louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06664125: Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Official title: A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hyperphosphatemia
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-10-29
Enrollment: 50
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: A Phase 2a, Multicenter, Randomized, Open-label, Active Drug-controlled Trial to Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Detailed description: Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia

Eligibility criteria: Inclusion Criteria:

1. Able to understand the procedures of this trial and provide written informed consent voluntarily;
2. Age ≥ 18 years, male or female;
3. On a stable hemodialysis regimen at a frequency of two or three times per week for at least 12 weeks prior to the screening visit;
4. Serum phosphorus within the trial-required range.

Exclusion Criteria:

1. Any history of inflammatory bowel disease or diarrheal irritable bowel syndrome;
2. Pregnant or breastfeeding;
3. Any history of a parathyroid intervention;
4. Diarrhea or loose stools occurred within 1 week prior to randomization.

Primary outcomes:
measure: To preliminarily evaluate the efficacy of JMKX003002 in decreasing serum phosphorus of ESRD patients on hemodialysis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00877825: The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Official title: The Influence of Soy Isoflavnoids on the Hypocholesterolemic Effects of Soy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
Cardiovascular Diseases
Keywords: Diet Therapy
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2009-04-08
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Isoflavonoids, through their estrogen-like activity, are in part responsible for the cholesterol lowering properties of soy foods. If this is found to be so, then it would be advantageous not only to promote soy consumption, but also to identify and use soy cultivars with high isoflavonoid content in production of soy food products. These foods may have a use in the reduction of serum cholesterol and if they effectively increase the phytoestrogen activity of soy, may have a role in the prevention of other hormone dependent diseases (e.g. osteoporosis, certain cancers) in the same way as natural estrogens.


Eligibility criteria: Inclusion Criteria:

* men and post-menopausal women
* LDL-C \> 4.1mmol/L at recruitment
* living within a 40 km radius of St. Michael's Hospital

Exclusion Criteria:

* lipid lowering medications
* clinical or biochemical evidence of diabetes, renal or hepatic disease
* body mass index (BMI) \>38 kg/m2
* antibiotic use within the last three months
* hormone replacement therapy
* smoking or significant alcohol use (\>1 drink/d)
* triglyceride level \> 4.0mmol/L

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto and St. Michael's Hospital
name: David JA Jenkins, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong JM, Kendall CW, Marchie A, Liu Z, Vidgen E, Holmes C, Jackson CJ, Josse RG, Pencharz PB, Rao AV, Vuksan V, Singer W, Jenkins DJ. Equol status and blood lipid profile in hyperlipidemia after consumption of diets containing soy foods. Am J Clin Nutr. 2012 Mar;95(3):564-71. doi: 10.3945/ajcn.111.017418. Epub 2012 Feb 1.
Clinical trial NCT01516125: Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
Official title: Screening of Healthy Adults for Genetic Variations That Control Fatty Acid Processing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: healthy adult
genetic variation
botanical oils
polyunsaturated fatty acid
fish oil
fat metabolism
Genetic variation of fat metabolism in healthy adults
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Office of Dietary Supplements (ODS)
name: University of Arizona
First posted: 2012-01-24
Enrollment: 458
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian or African American adults between 21 and 65 years of age

Brief summary: The purpose of this research study is to screen healthy African American and Caucasian persons for specific differences in genes that control how fats are processed in the body.

Detailed description: Healthy African American and Caucasian persons will be screened for specific differences in genes that control how fats are processed in the body. Persons with the needed genotypes will be added to a database of healthy persons who may be asked to join a larger study comparing differences in diet on lipid metabolism and inflammatory biomarkers as well as future studies. A key hypothesis for the larger study is that variations in genes involved in lipid metabolism play a role in determining levels of long chain polyunsaturated fatty acids (LC-PUFAs).

Eligibility criteria: Inclusion Criteria:

* Be Caucasian or African American between 21-65 years of age
* Be healthy and free of any major illness
* Be a nonsmoker
* Have an intact gallbladder
* Have TG \< 150 and blood pressure less than 130/90
* Must be willing to be re-contacted for future studies

Exclusion Criteria:

* Not have: myocardial infarction, vascular surgery or stroke within the past year
* Not be taking niacin, more than 100 mg aspirin/day or montelukast allergy medications
* BMI equal to or greater than 30 or less than 19
* Fasting glucose greater than 125 mg/dl
* Pregnancy

Primary outcomes:
measure: Determine the genotype at the rs174537 single-nucleotide polymorphism (SNP) in the fatty acid desaturate (FADS) gene cluster
timeFrame: up to 52 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Heath Sciences
name: Susan Sergeant, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02092025: Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
Official title: Azilsartan Tablets Special Drug Use Surveillance: Long-term Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-03-19
Enrollment: 3437
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertension

Brief summary: The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in patients with hypertension in a routine clinical setting.

Detailed description: This surveillance was designed to evaluate the safety and efficacy of long-term use of azilsartan tablets (Azilva Tablets) in hypertensive patients in daily medical practice.

The usual dosage for adult is 20 mg of azilsartan administered orally once daily. The dose can be adjusted according to the patient's age and condition. The maximum daily dose is 40 mg.

Eligibility criteria: Inclusion Criteria:

* Hypertensive patients

Exclusion Criteria:

1. Patients with a history of hypersensitivity to any of the ingredients of Azilsartan
2. Patients who are pregnant or having possibilities of being pregnant

Primary outcomes:
measure: Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point
timeFrame: Baseline, Month 1 and final assessment (up to 12 Months)
measure: Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point
timeFrame: Baseline, Month 1 and Final assessment (up to 12 Months)
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06924125: Spanish Natural History Study for LAMA2 Muscular Dystrophy
Official title: Spanish Natural History Study for LAMA2 Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: LAMA2-MD (Merosin Deficient Congenital Muscular Dystrophy, MDC1A)
Merosin Deficient CMD (Full or Partial)
Merosin Deficient Congenital Muscular Dystrophy
Muscular Dystrophies
Cohort Studies
Keywords: Merosin
LAMA2
Laminin
Dystrophy
natural history
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: ASOCIACIÓN IMPÚLSATE PARA LA CURA DE LOS NIÑOS CON DÉFICIT DE MEROSINA
First posted: 2025-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with compatible clinical presentation and genetical confirmation LAMA2-RD

Brief summary: The objective of this natural history study is to comprehensively characterize the disease progression and clinical features of LAMA2-related dystrophies (LAMA2-RD) in the pediatric population. The study aims to establish a well-defined cohort of patients in Spain, enabling long-term follow-up and facilitating recruitment for future clinical trials.


Eligibility criteria: Inclusion Criteria:

* All patients with compatible clinical presentation and identification of 2 pathogenic variants in LAMA2, or muscle biopsy with decreased laminin alpha2 protein and at least one pathogenic variant
* Signed informed consent by the Legal Authority Responsible and/or assent by the subject (starting from 6 years old)

Primary outcomes:
measure: Change in Motor function Measurement (MFM32) score
timeFrame: Change from baseline through study completion, an average of 5 years
measure: Change in Motor Milestones
timeFrame: Change from baseline through study completion, an average of 5 years
measure: Change in Muscle Echogenicity by Muscle Ultrasound
timeFrame: Change from baseline through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
Clinical trial NCT06176430: Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy
Official title: Comparison of Twice Weekly Versus Daily Iron Therapy in Treating Anemia in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cerebral Palsy
Iron Deficiency Anemia
Keywords: cerebral palsy, anemia
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a randomized clinical trial to compare the effect of twice weekly versus daily iron therapy in treating anemia in children with cerebral palsy, to be conducted at Department of pediatric medicine children's hospital PIMS islamabad.

Detailed description: a total of 160 children of either gender with age between 6 and 60 months diagnosed with cerebral palsy and concomitant iron deficiency anemia will be enrolled, they will be allocated two groups by lottery method. one group will be given ferrous sulphate 3mg/kg daily in the form of syrup and other group will be given ferrous sulphate 3mg/kg twice weekly in the form of syrup for a period of 4 weeks. the primary outcome will be measured as rise in hemoglobin levels more than or equal to 1g/dl at 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. All the children with cerebral palsy who are diagnosed cases of iron deficiency anaemia
2. Age 06 months to 5 years
3. Both genders

Exclusion Criteria:

1. \>5 years of age
2. Children with severe anaemia requiring transfusion (Hb\<5 g/L)
3. Children with history of taking oral/IV iron supplements or repeated blood transfusions during last one month
4. Children with concomitant diarrheal disease
5. Where parents are not willing to participate in the study

Primary outcomes:
measure: Change in Hemoglobin levels from baseline
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean change in MCV (Mean Corpuscular Volume)
timeFrame: 4 weeks
measure: Mean change in mean corpuscular hemoglobin concentration (MCHC)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Yusra Kafait, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00849030: ATAC - Arimidex, Tamoxifen Alone or in Combination
Official title: A Randomised, Double Blind Trial Comparing Arimidex Alone With Nolvadex Alone With Arimidex and Nolvadex in Combination, as Adjuvant Treatment in Post-Menopausal Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 9358
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test whether Arimidex alone or in combination with Tamoxifen is beneficial in the treatment of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven operable invasive breast cancer
* Patients who have completed all primary surgery and chemotherapy (if given), and are candidates to receive hormonal adjuvant therapy
* Women defined as post-menopausal

Exclusion Criteria:

* Patients in whom there is any clinical evidence of metastatic disease
* Patients who, for whatever reason (e.g. confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
* Patients whose chemotherapy was started more than 8 weeks (ie 56 days) after completion of primary surgery or whose chemotherapy was completed more than 8 weeks (ie 56 days) before starting randomised treatment

Primary outcomes:
measure: Time to recurrence of breast cancer
timeFrame: Earliest of local or distant recurrence, new primary breast cancer, or death
measure: Safety and side effects
timeFrame: Earliest of local or distant recurrence, new primary breast cancer, or death
Secondary outcomes:
measure: Time to distant recurrence
timeFrame: Earliest of local or distant recurrence, new primary breast cancer, or death
measure: Survival
timeFrame: Earliest of local or distant recurrence, new primary breast cancer, or death
measure: New breast primaries
timeFrame: Earliest of local or distant recurrence, new primary breast cancer, or death
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03755648: Effect of Delorme Resistance Exercises Versus Treadmill Training in Cerebral Palsy
Official title: Effect of Delorme Resistance Exercises Versus Treadmill Training on Locomotor Abilities in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Delorme resistance exercises
treadmill training
locomotor abilities
tendon of achilles lengthening
Lead sponsor: Ghurki Trust and Teaching Hospital
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cerebral palsy is one of the most important source of disability among children and its incidence is almost 3.6 in thousand live births.Children with Cerebral Palsy presents with ambulatory difficulties.The current study highlights the effect of treadmill training as compared to DeLorme resistance exercises on locomotor activities in cerebral palsy child.The present study would add to the clinical knowledge of physical therapists by promoting the implementation of treadmill training and DeLorme resistance exercises for this prevalent pediatric neurodevelopmental disorder. The study would decrease the burden of disease among community and enhance the social participation of cerebral palsy children. This in turn would improve the quality of living of these disabling diseased children.


Eligibility criteria: Inclusion Criteria:

* Children with Gross Motor Functional Scale Level II and III
* Ability to understand commands and directions
* Diplegic type of cerebral palsy
* Children who had undergone bilateral Tendon of Achilles Lengthening procedure 3 to 6 months post-operatively

Exclusion Criteria:

* Children presenting with other types of Cerebral Palsy
* Children with audiovisual impairment that can hinder the treatment
* leg length discrepancy greater than 2 cm,
* Fixed contractures, joint instability and associated cardiovascular condition.

Primary outcomes:
measure: Locomotor ability
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Samreen Sadiq
state: Punjab
Study officials:
affiliation: Lahore Medical and Dental college
name: Hafiz Asim, DPT (USA)
role: STUDY_CHAIR
References:
Clinical trial NCT06210230: Double-blind and Placebo-controlled Study on Intervention Effect of Medium and Long Chain Fatty Acid Triglyceride on Glycolipid Homeostasis in Patients With Metabolic Syndrome and Mechanisms
Official title: Double-blind and Placebo-controlled Study on Intervention Effect of Medium and Long Chain Fatty Acid Triglyceride on Glycolipid Homeostasis in Patients With Metabolic Syndrome and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
MLCT
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms


Eligibility criteria: Inclusion Criteria:

* Diagnosed metabolic syndrome according to IDF diagnostic criteria;
* Rarely eating out of home;
* Aged between 40 and 70 years.

Exclusion Criteria:

* Breastfeeding or pregnancy;
* History of heart disease, coronary heart disease, stroke, cerebral infarction, viral liver disease (hepatitis A, hepatitis B, etc.), chronic kidney disease (GFR\<60 ml/min) or cancer;
* Diabetic ketoacidosis or hyperketosis;
* Drug use has changed in the past six months;
* Taking insulin;
* Used MLCT edible oil in the past six months;
* Have participated in other clinical trials in the last three months.

Primary outcomes:
measure: Change in blood glucose from baseline
timeFrame: 6 months
measure: Change in blood lipids from baseline
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Lanxi Traditional Chinese Medicine Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT06596330: Integration of a Trained Language Model to Improve Glycemic Control Through Increased Physical Activity: a Fully Digital My Heart Counts Smartphone App Randomized Trial
Official title: Integration of a Trained Language Model to Improve Glycemic Control Through Increased Physical Activity: a Fully Digital My Heart Counts Smartphone App Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type2diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes (T2D) is one of the most common and fastest growing diseases, affecting 1 in 8 adults (nearly 800 million) worldwide by 2045. Sedentary behavior and increased adiposity are major risk factors for T2D. Cardiovascular disease is the leading cause of death in those with T2D, while diabetic microvascular disease, causing kidney disease, neuropathy, and retinopathy, contributes to T2D morbidity.

Physical activity is one of the most potent therapies in preventing/treating T2D and its complications. Mean daily steps is a proxy for physical activity, with even modest improvements in step count (i.e., +500 steps) associated with decreased T2D and mortality. However, adherence to regular physical activity remains low in T2D patients, with short-term decreases in daily step count associated with impaired glycemic control and T2D recurrence.

The investigators have developed an artificial intelligence (AI) language model (similar to ChatGPT), which can automatically generate coaching prompts to encourage physical activity by incorporating an individual's stage of change. The investigators will extend our research using the My Heart Counts (MHC) smartphone app to 1) validate the efficacy of the AI-generated prompts in patients with T2D and 2) perform a longer-term randomized crossover trial using the language model as a social accountability chatbot - encouraging participants to maintain their physical activity changes over months. The investigators hypothesize that my AI-assisted coaching prompts will significantly increase 1) mean daily step count by 500 steps in 1,000 adults recruited nationwide over a 7-day period, and 2) improve HbA1c and weight via long-term behavior change over a 24-week intervention period.


Eligibility criteria: Inclusion Criteria:

* Individuals aged ≥18 years old, with a clinical diagnosis of T2D, able to read and understand English, and who are physically able to walk, will be included in our study

Exclusion Criteria:

* Criteria that fall outside of the inclusion criteria.

Primary outcomes:
measure: Mean daily steps
timeFrame: 7 days and 24 weeks
Secondary outcomes:
measure: Change in weight
timeFrame: 24 Weeks
measure: Change in HbA1c
timeFrame: 24 Weeks
measure: Weekly Active Minutes
timeFrame: 7 days and 24 Weeks
Other outcomes:
Locations:
Study officials:
References: