louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01957293: Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects
Official title: Influence of Salbutamol on Emotional and Cognitive Functions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Memory Functions
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2013-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Aim is to investigate the effect of beta2 adrenergic stimulant salbutamol on emotional and cognitive functions in healthy humans.


Eligibility criteria: Inclusion Criteria:

Healthy, male and female, aged between 18 and 40, BMI be-tween 19 and 27 kg/m2, normotensive (BP between 90/60 mmHg and 140/90 mmHg), native or fluent German-speaking, caucasian (European ancestry), able and willing to give written informed consent and comply with the requirements of the study protocol, willing to donate saliva sample for DNA-analysis -

Exclusion Criteria:

Acute or chronic psychiatric or somatic disorder, tachycardia at rest (\> 100 bpm), known hypersensitivity to salbutamol, pathological ECG, pregnancy, breast-feeding, long-term medication within last 3 months (oral contraceptives are disregarded) smoking (\>3 cigarettes per day), concurrent participation in another study, participation in one of our previous studies using the same memory tests, inability to read and understand the participant's information. -

Primary outcomes:
measure: Change of emotional memory functions under Salbutamol
timeFrame: two testing days within 10 days
measure: Change of episodic memory functions under Salbutamol
timeFrame: two testing days within10 days
Secondary outcomes:
measure: Change of emotional state under salbutamol
timeFrame: Two testing days within 10 days
measure: change of attention functions under salbutamol
timeFrame: two testing days within 10 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive neuroscience
Study officials:
affiliation: University of Basel
name: Dominique de Quervain, Prof. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02908893: Promoting Flu Vaccination Through a Mobile Wellness Program
Official title: Promoting Flu Vaccination Through a Mobile Wellness Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Not Condition-specific
Lead sponsor: Evidation Health
Sponsor class: INDUSTRY
Collaborators: name: Defense Advanced Research Projects Agency
name: Army Research Office (ARO)
First posted: 2016-09-21
Enrollment: 77983
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators design a 6-week messaging campaign aimed at promoting flu vaccination among fully insured members of a national payer that participate in a wellness program offered by the insurer through a mobile app. Outcomes measured will include uptake in flu vaccination rate as measured by the insurer and engagement with the campaign through the app.

The goal of the research is to assess the effectiveness of pervasive computing messaging in promoting preventative care treatments such as flu shots. An additional goal is that of quantifying the importance of emphasizing incentives to increase efficacy of the messages.


Eligibility criteria: Inclusion Criteria:

* belongs to fully insured population
* continuous health coverage between January 1, 2015 and June 1, 2016
* has downloaded and installed the wellness platform app

Exclusion Criteria:

* has declined the messaging from the platform

Primary outcomes:
measure: Increase in vaccination rate vs control
timeFrame: Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)
measure: Increase in vaccination rate of salient vs non-salient
timeFrame: Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)
Secondary outcomes:
measure: Decrease in medically attended flu events of messaged vs control
timeFrame: Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)
measure: Increase in reporting of flu vaccination through wellness app of salient vs non-salient
timeFrame: Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)
measure: Increase in vaccination rate for users messaged within 2 days before of an expected rx pick-up.
timeFrame: Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)
measure: Increase in message open rate of Salient vs Non-salient arm
timeFrame: Up to 1 week after the end of each of the three batches of the intervention (Oct 1/15/28 2016)
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Evidation Health
state: California
Study officials:
References:
citation: Lee WN, Stuck D, Konty K, Rivers C, Brown CR, Zbikowski SM, Foschini L. Large-scale influenza vaccination promotion on a mobile app platform: A randomized controlled trial. Vaccine. 2020 Apr 16;38(18):3508-3514. doi: 10.1016/j.vaccine.2019.11.053. Epub 2019 Nov 29.
Clinical trial NCT00579293: Development of a Computer Assisted Survivor Screening For Adult Survivors of Childhood Cancer
Official title: Development of a Computer Assisted Survivor Screening For Adult Survivors of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer
Keywords: adult survivor of childhood cancer
computer assisted screening of survivors (CASS)
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult survivors of childhood cancer

Brief summary: This study will compare two ways of having people respond to a questionnaire about health and emotional well-being: on a computer and with paper and pencil. We will see how long it takes using both methods. We will also ask you how you feel about using a computer to answer the questions.

Detailed description: To determine feasibility of using the Computer Assisted Survivor Screening (CASS) as a routine screening measure for the survivor population. Specifically, to determine patient acceptance, time to completion, and burden associated with the CASS. To examine the potential utility of the CASS as a routine screening measure in the survivor population. To validate the CASS against the SCL-90-R screening measure. Calculate the sensitivity,specificity, positive and negative predictive values, diagnostic agreement and ROC curve of the CASS compared to the SCL-90. Determine the optimal cut-off scores to optimize agreement between the CASS and the SCL-90.

Eligibility criteria: Inclusion Criteria:

* Currently at least 18 years of age and not older than 49 years of age
* Diagnosed with first malignancy before the age of 22
* Completed all cancer treatment at least three years prior
* Able to complete the survey instruments in English
* Scheduled for a routine off-treatment follow-up oncology appointment
* Currently disease-free and not receiving any cancer treatment

Exclusion Criteria:

* History of a central nervous system tumor
* A sensory or cognitive impairment that would interfere with completion of the survey
* Currently undergoing treatment by a psychiatrist or psychologist (ie., currently receiving psychotherapy and/or psychotropic medications, as per self-report)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Ford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690193: Feasibility and Efficacy of the Ketogenic Diet in Alzheimer's Disease
Official title: Alzheimer's Disease Ketogenic Diet Retention and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Ketogenic Diet
Alzheimer's disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the KDRAFT study is to assess the feasibility and preliminary cognitive efficacy of a ketogenic diet therapy in patients with Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Alzheimer's disease (CDR 0.5, 1, \& 2)
* Active study partner
* BMI \> 21
* English speaking

Exclusion Criteria:

* BMI \< 21
* Consume greater than 14 drinks of alcohol per week
* Insulin Dependent Diabetes Mellitus
* Diagnosis of active cancer
* Myocardial infarction or symptoms of coronary artery disease (e.g. angina) in last year

Primary outcomes:
measure: Proportion of days positive for urinary ketone production
timeFrame: Daily for 90 days (the length of the diet intervention)
measure: Change in blood ketone levels induced by ketogenic diet
timeFrame: Change from baseline serum beta-hydroxybutyrate levels at month 1, 2, 3 (end of ketogenic diet), and 4 (after 1-month washout).
Secondary outcomes:
measure: Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-Cog)
timeFrame: Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).
measure: Change in cognitive performance on the Mini-Mental State Exam (MMSE)
timeFrame: Change from baseline global cognitive scores at month 3 (end of ketogenic diet) and change from month 3 global cognitive scores at month 4 (end of 1-month washout).
measure: Dietary intake characterization prior to and after ketogenic diet initiation
timeFrame: Dietary intake will be collected at Baseline, Month 1, Month 2, Month 3
Other outcomes:
Locations:
Study officials:
References:
citation: Taylor MK, Swerdlow RH, Burns JM, Sullivan DK. An Experimental Ketogenic Diet for Alzheimer Disease Was Nutritionally Dense and Rich in Vegetables and Avocado. Curr Dev Nutr. 2019 Feb 20;3(4):nzz003. doi: 10.1093/cdn/nzz003. eCollection 2019 Apr.
Clinical trial NCT05022693: PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Official title: An Open-Label, Single-Dose Pharmacokinetic Study of Liquid Subcutaneous Formulation of BIO89-100 in Subjects With Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: 89bio, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single dose, PK study
Primary purpose: OTHER

Brief summary: This is an open-label, single-dose study to evaluate the PK profile of the liquid SC formulation of BIO89-100 in approximately 8 male and female subjects with NASH with compensated cirrhosis.


Eligibility criteria: Key Inclusion Criteria:

* Age 21 to 65
* Diagnosis of NASH with compensated cirrhosis by a hepatologist based on Liver Forum criteria.
* Model for End-Stage Liver Disease (MELD) score \< 12.
* Child-Turcotte-Pugh (CTP) score \< 7 (Class A).
* Fibrosis stage F4 by FibroScan.

Key Exclusion Criteria:

* History of hepatic cirrhosis decompensation, OR overt hepatic encephalopathy OR signs of hepatic cirrhosis decompensation.
* Prior transjugular intrahepatic portosystemic (TIPS) shunt procedure.
* known condition other than cirrhosis that may possibly interfere with drug absorption, distribution, metabolism, or excretion.
* Significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening.

Primary outcomes:
measure: PK Profile of liquid formulation of BIO89-100
timeFrame: 22 days
measure: PK Profile of liquid formulation of BIO89-100
timeFrame: 22 days
Secondary outcomes:
measure: Evaluate the safety and tolerability of the BIO89-100 liquid formulation
timeFrame: 22 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: 89bio Clinical Study Site
state: Arizona
Study officials:
References:
Clinical trial NCT05779293: Effect of Vagus Nerve Stimulation on Chronic Stroke Patients
Official title: Effect of Vagus Nerve Stimulation on Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is still one of the top causes of death and adult-onset disability in the world.

Despite physiotherapy and rehabilitation, a sizable percentage of chronic stroke patients are permanently disabled. These neurological deficiencies include cognitive impairment, sensory impairment, loss of coordination, spasticity, dysphasia, dysphagia, visual field dysfunction, and weakness.

Detailed description: Exercises, neurophysiological and electrical stimulations, compensatory strategies, strengthening facilitation approaches programs, and programs are all used as general approach methods in the rehabilitation of stroke patients.

Transcutaneous stimulation of the vagus nerve offers non-invasive stimulation of the vagus nerve and is commonly carried out by stimulating the auricular vagus nerve in the ear or transcutaneous cervical branch vagus in the neck.

Eligibility criteria: Inclusion Criteria:

* To be between the ages of 18-80.
* Having been diagnosed with a stroke by a neurologist.
* Speech disorder after a cerebrovascular accident to be.
* To volunteer to participate in the study.

Exclusion Criteria:

* Being mentally affected (Mini-Mental Test Score \<24).
* Having other neurological diseases other than stroke.
* Concomitant symptoms that prevent individuals from participating in the study (Having undergone amputation surgery, having cardiac arrhythmias be etc.)

Primary outcomes:
measure: Brunstrom Hemiplegia Recovery Stages
timeFrame: 4 weeks
measure: Timed Get Up and Go Test
timeFrame: 4 weeks
measure: Berg Balance Scale
timeFrame: 4 weeks
measure: The Modified Ashworth Scale,
timeFrame: 4 weeks
measure: Montreal Cognitive Assessment Scale
timeFrame: 4 weeks
measure: Standardized Mini Mental State Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Stroop test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol hospital
Study officials:
References:
citation: Baig SS, Kamarova M, Ali A, Su L, Dawson J, Redgrave JN, Majid A. Transcutaneous vagus nerve stimulation (tVNS) in stroke: the evidence, challenges and future directions. Auton Neurosci. 2022 Jan;237:102909. doi: 10.1016/j.autneu.2021.102909. Epub 2021 Nov 14.
Clinical trial NCT01139593: A Trial Comparing Qam With Qpm Dosing in Assisted Reproductive Technologies (ART)
Official title: A Prospective Randomized Trial Comparing Qam With Qpm Daily Dosing in Assisted Reproductive Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: IVF
ICSI
gonadotropin
am dose
pm dose
pregnancy
implantation
live birth
Lead sponsor: Virginia Center for Reproductive Medicine
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 128
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women between 21 and 44 years old

Brief summary: This is a prospective randomized trial comparing the outcome in women undergoing IVF/ICSI when taking their gonadotropin dosage in the morning (am) or evening (pm).


Eligibility criteria: Inclusion Criteria:

* women between 21-42 undergoing IVF

Exclusion Criteria:

* women \> 45,
* women with one ovary,
* donor egg,
* surrogacy,
* FET cycles,
* uterine problems,
* large fibroids

Primary outcomes:
measure: Live birth rate
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reston
country: United States
facility: Virginia Center for Reproductive Medicine
state: Virginia
Study officials:
References:
Clinical trial NCT05156593: 'Long COVID-19' in Suffolk and North Essex: Defining the Disease and Optimising Outcomes
Official title: 'Long COVID' in Suffolk and North Essex: Defining the Disease and Optimising Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Lead sponsor: East Suffolk and North Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with diagnosed Long COVID

Brief summary: To accurately describe the rehabilitation needs of individuals with post-COVID-19 syndrome up to 36 months after infection, allowing better diagnosis, triage and resource management. A major focus will be the impact on everyday life to return to normal activities.


Eligibility criteria: Inclusion criteria Individuals 18 years old and over (no upper age limit) Female and male Diagnosed with COVID-19 via PCR testing Or, Experienced symptoms of COVID-19 (new continuous cough, a high temperature, loss of taste and smell) And Clinically diagnosed with Post-COVID-19 Syndrome by their GP Participants who live within Suffolk and North East Essex

Exclusion criteria Individuals unable to consent for themselves Individuals without sufficient proficiency in English language to take part in telephone or video call, where the research team have been unable to make adjustments to enable their participation Individuals under 18 years old

Primary outcomes:
measure: Symptomology
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ipswich
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust
Study officials:
affiliation: East Suffolk and North Essex NHS Foundation Trust
name: Kate Harrall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146793: The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort
Official title: National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Calciphylaxis
Renal Insufficiency, Chronic
Keywords: Calciphylaxis/complications
Kidney Failure, Chronic/complications
Renal Dialysis
Thiosulfates/therapeutic use
Time Factors
Lead sponsor: Centre Hospitalier St Esprit
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dialysis patients with calciphylaxis

Brief summary: The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.


Eligibility criteria: Inclusion Criteria:

* All dialysis patients with calciphylaxis in France who have obtained a temporary use authorization for sodium thiosulfate by National Agency for the Safety of Medicines

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: time factor on mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Hospitalier St ESPRIT
Study officials:
affiliation: Centre Hospitalier St EPSRIT AGEN FRANCE
name: Albert TRINH-DUC, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weenig RH, Sewell LD, Davis MD, McCarthy JT, Pittelkow MR. Calciphylaxis: natural history, risk factor analysis, and outcome. J Am Acad Dermatol. 2007 Apr;56(4):569-79. doi: 10.1016/j.jaad.2006.08.065. Epub 2006 Dec 1.
citation: Perceau G. [Uraemic and non-uraemic calcific arteriopathy: The need for rapid diagnosis and therapy]. Ann Dermatol Venereol. 2015 Aug-Sep;142(8-9):506-12. doi: 10.1016/j.annder.2015.06.009. Epub 2015 Aug 5. French.
citation: Nigwekar SU, Brunelli SM, Meade D, Wang W, Hymes J, Lacson E Jr. Sodium thiosulfate therapy for calcific uremic arteriolopathy. Clin J Am Soc Nephrol. 2013 Jul;8(7):1162-70. doi: 10.2215/CJN.09880912. Epub 2013 Mar 21.
citation: Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Kruger T, Floege J, Ketteler M. Calcific uraemic arteriolopathy (calciphylaxis): data from a large nationwide registry. Nephrol Dial Transplant. 2017 Jan 1;32(1):126-132. doi: 10.1093/ndt/gfv438.
citation: Sood AR, Wazny LD, Raymond CB, Leung K, Komenda P, Reslerova M, Verrelli M, Rigatto C, Sood MM. Sodium thiosulfate-based treatment in calcific uremic arteriolopathy: a consecutive case series. Clin Nephrol. 2011 Jan;75(1):8-15.