louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04291053: The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19
Official title: The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: COVID-19
Huaier granule
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world.There is no specific drug treatment for this disease. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment COVID-19.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 75 years, extremes included, male or female
2. Patients diagnosed with mild or common type COVID-19, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
3. patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
4. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. patients who are allergic to this medicine
3. patients meet the contraindications of Huaier granule
4. Patients with diabetes
5. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
6. patients can't take drugs orally

Primary outcomes:
measure: Mortality rate
timeFrame: up to 28 days
Secondary outcomes:
measure: Clinical status assessed according to the official guideline
timeFrame: up to 28 days
measure: The differences in oxygen intake methods
timeFrame: up to 28 days
measure: Duration (days) of supplemental oxygenation
timeFrame: up to 28 days
measure: Duration (days) of mechanical ventilation
timeFrame: up to 28 days
measure: The mean PaO2/FiO2
timeFrame: up to 28 days
measure: Length of hospital stay (days)
timeFrame: up to 28 days
measure: Length of ICU stay (days)
timeFrame: up to 28 days
measure: Pulmonary function
timeFrame: up to 3 months after discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05026853: Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice
Official title: Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Keywords: Health-related quality of life
PROMIS
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2021-08-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two arms (1: 1 randomization) of the trial to assess PRO integration into care
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will examine the impact of providing patient-reported outcomes measurement information system (PROMIS) scores to patients before appointments with their healthcare provider.


Eligibility criteria: Inclusion Criteria for patients:

* New and established patients seeking care at Michigan Medicine rheumatology clinics
* Patients should have access to the patient portal in MiChart patient portal
* Patients should have access to the internet at home to be able to complete the PROMIS PRO measures and study surveys online
* Patients should have completed PROMIS pain, physical function, and sleep disturbance measures at least one day before their baseline appointment
* At least one of the PROMIS PRO scores should be in the concerning zone (pain intensity ≥ 5, physical function ≤ 40, or sleep disturbance ≥ 60).

Exclusion Criteria:

* Non-English speakers
* under 18 years of age

Inclusion Criteria for providers:

* Rheumatology health care providers, including clinicians and advanced practice providers at Michigan Medicine who are currently treating rheumatology patients

Exclusion Criteria:

* Those not meeting the inclusion criteria

Primary outcomes:
measure: Percent of Appointments at Which Patient-Reported Outcomes Measurement Information System (PROMIS) Scores Are Documented in the Electronic Medical Record (EMR) Note by the Participating Health Care Provider (HCP)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP
timeFrame: Up to 3 months
measure: Quality of Patient-provider Communication
timeFrame: Up to 2 weeks
measure: Change in Score of the Most Bothersome PROMIS Domain
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Dinesh Khanna, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06183853: Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft
Official title: Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft: Aesthetic and Functional Satisfaction, Sensory Recovery and Bone Healing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Abnormalities
Keywords: Dysmorphoses
Maxillofacial Abnormalities
Maxillomandibular
Lip incompetence
Ventilation disorders
Genioplasty
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥ 18 years old) having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.

Brief summary: The correction of maxillomandibular dysmorphoses, responsible for both functional discomfort (lip incompetence, ventilation disorders, periodontal disease) but also aesthetic, calls in particular for genioplasty, of which there are several techniques. One of these chin repositioning techniques, called "Chin Wing", cuts the bone to optimize the functional and aesthetic result. While all genioplasty techniques expose the risk of nerve damage and lack of bone consolidation, these parameters are only rarely addressed in the literature in the specific context of this extensive bone cutting.

The objective of this work is to assess the satisfaction of patients who have benefited from chin advancement surgery using the "Chin Wing" technique.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥ 18 years old)
* having undergone "Chin Wing" type genioplasty surgery in the maxillofacial surgery department of Strasbourg between October 1, 2012 and June 30, 2022.
* Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed their opposition to the reuse of their data for scientific research purposes

Primary outcomes:
measure: Aesthetic and functional satisfaction of the patients' results of surgery
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Plastique, Reconstructrice, Esthétique et Maxillo-faciale - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01745653: Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device
Official title: Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the "Quadhelix"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bad Molar Teeth Arrangement Requiring Orthodontic Device
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 69
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.

As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.

Detailed description: Patient will be randomized into one of the 3 following arms :

* arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of the quadhelix.
* arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be installed but the laser will not be activated.
* arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT be installed

Eligibility criteria: Inclusion Criteria:

* Children aged between 8 and 15 years old who need to receive an orthodontic device ("quadhelix)
* informed consent form signed by parents who should be affiliated to French health insurance (french Social security)

Exclusion Criteria:

* malignant facial tumor
* not able to read or write correctly and thus not able to complete the questionnaire
* allergic or intolerant to paracetamol
* Informed consent not obtained

Primary outcomes:
measure: to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
timeFrame: change from baseline pain at 7 days
Secondary outcomes:
measure: effect of low level laser therapy on intake of antalgics
timeFrame: change from baseline antalgics intake at 7 days
measure: quality of food intake
timeFrame: change from baseline quality of food intake at 7 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital
state: Loire Atlantique
Study officials:
References:
Clinical trial NCT03078153: Effect of Social Media Support and Financial Incentives on PrEP Adherence
Official title: The Effect of Social Media Support and Financial Incentives on Adherence to HIV Pre-exposure Prophylaxis in Young MSM of Color in Washington, DC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Gilead Sciences
First posted: 2017-03-13
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if social media support and financial incentives improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24 living in the Washington, DC area who are at high risk for HIV acquisition.


Eligibility criteria: Inclusion Criteria:

* Male assigned at birth (regardless of current gender identity)
* Age 18-24
* Black/African American, Latino or Asian
* HIV negative
* History of unprotected anal sex with a man in the last 6 months
* Living within the DC metropolitan statistical area and anticipate remaining within the DC area for the next 6 months
* Not enrolled in any other HIV prevention trial
* Interested in taking PrEP
* Not a current PrEP user and have not taken PrEP in the last 30 days
* Able to provide informed consent

Exclusion Criteria:

* Female sex at birth
* Age younger than 18 or older than 24
* Caucasian
* HIV positive
* Actively taking PrEP or having taken PrEP within 30 days of enrollment
* Chronic hepatitis B infection
* Known renal insufficiency
* On probation or parole
* Any other conditions that the Principal Investigator may consider a contraindication to enrolling in the study

Primary outcomes:
measure: Adherence To Truvada
timeFrame: 6 months
Secondary outcomes:
measure: New Cases of HIV
timeFrame: 6 months
measure: Incidence of STIs
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: The GW Medical Faculty Associates
name: Marc Siegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00363753: Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack
Official title: Pilot Study of Continuing Aspirin Versus Switching to Clopidogrel After Stroke or Transient Ischemic Attack
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Transient Ischemic Attack
Stroke
Aspirin
Clopidogrel
Keywords: Transient ischemic attack
Stroke
Aspirin
Clopidogrel
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 0
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: Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

Detailed description: Pilot study of continuing aspirin versus switching to clopidogrel after stroke or transient ischemic attack.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older.
* Stroke or transient ischemic attack (TIA) while taking aspirin within one week of consent.
* Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period.

Exclusion Criteria:

* Any medical indication for a specific antiplatelet agent (aspirin, clopidogrel, ticlopidine, aggrenox), or an indication for a combination of antiplatelet agents.
* Any medical indication for anticoagulation, except subcutaneous heparin for deep vein thrombosis prophylaxis.
* Allergy to aspirin or clopidogrel.

Primary outcomes:
measure: mRS at three months.
Secondary outcomes:
measure: Incidence of stroke at three months, bleeding events.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Hillcrest
state: California
city: San Diego
country: United States
facility: UCSD
state: California
Study officials:
affiliation: UCSD Stroke Center
name: Matt B Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01225653: Topical Application of Latanoprost in Diabetic Retinopathy
Official title: Topical Application of Latanoprost in Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Retinopathy
Keywords: Latanoprost
vasodilation
diabetic retinopathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2010-10-21
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.

Detailed description: The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.

The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.

Eligibility criteria: Inclusion Criteria:

* Age 20-36 years old
* Diabetes mellitus with retinopathy

Exclusion Criteria:

* Pregnancy
* Previous ocular disease other than diabetic retinopathy
* General disease with possible influence on the eye

Primary outcomes:
measure: The diameter of retinal arterioles
timeFrame: 24 months
Secondary outcomes:
measure: The severity of diabetic retinopathy
timeFrame: 24 months
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Department of Ophthalmology, Århus University Hospital
Study officials:
affiliation: Dept of Ophthalmology, Århus University Hospital
name: Toke Bek, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652353: Mnemonic for the Ottawa Ankle Rule
Official title: Efficacy of a Mnemonic to Improve Knowledge of the Ottawa Ankle and Foot Rules Among Medical Students and Residents; a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Trauma
Education
Keywords: Clinical decision rule
Ottawa Ankle Rule
Ottawa Foot Rule
Ankle
Trauma
Education
Foot Trauma
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate wether the use of a mnemonic strategy could improve the recall of the Ottawa Ankle and foot Rules' guidelines among medical students and residents


Eligibility criteria: Inclusion Criteria:

* Being a medical student in rotation in pediatrics at CHU Sainte-Justine
* Being a resident in pediatric emergency rotation at CHU Sainte-Justine

Exclusion Criteria:

* None

Primary outcomes:
measure: Knowledge of the components of the Ottawa Ankle rule based on a 13 points evaluation
timeFrame: 3-4 weeks after intervention
measure: Knowledge of the components of the Ottawa foot rule based on a 10 points evaluation
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Proportion of perfect knowledge of the Ottawa Ankle and Foot Rules
timeFrame: 3-4 weeks
measure: Score on an exam evaluating management of 20 case scenarios describing patients with an ankle or foot trauma
timeFrame: 3-4 weeks post intervention
measure: Knowledge of the 13 components of the Ottawa Ankle Rule and the 10 components of the Ottawa Foot Rule
timeFrame: 6 months post intervention
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
citation: Gravel J, Roy M, Carriere B. 44-55-66-PM, a mnemonic that improves retention of the Ottawa Ankle and Foot Rules: a randomized controlled trial. Acad Emerg Med. 2010 Aug;17(8):859-64. doi: 10.1111/j.1553-2712.2010.00731.x.
Clinical trial NCT00040053: Ondansetron for the Treatment of Methamphetamine Dependence - 1
Official title: Double-Blind, Placebo-Controlled, Dose Response Trial of Ondansetron for the Treatment of Methamphetamine Dependence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amphetamine-Related Disorders
Keywords: amphetamine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2002-06-18
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess ondansetron for the treatment of methamphetamine dependence.

Detailed description: This study was designed to be a preliminary assessment of the efficacy and safety of 3-wide range doses of ondansetron (0.25, 1.0 and 4.0 mg taken orally twice per day) to reduce methamphetamine use in subjects with methamphetamine dependence and to determine the optimal dose of ondansetron.

Eligibility criteria: Inclusion Criteria:

18 years of age. Treatment seeking for meth dependence.

Exclusion Criteria:

Please contact site director for more details.

Primary outcomes:
measure: Clinicial improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: South Bay Treatment Center
state: California
city: Costa Mesa
country: United States
facility: Matrix Institute on Addictions
state: California
city: Honolulu
country: United States
facility: John A. Burns School of Medicine
state: Hawaii
city: Des Moines
country: United States
facility: Powell Chemical Dependency Center
state: Iowa
city: Kansas City
country: United States
facility: University of Missouri - Kansas City
state: Missouri
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Thomas Newton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01020253: The Effectiveness of Two Osteoporosis Drugs on Prosthetic Bone Mineral Density (BMD) Loss After Total Hip Arthroplasty(THA)
Official title: A Comparison of Alendronate vs. Alfacalcidol Medication for the Preservation of Bone Mineral Density Around the Femoral Implant and in the Lumbar Spine After a Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Density
Arthroplasty, Replacement, Hip
Keywords: bisphosphonate, vitamin D3
Total Hip arthroplasty
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 44
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the hip
* patients after total hip arthroplasty

Exclusion Criteria:

* diseases related to bone metabolism
* patients taking drugs which affect bone metabolism

Primary outcomes:
measure: DEXA QDR 2000, Hologic Co.
timeFrame: 1, 12, 24 and 48 weeks after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Department of orthopaedic surgery, Yokohama City University
state: Kanagawa
Study officials:
References: