louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01040182: Polymorphism of Estrogen Genes in Stroke
Official title: Polymorphism of Estrogen Genes in Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: ischemic stroke patients
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 300 incident ischemic stroke patients will be recruited in the program project.

Brief summary: The purpose of this study is to explore the association between the genetic polymorphisms of estrogen-related genes, including estrogen synthesis, metabolizing, and receptor genes, and ischemic stroke. Furthermore, independent and joint effects of traditional risk factors and estrogen related genes on risk of stroke in young adults will also be examined in this study.

Detailed description: Cerebrovascular diseases are the third leading cause of death in Taiwan in 2007. It is also the most important reason for disability among elderly adults. Sex hormones are well reported to be associated with cardiovascular disease risk. Several studies showed that estrogens have been shown to have beneficial effects on the cardiovascular system via favorable effects on anti-inflammatory effects. Genetic polymorphisms of estrogen related genes are speculated to influence estrogen level and will count for human susceptible to risk of stroke in young adults. In addition, several studies showed that the decrease in estrogen-induced vascular inflammatory markers including adhesion molecules and chemokines might be the mechanism for vascular protection. Recently, a novel and unique mechanisms for 17β-Estradiol (E2) anti-inflammatory activity which is E2 prevents inflammatory gene transcription induced by inflammatory agents by inhibiting NF-κB intracellular transport was found. Therefore, we proposed a study to explore the association between the genetic polymorphisms of estrogen-related genes, including estrogen synthesis, metabolizing, receptor genes, and NF-κB and ischemic stroke in young adults.

Eligibility criteria: Inclusion Criteria:

* incident ischemic stroke patients diagnosed by CT or MRI.

Exclusion Criteria:

* non ischemic stroke patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hung-Yi Chiou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06002282: HPV Vaccine Confident Families
Official title: HPV Vaccine Confident Families
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Human Papillomavirus Vaccines
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-08-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objectives of the study are to pilot test a tailored intervention among Black families with adolescents. The hypotheses are that the study protocol will be feasible and messages tailored to parents' needs will increase vaccine confidence and intention to vaccinate.


Eligibility criteria: Inclusion Criteria:

* parent or legal guardian of at least one child aged 9-13 years who has received 0 or 1 dose of HPV vaccine;
* identify as Black or African American adult;
* have access to personal mobile phone and agree to send/receive MMS messages;
* able to speak and understand English; and
* able to provide informed consent to participate

Exclusion Criteria:

* parent or legal guardian of child outside of participation age range or who has completed multiple doses of HPV vaccine;
* does not identify as Black or African American adult;
* does not have personal mobile phone;
* unable to speak and understand English;
* not willing to consent to participate

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: After enrollment completion, 6 months
measure: Feasibility - Retention
timeFrame: Post intervention completion, 1 year
measure: Feasibility - Intervention Delivery
timeFrame: Two weeks after intervention begins
measure: Feasibility - Intervention response
timeFrame: Two weeks after intervention completion
measure: Feasibility - Intervention utility
timeFrame: Two weeks after intervention completion
Secondary outcomes:
measure: Vaccine Intention
timeFrame: Immediately post-intervention (6 months)
measure: Vaccine Confidence
timeFrame: Immediately post-intervention (6 months)
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers
name: Racquel Kohler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06329882: Doxycycline in Type II Diabetes
Official title: Doxycycline in Combination With Sitagliptin on the Glycemic and Cardiac Indices in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disease characterized by hyperglycemia, weight loss, and cardio-metabolic complications. T2DM develops due to the progression of insulin resistance (IR), impairment of insulin insensitivity, and failure of the pancreatic β-cells to release sufficient amount of insulin in response to glucose burden


Eligibility criteria: Inclusion Criteria:

* Male or female sex more than 40 years old Newly diagnosed type II diabetes. HbA1c more than 6.5

Exclusion Criteria:

* Patient with chronic kidney disease, hepatic disorders, mental and psychiatric disorders, pregnancy, and lactation

Primary outcomes:
measure: Change in glycemic profile
timeFrame: 3 months
measure: Change in glycemic profile
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT05193682: Right Ventricular Dysfunction in Septic Shock Patients in ICU
Official title: Evaluation Of Right Ventricular Function In Septic Shock Patients In Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic shock patients

Brief summary: Assesment of right ventricular dysfunction in septic shock patients in intensive care unit.

Detailed description: Over the last decade, a few studies have highlighted the crucial role of right ventricular (RV) function in hemodynamic and respiratory diseases in critical care 1,2. However, RV failure is difficult to define in the critical care setting. A recent consensual definition proposed by different groups of experts characterizes RV failure as the association of a significant RV dilatation associated with systemic congestion 3-5. This definition is mainly physiologically based, not strictly validated, and the experts did not propose any threshold for RV size or congestion using critical care echocardiography (CCE) and central venous pressure (CVP), respectively.

Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with septic shock.
2. Patients will be evaluated within 24 h after diagnosis.

Exclusion Criteria:

1. Patients diagnosed more than 24 hours.
2. Patients with associated ischemic heart failure .

Primary outcomes:
measure: Right ventricular dysfunction in septic shock patients in intensive care unit
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00002082: Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
Official title: Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryptosporidiosis
HIV Infections
Keywords: Cryptosporidiosis
Acquired Immunodeficiency Syndrome
Azithromycin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine.
* Antidiarrheal medication with imodium or paregoric only.

Patients must have:

* HIV infection.
* Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions prior to study enrollment.
* Life expectancy of at least 2 weeks by clinical assessment. In states where the legal age of consent for medical procedures is 21 years, patients below the age of 21 must have consent of parent or guardian.

Prior Medication:

Allowed:

* Zidovudine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Marked abnormalities of liver or renal function.
* Causes for diarrhea other than, or in addition to, cryptosporidiosis.
* Inability to receive oral medication.

Concurrent Medication:

Excluded:

* Cancer chemotherapy (including therapy for Kaposi's sarcoma).
* Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin, somatostatin) with possible anticryptosporidial activity.
* Immunostimulant or lymphocyte replacement therapy.

Prior Medication:

Excluded:

* Another investigational drug within 7 days prior to study enrollment (investigational medications available through a treatment IND will be allowed with the approval of the sponsor, the treatment IND sponsor, and the Pfizer clinical monitor).
* Immunostimulant or lymphocyte replacement therapy.
* Cancer chemotherapy (including therapy for Kaposi's sarcoma).

Not expected to comply with the requirements of the protocol, in the opinion of the investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Infectious Disease Med Group
state: California
city: San Diego
country: United States
facility: UCSD Med Ctr
state: California
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: Memphis
country: United States
facility: Univ of Tennessee
state: Tennessee
Study officials:
References:
Clinical trial NCT02947620: Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type II Diabetes
Dyslipidemia
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-10-28
Enrollment: 185
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Subjects with Dyslipidemia and Type II Diabetes
* 19 years later, men and women under the age of 80

Exclusion Criteria:

* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
* Subject with type I Diabetes
* Subject with hypertension which does not controlled by treatment(have blood pressure \> 180/110mmHg)

Primary outcomes:
measure: Change in HbA1c
timeFrame: Change from baseline at 16 weeks
measure: Change in LDL Cholesterol
timeFrame: Change from baseline at 16 weeks
Secondary outcomes:
measure: Change in LDL-C
timeFrame: Baseline and 16 weeks
measure: Change in HbA1c
timeFrame: Baseline and 16 weeks
measure: Percentage of subjects reaching the LDL-C treatment goal defined by the NCEP ATP III guideline (<100mg/dL) after 16 weeks of treatment with investigational products
timeFrame: 16 weeks
measure: Percentage of subjects reaching HbA1c <7.0% and <6.5% after 16 weeks of treatment with investigational products
timeFrame: 16 weeks
measure: Change in LDL-C and the associated rate of change after 4, 8, and 12 weeks of treatment with investigational products compared to baseline
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks
measure: Change in LDL-C after 16 weeks, relative to baseline, in subjects treated with investigational products
timeFrame: Baseline and 16 weeks
measure: Change in lipid variables and the associated rate of change
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
measure: Change in average fasting plasma glucose (FPG) after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
measure: Change in Insulin, HOMA-β, HOMA-IR after 4, 8, 12, and 16 weeks of treatment with investigational products compared to baseline.
timeFrame: Baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01801020: Different Modes of Temperature Measurement in the Emergency Department
Official title: Different Modes of Temperature Measurement in the Emergency Department
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Sepsis
Keywords: temperature
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: Temperature measurement is a crucial and integral element in the assessment of the emergency department patients. The basis of triage and treatment is often directly influenced by temperature measurement. The finding of hyper/hypothermia may differentiate between a simple urinary tract infection and pyelonephritis, or in more extreme cases may discern "weakness" in the elderly from sepsis. This brief encounter of temperature measurement may be paramount to the medical treatment of the emergency department patient. The investigators will explore the different modes of temperature measurements in emergency department patients.

Detailed description: Temperature measurement is a crucial and integral element in the assessment of the emergency department patients. The basis of triage and treatment is often directly influenced by temperature measurement. The finding of hyper/hypothermia may differentiate between a simple urinary tract infection and pyelonephritis, or in more extreme cases may discern "weakness" in the elderly from sepsis. This brief encounter of temperature measurement may be paramount to the medical treatment of the emergency department patient.We will explore the different modes of temperature measurements in emergency department patients. We will check which temperature measurement is beneficial.

Eligibility criteria: Inclusion Criteria:

* patients who arrive to the emergency department

Exclusion Criteria:

* patients who refuse

Primary outcomes:
measure: Different modes of temperature measurement in the emergency department
timeFrame: Three years
Secondary outcomes:
measure: Different modes of temperature measurement in the emergency department
timeFrame: three years
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center Emergency Department
Study officials:
affiliation: HaEmek Medical Center - Afula, Israel 18101
name: Batshev Tzadok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04053920: Resistance Exercise Training at Different Intensities
Official title: Resistance Exercise Training at Different Intensities in Healthy and Frail Older People: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Frailty
Aging
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study, therefore, is to determine the feasibility of recruitment and adherence to resistance exercise training interventions performed at low and high loads, to volitional muscular failure, in a trial population that includes both healthy and frail older people.


Eligibility criteria: Inclusion Criteria:

* Over age of 65 years

Exclusion Criteria:

* Current participation in an exercise programme
* Exercise deemed unsafe by clinical team

Primary outcomes:
measure: Muscle strength
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Vastus lateralis muscle thickness
timeFrame: Change from baseline to 8 weeks
measure: Muscle strength
timeFrame: Change from baseline to 8 weeks
measure: One-repetition maximum
timeFrame: Change from baseline to 8 weeks
measure: Biomechanics during walking and stair climbing
timeFrame: Change from baseline to 8 weeks
measure: Short performance physical battery test
timeFrame: Change from baseline to 8 weeks
measure: Quality of life measure
timeFrame: Change from baseline to 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: GRI Clinical Research Facility
Study officials:
affiliation: University of Glasgow
name: Stuart Gray
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417320: Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
Official title: Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nephrotic Syndrome in Children
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:

1. Proteinuria
2. Renal survival indices

Detailed description: This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.

Eligibility criteria: Inclusion Criteria:

* Age between 10 and 18 years old,
* Nephrotic resistant patients,
* No history of diabetes,
* Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
* Caregivers' acceptance to be enrolled in the study.

Exclusion Criteria:

* Uncontrolled urinary tract infection at screening,
* Blood pressure is less than 5th percentile of the same gender, age, height,
* At risk of dehydration or volume depletion,
* Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase \>2 times the upper limit of normal during screening,
* History of organ transplantation, cancer, liver disease,
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

Primary outcomes:
measure: Protein free period, eGFR
timeFrame: 12 weeks following end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Children's Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University-Faculty of Medicine-Pediatric
name: Ahmed El Refaey, MBBCh,MSc,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05715320: Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double Blind, Parallel-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate-to-severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-08
Enrollment: 160
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: This study is a multi-center, randomized, double-blind, parallel controlled phase 2 study, aimed at evaluating the efficacy and safety of CM310 in the treatment of patients with moderate-to-severe atopic dermatitis, and observing Pharmacokinetics characteristics, Pharmacodynamics effects and immunogenicity.

Detailed description: This study includes screening, treatment and follow-up periods. 160 subjects will be enrolled to receive CM310.

Eligibility criteria: Inclusion Criteria:

* Have the ability to understand the study and voluntarily sign a written ICF.
* Age ≥ 18 and ≤ 75 years old, male or female.
* The fertile subjects agreed to take effective contraceptive measures throughout the study period.
* The subjects can communicate well with the investigators and complete the follow-up according to the protocol.

Exclusion Criteria:

* Live vaccine or attenuated live vaccine has been vaccinated or planned to be vaccinated within 12 weeks before randomization.
* He received allergen-specific immunotherapy (desensitization therapy) within 6 months before randomization.
* Major surgery is planned during the study period.
* Previous history of atopic keratoconjunctivitis and corneal involvement.
* Other combined skin diseases that may affect the evaluation of the study.
* Confronting IL-4R α Monoclonal antibody or CM310/placebo drug or ingredient allergy.

Primary outcomes:
measure: Proportion of subjects achieving EASI-75
timeFrame: up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References: