louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02135900: The Use of Heliox in Obstructive Sleep Apnea Syndrome
Official title: The Use of Heliox in Obstructive Sleep Apnea Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Heliox
Obstructive Sleep Apnea
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2014-05-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).

Detailed description: Obstructive sleep apnea syndrome (OSAS) is a common condition affecting up to 2-4 % of the general population. The pathophysiologic consequences of OSA include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (HTN), stroke and possibly coronary artery events. In addition, patients with severe and untreated obstructive sleep apnea (OSA) have increased mortality compared to patients with treated severe OSA.The main stay of treatment of OSAS is the application of continuous positive airway pressure (CPAP) during sleep. The main problem with CPAP therapy is compliance. Heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. In this study, the investigators will evaluate the effectiveness of Heliox in the treatment of OSAS. Adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for CPAP titration will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Adults 18 or older with obstructive sleep apnea syndrome (OSAS) presenting for CPAP titration.

Exclusion Criteria:

* Professional singers.
* Television or Radio hosts.
* Disk Jockeys.
* Subjects requiring oxygen therapy.
* Subjects younger than 18 year old.
* Pregnant women.
* Patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume 1 (FEV1) less than 50%.
* History of anatomic upper airway obstruction.
* Uncontrolled asthma.

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
measure: Apnea Index (AI)
timeFrame: Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.
measure: Lowest Oxygen Saturation (L SO2)
timeFrame: Baseline and in 6-8 hours.
measure: Mean Oxygen Saturation (M SO2)
timeFrame: Baseline and in 6-8 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Sleep center, Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Michel Chalhoub, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01313000: Study To Evaluate Upper Arm Autologous Fat Transfer
Official title: Pilot Study To Evaluate Upper Arm Autologous Fat Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cosmetic and Circumferential Change After Fat Transfer
Keywords: fat, transfer, autologous fat transfer, bicep
Lead sponsor: Sound Surgical Technologies, LLC.
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients undergoing abdominal liposuction who wish autologous fat transfer to the upper arms

Brief summary: The objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization.


Eligibility criteria: Inclusion Criteria:

1. Is male.
2. Is between 20 and 50 years of age, inclusive, on the day of enrolment.
3. Is to undergo abdominal liposuction.
4. Wishes to undergo autologous fat transfer to the upper arms.

Exclusion Criteria:

1. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
2. Undergoing body contouring for reconstruction following injury or disease.
3. Deemed inappropriate candidates for the surgical procedures for any reason.
4. Are unwilling to undergo the study procedures or participate fully in all follow-up.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Dr David Matlock
state: California
Study officials:
References:
Clinical trial NCT00029900: ADI-PEG in Patients With Metastatic Melanoma
Official title: Phase I Testing of ADI-PEG in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Neoplasm Metastasis
Keywords: Dose-Response Relationship, Drug
Polyethylene Glycol
Arginine Deiminase
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-25
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.

Detailed description: The use of amino acid degrading enzymes derived from microbial sources has proven to be an effective means of controlling some forms of cancer auxotrophic for nonessential amino acids. Recently it has been shown that human melanomas are auxotrophic for arginine. As arginine is a nonessential amino acid for humans, elimination of it may prove to be an effective method for controlling cancer. Laboratory studies have provided promising results with the arginine-degrading enzyme arginine deiminase (ADI) coupled to polyethylene glycol (PEG) to enhance its circulating half-life.

In this study, patients each receive 3 intramuscular treatments of ADI-SS PEG over a 4-week period. There are 4 cohorts of patients each receiving a different dose level. Pharmacokinetics, pharmacodynamics, safety and toxicity, and immunogenicity studies will be performed.

Eligibility criteria: Inclusion criteria:

* Histologically confirmed metastatic melanoma
* Nonresectable disease
* Measurable or evaluable disease
* Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy
* Recovered from prior surgery
* Karnofsky performance status 70 or higher
* Expected survival of at least 12 weeks
* Bilirubin less than 2.0 mg/dL
* Albumin greater than 3.0 g/dL
* SGOT less than 5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 5 times ULN
* Ammonia less than 55 microg/dL
* Glucose greater than 60 mg/dL
* Amylase less than 1.5 times ULN
* Absolute neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3
* Patients must use 2 forms of effective contraception

Exclusion criteria:

* Prior therapy within the past 4 weeks
* Ascites or pleural effusion
* Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease)
* Pregnant or nursing
* Concurrent enrollment in another IND study
* Serious infection requiring antibiotics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT05558800: Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants With Different Surfaces.
Official title: Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Geometry
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.


Eligibility criteria: Inclusion Criteria:

* • Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.

  * Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
  * Healed bone crest (≥ 3 months elapsed after extraction or tooth loss).
  * Age \> 18 years.
  * Ability to examine and fully understand the study protocol.

Exclusion Criteria:

* • Myocardial infarction within the past 6 months.

  * Poorly controlled diabetes (HBA1c \> 7.5%).
  * Coagulation disorders.
  * Radiotherapy to the head/neck area within the past two years.
  * Present or past treatment with intravenous bisphosphonates.
  * Immunocompromised patients.
  * Psychological or psychiatric problems.
  * Alcohol or drug abuse.
  * Poor oral hygiene and motivation (full mouth plaque score \> 30% and/or full mouth bleeding score \> 20%).
  * Uncontrolled periodontal disease.

Primary outcomes:
measure: Bone to implant contact
timeFrame: 4 weeks healing period after implant placement
measure: Bone to implant contact
timeFrame: 6 weeks healing period after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University
Study officials:
affiliation: Saint Joseph University - Beirut
name: Christian Makary, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02160600: Dual Energy CT vs Standard Triple Phase CT-A Randomised Control Trial
Official title: Role of Split Bolus Dual Energy Single Acquisition CT in Evaluation of Urological Diseases of the Upper Urinary Tract.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Renal Cysts
Transitional Cell Carcinoma
AML
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To compare SBDECT with standard Triple Phase Multi-Detector CT (TPMDCT) in renal mass evaluation in terms of appropriateness of treatment received after diagnosis. To determine SBDECT diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected renal masses needing further evaluation with a contrast enhanced CT scan
* Patients who are referred for CT Urography

Exclusion Criteria:

* Patients not willing to participate in the study
* Age \<18 yrs
* Pregnant females
* Patients with previous h/o serious allergic reactions or Contrast allergy
* Impaired renal function (estimated GFR\<45mL/min/mm2)
* Sonographically proven benign renal mass needing no further evaluation

Primary outcomes:
measure: Appropriateness of the treatment recieved
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT06464900: Effects of a Health Intervention on Fear of Hypoglycemia
Official title: Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health-Related Behavior
Health Education
Fear of Hypoglycemia
Impaired Awareness of Hypoglycemia
Self-Management
Type2 Diabetes Mellitus
Keywords: Behaviour Change Wheel
Health educational intervention
Fear of hypoglycaemic
Impaired awareness of hypoglycaemia
Medical support
Self-management attitude
Type 2 diabetes mellitus
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

Detailed description: In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;
* Age ≥18 years;
* Duration of diabetes mellitus ≥1 year;
* FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);
* Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;
* Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;
* Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

* Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;
* Patients with comorbid psychiatric diseases or taking psychotropic drugs;
* Patients who have recently or are participating in other studies on similar topics.

Primary outcomes:
measure: Hypoglycemia fear survey
timeFrame: Baseline, 4 and 12 weeks post-intervention
Secondary outcomes:
measure: Gold Rating
timeFrame: Baseline, 4 and 12 weeks post-intervention
measure: The Patients Assessment Chronic Illness Care( PACIC)
timeFrame: Baseline, 4 and 12 weeks post-intervention
measure: The self-management attitude scale for diabetes patients
timeFrame: Baseline, 4 and 12 weeks post-intervention
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Yangzhou University
state: Jiangsu
Study officials:
affiliation: Yangzhou University
name: Zhao Yueqi, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02173600: Cardiovascular Risk Factors And Intensive Dietary Counselling
Official title: Estimation of Cardiovascular Risk After Intensive Dietary Counselling in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Blood Pressure
Hypercholesterolemia
Tobacco Smoking
Keywords: Cardiovascular risk
Primary prevention
Intensive dietary counselling
Physical exercise
Lead sponsor: Andalusian Regional Ministry of Health
Sponsor class: OTHER_GOV
Collaborators: name: Andaluz Health Service
First posted: 2014-06-25
Enrollment: 630
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion activity. It is being implemented by the Andalusian Health Service to reinforce basic intervention advice on healthy diet and exercise. The IDC intervention is aimed at the prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and stroke).

The main objective of the present study is to assess adherence to the IDC intervention and, consequently, its effectiveness on the prevention of the above mentioned diseases.


Eligibility criteria: Inclusion Criteria:

* Age between 40-65 years
* Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)

Exclusion Criteria:

* Currently diagnosed with any vardiovascular disease
* Currently involved in any other clinical trial
* Cognitive impairment that prevents from providing an informed consent

Primary outcomes:
measure: Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.
timeFrame: upt to 12 months from the beginning
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Baseline, 6 and 12 months from the beginning
Other outcomes:
measure: Chronic low-grade inflammation
timeFrame: Baseline, 6 and 12 months from the beginning
Locations:
Study officials:
References:
Clinical trial NCT02941900: Interest and Impact of Skin Cancer Genetic Testing
Official title: PERSONALIZED GENOMIC TESTING FOR MELANOMA: MAXIMIZING COMPREHENSION AND HEALTH OUTCOMES IN SKIN CANCER PATIENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-melanoma Skin Cancer (NMSC)
Keywords: Genetic Testing
16-1243
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 53
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: MSK clinics

Brief summary: The purpose of this study is to learn whether the patient might be interested in skin cancer genetic testing, and if so, what kinds of thoughts, feelings, and behaviors might result from this testing. Testing for skin cancer risk based on the MC1R gene is not currently used in clinical practice; it will be offered in this study for research purposes only.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* English fluent as we do not have the resources to translate all the materials including the website and risk feedback materials into other languages
* Prior history of stage 0, I or II NMSC as per EMR or clinical judgment

Exclusion Criteria:

* Inability to provide meaningful informed consent due to cognitive or psychiatric disability as determined by the judgement of the consenting professional or clinician

Primary outcomes:
measure: number of patients interested in MC1R testing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jennifer Hay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05903300: Validation of the Polish Version of the MPIIQM Questionnaire for Musicians
Official title: Validation of the Polish Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-P)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Musculoskeletal Pain
Questionnaire
Keywords: Occupational Diseases
Musculoskeletal Pain
Questionnaires
Validation Studies
Pain Measurement
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group consists of adult, professionally active people (women and men) who are professional orchestra musicians. The mother tongue of the respondents must be Polish.

Brief summary: The aim of this study, originally named "Cross-Cultural Adaptation and Validation of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians of the Polish Population (MPIIQM-P)" is the enlargement of validation of the Polish questionnaire.

Detailed description: The aim is to determine the following psychometric properties: convergent and divergent validity, two-time reliability analysis, and exploratory factor analysis according to the recommended number of subjects of ≥45 subjects. In addition, the aim of the study is to assess the psychometric properties of the MPIIQM-P questionnaire in the online version and to compare these results with the results for the paper version obtained by Cygańska et al., 2021.

Eligibility criteria: Inclusion Criteria:

* permanent musician in an orchestra
* Polish as a native language

Exclusion Criteria:

• freelance musician

Primary outcomes:
measure: Pain Intensity MPIQIM
timeFrame: Baseline and change between baseline and after few (3/4) days
measure: Pain Intensity BPI
timeFrame: Baseline and change between baseline and after few (3/4) days
measure: Pain Interference MPIQIM
timeFrame: Baseline
measure: Pain Interference BPI
timeFrame: Baseline
measure: Pain Interference
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Józef Piłsudski University of Physical Education in Warsaw
Study officials:
affiliation: Józef Piłsudski University of Physical Education in Warsaw
name: Anna K. Cygańska, Cygańska
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01535300: Ultrasound and Paediatric Endotracheal Tube Size
Official title: Role of Ultrasound Compared to Age-related Formulas for Uncuffed Endotracheal Intubation in a Paediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncuffed Endotracheal Intubation
Keywords: Ultrasound
Minimal transverse tracheal diameter
Endotracheal tube size
Paediatric age-based formulas
Sonographic measurement of the trachea
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: SonoSite, Inc.
First posted: 2012-02-17
Enrollment: 50
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children \<= 5 years of age scheduled for elective surgery

Brief summary: The aim of the present study was to evaluate the role of ultrasound in paediatric patients to compare the correct size of an uncuffed endotracheal tube (ETT) with the minimal transverse tracheal diameter (MTTD) measured by ultrasound and with tube size predicted by different age-related formulas.

The investigators hypothesize that a prediction of pediatric ETT is possible with the ultrasonographic measurement of the MTTD.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* children \<= 5 years of age
* elective surgery requiring endotracheal intubation

Exclusion Criteria:

* missing informed consent
* allergy to ultrasound gel

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Konstanze Plaschke, Professor
role: STUDY_CHAIR
affiliation: Heidelberg University
name: Christoph Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References: