louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04637828: A Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection
Official title: Cure COVID: A Prospective, Controlled, Randomized Study to Compare the Efficacy of GNS561 Versus Standard of Care in Patients With SARS-CoV-2 (COVID-19) Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Genoscience Pharma
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open-label, controlled, randomized phase 2 study
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, controlled, randomized phase 2 study designed to evaluate the safety and efficacy profile of GNS561 in patients with COVID-19.

Detailed description: Patients will be treated either with oral GNS561 plus standard of care or only standard of care. All patients in experimental arm will be treated for ten days. Study drug will be provided as oral capsules containing 200 mg of GNS561. Patients will be followed-up during hospitalization and after discharge.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory).
* Clinical status: Hospitalized for moderate COVID-19 with News2 score between 5 and 6

Exclusion Criteria:

* Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, tafenoquine, hydroxychloroquine, mefloquine).
* History of QT prolongation (QTc ≥ 500 ms) or QTc ≥ 500msec at screening or bradycardia \< 50/mn
* Current use of loop diuretics and potassium supplementation or documented history of hypokalemia or hypokalemia \< 3.5mmol/l at screening
* Prior allogeneic bone marrow transplantation or solid organ transplant in the past.
* Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.

Primary outcomes:
measure: number and proportion of participants, per randomized group, with a loss of one or two grades of National Early Warning Score (NEWS2) score at day-7 compared to baseline
timeFrame: 7 days
Secondary outcomes:
measure: the 28-day survival rate
timeFrame: 28 days
measure: the rate of intensive care unit admission
timeFrame: 14 days
measure: the rate of nasopharyngeal swab negativation at D7, D14 and D28
timeFrame: 7 days, 14 days and 28 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Genoscience Pharma
Study officials:
References:
Clinical trial NCT05840328: DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY
Official title: INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Painless Vainal Labour
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor


Eligibility criteria: Inclusion Criteria:

* Full term (≥ 37 weeks) healthy primigravida parturients ASA2
* with single fetus scheduled for vaginal delivery
* with cephalic presentation
* requesting labor analgesia.

Exclusion Criteria:

* Allergy to dexmetomidine.(based on previous history)
* Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
* Twins.
* Malpresentation.
* Preeclampsia or gestational hypertension
* Uncontrolled diabetes HBA1c ≥ 6.5%
* Uncontrolled renal failure
* Uncontrolled liver disease
* Bleeding tendency or coagulopathy.
* Contraindication or patient refusal to epidural block.
* Body mass index ≥ 35.

Primary outcomes:
measure: pain relief
timeFrame: at 30 min after induction of block
measure: pain relief
timeFrame: on delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University Hospitals
state: Menoufia
Study officials:
affiliation: Menoufia University
name: mostafa M mansour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01523028: Influence of Breakfast Consumption on Chlorogenic Acid Metabolism in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Data and knowledge gathered on bioavailability of coffee phenolics is becoming more and more important, hence underlying the importance of better understanding the fate of these potential health promoting antioxidants. However, some analytical barriers as well as some key aspects of metabolism still remain to be fully elucidated to get the full picture of coffee metabolism and bioavailability. One aspect addressed in the present study is the impact of food matrix in modulating absorption, plasma appearance and urinary excretion of coffee bioactives.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Aged 20-44 years
* Caucasian origin
* Body mass index (BMI) 19-25 kg/m2
* Used to drinking coffee (similar to study coffee) on a daily basis
* Being able to tolerate a 48-hour coffee abstinence
* Normal oral glucose tolerance test
* Having signed the informed consent form

Exclusion Criteria:

* Taking medication or dietary supplements
* Smoking
* Performing a competitive sport
* Having metabolic disorders
* Long gut transit time (\>24 h)
* Blood donor
* Irregularity in menstrual cycle (for women)
* Pregnancy (for women)
* Subject who cannot be expected to comply with the study procedures.
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Primary outcomes:
measure: Sum of plasma areas under the curve of coffee phenolics
timeFrame: Measurements over 24h after coffee ingestion
Secondary outcomes:
measure: Plasma AUC, Cmax and Tmax of individually measured coffee chlorogenic and phenolic acids
timeFrame: Measurements done over 24h after coffee ingestion
measure: Urinary excretion of coffee chlorogenic and phenolic acids expressed as % ingested dose
timeFrame: Measurements done over 24h after coffee ingestion
Other outcomes:
Locations:
city: Kaiserslautern
country: Germany
facility: University of Kaiserslautern
Study officials:
References:
Clinical trial NCT00090428: Diet and Behavior in Young Children With Autism
Official title: Diet and Behavior in Young Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism
Autistic Disorder
Keywords: Autism
Applied Behavioral Analysis
Gluten
Casein
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-08-27
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

Detailed description: Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy.

Children in this study will be following a gluten free and casein free diet for 18 weeks. All subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They also will be receiving uniform educational and behavioral services through their provider. Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. An end of study, follow-up assessment will be completed at 30 weeks after the start of the study.

Eligibility criteria: Inclusion Criteria:

* Autism spectrum disorder or pervasive developmental disorder, ADI-R and ADOS positive.
* Participation in applied behavioral analysis classes for at least 4 months, with at least 10 hours per week of service, and at least 1 hour of service in the home
* A score higher than 30 on the Mullen Early Learning scale
* Ability to maintain a gluten- and casein-free diet during the study
* In order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the Rochester area

Primary outcomes:
measure: Safety and efficacy of the gluten free casein free diet
timeFrame: Measured at Weeks 6,18 and 30
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Susan Hyman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02137928: Carboplatin Periocular Injection for Retinoblastoma
Official title: Carboplatin Periocular Injection in the Treatment for Retinoblastoma--A Single Center, Randomized Study to Evaluate the Efficacy of Carboplatin in Subjects With Retinoblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Retinoblastoma
Keywords: Retinoblastoma
carboplatin
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical efficacy of periocular injections of carboplatin together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

Detailed description: This study will be a phase Ⅲ open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without periocular injections of carboplatin at a dose of 20mg/2 ml. Patients will receive carboplatin periocular on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* linical diagnosis of retinoblastoma, Stage 0 or Ⅱ base on International Retinoblastoma Staging System.

Exclusion Criteria:

* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* History of chemical intervention for retinoblastoma in the study eye.

Primary outcomes:
measure: all cause mortality
timeFrame: two years
Secondary outcomes:
measure: side effects of carboplatin periocular injection in the Treatment of Retinoblastoma
timeFrame: two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Huasheng Yang, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01820728: A Phase III Clinical Study to Compare the Efficacy and Safety of DA-3801 and That of Gonal-F®
Official title: A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Anovulation
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 93
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: open label, active-controlled, randomized, parallel group, comparative study.

Detailed description: This is a phase III comparative study to evaluate the effectiveness and safety of DA-3801 in treatment of the patients with WHO Group II anovulatory infertility failing to clomiphene citrate treatment. The study is conducted with following methods: open label, active-controlled, randomized, parallel group, comparative.

Eligibility criteria: Inclusion Criteria:

* WHO group II
* Clomiphene citrate resistance
* BMI: 17\~29 kg/m\^2
* Irregular menstrual cycle
* Normal blood concentration of FSH, E2, prolactin and TSH

Exclusion Criteria:

* Uncontrolled endocrine disease
* Ovarian cystic tumor which are NOT related to PCOS
* Severe endometriosis
* Chronic cardiovascular disease, liver complaint

Primary outcomes:
measure: The ovulation rate after 3 cycles of the injection
timeFrame: 5 weeks maximum
Secondary outcomes:
measure: Total dose used, IU (International Unit)
timeFrame: 5 weeks
measure: Duration of stimulation, days
timeFrame: 5 weeks
measure: Threshold dose, IU
timeFrame: 5 weeks
measure: Number of follicles
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Institutional Review Board
Study officials:
affiliation: Dongguk University Hospital
name: Eung Gi Min, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: Chang Suk Suh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Doo Seok Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Chung Hoon Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Jong Min Park, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Kyung Joo Hwang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05950828: Evaluating the Impact of Online Educator Microskill Training on Educator Knowledge and Skill
Official title: Evaluating the Impact of Online Educator Microskill Training on Educator Knowledge and Skill
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS Prevention
STI Prevention
Pregnancy Prevention
Lead sponsor: Philliber Research & Evaluation
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to evaluate the efficacy of SkillTalk, a subscription-based microskills video training library designed to enhance the skills of high school sex educators to implement the frequently used core components of sexual and reproductive health (SRH) curricula.

The overall goal of this study is to evaluate the impact of SkillTalk on educators' demonstrable sexual health education skills.

Participants will be asked to:

* Complete a consent form.
* Attend two simulated classroom sessions, either in person or virtually, during which they will teach two prepared lessons that have will be provided to them.
* Be video recorded while teaching.
* Complete a baseline survey and a post-survey.
* If assigned to the treatment group, they will be granted access to SkillTalk for one week to view the videos associated with the answering sensitive questions and using trauma-informed strategies skill sets.

Researchers will compare the treatment group to the control group to see if SkillTalk has an impact on educators' demonstrable sexual health education skills.


Eligibility criteria: Inclusion Criteria:

* Teach or have taught groups of youth in a school, clinic or community setting. Group is defined as 4 or more youth. Youth is defined as high school aged youth in grades 9-12.
* Have fewer than three years of experience teaching sexual health education
* Comfortable participating in the role
* Must reside in the U.S.
* Must be at least 18 years of age.

Primary outcomes:
measure: Demonstrable use of microskills
timeFrame: 1 week
Secondary outcomes:
measure: Knowledge of microskills
timeFrame: 1 week
measure: Self-efficacy and comfort
timeFrame: 1 week
Other outcomes:
Locations:
city: Accord
country: United States
facility: Philliber Research & Evaluation
state: New York
Study officials:
References:
Clinical trial NCT02369328: Multimodal MRI Study of Ischemic Stroke
Official title: Multimodal MRI Study of Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STROKE
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Stroke is the second most frequent causes of mortality in the word after cardiovascular disease and the most frequent cause of disability. The majority of strokes are ischemic (87%). Ischemic stroke may benefit from efficient therapy if the delay from stroke onset not exceeds 4H30 (intra-venous thrombolysis). In case of irreversible cerebral lesion, the long term functional recovery is largely dependent from the ability of the brain to reorganize. Conventional magnetic resonance imaging represents the most sensitive tool to diagnose stroke at the acute phase. However, up to now, no imaging tool is available to determine the time of stroke onset. Moreover, no imaging tool is available to precisely quantify the functional and structural plasticity mechanisms occurring after stroke. The main objective of the present study is to test the accuracy of sodium MRI to determine the time of stroke onset. The secondary objectives of the study are to determine the ability of non-conventional MRI techniques to quantify the degree of tissue damage and brain reorganization after stroke. Thirty patients will be included during the first 24 hours after stroke onset. Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) and clinical evaluation will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months.


Eligibility criteria: Inclusion Criteria:

- Patient having presented a cerebral infarct beforehand confirmed by the brain imaging

* Patient having presented a cerebral infarct the hour of the beginning of which is known with certainty and dating less than 24 hours
* Patient having presented a cerebral infarct the area(extent) of which is superior to 1,5 ml

Exclusion Criteria:

* Patients presenting the usual contraindications to the MRI (pacemaker, agitation, metallic brightness, claustrophobia etc.)
* Patients presenting a risk of not compliance to the examination: disorders(confusions) of the elementary understanding, the confusion, the involuntary movements, the bad tolerance of the prolonged dorsal decubitus

Primary outcomes:
measure: The time of stroke onset
timeFrame: 3 years
Secondary outcomes:
measure: The degree of tissue damage and brain reorganization after stroke
timeFrame: 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT02648828: Understanding Physician Signout Risk Perception
Official title: Understanding Physician Signout Risk Perception
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physician Judgment
Keywords: Judgment
risk assessment
clinical deterioration
cardiac arrest
Rothman Index
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2016-01-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohorts will be selected from the teaching teams of the University of Pittsburgh's General Internal Medicine wards.

Brief summary: The purpose of the study is to compare the ability of physicians and a statistical index (the Rothman score) to predict clinical deterioration over the next 24 hours. Clinical deterioration is defined as concern in change in vital signs or patient status requiring a call to the rapid response team, cardiopulmonary arrest, or transfer to the ICU.

Detailed description: The proposed study will ask interns, residents, and attending physicians from general internal medicine teaching teams in a large teaching hospital to make predictions about the probability of their patient having a clinical deterioration in the next 24 hours. The investigators will compare these judgments to the Rothman index.

Eligibility criteria: Inclusion Criteria:

* Interns, residents, attendings in the Department of Medicine, Division of General Internal Medicine, University of Pittsburgh.
* Rotating on the general medical service at the University of Pittsburgh Medical Center - Presbyterian Hospital.

Exclusion Criteria:

* None

Primary outcomes:
measure: Difference between physician prediction of risk of clinical deterioration and Rothman Index
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Janel A Hanmer, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Deepika Mohan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carnegie Mellon University
name: Alex Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold J, Davis A, Fischhoff B, Yecies E, Grace J, Klobuka A, Mohan D, Hanmer J. Comparing the predictive ability of a commercial artificial intelligence early warning system with physician judgement for clinical deterioration in hospitalised general internal medicine patients: a prospective observational study. BMJ Open. 2019 Oct 10;9(10):e032187. doi: 10.1136/bmjopen-2019-032187.