louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03741894: Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Official title: Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alveolitis of Jaw
Alveoli, Teeth; Inflammation
Dry Socket
Impacted Third Molar Tooth
Keywords: alveolitis
iodoform
chlorhexidine
minor complications
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.


Eligibility criteria: Inclusion Criteria:

* Pell-Gregory II/B impaction
* mesioangular impactions
* tooth sectioning is not necessary for removal
* without local infection of third molar

Exclusion Criteria:

* no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)

Primary outcomes:
measure: Change in minor postoperative complications (trismus)
timeFrame: day of surgery, 3rd, 7th postoperative days
measure: Change in minor postoperative complications (oedema)
timeFrame: day of surgery, 3rd, 7th postoperative days
measure: Change in minor postoperative complications (pain)
timeFrame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
measure: Change in necessity of postoperatively taken analgesics
timeFrame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
measure: Change in necessity of postoperatively taken analgesics
timeFrame: 1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Department of Oral and Maxillofacial Surgery, University of Pécs
Study officials:
References:
Clinical trial NCT02232594: Postmarketing Surveillance Study of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Official title: Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berodual® Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-05
Enrollment: 834
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive respiratory tract disease recruited at general physicians and internists

Brief summary: The aim of this postmarketing surveillance is to obtain further information about the tolerability and efficacy of Berodual® metered-dose inhaler in the treatment of chronic obstructive respiratory tract disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Patients of either sex over 40 years with the symptoms of a chronic obstructive airways disease
* Only patients which have not been treated with Berodual® within the last year should be included

Exclusion Criteria:

* Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berodual® metered-dose inhaler

Primary outcomes:
measure: Overall severity of the clinical picture rated on a 4- point scale
timeFrame: after 3 and 6 weeks
Secondary outcomes:
measure: Assessment of efficacy by investigator on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of efficacy by patient on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Assessment of tolerability by patient on a 4-point scale
timeFrame: after 3 and 6 weeks
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01399294: Cross Sectional Study of Constipation in Advanced Cancer Patients
Official title: Traditional Chinese Medicine Syndrome Distribution of Advanced Cancer Patients With Constipation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Palliative Care
Constipation
Traditional Chinese Medicine
Keywords: Palliative Care
Advanced Cancer
Constipation
Traditional Chinese Medicine
Syndrome Distribution
Lead sponsor: Yan Chai Hospital
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
name: Hong Kong Baptist University
First posted: 2011-07-21
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced cancer patients (aged 18 or above) under the care of palliative care units who are on laxatives and who have constipation during recruitment.

Brief summary: Constipation is a common problem in palliative cancer patients. However, there were insufficient randomized controlled trial (RCT) data to identify the "best" laxative or combination of laxatives in these patients.

Traditional Chinese medicine (TCM) in holistic approach is popular among cancer patients. More than half had received at least one form of TCM therapy according to the survey carried in 2008. Chinese herbal medicine (CHM) in compound formulation with nourishing and purging effects simultaneously may be more preferred to relieve constipation by local palliative cancer patients.

TCM syndrome differentiated by collecting all symptoms and signs through the classic four diagnostic methods is the foundation for making diagnosis and prescription in TCM practice.

The present study is the first local study to evaluate the bowel habits and TCM syndrome of advanced cancer patients with constipation. We hope that the results not only can shed light on patient's own reporting or experience of constipation and the effectiveness of current practice, but also can draw up a CHM formulation for advanced cancer patients with constipation.


Eligibility criteria: Inclusion Criteria:

* advanced cancer patients
* on medication for facilitating bowel movement and/or constipation visual analogue scale \>=2

Exclusion Criteria:

* unable to communicate
* cognitive impaired
* put on colostomy bag
* clinically diagnosed gastrointestinal obstruction
* at end-of-life

Primary outcomes:
measure: TCM syndrome distribution
timeFrame: End of recruitment (estimated timeframe: 3 months)
Secondary outcomes:
measure: bowel habit
timeFrame: End of recruitment (estimated timeframe: 3 months)
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Caritas Medical Centre
state: Hong Kong
city: Hong Kong
country: China
facility: Our Lady of Maryknoll Hospital
state: Hong Kong
Study officials:
affiliation: Department of Medicine & Geriatrics / ICU, Caritas Medical Centre
name: Doris MW Tse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01221194: Therapeutic Stockings to Prevent Foot Ulcers
Official title: Therapeutic Stockings to Prevent Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
foot ulcer prevention
therapeutic stockings
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-10-14
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients.
2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.

Detailed description: We will identify a cohort of high-risk diabetic patients and assign them to two treatment groups. We plan to enroll patients from three sites: Scott and White Hospital in Temple Texas, Manchester Royal Infirmary, UK , and Trinity College Dublin at St James Hospital.. The two treatment arms will involve a Standard Therapy Group, and a Stocking Therapy Group. The Stocking Therapy group will use the special padded and friction reducing stockings in their standard shoes during the course of the study. Patient enrollment will occur over a one-year period. All patients will be followed for 30 months. The Standard Therapy Group will receive therapeutic shoes, standard insoles, patient education and regular foot evaluations by a physician every 10-12 weeks. The Stocking Therapy Group will receive standard therapy as described above but use the special stockings instead of their usual hose. The investigator at each site will be blinded regarding the treatment.

Eligibility criteria: Inclusion Criteria:

* Men or women 18 years old or older
* Diagnosis of Diabetes Mellitus\*
* History of diabetes related foot ulceration

Spanish-speaking subjects will be eligible to participate.

Exclusion Criteria:

* Active Charcot Arthropathy
* Gangrene, active infection
* Midfoot or higher level amputation
* Alcohol or substance abuse within 6 months
* Unreliable, unwilling or unable to comprehend informed consent

Primary outcomes:
measure: Number of Participants Who Developed Foot Ulcer During Study Time Frame
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital Systems
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Temple
country: United States
facility: Scott & White
state: Texas
city: Manchester
country: United Kingdom
facility: University of Manchester
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Lawrence Lavery, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402894: Follow-up of Person-centered Care of Young Adults With Rheumatic Disease
Official title: Follow-up of Person-centered Care of Young Adults With Rheumatic Disease Uppföljning av Personcentrerat omhändertagande av Unga Vuxna Med Reumatisk Sjukdom (Unga-vuxna Studien) (Swedish)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Spondylarthritis
Arthritis, Psoriatic
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2015-03-30
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care. In total 100 patients, no healthy controls.

Brief summary: The purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.


Eligibility criteria: Inclusion Criteria:

* 16-23 years
* newly diagnosed RA according to the ACR / EULAR 2010 criteria, SpA according to CASPAR criteria, or AS according to the ASAS criteria.
* Ability to understand the Swedish language in speech and writing.

Exclusion Criteria:

* Existing rheumatic disease
* Other healthcare demanding serious illness

Primary outcomes:
measure: General health as measured by VAS
timeFrame: This study consists of a 1-year primary study and a long term follow-up (up to 50 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Reumatology, Sahlgrenska University Hospital, VastraGotaland
Study officials:
References:
Clinical trial NCT05372094: Noise Reduction Preferences in Teenagers and Pre-teens
Official title: Noise Reduction Preferences in Teenagers and Pre-teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University
First posted: 2022-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.
Primary purpose: TREATMENT

Brief summary: Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.

Detailed description: The purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid Bluetooth streaming programs for this population. Subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. Blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. These tasks will be done using different levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control).

.

Eligibility criteria: Inclusion Criteria:

* mild, moderate, or moderate-severe bilateral sensorineural hearing loss
* native English speakers with ability to communicate verbally
* able to read and follow directions
* access to smartphone and willing to download a hearing aid app
* experienced hearing aid user (6+ months)

Exclusion Criteria:

* unable to follow verbal directions
* unable to communicate verbally
* unable to wear study devices for required home trials
* active middle ear infection
* unable to attend lab visits required for study

Primary outcomes:
measure: Subjective Rating of Listening Effort Questionnaire
timeFrame: Day 14 of study, visit 2
Secondary outcomes:
measure: Speech Reception Threshold
timeFrame: Day 28, visit 3
measure: Physical Response Time
timeFrame: Day 14 of study, visit 2
measure: Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings
timeFrame: Day 1 of study, visit 1
measure: Subjective Questionnaire on Preference for Accessing Bluetooth on Phone
timeFrame: Day 28, visit 3
measure: Verbal Response Accuracy
timeFrame: Day 14 of study, visit 2
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
Clinical trial NCT02994394: A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Male
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 84
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.


Eligibility criteria: Inclusion Criteria:

* Body weight of at least 50.0 kg
* BMI \[body weight in kg / (height in m)2\] of at least 17.6 kg/m2 and less than 25.0 kg/m2
* Judged by the investigator or subinvestigator to be capable of providing written informed consent prior to the start of any trial-related procedures and capable of complying with the trial procedures for this study.

Exclusion Criteria:

* Judged by the investigator,subinvestigator, or sponsor to have a clinically significant abnormality in results of the screening examination (including a notable deviation from the site's standard values) or a medical history that could place the subject at risk or affect the evaluation of drug absorption, distribution, metabolism, or excretion
* History of alcohol or drug dependence or abuse within 2 years prior to the trial
* History or current infection with hepatitis or acquired immunodeficiency syndrome (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test
* History of any severe drug allergy
* Positive results in alcohol screening test or urine drug screening test at time of screening examination or trial site admission
* Use of any other investigational medicinal product (IMP) within 120 days prior to Period 1 IMP administration
* Consumption of any food or beverage containing St. John's wort within 14 days prior to Period 1 IMP administration
* Consumption of any food or beverage containing grapefruit, Seville orange, or star fruit within 7 days prior to Period 1 IMP administration
* Judgment by the investigator or subinvestigator that the subject should not participate in the study for any other reason.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of Tolvaptan
timeFrame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
measure: Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan
timeFrame: Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Kyusyu Region
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02150694: Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo
Official title: Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Apelins are substances which occur naturally in the body, and have an important role in heart disease. They have been shown to make blood vessels dilate, and improve the way the heart works.

The investigators have devised 2 sets of experiments to investigate how the apelins affect blood vessels.

In the first group of experiments,the investigators will give healthy volunteers up to 3 different apelin substances, and use special research techniques to see how they affect the way that blood vessels work in the forearm.

In the second group of experiments, the apelins will be given along with another form of apelin which blocks the effects of apelin in laboratory experiments. The investigators want to see if it blocks the effects of apelin in healthy humans.

The investigators intend to test the hypothesis that:

Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by an apelin receptor antagonist.

This study will help us to understand more about how apelins work, and to suggest how they might be used to treat heart disease.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 70 years
* Non-regular smoking (\<5 cigarettes per week)
* If female, postmenopausal or on days 2-9 of menstrual cycle

Exclusion Criteria:

* Hypertension (sustained BP \>160/100mmHg)
* Ischaemic Heart Disease
* Renal, respiratory or neurological disease
* Diabetes mellitus
* BMI \>30, BMI \<18
* Pregnant
* Smoker
* Use of vasoactive medication or NSAIDS/aspirin within 48 hours of study.
* Current involvement in other research studies

Primary outcomes:
measure: Forearm blood flow measured by forearm plethysmography in response to infused vasodilators
timeFrame: 2-3 hours
measure: Change in hand vein diameter measured by Aellig hand vein technique, in response to study peptides
timeFrame: 2-3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Vascular Research Unit
Study officials:
affiliation: University of Cambridge
name: Ian B Wilkinson, FRCP DM
role: STUDY_DIRECTOR
affiliation: University of Cambridge
name: Anthony P Davenport, MA PhD
role: STUDY_DIRECTOR
References: