louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00691665: Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Official title: A Double-masked, Randomized, Parallel Group, Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: Rhinitis
Seasonal Allergic Rhinitis
allergies
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis


Eligibility criteria: Inclusion:

* A history of spring/summer seasonal allergies.
* Positive skin prick test for the currently prevalent allergen of the area.
* Confirmed absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination prior to administration of test article.
* For pre-menopausal females, a negative pregnancy test prior to entry into the study, and, if sexually active, agreement to use adequate birth control methods throughout the study.

Exclusion:

* History of chronic sinusitis.
* Asthma, with the exception of intermittent asthma.
* Smokers.
* Known non-responders to antihistamines.
* Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or dermal potent or super-potent topical corticosteroids.
* Chronic use of long acting antihistamines.
* Upper or lower respiratory infection within 14 days of Visit 1. Diagnosis of acute sinusitis within 30 days of Visit 1.
* Relatives of study site staff or other individuals who had access to the clinical study protocol.
* Participation in any other investigational study within 30 days before entry into this study or concomitantly with this study.

Primary outcomes:
measure: Mean Percent Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
timeFrame: 14 Days minus baseline
measure: Mean Percent Change in Instantaneous Total Nasal Symptom Score (iTNSS) From Baseline
timeFrame: 14 days minus baseline
measure: Mean Percent Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
timeFrame: 14 Days minus baseline
measure: Mean Percent Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
timeFrame: 14 Days minus baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento, CA
state: California
Study officials:
References:
Clinical trial NCT01269840: Comparison of Two Radial Head Implants
Official title: Comparison of Monopolar In-Growth and Loose Bipolar Radial Head Implants in the Treatment of Irreparable Radial Head Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Head Fractures
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Rush University
name: North Shore University Hospital
First posted: 2011-01-04
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering radial head fractures, with or without other elbow injuries, requiring radial head replacement

Brief summary: In severe injuries of the radial head with multiple, displaced fracture fragments and concomitant ligament damage, excision of the fragments and replacement of the radial head with a metallic implant are indicated. Current radial head implants are composed of metal or a combination of metal and high molecular weight polyethylene. The prostheses are assembled intra-operatively as a solid unit (monopolar) or as an articulating implant with motion between the stem and head (bi-polar). The stem of the implant is inserted into the proximal radius for support and can be classified as either loose-fitting or fixed. According to the investigators, there are no studies that directly compare the clinical and radiographic outcomes between different radial head implant designs. The purpose of this retrospective study is to compare the clinical and radiographic results in patients treated for an irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a monopolar, in-growth radial head implant. The study findings may provide useful clinical information regarding the similarities and differences in these two implant designs.

Detailed description: Data has been completed.

Eligibility criteria: Inclusion Criteria:

* Suffered radial head fracture requiring radial head replacement with the Katalyst or Acumed Radial Head Implant from 2002-2009

Exclusion Criteria:

* Unwilling to provide informed consent
* Traumatic brain injury that occurred at the time of elbow fracture

Primary outcomes:
measure: Disability of Arm, Shoulder, and Hand (DASH)
timeFrame: 1 clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University/Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University/Midwest Orthopaedics at Rush
state: Illinois
city: Evanston
country: United States
facility: North Shore University Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: John Berschback, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00212940: Supportive Therapy for Adherence to ART(STAART)
Official title: Increasing Patient Adherence to HIV Medications: A Prospective Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Treatment Naive
HIV
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ontario HIV Treatment Network
First posted: 2005-09-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether a psycho-educational intervention can help people living with HIV handle the changes of treatment adherence.

Detailed description: Participants will be randomly assigned to one of two study groups:

* Group 1: participants in this group will engage in weekly psycho-educational sessions with an HIV therapist for four weeks prior to starting their regimens. The sessions will cover topics such as becoming active in treatment care, improving coping abilities and developing skills for treatment adherence. They will also involve questionnaires and readings.
* Group 2 (the control group):participants in this group will simply receive their regular treatment regimens.

Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age
* have viral load above 500 copies/ml
* not be currently on HAART
* be able to read and speak English/French

Exclusion Criteria:

* current Substance Abuse
* actively psychotic or suicidal

Primary outcomes:
measure: psycho-educational intervention can help people living with HIV handle the changes of treatment adherence
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: OHRI
name: William Cameron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03573440: The Effects of Mindful Eating Education on Increasing Satiety Signals
Official title: The Effects of Mindful Eating Education on Increasing Satiety Signals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this graduate student research study is to is to examine the effects of mindful eating education on increasing satiety signals.

Reasons for conducting the study: Add to the body of knowledge on the science of mindful eating.

Detailed description: The procedures include:

Visit 1:

* The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion, sign an informed consent form, sign in, and provide an email address and phone number.
* After the initial briefing, the subject will be asked to eat their meal with an investigator present.
* The subject will inform the investigator verbally when they are feeling full.
* After the subject decides to end their meal, the subject will be asked to fill out a questionnaire and be reminded to bring the same meal the following week.

Visit 2:

* The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion with the same meal as the previous week.
* After receiving a brief education session, the subject will be asked to eat their meal with an investigator present.
* The subject must inform the investigator verbally when they are feeling full.
* After the subject has decided to end their meal, they will be asked to fill out a questionnaire and be reminded to meet the investigator at the same time the following week.

Visit 3:

* The subject will be asked to meet the student investigators at the Loma Linda Student Pavilion.
* The subject will be asked to complete a follow-up survey on the study.

Eligibility criteria: Inclusion Criteria:

* currently enrolled at Loma Linda University
* pack or purchase their own lunch on a regular basis (willingness bring/buy the same lunch the following week)
* have a 1 hour or less lunch period.

Exclusion Criteria:

* skip breakfast
* have exercised within 2 hours of their lunch time
* smoke nicotine or marijuana
* have the condition of Type 1 or Type 2 diabetes
* have newly prescribed medications 2 weeks prior to testing.

Primary outcomes:
measure: Change in satiety
timeFrame: change from baseline to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University
name: Georgia Hodgkin, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05215665: GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
Official title: Efficacy, Safety Evaluation and Biomarker Screening of GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholangiocarcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years old ≤ age ≤ 70 years old
* ECOG PS scores 0-1
* Expected survival time \> 12 weeks
* Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria)
* Not received any previous systemic or local treatment for the tumor
* Sufficient organ and bone marrow function

Exclusion Criteria:

* Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ)
* Ampullary tumor
* Received treatment from other clinical trials within 4 weeks before the first dose
* Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy
* Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction
* Uncontrollable pleural effusion, pericardial effusion or ascites
* Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment
* Allergic reactions to the drugs used in this study
* HIV antibody positive, active hepatitis B or C (HBV, HCV)
* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
* other conditions that the investigator deems inappropriate for enrollment

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: up to 90 days after last treatment administration
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: up to 90 days after last treatment administration
measure: Progression free survival (PFS)
timeFrame: up to 3 years
measure: Overall survival (OS)
timeFrame: up to 3 years
measure: The frequency, duration, and severity of adverse events
timeFrame: up to 30 days after last treatment administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT01697865: Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction
Official title: Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Shoulder
Keywords: Reverse total shoulder
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to compare the clinical benefit and safety of two different surgical techniques of primary reverse total shoulder arthroplasty for the treatment of shoulder pseudoparalysis from chronic rotator cuff disease with associated teres minor dysfunction. The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group) and the second technique does not include a concomitant latissimus and teres major transfer (control group).


Eligibility criteria: Inclusion Criteria:

* Shoulder pseudoparalysis due to chronic rotator cuff dysfunction with or without glenohumeral arthritis.
* Chronic rotator cuff tear with severe retraction, atrophy, fatty infiltration.
* Active forward elevation of less than 90 degrees
* Teres minor dysfunction
* Positive lag and hornblower sign
* Grade 2 or greater fatty infiltration of the teres minor and infraspinatous seen on MRI
* Able to attend scheduled office visits
* Meet all criteria to have a latissimus and teres major transfer

Exclusion Criteria:

* Revision arthroplasty
* Previous shoulder infection
* Neuro-muscular disorder (ie: Parkinson's)
* Advanced dementia

Primary outcomes:
measure: ADLER Score
timeFrame: 2 Year
Secondary outcomes:
measure: DASH Score
timeFrame: 1 Year, 2 Year
measure: ASES score
timeFrame: 1 Year, 2 Year
measure: SF-12 Score
timeFrame: 1 Year, 2 Year
measure: Range of Motion
timeFrame: 1 Year, 2 Year
measure: X-Ray Measurements
timeFrame: 1 Year, 2 Year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
Study officials:
References:
Clinical trial NCT05522465: Short-course High-dose Prednisone and Dexamethasone in Children With ITP
Official title: Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Immune Thrombocytopenia
Glucocorticoids
Child, Only
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Xiamen University
name: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Quanzhou First Hospital
name: Nanping First Hospital Affiliated to Fujian Medical University
name: The Second Hospital of Anhui Medical University
name: The Affiliated Hospital Of Guizhou Medical University
name: Longyan City First Hospital
name: The Affiliated Hospital of Putian University
First posted: 2022-08-31
Enrollment: 608
Sex: ALL
Minimum age (years): 29
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)


Eligibility criteria: Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

1. Meet the ITP diagnostic criteria, within 3 months of the first diagnosis
2. Age \> 28 days and ≤ 14 years old
3. Untreated PLT\<20×109/L, or PLT\<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment
4. Have signed the informed consent

Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:

1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.)
2. Received glucocorticoid therapy within 6 months
3. Menstrual female children
4. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
5. Patients who have received radiotherapy and chemotherapy
6. There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.)
7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results

Primary outcomes:
measure: initial treatment response
timeFrame: 30 days after treatment
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 1 month
Other outcomes:
Locations:
city: Fujian
country: China
facility: Children with newly dignosed ITP
state: Fujian
Study officials:
References:
Clinical trial NCT03373565: Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
Official title: Snuff-box Deep Palmar Arch Artery Versus Radial Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 200
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: Angiography is a common diagnostic and therapeutic procedure in patients with acute coronary syndrome (ACS). The complications are variable between mild self-limited complications to severe life-threatening complications which need early interventions.

New angiographic methods are associated with variable complications. Death, myocardial infarction, and stroke are among major angiography complications. In addition, some local complications including bleeding at the site of insertion, infection, arteriovenous fistula, pseudoaneurysm, and thrombosis is reported after angiography.

Radial and femoral methods are common angiographic methods. Its shown that radial method is associated with less complications and patients need shorter duration of hospitalization.

Radial artery thrombosis is common complication of radial angiography. However, the prevalence is between 5 to 19 percent but often it is not clinically important. Risk of ischemia due to thrombosis is low because of blood flow in radial and ulnar and collaterals. In patients with incomplete palmar arch this is important and may cause ischemia.

The aim of this study is to compare the outcomes of coronary angiography using Snuff-box deep palmar arch artery and radial artery in patients attending angiography center of Shahid Mohammadi hospital in Bandar Abbas in 2017.


Eligibility criteria: Inclusion Criteria:

* indication of coronary artery angiography confirmed by a cardiologist
* Accepting to sign the written informed consent

Exclusion Criteria:

* No follow up visit after one-month period

Primary outcomes:
measure: Thrombosis
timeFrame: 1 months
Secondary outcomes:
measure: Infection
timeFrame: 1 months
measure: Pain
timeFrame: 1 months
measure: Numbness
timeFrame: 1 months
measure: Loss of movement
timeFrame: 1 months
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences
state: Hormozgan
Study officials:
References: