louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01742949: Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Official title: Evaluation of Advantages Linked to the Use of Humidification by ThermoSmart During Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2012-12-06
Enrollment: 40
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 aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI\>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG).
* Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
* Patients receiving social security coverage (excluding MEAs)
* Fluent spoken and written French

Exclusion Criteria:

* Severe heart disease
* Co-existing lung disease
* Co-existing sleep disorder
* Pregnant
* Refused participation

Primary outcomes:
measure: Adherence
timeFrame: 8 weeks
Secondary outcomes:
measure: Epworth Sleepiness Score
timeFrame: 8 weeks
measure: Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)
timeFrame: 8 weeks
measure: Subjective Dry Nose
timeFrame: 8 weeks
measure: Subjective Dry Mouth
timeFrame: 8 weeks
measure: Subjective Sinusitis
timeFrame: 8 weeks
measure: Preference
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
state: Paris Cedex
city: Paris
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hôpital La Pitie Salpetriere
city: Paris
country: France
facility: Hôpital Louis Mourier
Study officials:
affiliation: Hôpital Bichat-Claude Bernard
name: Marie-Pia D'Dortho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00702936: Telmisartan Versus Ramipril After Acute Coronary Syndrome
Official title: Telmisartan vs Ramipril for Reduction of Inflammation and Recruitment of Endothelial Progenitor Cells After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Coronary Disease
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2008-06-20
Enrollment: 50
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: The purpose of this study is to compare the antinflammatory and endothelial progenitor cell (EPC) mobilizing effect of Ramipril and Telmisartan in patients presenting with acute coronary syndrome


Eligibility criteria: Inclusion Criteria:

* Biochemical evidence of myocardial infarction as indicated by elevation of cTnT,
* presence of ECG ischemic changes,
* angiographic evidence of a primary coronary event, such as plaque erosion and/or rupture, fissuring, or dissection at coronary angiography,
* successful coronary revascularization of at least one culprit coronary vessel.

Exclusion Criteria:

* Age\>80 years, current ACE inhibitor or ARB treatment,
* ejection fraction \<35%, infarction secondary to ischemia due to an imbalance of O2 supply and demand,
* ECG abnormalities that could affect the recognition of ST segment shift,
* recent or chronic infective or inflammatory diseases,
* malignancy, and myocardial infarction,
* surgery or trauma in the previous month.

Primary outcomes:
measure: High sensitivity C-Reactive Protein
timeFrame: 20 days after hospital discharge
Secondary outcomes:
measure: Endothelial Progenitor Cells
timeFrame: 20 days after hospital discharge
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Italo Porto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of the Sacred Heart
name: Luca Di Vito, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biasucci LM, Lombardi M, Piro M, Di Giannuario G, Liuzzo G, Crea F. Irbesartan significantly reduces C reactive protein concentrations after 1 month of treatment in unstable angina. Heart. 2005 May;91(5):670-1. doi: 10.1136/hrt.2004.036509. No abstract available.
citation: Liakishev AA. [Telmisartan, ramipril, or both in patients at high risk for vascular events. Results of the ONTARGET trial]. Kardiologiia. 2008;48(5):72. No abstract available. Russian.
citation: Porto I, Di Vito L, De Maria GL, Dato I, Tritarelli A, Leone AM, Niccoli G, Capogrossi MC, Biasucci LM, Crea F. Comparison of the effects of ramipril versus telmisartan on high-sensitivity C-reactive protein and endothelial progenitor cells after acute coronary syndrome. Am J Cardiol. 2009 Jun 1;103(11):1500-5. doi: 10.1016/j.amjcard.2009.01.370.
Clinical trial NCT02442336: A Web-Based Multimedia Intervention for Head and Neck Cancer Patients
Official title: A Web-based Multimedia Intervention for Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Head and Neck
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall goal is to develop and examine the acceptability of a web-based (Internet) intervention program for patients with head and neck cancer who have recently completed radiation therapy.

Detailed description: The overall goal is to develop and examine the acceptability of a theory-guided, web-based multimedia intervention program for head and neck cancer patients who have recently completed radiation therapy. The effects of this intervention on patients' quality of life (QOL) will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* Are receiving or have completed radiation therapy within in the past 12 months

Exclusion Criteria:

* Inability to read and/or communicate in English
* Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, adenocarcinoma, sarcoma)
* Blindness or severity of visual impairment that precludes one's ability to view images/text
* Inability to provide informed consent

Primary outcomes:
measure: Patient Distress
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fang CY, Longacre ML, Manne SL, Ridge JA, Lango MN, Burtness BA. Informational Needs of Head and Neck Cancer Patients. Health Technol (Berl). 2012 Apr 1;2(1):57-62. doi: 10.1007/s12553-012-0020-9. Epub 2012 Feb 14.
citation: Fang CY, Galloway TJ, Egleston BL, Bauman JR, Ebersole B, Chwistek M, Buhler JG, Longacre ML, Ridge JA, Manne SL, Manning C. Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. Front Oncol. 2020 Dec 15;10:602202. doi: 10.3389/fonc.2020.602202. eCollection 2020.
Clinical trial NCT00129649: Service Development: Assessing Non-attendance Rates in Outpatient Clinics
Official title: Service Development: Assessing Non-attendance Rates in Outpatient Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Sleep Apnea Syndromes
Tuberculosis
COPD
Keywords: Telephone reminder
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-08-12
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many studies have shown a high non-attendance rate in hospital outpatient clinics. The investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will improve attendance rates. Patients will be randomised into two groups; one group will receive a reminder phone call one week prior to their hospital consultation and the other group will be managed in the standard manner (i.e. no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a respiratory nurse specialist and a research officer for two asthma clinics based on a Wednesday morning and a Thursday afternoon.

Detailed description: Many studies have shown a high non-attendance rate in hospital outpatient clinics. The investigators have found a non-attendance rate of 25% in their asthma clinics and would like to investigate whether a reminder phone call will improve attendance rates. Patients will be randomised into two groups; one group will receive a reminder phone call one week prior to their hospital consultation and the other group will be managed in the standard manner (i.e. no reminder of any sort). The phone calls will be carried out on a Friday afternoon by a respiratory nurse specialist and a research officer for two asthma clinics based on a Wednesday morning and a Thursday afternoon.

To have an 80% chance of detecting a 10% reduction in non-attendance rates (at 5%) 500 patients are required for this study. The rate of non-attendance will be monitored for all the patients in both groups and some demographic information will be recorded for each patient(age, sex, diagnosis and home postcode).

Eligibility criteria: Inclusion Criteria:

* Patients with appointments booked for 2 respiratory outpatient clinics

Exclusion criteria

Patients likely to only need one appointment

Primary outcomes:
measure: Attendance Rates at Respiratory Outpatient Clinics
timeFrame: after phone call within 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: NHLI Imperial College
Study officials:
affiliation: Imperial College London
name: Martyn R Partridge, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts N, Meade K, Partridge M. The effect of telephone reminders on attendance in respiratory outpatient clinics. J Health Serv Res Policy. 2007 Apr;12(2):69-72. doi: 10.1258/135581907780279567.
Clinical trial NCT03846349: Reinforcement of Upper Airway Muscles in Patients With OSAS
Official title: Non-invasive Reinforcement of the Upper Airway Dilator Muscles as an Alternative Approach to Treat Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 36
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: This study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (OSAS) severity.

Detailed description: This is a randomized controlled study. Participants with moderate OSAS severity will be either allocated to receive a myofunctional reeducation protocol (study group) or a sham protocol (control group). Apnea-hypopnea index (AHI) will be measured before and at the end (6 weeks) of the protocol. Participants from the study group will follow an upper airway reinforcement regimen using the IOPI (Iowa Oral Performance Instrument) device over 6 weeks while participants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance.

Eligibility criteria: Inclusion Criteria:

* Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour)
* Poor adherence to continuous positive airway pressure (\< 4h per night)

Exclusion Criteria:

* Craniofacial malformation
* Use of hypnotic medication
* Had stroke in the past
* Present a concurrent neuromuscular or severe obstructive nasal disease

Primary outcomes:
measure: Change in AHI (apnea-hypopnea index) on polygraphy
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in tongue strength using the IOPI device
timeFrame: Baseline and 6 weeks
measure: Change in tongue endurance using the IOPI device
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Genève
country: Switzerland
facility: Ligue Pulmonaire Genevoise
city: Lausanne
country: Switzerland
facility: Haute Ecole de Santé Vaud (HESAV)
Study officials:
References:
Clinical trial NCT05723549: A Study to Evaluate the PK, Safety and Tolerability of HCP1803.
Official title: A Randomized, Open-label, Single-Dose, Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1803 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2023-02-10
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose parallel study to evaluate the pharmacokinetics, safety and tolerability of HCP1803 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

1. Age 19\~45 years in healthy male volunteers
2. Weight ≥ 55kg and BMI 18 \~ 30 kg/m\^2
3. Subjects who agree to use clinically accepted dual contraceptives up to 14 days after the last administration date of the investigational product and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator

Primary outcomes:
measure: Cmax
timeFrame: 0~144hours
measure: AUC last
timeFrame: 0~144hours
Secondary outcomes:
measure: AUC inf
timeFrame: 0~144hours
measure: Tmax
timeFrame: 0~144hours
measure: t1/2
timeFrame: 0~144hours
measure: CL/F
timeFrame: 0~144hours
measure: Vd/F
timeFrame: 0~144hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yangji Hospital
Study officials:
References:
Clinical trial NCT03059849: Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
Official title: Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine whether a temporary three month increase in adalimumab dosing will prevent relapse in patients with inflammatory bowel disease in clinical remission who have elevated calprotectin.

Detailed description: Patients using adalimumab for Crohn's disease or ulcerative colitis who are in clinical remission will be followed with fecal calprotectin monitoring every 3 months. Patients with a sustained rise in calprotectin who maintain clinical remission will be offered an opportunity to have an increase in adalimumab for three months. Patients who use the three months of increased adalimumab dosing will be compared to patients who do not use increased dosing to determine if relapse rates differ between these two groups.

Eligibility criteria: Inclusion Criteria:

1. Adults ages 18 and older with Crohn's disease and ulcerative colitis
2. Patients are in clinical remission according to the last 'Abbvie Care' clinical symptom assessment (using Partial Mayo score \< 2 or Harvey-Bradshaw Index \< 4)
3. Patient using adalimumab at a dose of at least 40mg subcutaneously bi-weekly, and at a maximum dose of 40mg subcutaneously weekly (or 80mg subcutaneously bi-weekly).

Exclusion Criteria:

1. Pregnant women or plans for pregnancy within 3 months of study inclusion
2. Abdominal abscess
3. Inability or unwillingness to provide informed consent
4. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Primary outcomes:
measure: Number of patients with clinical relapse
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03141749: Venous Thromboembolism in DM1
Official title: Incidence and Predictors of Venous Thromboembolism in Myotonic Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Pulmonary Embolism
Deep Vein Thrombosis
Myopathy
Myotonic Dystrophy 1
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 2810
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: Adult patients with genetically proven myopathy

Brief summary: The risk for venous thromboembolism (VTE) in DM1 and in other inherited myopathies, which can lead to chronic immobilization, are unknown. The purpose of this study is to evaluate incidence of VTE in cohort of patients presenting with DM1 with a comparison to a group of other inheritable myopathies and to a community-based population.

Detailed description: A cohort of more that 2,800 adult patients admitted to our Institutions between January 2000 and November 2014 with genetically proven myopathy will be retrospectively included.

Any information relative to their demographic and genetic characteristics, their muscular functional status and the occurrence of VTE will be collected.

Statistical analysis will be performed to estimate the incidence of venous thromboembolism in this population, to identify predictors of VTE, and to compare its incidence to a community-based population.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Genetically proven myopathy
* Admission in our institutions from January 2000 to November 2014

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Any episode of pulmonary embolism and/or deep vein thrombosis, diagnosed according to 2011 AHA guidelines on venous thromboembolism management
timeFrame: 14 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut de Myologie, Paris, FRANCE
name: Karim Wahbi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298749: Safety and Tolerability of GX-P1 in Healthy Male Volunteers
Official title: A Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-P1 After Single IV Infusion in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1


Eligibility criteria: Inclusion Criteria:

1. Capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF)
2. Healthy male volunteers aged 19-45 years within screening periods
3. Body weight of 50-90 kg, and body mass index (BMI) of 18.0-30.0 kg/m2
4. Healthy subjects as determined by medical history, physical examination vital signs, ECG and clinical laboratory testing

Exclusion Criteria:

1. Any clinical significant pancreatic, hepatic, renal, gastrointestinal, cardiovascular, respiratory, hematological, central nervous system disease or other significant diseases which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation
2. History of or current disease evidence including malignant tumor
3. History of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug
4. Have participated in another clinical trial with investigational drug within 180 days prior to screening period
5. Positive for HCV antibody, HBsAg, or HIV antibody at screening period
6. Other clinically significant abnormalities which make subject unsuitable for inclusion this study judged by investigator

Primary outcomes:
measure: Safety and tolerability as measured by AEs
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Cmax, Maximum observed concentration
timeFrame: up to 4 weeks
measure: Tmax, Time to maximum observed concentration
timeFrame: up to 4 weeks
measure: T1/2, Elimination half life of GX-P1
timeFrame: up to 4 weeks
measure: AUC(0-inf), Area under the concentration-time curve from time zero extrapolated to infinite time
timeFrame: up to 4 weeks
measure: Change in number of T cells
timeFrame: up to 4 weeks
measure: Incidence of Treatment Emergent anti-drug antibody(ADA) formation
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: