louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01189279: Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alopecia
Alopecia, Androgenetic
Baldness
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.


Eligibility criteria: Inclusion Criteria:

* Males with moderate male-pattern baldness (androgenic alopecia)
* Females with moderate female pattern hair loss
* Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products

Exclusion Criteria:

* Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
* Use of bimatoprost or other prostaglandin analogs within 3 months
* Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
* Any prior hair growth procedures (eg, hair transplant or laser)
* Blood donation or equivalent blood loss within 90 days
* History of alcohol or drug addiction

Primary outcomes:
measure: Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
timeFrame: Day 1
measure: Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
timeFrame: 17 Days
Secondary outcomes:
measure: Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: 17 Days
measure: Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
timeFrame: Baseline, 20 Days
measure: Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
timeFrame: Baseline, 20 Days
Other outcomes:
Locations:
city: Tempe
country: United States
state: Arizona
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00953979: Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis
Official title: A Clinical Trial About the Efficacy and Safety of Kunxian Capsule in Treatment Patients With Early Ankylosing Spondylitis: a 12-week, Multi-center, Randomized, Double-blind, Active Drug and Placebo Compared Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Treatment
Keywords: ankylosing spondylitis
treatment
Sulfasalazine
kunxian capsule
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: China-Japan Friendship Hospital
name: Dongguan People's Hospital
name: Zhujiang Hospital
name: Huashan Hospital
First posted: 2009-08-06
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled study to evaluated the efficacy and safety of kunxian capsule in treating of patients with early ankylosing spondylitis (AS). The major outcome index is proportion of patients achieving ASAS20 response at week12, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. The adverse events at any time were recorded to evaluate the safety.


Eligibility criteria: Inclusion Criteria:

* 16 to 65 years old, having signed the informed consent;
* fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
* BASDAI score more than 4;
* stop taking DMARDs for at least 4 weeks;
* NSAIDs dosage has been stable for at least 4 weeks;

Exclusion Criteria:

* Intra-articular injection of cortisone within 3 months.
* History of heart failure, multiple sclerosis, COPD, lymphoma or other tumors;
* Accompanied by fibromyalgia or other rheumatic diseases;
* Female of pregnancy or breast feeding;
* History of mental disease and poor compliance.
* History of drug abuse or alcoholism.

Primary outcomes:
measure: proportion of patients achieving ASAS20 response
timeFrame: 12th week
Secondary outcomes:
measure: proportion of patients achieving BASDAI20/50/70 response
timeFrame: 12th week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Rheumatology Department, Third Affiliated Hospital of Sun Yat-sen University
name: Jieruo Gu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Q, Li L, Bi L, Xiao C, Lin Z, Cao S, Liao Z, Gu J. Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial. Trials. 2016 Jul 22;17(1):337. doi: 10.1186/s13063-016-1438-6.
Clinical trial NCT05888779: Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition
Official title: Beverages for Thought: Exploring the Relationship Between Blood Glucose and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Healthy Weight
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2023-06-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to conduct novel research on the relationship between blood sugar and cognition.

Detailed description: This study is an acute parallel study design with one intervention visit needed per participant. There are 2 groups and 80 participants will be randomized into each group. Following the consent process, participants in each group will be seated individually in quiet rooms, with written instructions, several magazines, and a mini-fridge with beverages containing 110-120 kcals/8 fl oz. Participants will be provided instructions for the study, stating, "The study we are conducting explores the relationship between blood glucose and cognitive abilities. After consuming food or drink, your body regulates your blood glucose. Physical exertion can also affect blood glucose. Therefore, we ask that you relax in this space for 10-15 minutes. You can read the provided magazines during this time. Drinking a beverage will bring your body's blood glucose into the right phase for our questionnaires. In the fridge are some beverages, and we ask that you drink something."

After 10-15 minutes, participants will be given a cognitive test (a questionnaire on paper) and asked to complete as much of it as they can within 5 minutes. Then, moving to a separate area, weight and height measurements will be taken.

Eligibility criteria: Inclusion Criteria:

* No food allergies or food intolerances
* Healthy (no chronic disease) as determined by online questionnaire
* Non-pregnant and non-lactating
* Not currently dieting or planning to follow a special diet
* Minimal restricted eating practices

Exclusion Criteria:

* Pregnant or lactating
* Currently dieting or planning to follow a special diet

Primary outcomes:
measure: Written cognitive task results from novel cognitive assessment questionnaire.
timeFrame: 10 minutes post beverage ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Julie Hess, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06420479: The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality
Official title: The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Cardiovascular Diseases
Morality
Keywords: bariatric surgery
Cardiovascular Diseases
Mortality
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of individuals eligible for bariatric surgery in Sweden

Brief summary: The association between weight, and cardiovascular disease and mortality is well established, however, the causal effect of weight-loss in midlife on these outcomes is less clear. Bariatric surgery results in substantial weight-loss and is an ideal candidate to study the causal effects of weight-loss. The investigators propose a project that will use causal inference and machine learning methods to answer two important questions:

1. Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
2. Which type of bariatric surgery (gastric bypass or sleeve gastrectomy) is most effective, and for who? The investigators will use data from various Swedish registers to identify individuals with obesity who are eligible for bariatric surgery. We will then compare cardiovascular and mortality outcomes among those undergoing different types of bariatric surgery with those receiving non-surgical obesity management using causal inference methods. The investigators will use causal forests and expert knowledge to estimate indiviual treatment effects, and identify the groups of patients who benefit the most from these surgeries.


Eligibility criteria: Inclusion Criteria:

* Men and women of reproductive age with a diagnosis of obesity, no prior history of cardiovascular disease or cancer, and no contraindications for surgery after 1982

Exclusion Criteria:

* Contraindications to bariatric surgery

Primary outcomes:
measure: Cardiovascular disease
timeFrame: 20 year
Secondary outcomes:
measure: Death from any cause
timeFrame: 20 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
Clinical trial NCT02283879: Human Umbilical Cord Mesenchymal Stem Cell in Cerebral Hemorrhage Sequela
Official title: Human Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Cerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cerebral Hemorrhage
Keywords: Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Cerebral hemorrhage
Lead sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD
Sponsor class: INDUSTRY
Collaborators: name: Fifth Affiliated Hospital of Guangzhou Medical University
First posted: 2014-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for cerebral hemorrhage sequela.

Detailed description: Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into neural cells, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of cerebral hemorrhage.

To investigate the effects of hUC-MSC treatment for cerebral hemorrhage sequela, 20 patients with cerebral hemorrhage will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility criteria: Inclusion Criteria:

* Aged 40-70 intracerebral hemorrhage patient
* With stroke history of more than 3 months, less than 60 months
* National Institutes of Health stroke scale(NIHSS) score of 7 or more points
* Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \<7 mg, and normal urea/electrolytes for at least 48 hours.)

Exclusion Criteria:

* History of neurological disease, head injury or psychiatric disorder;
* Pregnant women;
* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
* Progressive apoplexy;
* With malignant tumors.

Primary outcomes:
measure: Safety evaluation through vital signs, the results of clinical lab tests and adverse events (AEs)
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of infarct size measured by brain MRI
timeFrame: before the transplant and 1, 6, 12 months after transplantation
measure: Modified Barthel index
timeFrame: before and 1, 3, 6 and 12 months after transplantation
measure: National Institutes of Health stroke scale(NIHSS) score
timeFrame: before the transplant and after the transplant 1, 2 and 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital Immunotherapy center
state: Guangdong
Study officials:
affiliation: Fifth Affiliated Hospital of Guangzhou Medical University
name: Ping J Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05862779: Effects of Omega-3 and Whey Protein Supplementation on Lean Mass in Older Adults
Official title: Effects of Omega-3 and Whey Protein Supplementation on Lean Mass and Strength Gains in Older Adults Performing Resistance Exercise: A Randomized, Double-Blind and Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 80
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of omega-3 supplementation combined with whey protein intake on lean mass and strength gains in older adults performing resistance exercise. Participants will be randomized into the 4 groups. The placebo group will receive 4 g per day of corn oil and 40 g per day of maltodextrin. The omega 3 + placebo group will receive 4 g per day of fish oil and 40 g per day of maltodextrin. The whey protein + placebo group will receive 40g per day of whey and 4g per day of corn oil. The omega 3 + whey group will receive 4g per day of fish oil and 40g per day of protein. All will perform the same exercise protocol for 12 weeks


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women (at least 1 year of menstrual interruption, self-reported);
* To be able to practice strength exercises;
* To be able to carry out supplementation;
* Do not present physical, orthopedic or cardiovascular complications that prevent the performance of physical exercises;
* No history of stroke or acute myocardial infarction;
* Not being a smoker and/or alcoholic;
* Do not perform hormone replacement therapy;
* Do not use anti-inflammatory drugs;
* To have normal kidney function;
* To submit a medical certificate of health that proves that the individual is able to perform exercises.

Exclusion Criteria:

* Do not provide the necessary information for the development of the study;
* Individuals with diseases previously diagnosed and undergoing treatment, such as type II diabetes mellitus, cancer, rheumatoid arthritis, high blood pressure, dyslipidemia, cardiovascular, and kidney and/or liver diseases.

Primary outcomes:
measure: Changes in lean mass (kg) using ultrasound and electrical bioimpedance in postmenopausal women
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Changes in strength (kg) using dynamometer in postmenopausal women
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Federal University of Uberlandia
state: Minas Gerais
Study officials:
References:
Clinical trial NCT03643679: Tobacco Cessation for Sexual Minorities
Official title: Tobacco Cessation for Sexual Minorities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is a growing body of evidence revealing disproportionately higher rates of tobacco use among sexual and gender minority (SGM) individuals, compared to their heterosexual peers. These disparities have led organizations to support the inclusion of SGM in all local, state, and national tobacco prevention and control activities. In an attempt to leverage the online milieu for health-related interventions, mobile apps have been created to support tobacco cessation. However, evidence-based apps promoted by the National Cancer Institute are unpopular, remain poorly supported, and were not studied for use by SGM persons. Commercial apps, on the other hand, have been downloaded millions of times, contain many valuable features, and enjoy better infrastructure. Unfortunately, they are not evidence-based and have not been rigorously tested.

The University of Pittsburgh (Pitt) is currently conducting a randomized controlled trial to assess the feasibility and efficacy of using the Kwit tobacco cessation app with patients at UPMC Montefiore and Presbyterian hospitals (PI: Chu). It is a pragmatic clinical trial applying a patient-centered outcomes framework to ensure that-rather than focusing only on successful cessation-the study includes measurements for quality of life, mobility, and social interactions. We propose to extend the study to underrepresented SGM young adults.

Survey measures will be adapted as needed to address issues specific to the SGM population.


Eligibility criteria: Inclusion Criteria:

* Age 18-30
* Self-identified as a sexual minority (gay, lesbian, bisexual)
* Smokers interested in cessation (\>1 cigarettes/day over the past 30 days)
* Must own an Apple or Android based smartphone.

Exclusion Criteria:

* Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation

Primary outcomes:
measure: Helpfulness, frequency of use, and ease of use of the intervention smartphone app
timeFrame: 1-month and 3-month
Secondary outcomes:
measure: Cessation (self-report)
timeFrame: 1-month and 3-month
measure: Cessation (bio-chemical)
timeFrame: 1-month and 3-month
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kar-Hai Chu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04444479: Insertion of PICC With Intracavitary ECG Navigation
Official title: PICC Insertion With the Use of IC ECG Navigation to Confirm the PICC Tip Location Compare to Chest X-ray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long-term Venous Access
Keywords: peripherally inserted central catheter
ECG navigation
chest x-ray
PICC tip navigation
catheter tip location
intracavitary ECG
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study subjects enrolled in the study will be assigned to one study group. No randomization is performed.
Primary purpose: OTHER

Brief summary: The study subjects who are indicated for peripherally inserted central (PICC) catheter placement will undergo this procedure under the control of ECG, the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Detailed description: The study subjects who are indicated for PICC catheter placement will undergo this procedure under the control of electrocardiography (ECG), the correct position of the PICC catheter tip will be subsequently verified X-ray imaging.

Conducting this study should allow us to see the feasibility of using real-time ECG navigation, its accuracy comparing to the chest X-ray method. ´ The second goal is to eliminate chest X-ray as an obsolete method, Also the advantages and disadvantages of both methods will be assessed.

Eligibility criteria: Inclusion Criteria:

* indication for establishing long-term venous access
* 18 years of age and over

Exclusion Criteria:

* oncological patients
* non-signing the informed consent form

Primary outcomes:
measure: Time interval between ECG and X-ray
timeFrame: 2 hours
Secondary outcomes:
measure: Success-rate of correct PICC tip location
timeFrame: 2 hours
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Iveta Constantine, Bc.,MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pittiruti M, La Greca A, Scoppettuolo G. The electrocardiographic method for positioning the tip of central venous catheters. J Vasc Access. 2011 Oct-Dec;12(4):280-91. doi: 10.5301/JVA.2011.8381.
citation: Bidgood C. Improving the patient experience with real-time PICC placement confirmation. Br J Nurs. 2016 May 26-Jun 8;25(10):539-43. doi: 10.12968/bjon.2016.25.10.539.
citation: Johnston AJ, Holder A, Bishop SM, See TC, Streater CT. Evaluation of the Sherlock 3CG Tip Confirmation System on peripherally inserted central catheter malposition rates. Anaesthesia. 2014 Dec;69(12):1322-30. doi: 10.1111/anae.12785. Epub 2014 Jul 10.