louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02615431: The Influence of MitraClip on Apnoea Asleep
Official title: the Influence of MitraClip on Apnoea Asleep
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnoea
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 34
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: male and female patients is planned an interventional MitraClip examination

Brief summary: The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.


Eligibility criteria: Inclusion Criteria:

* patient suffer on severe symptomatical mitral insufficience
* male and female patients is planned an interventional MitraClip examination
* Dyspnea with a NYHA (New York Heart Association) II - III
* an high logistic Euro-Score (\> 20)
* no execution of surgical intervention because of relevant comorbidities

Exclusion Criteria:

* younger than 18 years
* pregnancy and breast-feeding
* persons without mental ability of capacity to understand and follow the instructions of the investigator
* persons in dependence from the sponsor or working with the sponsor
* participation in other studies

Primary outcomes:
measure: Apnoea-Hypopnoea-Index
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen, 52074
country: Germany
facility: University Hospital RWTH Aachen, Department of Medical Clinic I
Study officials:
affiliation: Uniklinik RWTH Aachen, Med. Klinik I
name: Michael Dreher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01401231: Behavioral Activation for Perinatal Depression
Official title: Pilot Trial of Behavioral Activation Psychotherapy for Perinatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression During Pregnancy
Keywords: depression
pregnancy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: HealthPartners Institute
First posted: 2011-07-25
Enrollment: 163
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will examine the feasibility, acceptability, and effectiveness of a brief behavioral activation psychotherapy for women with perinatal depression.


Eligibility criteria: Inclusion Criteria:

- Pregnant PHQ9 Depression Score of 15 or greater Receiving prenatal care at one of the participating sites

Exclusion Criteria:

- Known diagnosis of bipolar or psychotic disorder Active substance dependence Immediate risk of self harm Immediate need for inpatient mental health treatment

Primary outcomes:
measure: PHQ9 Depression Score
timeFrame: 3 months post-partm
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
References:
citation: Dimidjian S, Goodman SH, Sherwood NE, Simon GE, Ludman E, Gallop R, Welch SS, Boggs JM, Metcalf CA, Hubley S, Powers JD, Beck A. A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women. J Consult Clin Psychol. 2017 Jan;85(1):26-36. doi: 10.1037/ccp0000151.
Clinical trial NCT05918731: Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients Compared to Usual Care
Official title: Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients: A Primary Healthcare Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the effectiveness of COPD self-management interventions compared to usual on Quality of life, functional status, patient education, depression, and anxiety in primary healthcare users in the prefecture of Heraklion, Greece.

Detailed description: To the best of our knowledge, no previous study has examined the effects of self-management programs on patients with COPD in Greece. Therefore, the investigators conducted a randomized controlled trial with a post-test design, to evaluate the implementation and clinical effectiveness of a COPD self-management intervention compared to usual care in terms of the following outcomes: Quality of life, functional status, patient education, depression, and anxiety.

Eligibility criteria: Inclusion Criteria:

* patients aged ≥18 years
* had previously been given a physician-diagnosis of mild COPD
* stable on their medications (no treatment modifications) in the last three months
* able to speak, read and/or understand Greek

Exclusion Criteria:

* refusal to participate
* concurrent oncological diseases
* severe cognitive impairment
* neurological, or psychiatric disability

Primary outcomes:
measure: Assessement of Quality of life
timeFrame: 6 months
measure: Assessment of Functional status
timeFrame: 6 months
measure: Assessment of Depression
timeFrame: 6 months
measure: Assessement of Anxiety
timeFrame: 6 months
measure: Assessement of Patient education
timeFrame: 6 months
measure: Assessment of Functional status
timeFrame: 6 months
measure: Assessement of Patient education
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University of Crete
Study officials:
affiliation: University of Crete, Greece
name: Ioanna Tsiligianni
role: STUDY_CHAIR
References:
Clinical trial NCT04555031: Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
Official title: Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Habitual Soft Contact Lens Use
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 10
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: Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.


Eligibility criteria: Inclusion Criteria:

* 18 years or older and have full legal capacity to volunteer.
* Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* No active ocular disease or allergic conjunctivitis.
* Not using any topical ocular medications.
* Willing and able to follow instructions.
* Signed a statement of informed consent.

Exclusion Criteria:

* Participating in a conflicting study in the opinion of the Investigator.
* Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Surface Refractive Index Shifts at 5 Minutes
timeFrame: 5 minutes
measure: Surface Refractive Index Shifts at 10 Minutes
timeFrame: 10 minutes
measure: Surface Refractive Index Shifts at 15 Minutes
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch and Lomb Site 01
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04916431: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
Official title: A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231, Encoding for a Human Serum Albumin - Interleukin-2 Mutein Fusion Protein (HSA-IL2m), in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: mRNA-6231
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: There are 2 parts to this study: a single ascending dose (single dose of mRNA-6231) part and a multiple ascending dose (repeat doses of mRNA-6231) part. The main goal of this study is to evaluate the safety and tolerability of escalating doses of single and repeat subcutaneous (SC) administration of mRNA-6231. Dose levels of mRNA-6231 are planned to be investigated in a dose-escalation manner.


Eligibility criteria: Key Inclusion Criteria:

* Understand and agree to comply with the study procedures and provide written informed consent

Key Exclusion Criteria:

* Has received any investigational product (for example, study drug, biologic, device) within 30 days or 5 elimination half-lives, whichever is longer
* Pregnant or lactating women
* Men and women of childbearing potential without effective contraception during the study
* Has any lab abnormalities or clinically significant medical condition that could interfere with the interpretation of study results or limit the participant's enrollment

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Up to Day 84
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
timeFrame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
measure: Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)
timeFrame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
measure: Time to Maximum to Observed Effect (TEmax) of mRNA-6231
timeFrame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
measure: Maximum Observed Effect (Emax) of mRNA-6231
timeFrame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
measure: Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231
timeFrame: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Limited
state: Victoria
Study officials:
References:
Clinical trial NCT02647931: The Role of Therapy for Muscle Tension Dysphagia
Official title: Muscle Tension Dysphagia Treatment Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tension Dysphagia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing function as evidenced by videofluoroscopic swallow study. These patients also demonstrate abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the unloading of the supraglottic muscle tension has been shown to be highly effective in symptom resolution per the investigators' clinical experience. The study is designed to answer efficacy of treatment being offered to patients with muscle tension dysphagia.


Eligibility criteria: Inclusion Criteria

* Age 18-99
* Diagnosed with Muscle Tension Dysphagia

Exclusion Criteria

* Physical or emotional disorder preventing the completion of therapy

Primary outcomes:
measure: Improvement of dysphagia measured via patient self-report measures
timeFrame: Duration of therapy, approximately 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Christina Kang, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749031: Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults
Official title: The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Health
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized crossover intervention designed to evaluate effects of daily intake of beverages containing orange or apple Pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health and self-reported GI symptoms and dietary intake as well as analysis of gut microbiota.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females 18-60 years old
* Willing and able to consume 16 oz. of orange or apple beverage per day for 4 week periods
* Willing to maintain usual diet, smoking status, physical activity pattern, supplements and meds

Exclusion Criteria:

* Food allergies or sensitivities to ingredients in study beverages
* Presence or history of GI condition, endocrine (including diabetes), cardiovascular disease or other disease or condition that could interfere in the interpretation of the study results in the opinion of the Investigator.
* Extreme dietary habits including vegetarian, vegan or Atkins diet
* Females or are pregnant, planning to become pregnant or breast feeding during the study period.

Primary outcomes:
measure: stool frequency
timeFrame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
Secondary outcomes:
measure: Self-reported GI symptoms
timeFrame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
measure: Stool consistency
timeFrame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
measure: Ease of stool passage
timeFrame: Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
measure: microbiota changes
timeFrame: Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7)
measure: Dietary analysis
timeFrame: Changes from 2 week run in (baseline) to the last week of treatment (Week 4) and the last week of 3 week washout (Week 7)
Other outcomes:
Locations:
city: Addison
country: United States
facility: BioFortis
state: Illinois
Study officials:
affiliation: BioFortis
name: Kathleen Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869531: Effect of Wholegrain Wheat on Body Weight and Composition and Cardiovascular Risk
Official title: Healthgrain WP 4.4.3: Effects of Whole Grain on Weight Maintenance/Weight Reduction in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
wholegrain
wheat
cardiovascular disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: BARILLA G. e R. Fratelli S.p.A., Parma, Italy
name: European Commission
First posted: 2009-03-26
Enrollment: 85
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the potential beneficial effect of wholegrain on body weight and composition as well as cardiovascular risk in overweight women.

Detailed description: Objective: To study the effect of the 'wholegrain concept', i.e. high intake of wheat wholegrain (WW) vs. refined wheat (RW) grain products on body weight and composition.

Design: In this open-labeled randomized trial, 72 postmenopausal women with metabolic syndrome features were prescribed a mild calorie-restricted diet with a deficit of \~1,250kJ/d. Following 2 weeks run-in period on RW products, they were randomized to 12 weeks intervention with RW or WW products providing 2,000kJ/d.

Eligibility criteria: Inclusion Criteria:

* BMI 27-37
* Postmenopausal (\>1y) women
* 40-70 years old

Exclusion Criteria:

* Medication (hypertensive treatment not included)
* BP \> 160/100
* Fasting glucose \> 7mM
* Fasting cholesterol \> 6.5mM
* Smoking
* Known chronic illnesses

Primary outcomes:
measure: Body weight and composition
timeFrame: 0, 6 and 12 wks
Secondary outcomes:
measure: Cardiovascular risk markers
timeFrame: 0, 6 and 12 wks
measure: Fecal parameters
timeFrame: 0 and 12 wks
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: University of Copenhagen, Department og Human Nutrition
Study officials:
References:
Clinical trial NCT02306031: Topical Diclofenac on Macular Thickness After Phacoemulsification
Official title: The Effect of Topical Sodium Diclofenac on Macular Thickness in Diabetic Eyes After Phacoemulsification: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Oculopathy
Keywords: diclofenac
macular thickness
phacoemulsification
OCT(Optical coherence tomography )
diabetic
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with non-proliferative diabetic retinopathy that were candidate for phacoemulsification and intraocular lens implantation

Exclusion Criteria:

* Eyes with clinically significant macular edema based on the ETDRS(Early Treatment Diabetic Retinopathy Study) study and/or central macular thickness \>260µ were not included. Neither did we include the eyes with other accompanying diseases affecting the macula or eyes with history of previous retinal laser photocoagulation or intraocular surgery.
* Eyes with severe cataract that preclude performing an acceptable quality optical coherence tomography (OCT) were not enrolled either.

Primary outcomes:
measure: macular thickness changes
timeFrame: preoperatively until 90 days
Secondary outcomes:
measure: best corrected visual acuity (BCVA) changes
timeFrame: preoperatively until 90 days
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad medical center
Study officials:
References:
Clinical trial NCT05578131: High-flow Nasal Cannula for Pediatric Anesthetic Induction
Official title: The Effectiveness of Preoxygenation and Apneic Oxygenation Using High-flow Nasal Cannula for Pediatric Anesthetic Induction: a Prospective Randomized Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Deficiency
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 132
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation.

The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 132 patients undergoing elective surgery aged \<=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.


Eligibility criteria: Inclusion Criteria:

* Infants undergoing general anesthesia with endotracheal intubation.

Exclusion Criteria:

* infants who diagnosed as cardiorespiratory problem preoperatively.

Primary outcomes:
measure: Occurrence of oxygen desaturation <95%
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Secondary outcomes:
measure: Occurrence of oxygen desaturation <90%
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: the lowest oxygen saturation
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: the changes in oxygen reserve index
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: ETCO2 in first breath after intubation
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: ETO2 in first breath after intubation
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Number of intubation attempts
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Intubation times
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Occurrence of rescue bag mask ventilation
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
measure: Occurrence of gastric insufflation
timeFrame: from induction of anesthesia to 1 minutes after intubation, about 10 minutes.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Eun-hee Kim
role: PRINCIPAL_INVESTIGATOR
References: