louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00889447: Screening Evaluation for Studies of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Screening Evaluation for Studies of COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary disease (COPD)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-04-29
Enrollment: 670
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both Male and Female 40 years and older

Brief summary: This research is being done to study mechanisms of progression of COPD and to develop treatments for it. The investigators are doing the present study to identify people age 40 and older with mild to moderate COPD who will qualify for such studies to include in a database. The study will include establishing a screening evaluation or characterization of the following two studies:

* Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980
* Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA_00001771

Detailed description: This is a program to recruit and screen participants for clinical trials or more detailed observational studies of COPD. There are no interventions or comparative results to be published from this study.

Eligibility criteria: Inclusion Criteria:

* Age 40 years and older, either sex
* Mild to moderate COPD (FEV1/Forced vital capacity (FVC) ratio ≤ 0.70, FEV1 30-70% predicted, Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥35% predicted)
* On stable maintenance therapy for 2 months
* Current or former smoker (patient report of at least a 10 pack-year history)
* Ability to understand and willingness to sign consent documents

Exclusion Criteria:

* COPD exacerbation requiring treatment within past 6 weeks
* Untreated arterial hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg)
* Decompensated heart failure
* Myocardial infarction within past 3 months or ever
* Evidence of interstitial, occupational or chronic infectious lung disease
* Renal dysfunction
* Supplemental oxygen \> 2 liters/m at rest
* Failure to keep screening appointments

Primary outcomes:
measure: Establish a screening evaluation or characterization
timeFrame: Determined during screening clinical visit
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory Diette, MD,MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00127647: An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
Official title: MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-08-08
Enrollment: 1375
Sex: ALL
Minimum age (years): 15
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion Criteria:

* Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

Primary outcomes:
measure: Composite Nasal Symptom Score
Secondary outcomes:
measure: Daytime nasal symptom score, Nighttime nasal symptom score
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Okubo K, Baba K. A double-blind non-inferiority clinical study of montelukast, a cysteinyl leukotriene receptor 1 antagonist, compared with pranlukast in patients with seasonal allergic rhinitis. Allergol Int. 2008 Dec;57(4):383-90. doi: 10.2332/allergolint.O-08-533. Epub 2008 Nov 1.
Clinical trial NCT06066047: Effect of Attentional Touch in Stabilometric Assessments
Official title: Low Term Effect of Attentional Touch on Sway Rate Variation of CoP in Asymptomatic Subjects: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Lead sponsor: Accademia Italiana Medicina Osteopatica
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Postural balance has been studied in the literature and ideal body mass distribution has been shown to provide stability to the body in an upright position. The use of stabilometry to assess posture is a standard in clinical practice and medical research. In the literature we find osteopathic treatment evaluated with stabilometry in specific pathological conditions. We will experiment on asymptomatic volunteers how attentive touch is effective compared to non-attentive touch and compared to an untreated group by measuring specific parameters that indicate postural balance.

Detailed description: Stabilometry measurements will be taken on asymptomatic volunteers before and after several specific treatments, in particular to measure whether the variance in sway speed is reduced after the treatments. The effect of attentional versus non-attentional touch will be compared in the other two groups, in addition to a control group that receives no treatment.

Eligibility criteria: Inclusion Criteria:

• aymptomatics

Exclusion Criteria:

* serious illnesses
* balance disorders
* recent trauma (within 2 years) to the lower limbs

Primary outcomes:
measure: the velocity variation of the displacement of the centre of pressure (CoP).
timeFrame: baseline
measure: the velocity variation of the displacement of the centre of pressure (CoP).
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mantova
country: Italy
facility: Studio osteopatico Bettoni
Study officials:
References:
Clinical trial NCT02336347: A Phase 1 Study Comparing AVP-786 With AVP-923
Official title: A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, 2-way Crossover Study Comparing AVP-786 With AVP-923
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Pharmacokinetics
Healthy Volunteers
deuterated dextromethorphan
deuterated dextromethorphan with quinidine
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare pharmacokinetics (PK) of AVP-786 (deuterated \[d6\] dextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) to AVP-923 (dextromethorphan hydrobromide \[DM\]/Q) at steady state.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males or females
* 18 - 60 years of age
* BMI 18 - 32 kg/m2

Exclusion Criteria:

* History or presence of significant disease
* History of substance abuse and/or alcohol abuse with the past 2 years
* Use of tobacco-containing or nicotine-containing products within 6 months
* Use of any prescription or the over-the-counter medications within 14 days

Primary outcomes:
measure: PK of d6-DM in AVP-786 compared to DM in AVP-923
timeFrame: 8 days
Secondary outcomes:
measure: PK of metabolites
timeFrame: 8 days
measure: Safety and tolerability
timeFrame: 8 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Dallas Clinical Research Unit
state: Texas
Study officials:
affiliation: Avanir Pharmaceuticals
name: Nadine Knowles
role: STUDY_DIRECTOR
References:
Clinical trial NCT05323747: Prospective Evaluation of a Commercially Available Hydrogel Spacer
Official title: Clinical Protocol for the Prospective Evaluation of a Commercially Available Hydrogel Spacer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate
Prostate Cancer
Spacer
Perirectal spacer
Lead sponsor: BioProtect
Sponsor class: INDUSTRY
First posted: 2022-04-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate Cancer

Brief summary: Dosimetry efficacy evaluation of the hydrogel spacer

Detailed description: Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in 20 males undergoing radiotherapy to treat prostate cancer. Study will utilize pre and post gel insertion CT images to determine the endpoints.

Eligibility criteria: Inclusion Criteria:

* Males
* At lease 18 years of age
* Undergoing external beam or brachy radiation therapy with a hydrogel spacer

Exclusion Criteria:

* Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Primary outcomes:
measure: Dosimetry changes
timeFrame: 1 month
Secondary outcomes:
measure: Prostate to rectum spacing
timeFrame: 1 month
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Western Radiation Oncology
state: California
city: Reno
country: United States
facility: Northern Nevada Radiation Oncology
state: Nevada
Study officials:
References:
Clinical trial NCT05729347: Treatment of Parental Anxiety Virtual Reality (VR)
Official title: Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Parents
Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations


Eligibility criteria: Inclusion Criteria:

* Ages 18-99 (Patient's parents will be enrolled)
* Able to consent

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems Patients whose children are clinically unstable or require urgent/emergent intervention

Primary outcomes:
measure: Procedural-Related Anxiety
timeFrame: Duration of intervention, approximately 20-30 minutes
Secondary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: baseline, immediately after the intervention
measure: Change in anxiety levels
timeFrame: baseline, immediately after the intervention
measure: Device satisfaction
timeFrame: immediately after intervention
measure: Modified Pain Catastrophizing Scale
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Parkard Children's Hospital
state: California
Study officials:
References:
citation: Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022.
Clinical trial NCT02455947: IBSR Meditation Technique for Teachers' Burnout
Official title: The Effect of Inquiry Based Stress Reduction (IBSR) Meditation Technique on Levels of Burnout and Wellbeing Among Teachers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: Burnout
Teachers
Meditation
IBSR
"The Work"
Byron Katie
Lead sponsor: Tel Aviv Medical Center
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2015-05-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effect of Inquiry based stress reduction (IBSR) meditation technique on levels of burnout and wellbeing among teachers.

Detailed description: Teachers' burnout is a well-known phenomenon with personal and professional implications. The current study investigates the effect of inquiry based stress reduction (IBSR) technique on burnout and well-being among teachers.

Eligibility criteria: Inclusion Criteria:

* All the teachers working in 'Begin' high-school, Rosh Hayin, Israel
* agreed to sign an informed consent form

Exclusion Criteria:

* Teachers with previous experience with IBSR technique

Primary outcomes:
measure: Burnout levels, Maslach Burnout Inventory (MBI)
timeFrame: 3 months
Secondary outcomes:
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: 3 months
measure: Depression, Anxiety, Stress (DASS)
timeFrame: 3 months
measure: Perceived Stress Scale (PSS )
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Integartive Medicine, Tel Aviv Medical Center
name: Shahar Lev-Ari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274247: Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn
Official title: Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Neonatal Tongue-tie
Maternal Nipple Pain Upon Breastfeeding
Neonatal Latch Difficulties
Keywords: Tongue-tie
Ankyloglossia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-01-11
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.


Eligibility criteria: Inclusion Criteria:

* Full term Newborn infant
* Tongue-tie upon physical examination
* Maternal complains of nipple pain or difficult latch

Exclusion Criteria:

* Abnormal oral or nasopharyngeal anatomy
* Any known congenital malformations
* Prematurity

Primary outcomes:
measure: Duration of cry after lingual frenotomy
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tel AViv
country: Israel
facility: Department of Neonatology, Tel AViv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Shaul Dollberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05958147: Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy
Official title: Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy- a Split Mouth Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Periodontal Pocket
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is a prospective randomised split mouth study to evaluate the effect of concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing

Detailed description: Twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.

All the patients underwent scaling and root planing. As it is split mouth study design the test site is treated with Concentrated platelet rich fibrin( C-PRF) and the contralateral site is not treated with C-PRF. Periodotal pack was placed and patient was recalled after 6 weeks for the follow up.

Eligibility criteria: Inclusion Criteria:

1. Patient age ranging from 18-45 years
2. Contralateral sites with probing depth 5mm-7mm associated with premolar and molar teeth with no furcation involvement
3. No systemic disease
4. Not under any medication which effect the outcome of periodontal therapy

Exclusion Criteria:

1. History of any periodontal therapy within past 6 months
2. Pregnant and lactating mothers
3. Smokers smoking \>10 cigarettes per day
4. Patients with blood disorders or platelet count less than 50000 cells/ µL
5. Patients with known systemic disease
6. Non-compliant patients

Primary outcomes:
measure: Probing pocket Depth
timeFrame: 6 weeks
measure: Relative attachment level
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
References:
Clinical trial NCT01848847: Relationship Between Bladder Distention and Hysteroscopy Application
Official title: The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menorrhagia
Keywords: Hysteroscopy
Bladder
Pain
Feasibility
Duration
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 102
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to investigate the advantages and disadvantages of bladder filling during hysteroscopy procedure.

Detailed description: Women who should have diagnostic hysteroscopy procedure will be randomly allocated into two groups. In the first group hysteroscopy will be performed with a filled bladder and in the second group procedure will be performed with an empty bladder. The women will be assigned into groups randomly. The duration of the procedure, feasibility of the procedure and tolerability of procedure will be recorded.

Eligibility criteria: Inclusion Criteria:

* Women who are at reproductive age
* Women who are not pregnant at the time of presentation
* Women who are not nulliparous

Exclusion Criteria:

* Women who have previous cervical surgery or cervical incompetence.
* Women who have genitourinary infection
* Women who have profuse uterine bleeding or recent uterine perforation
* Women who have neurological disorders affecting evaluation of pain.

Primary outcomes:
measure: Ease of Cervical Entry
timeFrame: 2 months
measure: Pain Scoring(VAS)
timeFrame: 2 months
Secondary outcomes:
measure: Patient Acceptability and Pain Scoring
timeFrame: two months
measure: Procedure Duration
timeFrame: two months
Other outcomes:
Locations:
city: Tekirdag
country: Turkey
facility: Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology
Study officials:
affiliation: Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology
name: Cem Celik, Assist Prof
role: STUDY_DIRECTOR
References:
citation: Kabli N, Tulandi T. A randomized trial of outpatient hysteroscopy with and without intrauterine anesthesia. J Minim Invasive Gynecol. 2008 May-Jun;15(3):308-10. doi: 10.1016/j.jmig.2008.01.013. Epub 2008 Mar 20.
citation: Carta G, Palermo P, Marinangeli F, Piroli A, Necozione S, De Lellis V, Patacchiola F. Waiting time and pain during office hysteroscopy. J Minim Invasive Gynecol. 2012 May-Jun;19(3):360-4. doi: 10.1016/j.jmig.2012.01.017. Epub 2012 Mar 3.
citation: De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2.
citation: Pansky M, Feingold M, Bahar R, Neeman O, Asiag O, Herman A, Sagiv R. Improved patient compliance using pediatric cystoscope during office hysteroscopy. J Am Assoc Gynecol Laparosc. 2004 May;11(2):262-4. doi: 10.1016/s1074-3804(05)60211-3.