerl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benady A, Zadik S, Eimerl D, Heymann S, Bergman H, Israel Z, Raz A. Sedative drugs modulate the neuronal activity in the subthalamic nucleus of parkinsonian patients. Sci Rep. 2020 Sep 3;10(1):14536. doi: 10.1038/s41598-020-71358-3.