louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05776420: Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes
Official title: Effect of a Healthy Food Voucher on Blood Glucose Control in People With Type 2 Diabetes or Prediabetes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabete Type 2
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 390
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial (RCT) will determine if access to a voucher for healthy foods reduces blood sugar levels among people living on a low income who have type 2 diabetes or elevated blood sugar.


Eligibility criteria: Inclusion Criteria:

* hemoglobin A1c 6.0 to 11.0
* report food insecurity or financial insecurity

Exclusion Criteria:

* live with a current study participant
* life expectancy \< 6 months
* multiple life-threatening allergies to common foods
* require total parenteral nutrion
* blood dyscrasia that interferes with hemoglobin A1c interpretation
* hemoglobin A1c \>11

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: General health ("In general, how would you rate your health today?")
timeFrame: 6 months
measure: Financial security ("Do you have trouble making ends meet at the end of the month?")
timeFrame: 6 months
measure: Food insecurity measured by 6 questions from Household Food Security Survey
timeFrame: 6 months
measure: Fruit and vegetable consumption
timeFrame: 6 months
measure: Health care utilization using administrative data
timeFrame: 6 months
measure: Carotenoid level
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital Academic Family Health Team
Study officials:
References:
Clinical trial NCT05138120: COMET India Follow-up Trial
Official title: Evaluating an Online Single-session Intervention (COMET) for Indian College Students
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Depressive Symptoms
Anxiety
Happiness
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 0
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: PREVENTION

Brief summary: We are evaluating an online single-session intervention for mental health promotion among Indian college students.


Eligibility criteria: Inclusion Criteria:

* College Student
* Access to internet
* Proficient in English

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 8 weeks post-intervention
measure: Change in Generalized Anxiety Disorder Screener-7 (GAD-7)
timeFrame: Up to 8 weeks post-intervention
measure: Change in the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: Up to 8 weeks post-intervention
Secondary outcomes:
measure: Ratings on the Acceptability of Intervention Measure (AIM)
timeFrame: Immediately after the intervention
measure: Ratings on the Intervention Appropriateness Measure (IAM)
timeFrame: Immediately after the intervention
measure: Mechanisms of Change
timeFrame: Up to 8 weeks post-intervention
measure: Secondary Control
timeFrame: Up to 8 weeks post-intervention
measure: Positive and Negative Affect Schedule
timeFrame: Up to 8 weeks post-intervention
measure: Perceived Stress Scale-4
timeFrame: Up to 8 weeks post-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03660020: Ultrasound Guided Erector Spinae Plane Block in Breast Surgery
Official title: Effect of Hyalorounidase on the Spread of Local Anaesthetics in Erector Spinae Plane Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

Detailed description: two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.

Eligibility criteria: Inclusion Criteria:

1. Female
2. ASA I, II, III
3. Elective surgery

Exclusion Criteria:

1. Patient refusal
2. Infection at injection site
3. Allergy to the given drugs

Primary outcomes:
measure: degree of local anaesthetics spread after injection in both group
timeFrame: 10 minutes after block
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: saeid elsawy
role: STUDY_CHAIR
References:
Clinical trial NCT06352320: Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH）
Official title: Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH Trial): a National Multi-center, Retrospective-prospective, Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiomyopathies
Keywords: Cardiomyopathies
Prognostic factors
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with cardiomyopathy at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.

Brief summary: This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

Detailed description: This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* The diagnosis of cardiomyopathy was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
* Patients or their families agreed to participate in the study and authorized informed consent.

Exclusion Criteria:

* Incomplete clinical data.
* Do not agree to the inclusion or refuse to authorize the informed consent.

Primary outcomes:
measure: Change in the incidence of mortality rate
timeFrame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3, 5, 10 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiantong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03723720: Calculating of Correlations Between ADR, PDR, MAP
Official title: Calculating of Correlations Between ADR, PDR, MAP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Neoplasm
Lead sponsor: Hospital Frydek-Mistek
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 6925
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people over 50 years of age coming for colonoscopic examination

Brief summary: The aim of our study is to compare MAP (mean adenoma per colonoscopy) with ADR (adenoma detection rate) and PDR (polyp detection rate) of all colonoscopists in our department

Detailed description: ADR (adenoma detection rate) is generally accepted quality indicator. For possible gaming with ADR other indicators are needed. MAP (mean adenoma per colonoscopy) reflects the quality of examination of entire colon and is considered to be the most objective quality indicator. The aim of our study is to compare MAP with ADR and PDR (polyp detection rate) of all colonoscopists in our department.

We want to retrospectively assess the quality indicators of all colonoscopies from January 2013 to December 2017. We want to calculate ADR, PDR and MAP of all our endoscopists for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlations between MAP/ADR and MAP/PDR will be performed using Pearson´s correlation coefficient.

Eligibility criteria: Inclusion Criteria:

* people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)

Exclusion Criteria:

* age under 50 years
* indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies

Primary outcomes:
measure: correlation between MAP and ADR for all and screening colonoscopies
timeFrame: january 2013 - december 2017
measure: correlation between MAP and PDR for all and screening colonoscopies
timeFrame: january 2013 - december 2017
measure: correlation between ADR and PDR for all and screening colonoscopies
timeFrame: january 2013 - december 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Frýdek-Místek
country: Czechia
facility: Hospital Frydek-Mistek
Study officials:
affiliation: Doctor
name: Ivana Mikoviny Kajzrlikova
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06039020: ATGAM General Investigation
Official title: ATGAM INTRAVENOUS INFUSION 250mg GENERAL INVESTIGATION
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aplastic Anemia
Keywords: ATGAM;
Anti-human thymocyte immunoglobulin, equine;
Aplastic anemia;
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe aplastic anemia who receive ATGAM

Brief summary: The objective of this study is to confirm the safety of ATGAM in patients with moderate to severe aplastic anemia under the actual use in Japan.

The registration criteria is patients with moderate to severe aplastic anemia who receive ATGAM.

The observation period is 24 weeks (6 months) from the start of administration (Day 1). However, in cases where treatment has been completed or discontinued less than 24 weeks after the start of administration, observation is continued until completion (discontinuation) of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe aplastic anemia who receive ATGAM

Exclusion Criteria:

* No exclusion criteria is set out in this study.

Primary outcomes:
measure: Number of participants with adverse drug reactions (ADRs)
timeFrame: 24 weeks (6 months) from the start of administration (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00051220: Treatment for Specific Phobias in Children
Official title: One-Session Treatment for Specific Phobias in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Phobic Disorders
Anxiety Disorders
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-01-08
Enrollment: 150
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of three treatments in reducing symptoms of phobia in children and adolescents.

Detailed description: Children with specific phobias may experience academic, social, and personal distress, as well as interference in day-to-day activities. One-Session Treatment has been found a rapid and effective treatment for adults with phobic disorders. However, its utility in the treatment of childhood phobia has not been examined.

Participants are randomly assigned to 1 of 3 groups: a one-session treatment group, an education/support group, and a waitlist control group. The one-session treatment group is directly exposed to a phobia object or situation during a 3-hour treatment session. In the education/support group, children are given information about fear and phobias and are taught how to deal with them through workbook activities. Children who participate in the one-session treatment group or the education/support group are assessed 1 week post-treatment and again after 6 months. Participants with improved symptoms have a 1-year follow-up. Participants with phobias that persist at 6 months are encouraged to participate in alternative treatment. Waitlist control participants are assessed pre-treatment and 1 month post-treatment. Those who continue to have phobias at the 1-month assessment are randomly assigned to 1 of the 2 active treatments.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of specific phobia disorder

Exclusion Criteria:

* Mental retardation
* Developmental disabilities
* Suicide threat

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: VA Polytech. Institute and State University
state: Virginia
city: Stockholm
country: Sweden
facility: University of Stockholm
Study officials:
References:
Clinical trial NCT00875420: A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 2, Multi-Center, Dose-Finding Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hot Flashes
Keywords: hot flashes
hot flushes
vasomotor symptoms
postmenopausal
Lead sponsor: Radius Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
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 determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

1. Have documented evidence of a minimum of 7 moderate to severe hot flashes per day, or 50 per week.
2. Be in good general health as determined by medical history, physical examination, and inclusion procedures and is without evidence of any clinically significant abnormalities.
3. Have a normal pelvic assessment with no clinically significant signs on examination and pelvic ultrasound.
4. Have a normal mammogram at the time of study screening.

Exclusion Criteria:

1. A history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, immunologic or metabolic diseases to a degree that would compromise patient safety or interfere with the interpretation of study data. A history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders.
2. A history of active presence of stroke, transient ischemic attack (TIA), heart attack or ischemic heart disease.
3. Unexplained vaginal bleeding within the 3 months prior to study entry.

Primary outcomes:
measure: Percent Change in Frequency of Hot Flashes Over Time
timeFrame: Week 4 minus baseline week
measure: Percent Change in Composite Score Over Time
timeFrame: Week 4 minus baseline week
Secondary outcomes:
measure: Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.
timeFrame: Day 29 minus baseline
measure: Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.
timeFrame: Day 29 minus baseline
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Radius Health, Inc.
state: Massachusetts
Study officials:
affiliation: Radius Health, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Hattersley G, Harris AG, Simon JA, Constantine GD. Clinical investigation of RAD1901, a novel estrogen receptor ligand, for the treatment of postmenopausal vasomotor symptoms: a phase 2 randomized, placebo-controlled, double-blind, dose-ranging, proof-of-concept trial. Menopause. 2017 Jan;24(1):92-99. doi: 10.1097/GME.0000000000000726.
Clinical trial NCT03738020: Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of YVOIRE Classic Versus Restylane in Nasolabial Fold Intradermal Injection
Official title: A Randomized, Multi Center, Single-blind, Active-controlled, Matched Pairs Design Clinical Study to Evaluate the Correction of Wrinkles and Folds and Safety of HA IDF Versus Restylane in Nasolabial Fold Intradermal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporary Correction of Wrinkles
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 58
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: IND approved from KFDA
Primary purpose: TREATMENT

Brief summary: This study was purposed to evaluate the non-inferiority of HA IDF, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold intradermal injection, compared to Restylane, the control preparation.


Eligibility criteria: Inclusion Criteria:

1. Age: Women in 30\~55 years.
2. Those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically and who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent.

Exclusion Criteria:

1. Those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) or those with a history of severe allergy.
2. Patients with a disorder in autoimmune system
3. Those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly
4. Those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study.
5. Those who had underwent a chemical peeling, laser procedure (including IPL) or insertion of other bioadaptive material within 3 months prior to the study (however, those who had been treated with HA filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared).
6. Patients with a malignant tumor
7. Women in pregnancy or lactation
8. Hepatitis carriers or VDRL/HIV positive patients
9. Those with a hypersensitivity to the investigational medical device of this study
10. Other persons including those considered as difficult to perform this study by the principal investigator

Primary outcomes:
measure: Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device
timeFrame: Week 26 (Visit 7)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02592720: Cocktail Injection Improves Outcomes of FFR Guided PCI
Official title: Intracoronary Cocktail Injection Improves Outcomes of Fractional Flow Reserve Guided Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrom (ACS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndromes
Keywords: Acute Coronary Syndromes
Fractional Flow Reserve
Percutaneous Coronary Intervention
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).

Detailed description: This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Eligibility criteria: Inclusion Criteria:

* patients with a clinical diagnosis of recent ACS within 5 days

Exclusion Criteria:

* haemodynamic instability
* intolerance to anti-platelet drugs
* ineligible for coronary revascularization
* a treatment plan for non-coronary heart surgery (e.g. valve surgery)
* a history of prior PCI or CABG
* angiographic evidence of severe (e.g. diffuse calcification) or mild (\<30% severity) coronary disease
* a life expectancy less than 1 year
* adenosine allergy

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 1 year
Secondary outcomes:
measure: left ventricular function
timeFrame: 1 year
measure: Seattle Angina Questionnaire scores
timeFrame: 1 year
measure: Canadian Cardiovascular Society (CCS) Functional Angina classification
timeFrame: 1 year
measure: 6-minute walk distance (6MWD)
timeFrame: 1 year
measure: stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Dongdong Sun, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: