louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01349712: Study to Test the Accuracy of a Prototype Handheld PT/INR Device
Official title: Correlation of Feasibility Batches Using Warfarinised Blood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Coagulation Disorders
Lead sponsor: Universal Biosensors Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects currently receving coumadin(warfarin) treatment

Brief summary: The purpose of this study is to measure prothrombin time (PT) on an experimental device and a commercially available device on persons receiving coumadin (warfarin)treatment.

Detailed description: This study will require participants to have up to 2 finger-punctures taken and sample tested on a strip and meter system for both the experimental and commercially available devices.

Eligibility criteria: Inclusion Criteria:

* Currently taking coumadin (warfarin)
* Aged 18 years or older
* Able and willing to provide informed consent
* Can understand (read and write) English

Exclusion Criteria:

* None

Primary outcomes:
measure: PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device
timeFrame: Fives days to collect data and up to two weeks to generate correlation graph
Secondary outcomes:
Other outcomes:
Locations:
city: Batesville
country: United States
facility: White River Diagnostic Clinic
state: Arkansas
Study officials:
affiliation: Harding University
name: Richard Ward, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080312: Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Official title: Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniere's Disease
Keywords: Meniere's disease
endolymphatic hydrops
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: American Society of Head and Neck Radiology
First posted: 2014-03-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study of patients with clinical symptoms of Ménière's disease using injection of diluted magnetic resonance imaging (MRI) contrast agent into the ear to evaluate inner ear structures.

The goal is to reproduce imaging findings described by non-United States (US) institutions, improve on image quality with decreased scan time and evaluate the dynamics of the contrast movement into the inner ear structures.

Detailed description: Participants will be scheduled for study sessions on 2 consecutive days to include consent, baseline audiometric evaluation, intra-tympanic contrast administration, serial MR imaging, and follow-up audiometry evaluation in the injected ear.

Participants over 59 years old or who have medical conditions will have a blood test to check kidney function to ensure they can safely receive the contrast.

Eligibility criteria: Inclusion Criteria:

* Symptoms and clinical exam consistent with Ménière's disease
* Ability to undergo MR exam
* Interest in participating in this study
* Ability to provide informed consent

Exclusion Criteria:

* Children (under age 18),
* Contraindication to MR imaging (see attached UCSD MR Screening Form)
* Claustrophobia precluding MR exam without sedation
* Contraindication to receiving intravenous gadolinium-based contrast agent (see attached UCSD Contrast Policy)
* Patients who are pregnant or breast feeding (intravenous contrast agents are Category C)
* Contraindication to osmotic challenge (congestive heart failure, renal failure, hepatic failure)

Primary outcomes:
measure: Vestibular "Endolymphatic Hydrops (EH)"
timeFrame: 24 hours post injection
measure: Cochlear "Endolymphatic Hydrops (EH)"
timeFrame: 24 hours post injection
Secondary outcomes:
measure: Extension of Contrast From Perilymph to CSF
timeFrame: 24 hours post injection
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Health System
state: California
Study officials:
References:
citation: Bykowski J, Harris JP, Miller M, Du J, Mafee MF. Intratympanic Contrast in the Evaluation of Meniere Disease: Understanding the Limits. AJNR Am J Neuroradiol. 2015 Jul;36(7):1326-32. doi: 10.3174/ajnr.A4277. Epub 2015 Mar 26.
Clinical trial NCT04741412: Pediatric SARS-CoV-2 Infections: Course of COVID-19, Immune Responses, Complications and Long-term Consequences
Official title: SARS-CoV-2 Infections in Children and Adolescents: Course of COVID-19, Immune Responses, Complications and Long-term Consequences in Entire Households With Members Younger Than 18 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypohidrotic Ectodermal Dysplasia
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: households with children and/or adolescents and at least one member who has or had a SARS-CoV-2 infection

Brief summary: Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Complete households are investigated, including women who are pregnant when exposed to the virus and their newborn child(ren).


Eligibility criteria: Inclusion Criteria:

* household with one or more members registered as patient(s) in the University Hospital Erlangen
* at least one person \<18 years of age
* at least one household member who has or had a SARS-CoV-2 infection confirmed by a positive PCR test, detection of specific antibodies against this virus, or by development of COVID-19 symptoms after being in close contact with a person known to be infected with SARS-CoV-2
* informed consent

Exclusion Criteria:

* missing informed consent of one or more household members
* language barriers to communication that would prevent informed consent

Primary outcomes:
measure: age-dependence of SARS-CoV-2 infection
timeFrame: 3 months from the point in time at which the first household member shows symptoms of COVID-19
measure: percentage of household members infected by SARS-CoV-2
timeFrame: 3 months from the point in time at which the first household member shows symptoms of COVID-19
measure: duration of primary COVID-19 symptoms
timeFrame: 2 months from the onset of COVID-19 symptoms
measure: frequency of late-onset cardiovascular complications
timeFrame: 2-12 months from the onset of COVID-19 symptoms
measure: frequency of postviral fatigue
timeFrame: 2-12 months from the onset of COVID-19 symptoms
measure: frequency of noticeable temporary hair loss after COVID-19
timeFrame: 2-12 months from the onset of COVID-19 symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
affiliation: University Hospital Erlangen
name: Holm Schneider, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964912: Single Dose Study of BMS-820836
Official title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
* Right-handed, non-ambidextrous subjects for Part 2
* Men and women, ages 18 to 55 years, inclusive

Exclusion Criteria:

* Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* WOCBP using a prohibited contraceptive method
* Women who are pregnant or breastfeeding
* Sexually active fertile men not using effective birth control if their partners are WOCBP
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* History of cholecystectomy
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact the absorption of study drug
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate/swallow oral medication
* Difficulty with venipuncture and/or poor venous access
* Self-reported smokers
* Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
* Confirmed resting supine systolic blood pressure \> 130 mmHg
* Confirmed resting supine diastolic blood pressure \> 80 mmHg
* Confirmed QT value ≥ 500 msec
* Confirmed QTc (Bazett) value ≥ 450 msec
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
* History of peppermint allergies
* History of brain conditions (e.g. history of stroke, head trauma, etc.)
* History of or current psychiatric conditions
* History of claustrophobia

Primary outcomes:
measure: To assess the safety and tolerability of BMS-820836 following single-dose administration
timeFrame: Within 14 days of first dose
Secondary outcomes:
measure: To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007
timeFrame: Within 7 days of dosing
measure: To assess the pharmacodynamics of BMS-820836
timeFrame: Within 48 hours of dosing
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06911112: NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Depression
Major Depressive Disorder
NBI-1065845
TAK-653
MADRS
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2025-04-04
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: The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.


Eligibility criteria: Key Inclusion Criteria:

* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Key Exclusion Criteria:

* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

Primary outcomes:
measure: Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
timeFrame: Baseline, Day 56
Secondary outcomes:
measure: Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
timeFrame: Baseline, Day 56
measure: Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
timeFrame: Baseline, Day 56
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Neurocrine Clinical Site
state: Missouri
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT00291512: Promoting Safer Sex in HIV+ Homosexual and Bisexual Men Who Use Methamphetamine
Official title: Promoting Safer Sex in HIV+ MSM Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
STDs
Methamphetamine Abuse
Keywords: HIV
STDs
Methamphetamine abuse
MSM
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-02-14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project studies the effectiveness of a sexual risk reduction intervention among HIV+ Men who have Sex with Men (MSM) and who use methamphetamine.


Eligibility criteria: Inclusion Criteria:

* HIV+
* Men who have sex with men

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: HIV Neurobehavioral Research Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Thomas L. Patterson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01880112: Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
Official title: Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery Receiving Two Differing Doses of Pre-operative Cefazolin.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infection
Cesarean Delivery
Antibiotic Prophylaxis
Keywords: Infection
Cesarean delivery
Antibiotic prophylaxis
Cefazolin dosing
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2013-06-18
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery. It is unknown what the best dose for the usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level. These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in normal weight women undergoing c-sections.


Eligibility criteria: Inclusion Criteria:

1. Age 18 years or above
2. Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
3. Undergoing cesarean delivery

Exclusion Criteria:

1. BMI greater than 30.
2. Not undergoing Cesarean delivery.
3. Age less than 18 years.
4. Pre-existing infection.
5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
6. Cesarean delivery being performed under emergent circumstances

Primary outcomes:
measure: Cefazolin drug level.
timeFrame: Tissue and blood samples will be drawn during the surgical case only. Duration expected to be less than 120 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: West Virginia University
name: William H Holls, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Michael L Stitely, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06543212: Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery
Official title: Eye Alignment and Eye Control Changes Through Follow up Period After Application of Eye Exercises Post Strabismus Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus; Intermittent
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population from both groups will be selected from Research Institute of Ophthalmology and completed physiotherapy training program for 3 months to improve eye alignment and eye control post strabismus surgery.

Brief summary: The aim of this study is to determine the patient status through its follow up period and weather the eye alignment and eye control are as the same as the last physiotherapy treatment session or there is any deterioration of them.

Detailed description: This study is quantitative cohort observational study. The study depends on following a group of participants over a period of time ( 2 months after completed physiotherapy training program for 3 months to improve eye alignment and eye control post strabismus surgery ).

Through the study, there is observation to the changes in certain quantitative variables ( eye alignment and eye control ).

Eligibility criteria: Inclusion Criteria:

* Patients are both males and females.
* Their age will range from (5-15) years.
* All Patients received physiotherapy training for improving eye alignment and eye control.
* Patients applied the physiotherapy rehabilitation program for 3 months with the physiotherapist.
* All Patients complete their physiotherapy training sessions for improving eye alignment and eye control
* All Patients have a history of strabismus surgery.
* Intermittent exotropia was the type of strabismus which included to the study.

Exclusion Criteria:

* - Patient who didn't receive physiotherapy training program for improving eye control and eye alignment post strabismus surgery.
* Patient who didn't complete the physiotherapy training program for 3 months.
* Muscular disorders that will impair performance during training.
* Any organic lesion in the eye.
* Neurological disorders.
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders.

Primary outcomes:
measure: Eye deviation by prism-cover test
timeFrame: 3 months
measure: Measurement of eye control by Intermittent Exotropia Control Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Lecturer at faculty of physical therapy, Cairo University
name: Amany Abdel Wahid, Post doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01205412: An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain
Official title: An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women in the Kingdom of Bahrain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 552
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ≥ 20 years of age, attending out-patient health services for routine cervical screening and women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.

Brief summary: The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.


Eligibility criteria: Inclusion Criteria:

* Women ≥ 20 years of age attending a clinic for routine cervical screening OR
* Women ≥ 16 years of age presenting for post-natal check-ups
* Women providing a cervical sample
* Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject

Exclusion Criteria:

* Referral for abnormal cervical sample at the current visit
* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)
* Pregnant women
* History of hysterectomy
* Known diagnosis of immunosuppression, or patient on immunosuppressives
* Having received one or more doses of human papillomavirus vaccine prior to participating in the study

Primary outcomes:
measure: Prevalence of any Human Papillomavirus (HPV) deoxyribonucleic acid (DNA) and HPV type distribution among women undergoing cervical sample testing and post-natal check up.
timeFrame: Average time frame: 12 months
Secondary outcomes:
measure: Prevalence of any HPV DNA and HPV type distribution among women of different age strata undergoing cervical sample testing and post-natal check up.
timeFrame: Average time frame: 12 months
measure: Behavioural risk factors
timeFrame: During visit 1 (day 0)
measure: Awareness of HPV in relation to transmission and cause of cervical cancer
timeFrame: Average time frame: 12 months
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Moosa K, Alsayyad AS, Quint W, Gopala K, DeAntonio R. An epidemiological study assessing the prevalence of human papillomavirus types in women in the Kingdom of Bahrain. BMC Cancer. 2014 Dec 3;14:905. doi: 10.1186/1471-2407-14-905.