louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00678522: The Acute Effect of Atorvastain on Renal Function in Patients With Type II Diabetes
Official title: The Acute Effect of Atorvastatin on Renal Sodium Excretion, Glomerular Filtration Rate, Tubular Function and Vasoactive Hormones in Patients With Non-Insulin Dependent Type II Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Keywords: Atorvastatin
Renal function
Hemodynamics
Diabetes type II
sodium excretion
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
Collaborators: name: Medical Research
First posted: 2008-05-15
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients with type II diabetes, not in treatment with insulin.


Eligibility criteria: Inclusion Criteria:

1. Age: 40-70 yrs
2. estimated GFR between 30 and 90 ml/min
3. BMI\<35
4. Fertile women had to use oral contraceptives or IUD
5. HbA1c\< 10%
6. Urine-albumin\<1,5 g/l

Exclusion Criteria:

1. Treatment with insulin
2. Cerobrovascular insult or other disease of the brain
3. Insufficiency of the heart or lungs
4. Liverdisease with ALAT \> 200 U/L
5. hemoglobin \< 7,0 mmol/l
6. Cancer
7. Alcohol abuse
8. Medical treatment with psycopharmaca or/and analgetics
9. Pregnancy and breast feeding, 10 blood donation one month before the study.

Primary outcomes:
measure: GFR, clearance of sodium and lithium, fractional excretion of sodium and lithium, U-AQP-2, total sodium excretion, albumin excretion rate and free water clearance.
timeFrame: 6 months
Secondary outcomes:
measure: AVP, Ang-II, Aldo, ANP, BNP, PRC, BP, HR.
timeFrame: 6 months
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medical Reseach, Holstebro Hospital
city: Holstebro
country: Denmark
facility: Department of Medical Research, Holstebro Hospital
Study officials:
affiliation: Dept. of medical reaserch, Holstebro Hospital, Denmark
name: Erling B. Pedersen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921622: Vitamin Deficiency and Blood Pressure in Hospitalized Jewish General Hospital (JGH) Patients
Official title: Vitamin Deficiency and Blood Pressure in Hospitalized JGH Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitamin C Deficiency
Vitamin D Deficiency
Keywords: Blood pressure
Vitamin C
Vitamin D
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: vitamin C compared with vitamin D in prospective clinical trial
Primary purpose: TREATMENT

Brief summary: There is suggestive evidence that vitamin C and vitamin D deficiency may increase blood pressure across the range of blood pressures from normal to elevated. Information about this relationship is inadequate in part because of the rarity of individuals with subclinical vitamin C and D deficiency. The investigators have observed subnormal to deficient plasma vitamin C and 25-hydroxyvitamin D levels in a large proportion of patients under active treatment in the investigators' hospital. The clinical implications of widespread hypovitaminosis C and D are unknown. In this randomized prospective comparison trial the investigators will measure vitamin levels and blood pressure in clinically stable acutely hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital for at least 7 more days. The investigators will examine for an inverse relationship between baseline vitamin level and blood pressure across the range of blood pressures. Consenting patients will be randomized to receive vitamin C (500 mg twice daily) or vitamin D (1000 IU twice daily) for as long as 10 days. Blood pressure will be re-measured every 2 days and vitamin levels re-measured on the last study day. Treatment courses of at least 5 days will be considered sufficient for analysis. The hypothesis is that either treatment will reduce blood pressure in patients whose baseline systolic blood pressure is 110 or more; the investigators will also examine whether the reduction in blood pressure with treatment is proportional to the increase in the circulating vitamin level with treatment.


Eligibility criteria: Inclusion Criteria:

* Competent to grant informed consent
* Anticipated to remain in hospital at least 7 days after enrollment

Exclusion Criteria:

* End-stage renal disease on renal replacement therapy
* Critical illness
* Judged unstable clinical status at the time of enrollment

Primary outcomes:
measure: blood pressure
timeFrame: every 2 days for up to 10 days
Secondary outcomes:
measure: plasma vitamin levels: monitoring variable
timeFrame: at beginning and end of treatment course
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
citation: Gan R, Eintracht S, Hoffer LJ. Vitamin C deficiency in a university teaching hospital. J Am Coll Nutr. 2008 Jun;27(3):428-33. doi: 10.1080/07315724.2008.10719721.
Clinical trial NCT03849625: Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
Official title: Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspirin Sensitivity
Aspirin-exacerbated Respiratory Disease
Aspirin-Induced Angioedema-Urticaria
Aspirin Allergy
NSAID-Induced Asthma
NSAID-Induced Angioedema-Urticaria
NSAID-Induced Anaphylactoid Reaction
Aspirin-Induced Anaphylactoid Reaction
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 158
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at least 15 years of age with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs

Brief summary: Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand


Eligibility criteria: Inclusion Criteria:

* Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Results of skin test/provocation test
timeFrame: 4 years
Secondary outcomes:
measure: Phenotypes of allergic reactions
timeFrame: 4 years
measure: Urine leukotriene E4
timeFrame: 4 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klaewsongkram J, Buranapraditkun S, Mongkolpathumrat P, Palapinyo S, Chantaphakul H. Clinical Characteristics, Urinary Leukotriene E4 Levels, and Aspirin Desensitization Results in Patients With NSAID-Induced Blended Reactions. Allergy Asthma Immunol Res. 2021 Mar;13(2):229-244. doi: 10.4168/aair.2021.13.2.229.
Clinical trial NCT03078725: Failure Rate of GLyburide And Metformin Among Gestational Diabetics
Official title: Failure Rate of GLyburide And Metformin Among Gestational Diabetics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gestational Diabetes Mellitus, Class A2
Keywords: gestational diabetes
glyburide
metformin
failure rate
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized to two groups, one receiving glyburide and one receiving metformin.
Primary purpose: TREATMENT

Brief summary: A pragmatic, comparative effectiveness trial of glyburide versus metformin.

Detailed description: Patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. Dose increases will be determined by the patient's physician. Patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.

Eligibility criteria: Inclusion Criteria:

We will include women between 20 and 34 weeks gestational age, with a diagnosis of GDM as per the following criteria:

* 1 hour Glucose tolerance test of \>130 mg/dl, followed by two abnormal values on 3 hour Glucose tolerance test, or:
* A single 1 hour Glucose tolerance test value of \> 200 mg/dl, and:
* Failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria

Exclusion Criteria:

* - Known renal impairment.
* Known hepatic disease.
* Pre-gestational diabetes.
* Known allergy to glyburide, metformin or sulfa drugs.

Primary outcomes:
measure: Failure rate
timeFrame: from onset of oral therapy until delivery
Secondary outcomes:
measure: Mean overall plasma glucose
timeFrame: from enrollment to delivery
measure: Mean weekly fasting glucose
timeFrame: from enrollment to delivery
measure: preeclampsia
timeFrame: from enrollment to delivery
measure: cesarean section
timeFrame: from enrollment to delivery
measure: neonatal hypoglycemia
timeFrame: from enrollment to delivery
measure: LGA infant
timeFrame: from enrollment to delivery
measure: birthweight > 4500 grams
timeFrame: from enrollment to deliveryfrom enrollment to delivery
measure: gestational age at birth
timeFrame: from enrollment to delivery
measure: incidence of medication side effects
timeFrame: from enrollment to delivery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06605625: Vaccine Responses in Cancer
Official title: Vaccine Responses in Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Viral Vaccines
Keywords: influenza
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 250
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: Patients with cancer who are clinically indicated to receive influenza, recombinant shingles (Shingrix) and/or SARS-CoV-2 vaccine

Brief summary: The investigators are conducting a prospective unblinded study of individuals diagnosed with cancer who will receive one or more of the following: influenza, SARS-CoV2 and shingles.

Detailed description: Vaccinations are indicated for all adults, but the immunogenicity of vaccination has not been assessed in all situations. In particular, immune responses following vaccination have not been studied in the setting of cancer and in the context of various anti-tumor treatments. In this study, the investigators will look at the immune response of subjects receiving vaccination.

Eligibility criteria: Inclusion Criteria:

* adults over age 18 who are able to provide consent, who have a diagnosis of cancer, and are willing to receive the influenza, recombinant shingles, and/or SARS-CoV-2 vaccines.

Exclusion Criteria:

* allergic to influenza, shingles, and/or SARS-CoV-2 vaccination; have HIV infection; have a history of solid organ or bone marrow transplant.

Primary outcomes:
measure: Neutralizing antibody response
timeFrame: 45-90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Univeristy of Pennsylvania
name: E. John Wherry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06674525: Evaluation of 626 in Healthy Adult Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects (HS)
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.

Detailed description: Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.

Eligibility criteria: Inclusion Criteria:

* Able to understand protocol requirements and sign a written ICF.
* Male or female subjects aged 18-45 years when signing the ICF.
* Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m2.
* Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
* Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.

Exclusion Criteria:

* History of severe allergy, or with a history of allergy to the study treatment or related excipients.
* With any clinically significant diseases prior to the screening visit.
* Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
* History of of significant alcohol abuse.
* History of significant drug abuse.
* Subjects who have positive result for urine nicotine test at screening.
* Pregnant, or nursing females.

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: 90 days
Secondary outcomes:
measure: Cmax
timeFrame: 90 days
measure: Tmax
timeFrame: 90 days
measure: AUC0-last
timeFrame: 90 days
measure: Incidence of Anti-Drug Antibody
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
References:
Clinical trial NCT01217125: Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis
Official title: CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angiomyolipoma
Keywords: tuberousclerosis, angiomyolipoma, rapamycin
Lead sponsor: Fundacio Puigvert
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Spain
First posted: 2010-10-08
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
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 determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.


Eligibility criteria: Inclusion Criteria:

Diagnosis of tuberousclerosis Angiomyolipoma \>2cm age\>10 years

Exclusion Criteria:

Creatinine \>4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit\<27% Thrombocytopenia (\<100.000/mm3) Leukopenia (\<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(\>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides

Primary outcomes:
measure: Angiomyolipoma volume
timeFrame: 2 years
Secondary outcomes:
measure: skin lesions, AML complications,
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Fundacio Puigvert, Barcelona
name: Roser Torra, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabrera-Lopez C, Marti T, Catala V, Torres F, Mateu S, Ballarin J, Torra R. Assessing the effectiveness of rapamycin on angiomyolipoma in tuberous sclerosis: a two years trial. Orphanet J Rare Dis. 2012 Nov 11;7:87. doi: 10.1186/1750-1172-7-87.
Clinical trial NCT06827925: Telemedicine Wounds
Official title: Exploring the Effectiveness of Flipped Education in Distance Digital Learning for Long-term Care Nurses on Pressure Injury Staging Interpretation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pressure Injury
Keywords: Long-term care
nurse
Telemedicine
pressure injury
staging Interpretation
Lead sponsor: Asia University
Sponsor class: OTHER
Collaborators: name: Hualien Tzu Chi General Hospital
First posted: 2025-02-14
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to explore the effectiveness of the flipped education model applied to distance digital learning in enhancing the pressure injury staging interpretation skills of long-term care nursing staff. A quasi-experimental design was employed, dividing participants into a flipped education group and a conventional digital learning group. Pre- and post-intervention assessments were conducted to evaluate knowledge and skills, and differences in satisfaction and cognitive load were compared.


Eligibility criteria: Inclusion Criteria:

* Home care worker
* Those who have access to a smartphone and the Internet
* After the purpose of the study was explained, they agreed to participate in the study and signed the consent form.

Exclusion Criteria:

* Business managers or administrative managers who do not actually provide frontline care at the patient's home.

Primary outcomes:
measure: Pressure injury staging interpretation test
timeFrame: One month before intervention， and one month after intervention
Secondary outcomes:
measure: Satisfaction with teaching mode
timeFrame: One month before intervention， and one month after intervention
measure: Cognitive load of learning
timeFrame: One month before intervention， and one month after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University
Study officials:
References:
Clinical trial NCT01724125: An Electronic Personal Health Record for Mental Health Consumers
Official title: An Electronic Personal Health Record for Mental Health Consumers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Comorbid Conditions
Keywords: serious mental illness
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-11-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by shifting the ownership and locus of health records from being scattered across multiple providers to an approach that is longitudinal and patient-centered. Given the complex health needs and the fragmentation of care for persons with serious mental illnesses, these individuals could derive particular benefit from a PHR. However, there are currently no established PHRs developed for use in this population.

In order to fill this gap, the investigators propose to develop, test, and disseminate a Personal Health Record for persons with serious mental illnesses and one or more comorbid medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health record which was developed in partnership with medical consumers and is in wide use in a number of communities in the United States and abroad.


Eligibility criteria: Inclusion Criteria:

1. Currently in treatment at the CMHC.
2. Serious Mental Illness: based on or chart review;
3. One or more Chronic Medical Condition as ascertained via administrative records.

Primary outcomes:
measure: Quality of Care
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health Systems
state: Georgia
Study officials:
affiliation: Emory University
name: Benjamin Druss, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854425: L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Official title: Phase II Study of L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 efficacy and tolerability of L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma

Detailed description: The prognosis of patients with progressive and recurrent NK/T cell lymphoma is poor partially due to lack of effective treatment. L-asparaginase was reported to be effective in this setting by several case reports. The investigators aim to evaluate the efficacy and toxicity of L-asparaginase monotherapy in a prospective phase II study.

Eligibility criteria: Inclusion Criteria:

* Age range 18-75 years old
* Histological confirmed NK/T cell lymphoma with progressive or recurrent disease
* ECOG performance status 0-2
* Life expectancy of more than 3 months
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Primary outcomes:
measure: Response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Progression-free survival and overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References: