louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03294629: The Effectiveness of SensAwake™ for Continue Positive Airway Pressure Treatment of Obstructive Sleep Apnea Patients
Official title: Effects of Pressure Control Device (SensAwake™) on Obstructive Sleep Apnea (OSA) Patients Who Remove the Mask for Unknown Reasons During Automatic Continuous Positive Airway Pressure (Auto-CPAP) Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: cPAP
SenseAwake
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2017-09-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate Obstructive Sleep Apnea (OSA) and an automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial with crossover design, comparing compliance on standard APAP with compliance using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.


Eligibility criteria: Inclusion Criteria:

1. Participants will be recruited from OSA patients who will remove CPAP himself without any notable reasons.

Exclusion Criteria:

1. Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
2. Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
3. Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
4. Any known factor that result in mask taken of such as skin discomfort, nasal obstruction, water dripping inside the tubing system etc.

Primary outcomes:
measure: Compliance of Auto-CPAP Therapy
timeFrame: 2 weeks
Secondary outcomes:
measure: Average SA Detections
timeFrame: 2 weeks
measure: Average Pressures of Auto-CPAP Machine
timeFrame: 2 weeks
measure: 90th Percentile Pressures of Auto-CPAP Machine
timeFrame: 2 weeks
measure: Average Leaks of Auto-CPAP Machine
timeFrame: 2 weeks
measure: 90th Percentile Leaks of Auto-CPAP Machine
timeFrame: 2 weeks
measure: Residual Apnea-Hypopnea Index (AHI)
timeFrame: 2 weeks
measure: Time Used of Auto-CPAP Machine
timeFrame: 2 weeks
measure: Percentage of Day Used of Auto-CPAP Machine
timeFrame: 2 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 weeks
measure: Epworth Sleepiness Score (ESS)
timeFrame: 2 weeks
measure: Nasal Obstruction Symptom Evaluation (NOSE)
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: ChangGungMemorialHospital
name: Li-Pang Chuang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00857129: Can Differentiated Birth Care Improve the Service?
Official title: Differentiated Birth Service- an Improvement?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Risk Birth; Births With Low Risk Factor
Keywords: "normal birth"
"birth outcome"
"low risk birth"
"low risk units"
If type of birth care unit have effect on birth outcome
Apgar score
breast feeding frequency
patient satisfaction
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2009-03-06
Enrollment: 1111
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Prospective evaluation of birth complication in three differently staffed and equipped units in the same hospital.

Detailed description: The study will include approximately 1000 normal births in a county hospital. The mothers are randomly assigned to one of three different maternal wards; one run by midwives, one normally equipped according to national standards for a county hospital and one prepared for complicated births. Endpoints are number of operative births and complications.

Eligibility criteria: Inclusion Criteria:

* Healthy mother, normal pregnancy, no prior operations on the uterus, no prior birth complications, no condition with negative effect on pregnancy or birth,one fetus in head position, spontaneously going into birth between week 36,1 and 41,6 of pregnancy,normal cardiotocograph test BMI of 32 or less, smoking no more than 10 cigarettes per day, wants to participate in the study and signs the consent form.

Exclusion Criteria:

* Any condition that has negative effect on the pregnancy or the birth, more than one fetus, all other positions than head position, induction of labor,pre term or post term birth, BMI of more than 32, smoking more than 10 cigarettes per day, does not want to participate.

Primary outcomes:
measure: Number of operative deliveries
timeFrame: one week
Secondary outcomes:
measure: number of registered complications
timeFrame: one week
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Ostfold Hospital Trust
Study officials:
affiliation: University of Tromso, Norway
name: Pal Oian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernitz S, Oian P, Sandvik L, Blix E. Evaluation of satisfaction with care in a midwifery unit and an obstetric unit: a randomized controlled trial of low-risk women. BMC Pregnancy Childbirth. 2016 Jun 18;16(1):143. doi: 10.1186/s12884-016-0932-x.
Clinical trial NCT04160429: Biospecimen Analysis in Detecting Chemical Concentrations in Patients With Chronic or Infectious Diseases Receiving Meditations
Official title: Pilot Study to Evaluate Substances in Sweat, Saliva, and Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Disease
Infectious Disorder
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-11-13
Enrollment: 100
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: Patients with chronic or infectious diseases scheduled to receive medications

Brief summary: This trial collects and analyzes sweat and saliva samples compared to blood in detecting chemical concentrations in the body in patients with chronic or infectious diseases receiving medications. Wearable sweat sensors are capable of monitoring electrolytes and metabolites (sodium, potassium, glucose, lactate, etc.) for health monitoring and disease diagnosis. Designing wearable sweat sensors capable of providing information regarding drug administration may be challenging due to ultralow concentrations in biofluids. This trial seeks to determine if the use of a smart wristband can accurately measure the levels of chemicals and substances in sweat.

Detailed description: PRIMARY OBJECTIVE:

I. To compare novel, home-based methods of quantitating medication concentrations in either saliva or sweat to the 'gold standard' of liquid chromatography - mass spectrometry of plasma.

SECONDARY OBJECTIVES:

I. To compare novel home-based methods of quantitating substances in either saliva or sweat to the 'gold standard' in plasma.

II. Assess the ease of obtaining home-based samples.

OUTLINE:

Patients undergo collection of sweat samples via Macroduct Sweat Collection System 3710S and saliva and blood samples within 24 hours after medication administrations. Patients also complete questionnaires over 5-10 minutes and have medical charts reviewed.

After completion of study, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* Scheduled to receive medications including, but not limited to, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, metformin or busulfan (any dose, any number of doses, any dosing frequency) as part of treatment at any time. Patients with chronic or infectious diseases can participate
* Willingness to:

  * Provide blood, sweat, and saliva samples
  * Permit medical record review

Exclusion Criteria:

* Pilocarpine allergy
* Difficulty with understanding written English

Primary outcomes:
measure: Predictive performance of the home-based sampling
timeFrame: Up to 4 hours
measure: Observed plasma concentrations
timeFrame: Up to 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jeannine S McCune
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00816829: Effect of Fenofibrate on Sleep Apnea Syndrome
Official title: A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyslipidemia
Sleep Apnea Syndrome
Overweight
Obesity
Keywords: Dyslipidemia
Sleep Apnea Syndromes
Fenofibrate
Obese
Overweight or obese patients
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-01-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.


Eligibility criteria: Inclusion Criteria:

* Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea
* Overweight or obese, with BMI \>= 25 kg/m² and \< 40 kg/m².
* Known moderate hypertriglyceridemia, with fasting Triglycerides level \>= 2.0 and \< 6.0 mmol/L within 3 months before the inclusion.

Exclusion Criteria:

* indication for immediate CPAP
* other known endocrine disease, except treated and adequately controlled hypothyroidism
* renal failure or plasma creatinine level \>130 µmol/L
* current chronic liver disease or ALanine Amino Transferase (ALT)\> 2 times the upper normal limit (UNL)
* symptomatic gallbladder disease
* known muscular disease or creatine phosphokinase (CK) \> 3 times UNL.

Primary outcomes:
measure: Obstructive Apneas
timeFrame: at one month of treatment
measure: Desaturations
timeFrame: at one month of treatment
measure: Sleep Time With Oxygen Saturation Below 90%
timeFrame: at one month of treatment
measure: Apneas
timeFrame: at one month of treatment
measure: Hypopneas
timeFrame: at one month of treatment
measure: Index Apnea/Hypopnea
timeFrame: at one month of treatment
measure: Mixed Apneas
timeFrame: at one month of treatment
measure: Central Apneas
timeFrame: at one month of treatment
measure: Index of Apneas
timeFrame: at one month of treatment
measure: Index of Hypopneas
timeFrame: at one month of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Bruckert E, Duchene E, Bonnefont-Rousselot D, Hansel B, Ansquer JC, Dubois A, Gaymard B. Proof of concept study: does fenofibrate have a role in sleep apnoea syndrome? Curr Med Res Opin. 2010 May;26(5):1185-92. doi: 10.1185/03007991003693581.
Clinical trial NCT02869529: Institut Paoli Calmettes Chronic Lymphatic Leukemia Database
Official title: Institut Paoli Calmettes Chronic Lymphatic Leukemia Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 4200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic lymphatic leukemia

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic lymphatic leukemia

Exclusion Criteria:

* Score of Matutes \<4

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT00901680: Creation of the BioBank, Early Detection and Discovery Biomarkers
Official title: Creation of the BioBank,To Establish a Multidisciplinary Research Structure That Facilitates Projects That Bridge Specialties That Normally May or May Not Interact.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Head and Neck Cancer
Breast Cancer
Keywords: Tissue Bank
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2009-05-14
Enrollment: 3028
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population male/female from inpatient and outpatient hospital settings or doctor offices..

Brief summary: To establish a multidisciplinary research structure for tissue repository that facilitates projects that bridge specialties that normally may or may not interact.

Detailed description: To establish a multidisciplinary research structure that facilitates projects that bridge specialties that normally may or may not interact. The tissue bank will build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies in a fast and direct manner. Tissue banks can be used for numerous discovery applications such as the identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization, and validation of biomarkers that are predictive of disease and treatment.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers

Exclusion Criteria:

* N/A volunteers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospitals
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: George Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04717180: Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
Official title: Post Stroke Aphasia Rehabilitation Using Computer-based Arabic Software Program: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia Rehabilitation
Keywords: aphasia, post stroke
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 105
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: Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients.

Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.

Detailed description: Aphasia is a disorder of language processing caused by a lesion in particular brain regions. Treatment aims at improving or restoring impaired function or at compensating for deficits. More recently, computer technology has been integrated into treatment options. In this study, a detailed and comprehensive computerized software program for aphasia rehabilitation is designed for the treatment of Arabic speaking Egyptian aphasic patients.

Aim of the study: design a computerized software program for the rehabilitation of Arabic speaking Egyptian aphasic patients.

Subjects: The study was conducted on 50 patients with aphasia who attend the unit of Phoniatrics during the period of one year, Department of Otorhinolaryngology, Alexandria Main University Hospitals.

Methodology: The training materials were designed as a software program. Each patient was subjected to assessment before and after the application of the rehabilitation program. Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy. Therapy continued for 48 sessions over six months.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of aphasia
* Age 18 years or more

Exclusion Criteria:

* Intellectual disabilities.
* Visual impairment.
* Hearing impairment.
* Associated dysarthria and or apraxia of speech.
* Associated psychiatric disorders

Primary outcomes:
measure: The primary outcome was a measure of improvement in language abilities.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospitals
Study officials:
References:
Clinical trial NCT01231880: School Based Malaria Control in Ugandan Schoolchildren
Official title: School-based Malaria Control: Impact of Intermittent Preventive Treatment on Malaria Morbidity and Cognitive Function in Ugandan School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Malaria
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2010-11-01
Enrollment: 740
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesize that schoolchildren treated with IPT using DP over one year of follow-up will have a different risk of clinical malaria compared to those treated with placebo.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 6 - 14 years
* Pupils enrolled at participating school
* Willingness of the parent/guardian to provide consent
* Provision of assent by pupil (those above 8 years)

Exclusion Criteria:

* Known allergy or history of adverse reaction to study medications
* Intention of changing of schools during the follow-up period
* History (obtained from the parent/guardian) of any known serious chronic disease requiring frequent medical care

Primary outcomes:
measure: Risk of Clinical Malaria
timeFrame: 1 year
measure: Cognitive function tests
timeFrame: 1 year
Secondary outcomes:
measure: Risk of parasitemia
timeFrame: 1 year
measure: Risk of hospital admissions
timeFrame: 1 year
measure: Risk of adverse events
timeFrame: 1 year
measure: School performance
timeFrame: 1 year
measure: Prevalence of anemia
timeFrame: 1 year
Other outcomes:
Locations:
city: Tororo
country: Uganda
facility: Mulanda Sub-district
Study officials:
affiliation: Makerere University Kampala
name: Joaniter I Nankabirwa, MSc CEB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nankabirwa JI, Conrad MD, Legac J, Tukwasibwe S, Tumwebaze P, Wandera B, Brooker SJ, Staedke SG, Kamya MR, Nsobya SL, Dorsey G, Rosenthal PJ. Intermittent Preventive Treatment with Dihydroartemisinin-Piperaquine in Ugandan Schoolchildren Selects for Plasmodium falciparum Transporter Polymorphisms That Modify Drug Sensitivity. Antimicrob Agents Chemother. 2016 Sep 23;60(10):5649-54. doi: 10.1128/AAC.00920-16. Print 2016 Oct.
citation: Nankabirwa JI, Wandera B, Amuge P, Kiwanuka N, Dorsey G, Rosenthal PJ, Brooker SJ, Staedke SG, Kamya MR. Impact of intermittent preventive treatment with dihydroartemisinin-piperaquine on malaria in Ugandan schoolchildren: a randomized, placebo-controlled trial. Clin Infect Dis. 2014 May;58(10):1404-12. doi: 10.1093/cid/ciu150. Epub 2014 Mar 12.
Clinical trial NCT02789280: Mood Management Effects of Brief Unsupported Internet Interventions II
Official title: Mood Management Effects of Brief Unsupported Internet Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood
Lead sponsor: i4Health
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Detailed description: The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Method: A total of 275 adults residing in the United States will take part in a randomized controlled trial. Participants were randomly assigned to an experimental condition based on Behavioral activation or a one week wait list condition. They will be follow-up one week after consenting.

Eligibility criteria: Inclusion Criteria:

* most be U.S. citizens

Exclusion Criteria:

* non-U.S. residents

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002) scores
timeFrame: Baseline - 1 week follow-up
Secondary outcomes:
measure: Mood- Likert-type question
timeFrame: Baseline - 10 minutes after the intervention - 1 week follow-up
measure: Motivation - Likert-type question
timeFrame: Baseline - 10 minutes after the intervention - 1 week follow-up
measure: Confidence - Likert-type question
timeFrame: Baseline - 10 minutes after the intervention - 1 week follow-up
measure: Usefulness - Likert-type question
timeFrame: Baseline - 10 minutes after the intervention
measure: 7-item Generalized Anxiety Disorder questionnaire
timeFrame: Baseline - 1 week follow-up
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University
state: California
Study officials:
affiliation: Palo Alto University
name: Ricardo F Muñoz, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: