louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03066765: LTR for Treatment of Obstructive Sleep Apnea
Official title: Non-Randomized, Single Arm Study of the New Linguaflex Tongue Retractor for the Treatment of Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Linguaflex, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 16
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: Study of tongue implant for treatment of obstructive sleep apnea

Detailed description: Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.

Eligibility criteria: Inclusion Criteria:

* AHI\>10
* 18 years of age

Exclusion Criteria:

* Subjects with \>20% of their AHI accounted for from central apnea.
* Mallampanti score of 4
* Tonsillar hypertrophy (4+)
* Prior uvulopalatopharyngoplasty (UPPP) procedure
* Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray
* Tongue thickness \<40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis
* More than 10% of sleep time with blood O2 desaturation below 70%
* Unable and/or unwilling to comply with study requirements
* Females of child bearing age who are pregnant or intending to become pregnant
* Allergy to silicone
* History of radiation therapy to neck or upper respiratory tract
* Subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months

Primary outcomes:
measure: Number of subjects with AHI decrease greater than or equal to 50% and less than a score of 10 according to PSG testing
timeFrame: 1 year
Secondary outcomes:
measure: Number of subjects of Adverse Events and Serious Adverse Events through recording number, type and relation to device
timeFrame: 1 year
measure: Number of subjects with significant change in sleepiness and score of less than 10 using Epworth Sleep Scale
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Putrajaya Hospital
name: Balwinder Singh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05343065: A Continuous Glucose Monitor Based Insulin Bolus Calculator (CGM-IBC) Study B
Official title: Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: continuous glucose monitor, insulin calculator
Lead sponsor: Welldoc
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 27
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: This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor.

Detailed description: Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welldoc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.

Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes using the Dexcom G6 continuous glucose monitor

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: MedStar Health Research Institute
state: Maryland
Study officials:
affiliation: Medstar Health Research Institute
name: Jean Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03751865: Early Detection and Intervention for Women At-risk of Psychosis
Official title: Early Detection and Intervention for Women At-risk of Psychosis in Hong Kong: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prodromal Schizophrenia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effectiveness of the cognitive behavioral therapy in preventing the conversion of psychosis in a sample of individuals at-risk for psychosis.

Detailed description: Eligible subjects with informed consent provided will be randomly assigned to the cognitive behavioural therapy (CBT) group or psychoeducation group. Each group consists of 8 session spanning for 8 week.

Eligibility criteria: Inclusion Criteria:

* women of age 18-64
* at-risk mental state as defined by the Comprehensive Assessment of At-Risk Mental States (CAARMS)
* with an informed consent
* able to understand Cantonese and read/write Chinese

Exclusion Criteria:

* those mental conditions that requires other treatment priorities (e.g., suicidal risk, substance abuse, current or past episodes of psychotic disorder, personality disorders)
* those medical conditions that severely limits participation, comprehension, or adherence to the treatment (e.g., epilepsy, dementia, terminal medical illness);
* those who are receiving structured psychotherapy or counselling

Primary outcomes:
measure: Functioning: Measured by Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: Changes from baseline to immediate, 6- and 12-month post-intervention
measure: Functioning: Measured by Role Functioning Scale (RFS)
timeFrame: Changes from baseline to immediate, 6- and 12-month post-intervention
measure: Conversion of psychosis
timeFrame: 12-month post-intervention
Secondary outcomes:
measure: Positive psychotic symptoms
timeFrame: Immediate, 6- and 12-month post-intervention
measure: Beliefs about the auditory hallucination
timeFrame: Immediate, 6- and 12-month post-intervention
measure: Depressive symptoms
timeFrame: Immediate, 6- and 12-month post-intervention
measure: Social anxiety :Measured by Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Immediate, 6- and 12-month post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Eric Yu Hai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01732965: NB-UVB and PUVA Vitiligo Study
Official title: Prospective Open Parallel Right to Left Bilateral Study Comparing Narrowband Ultraviolet B Alone Versus Narrowband Ultraviolet B and Psoralen Plus Ultraviolet A for the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitiligo
Keywords: Vitiligo
Phototherapy
Photochemotherapy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.


Eligibility criteria: Inclusion Criteria:

* Vitiligo affecting more than 15% body surface area.

Primary outcomes:
measure: Determine the quantity of repigmentation
timeFrame: 6 months
Secondary outcomes:
measure: Determine the quality of repigmentation.
timeFrame: Study initiation, 3 months and 6 months.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Dermatology
state: Michigan
Study officials:
affiliation: Henry Ford Dermatology
name: Iltefat Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531465: High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
Official title: Pulmonary Function Testing in Infants With Respiratory Insufficiency While Receiving High Flow Nasal Cannula (HFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Respiratory insufficiency
Infants
High Flow Nasal Cannula (HFNC)
Nasal Continuous Positive Airway Pressure (NCPAP)
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. The investigators also will compare the effects of slightly changing the level of support these two different types of therapy on how easily your baby is breathing. Changes in the level of support and between these two respiratory support modalities are frequently done and are part of the routine care in the neonatal intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Infants who are between 28 and 40 weeks of corrected gestational age at the time of study entry
* Currently on high flow nasal cannula receiving 3 to 5 lpm or on nasal continuous positive airway pressure at 5 to 6 cmH2P with and FiO2 requirement \</= 40% by the clinical care team for clinical care purposes.
* On current mode of support for \>/= 12 hours and have been extubated from a mechanical ventilator for \>/= 48 hours.

Exclusion Criteria:

* Infants with skeletal or neuromuscular disorders that affect the accuracy of RIP PFT measurements.

Primary outcomes:
measure: lung compliance
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System - Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Care Health Systems
name: Beatriz de Jongh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Services
name: Robert Locke, DO
role: STUDY_DIRECTOR
References:
Clinical trial NCT04936165: Circulation and Oxygenation Changes of Deep Tissue Respond on LLLT
Official title: Circulation and Oxygenation Changes of Deep Tissue Respond on Low Level Light/Laser Therapy (LLLT) in the Healthy Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Level Light/Laser Therapy
Near Infrared Spectroscopy
Keywords: Low level light/laser therapy
Near infrared spectroscopy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the circulation and oxygenation changes of deep tissue respond on low level light/laser therapy (LLLT) in the healthy population. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to noninvasively monitor hemodynamic indicators of brain and forearm muscle groups, including total hemoglobin (\[tHb\]), and blood flow (BF) and oxygen consumption (VO2).

Detailed description: Low level light/laser therapy (LLLT) employs visible or near-infrared light generated from a laser or light emitting diode (LED) system. It has beneficial effects on a wide range of disease, including improving wound healing, reducing pain, improving memory, treat cancer, and many other human applications. This study aims to investigate the circulation and oxygenation changes of deep tissue respond on low level light/laser therapy (LLLT) in the healthy population. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to noninvasively monitor hemodynamic indicators of brain and forearm muscle groups, including total hemoglobin (\[tHb\]), and blood flow (BF) and oxygen consumption (VO2). Then the investigators concluded the effect of LLLT, according to compare the difference between the experimental group and control group.

Eligibility criteria: Inclusion Criteria:

* Healthy participants with no strenuous exercise or alcohol consumption prior to the test

Exclusion Criteria:

* having risk factors associated with cardiovascular disease

Primary outcomes:
measure: Δ[HbO2]
timeFrame: through study completion, an average of 1 year
measure: Δ[Hb]
timeFrame: through study completion, an average of 1 year
measure: Δ[tHb]
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Subcutaneous fat thickness
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: NIRS assessment for brain death
state: Tianjin
Study officials:
References:
Clinical trial NCT01440465: Management of Nausea and Vomiting Chemotherapy-induced in Normandy
Official title: Management of Nausea and Vomiting Chemotherapy-induced in Normandy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Nausea
Vomiting
Keywords: chemotherapy
cancer
nausea
vomiting
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with first line chemotherapy with intravenous (IV) to solid tumors or hematologic.

Brief summary: The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 years
* With solid tumors or hematologic in first line chemotherapy, administered intravenously,
* Able to understand the meaning of the questions
* Having given their written consent to participate in the survey.

Exclusion Criteria:

This does not concern patients who:

* Do not give their consent for participation
* Do not speak French
* Suffer from cognitive deficits
* Are under therapy
* Must receive a combination of radio-chemotherapy
* Present an occlusive syndrome
* Metastases (s) brain (s) clinically symptomatic (s) or radiologically proven (s) or a (of) tumor (s) brain (s)
* Have been previously treated with chemotherapy
* Present a cons-indication to corticosteroids, with anti-serotonin or NK1 receptor inhibitors
* Pregnant or breastfeeding.

Primary outcomes:
measure: acute nausea and vomiting
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Avranches
country: France
facility: Centre de la Baie
city: Bayeux
country: France
facility: Centre hospitalier
city: Caen
country: France
facility: Centre Maurice Tubiana
city: Caen
country: France
facility: Centre François Baclesse
city: Cherbourg-Octeville
country: France
facility: Centre hospitalier public du cotentin
city: Flers
country: France
facility: Centre Jacques Monod
Study officials:
affiliation: Centre François Baclesse
name: JOLY Florence, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01986465: Effectiveness of Steroid Injection in Treating Patients With Lateral Epicondylitis
Official title: Comparing the Effectiveness of Steroid Injection Versus Placebo and Immobilization Versus no Immobilization in Treating Patients With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lateral Epicondylitis
Keywords: lateral epicondylitis
treatment
steroid
immobilization
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of steroid injection and immobilization versus no immobilization in treating patients with lateral epicondylitis.


Eligibility criteria: Inclusion Criteria:

* age 18 to 65 years
* confirmed lateral epicondylitis
* had not received any treatment prior to enrolment

Exclusion Criteria:

* symptoms lasting less than 6 weeks
* history of acute trauma, fracture, and/or surgery within 12 months
* patients who had received corticosteroid injection, physiotherapy, splint or casting during the past 6 months
* bilateral involvement and history of cervical disk herniation, radiculopathy or abnormal electrophysiologic study

Primary outcomes:
measure: Function
timeFrame: Within the first 24 weeks after therapy
measure: Pain
timeFrame: Within the first 24 weeks after therapy
measure: Social-psychological
timeFrame: Within the first 24 weeks after therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Kashani University Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Mohamad A Tahririan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmad Z, Siddiqui N, Malik SS, Abdus-Samee M, Tytherleigh-Strong G, Rushton N. Lateral epicondylitis: a review of pathology and management. Bone Joint J. 2013 Sep;95-B(9):1158-64. doi: 10.1302/0301-620X.95B9.29285.
Clinical trial NCT00665665: Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers
Official title: Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 30.0-39.0 kg/m2 (obese)
* Females who consent to using double barrier method of contraception, are post-menopausal and older than 50 years, or have had total hysterectomy

Exclusion Criteria:

* Clinically significant diseases
* Blood pressure greater than 140/90 mmHg
* Evidence of depression
* Recent diet attempts, treatment with diet drugs (within 3 months)
* Liposuction or other surgery for weight loss within the last year
* Evidence of eating disorders (bulimia, binge eating)
* Restricted diets (Kosher, vegetarian)
* Smoker or history of drug or alcohol abuse
* Females of childbearing potential: positive pregnancy test

Primary outcomes:
measure: To determine the safety and tolerability of NNC 0070-0002-0182 multiple doses
timeFrame: after 6 weeks
Secondary outcomes:
measure: Pharmacokinetics of NNC 0070-0002-0182 and its isomer
timeFrame: at 8 weeks
measure: Assessment of changes in food consumption and hunger
timeFrame: at 6 weeks
measure: Change in weight, waist and hip measurements and mood
timeFrame: at 6 weeks
measure: Change in body composition and resting metabolism
timeFrame: at 6 weeks
measure: Intervention arm D only: Change in insulin sensitivity (HOMA)
timeFrame: at 6 weeks
measure: Intervention arm D only: Change from baseline in body fat (DEXA)
timeFrame: at 6 weeks
measure: Intervention arm D only: Change from baseline in indirect calorimetry
timeFrame: at 6 weeks
measure: Intervention arm D only: Change from baseline in adiponectin, hsCRP
timeFrame: at 6 weeks
measure: Intervention arm D only: Antibody assessment
timeFrame: at 10 weeks
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Madison
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05996965: Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device
Official title: Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device (HemoVista™) in the Clinical Filed
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 20 or older

Brief summary: In patients undergoing surgery under general anesthesia, the clinical utility of non-invasive hemodynamic status monitoring equipment using HemoVista is compared with invasive hemodynamic status monitoring equipment FloTrac.

Detailed description: For patients who are scheduled to monitor invasive blood pressure, invasive hemodynamic monitoring using FloTrac and additional HemoVista sensors are attached and output data are obtained at the same time during general anesthesia. FloTrac is used to conduct conventional anesthesia and fluid therapy, and the accuracy of HemoVista, a non-invasive hemodynamic monitoring equipment, is compared through prospective observational studies.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 20 or older who undergo surgery under general anesthesia for more than two hours
* invasive close hemodynamic monitoring with FloTrac is needed

Exclusion Criteria:

* problems in site where HemoVista is attached

Primary outcomes:
measure: degree of agreement in cardiac output
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hee-Soo Kim
state: Soul-t'ukpyolsi
Study officials:
References: