louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00962026: Rilonacept in Diabetes Mellitus Type 1: Safety Study
Official title: A Phase I, Open-label, Safety Study of Anti-inflammatory Therapy With Rilonacept in Adolescents and Adults With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Keywords: Interleukin 1
Type 1 diabetes mellitus
Rilonacept
Arcalyst
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-08-19
Enrollment: 13
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to see if an investigational drug called rilonacept is safe to use in patients with type 1 diabetes, and if it can slow the loss of the body's ability to secrete insulin in patients who are still able to make a small amount of insulin.


Eligibility criteria: Inclusion Criteria:

* Within 5 years of diagnosis of type 1 diabetes
* Between the ages of 16 to 45 years
* Have at least one diabetes-related autoantibody present
* Have mean C-peptide level \> 0.2 nmol/L on a mixed meal tolerance test
* Be taking insulin
* Complete written informed consent

Exclusion Criteria:

* Taking inhaled or oral steroids (for example Advair, Orapred)
* Have an active infection
* Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
* Have ongoing use of medications known to affect glucose tolerance
* Have a live vaccine 90 days prior to, or during this study
* Taking any other experimental medication within the past 28 days
* Have prior treatment with rilonacept
* Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
* Pregnant or lactating females
* Males and females unwilling to use an acceptable method of contraception for the duration of the study

Primary outcomes:
measure: Incidence and severity of infection in study participants
timeFrame: 7 months
Secondary outcomes:
measure: Incidence and severity of other adverse effects in study participants
timeFrame: 7 months
measure: Changes in participants' sex steroids (testosterone/estradiol)
timeFrame: 7 months
measure: Changes in participants' HbA1c levels, insulin doses, and beta cell preservation
timeFrame: 7 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Perrin C White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339426: Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection
Official title: Open-Label, Non-Randomized Study to Evaluate Anti-Malarial/Anti-Infective Combination Therapies in Patients With Confirmed COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Lead sponsor: HonorHealth Research Institute
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.

Detailed description: This is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed COVID-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. The first combination to be evaluated is atovaquone/azithromycin. Other combinations may be added to the study at future amendments as information of potential benefit arises. The first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed COVID-19 infection.

Eligibility criteria: Inclusion Criteria:

* Male and Female patients age 18 years or older
* COVID-19 confirmed positive test results
* High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score
* Hematology criteria: ANC \>500 cells/mcl, HGB \>9 g/dl, Platelet count \>75,000/mcl
* Metabolic criteria: Serum creatinine \<2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) \>30 ml/min, AST/ALT \<5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin \<ULN)

Exclusion Criteria:

* COVID-19 negative test result
* Inability to adhere to study protocol requirements
* Inability to provide informed consent
* Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study
* Pregnant and breastfeeding individuals
* QTc interval greater than 470 msecs at baseline
* History of hypersensitivity to atovaquone and/or azithromycin.
* History of known intolerance to atovaquone and/or azithromycin

Primary outcomes:
measure: Virology Cure Rate
timeFrame: 10 days
Secondary outcomes:
measure: Incidence of GI adverse events
timeFrame: 47 days
measure: Cardiac Toxicity
timeFrame: 10 days
Other outcomes:
measure: Changes in WBC w Diff, B cells, T cells, NK cells
timeFrame: 10 days
measure: Changes in cytokine levels, IL-1, IL-6, IL-12, IL-18, TNF-a
timeFrame: 10 days
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
Study officials:
affiliation: HonorHealth Research Institute
name: Michael Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742857: Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
Official title: Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Death
Lead sponsor: Bioquark Inc.
Sponsor class: INDUSTRY
Collaborators: name: Revita Life Sciences
name: Anupam Hospital
First posted: 2016-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).


Eligibility criteria: Inclusion Criteria:

* Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI
* Not willing for organ donation
* Written informed consent from the legally acceptable representative of the patient

Exclusion Criteria:

* Metallic clips/ metal implants or intracranial implants in the brain.
* Pregnancy

Primary outcomes:
measure: Reversal of brain death as noted in clinical examination or EEG
timeFrame: 15 days
Secondary outcomes:
measure: Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation
timeFrame: 15 days
measure: MRI analysis to analyze any changes in meninges
timeFrame: 15 days
measure: Pulse
timeFrame: 15 days
measure: O2 saturation
timeFrame: 15 days
measure: Blood Pressure
timeFrame: 15 days
measure: Respiration changes
timeFrame: 15 days
Other outcomes:
Locations:
city: Rudrapur
country: India
facility: Anupam Hospital
state: Uttaranchal
Study officials:
affiliation: Revita Life Sciences
name: Himanshu Bansal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04269057: Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in HFpEF Patients Treated With ARNI
Official title: Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in Patients With Heart Failure With Preserved Ejection Fraction Treated With ARNI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: NLRP3 protein
human
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: heart failure patients

Brief summary: Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan.

Detailed description: The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials.

Eligibility criteria: Inclusion Criteria:

* left ventricular ejection fraction ≥50%；
* with the symptoms and/or signs of heart failure；
* BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
* at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.

Exclusion Criteria:

* LVEF less than 45% at any time;
* severe infection;
* ACS;
* pregnancy;
* eGFR \<30 mL/min/1.73 m2, etc.

Primary outcomes:
measure: The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: The change from baseline in echocardiographic measures and so on
timeFrame: 12 months
measure: The change from baseline in quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03741257: Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
Official title: Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Obstruction Fluid Management With Hypertonic Saline
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background and Rationale :

Perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation.

Objectives :

* Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate
* The incidence rate of surgical complications; infection and anastomotic dehiscence

Study population \& Sample size :

There were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016).


Eligibility criteria: Inclusion Criteria:

* Age: 20-70 years old
* ASA≤III
* BMI 25-40kg/m.

Exclusion Criteria:

* Severe CVS diseases (EF\<50%)
* Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted)
* Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders.
* Pregnancy.
* Severe chronic renal disease (s. Creatinine\> 2gm/dl or patients on dialysis).
* Severe hepatic impairment (Child \& Pugh classification class C).
* Acid-base and electrolytes disturbances.

Primary outcomes:
measure: Total volume of infused fluids
timeFrame: 24 hours
Secondary outcomes:
measure: surgical complications rate
timeFrame: 4 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
References:
Clinical trial NCT06285357: The Effect of the Association EGCG, Folic Acid and Vitamin B12 in Preventing the Persistence of HPV Infection.
Official title: A Pilot Study to Test the Effect of the Association of Epigallocatechin Gallate (EGCG), Folic Acid and Vitamin B12 in Preventing the Persistence of Human Papilloma Virus (HPV) Infection.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Infection
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the effect of the administration of a dietary supplement consisting of epigallocatechin gallate (EGCG), vitamin B12 and folic acid in the treatment of infections with papilloma virus of the cervix.


Eligibility criteria: Inclusion Criteria:

* HR-HPV DNA test positivity

Exclusion Criteria:

* No HSIL

Primary outcomes:
measure: HPV DNA test negativity
timeFrame: 8 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
Study officials:
References:
Clinical trial NCT00288457: Ureteral Stent Length and Patient Symptoms
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Stones
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones

Brief summary: The Study of whether or not Ureteral Stent Length affects patient comfort after electro-shock wave treatment for kidney stones.

Detailed description: Patients undergoing electro shock wave for treatment of kidney stones are randomized to long or short stent length after signing an informed consent prior to their surgery. They keep a pain diary and medication diary for a two week period after the stent is placed. These are turned in at the two week post-op visit. Patients also complete a quality of life and urinary symptom score questionnaire pre and post operatively.

Eligibility criteria: Inclusion Criteria: Male or female over 18 years of age, will be receiving electro-shock wave therapy for kidney stones -

Exclusion Criteria:Under 18 years of age, inability to give informed consent

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Emory University
name: John G Pattaras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01372657: Intraocular Lens (IOL) Calculation Improvement
Official title: Intraocular Lens (IOL) Formula Calculation Improvement
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract
Keywords: cataract
refraction
iol
calculation
formula
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cataract patients

Brief summary: Intraocular Lens (IOL) formulas sometimes differ from expected. Using novel measurement methods before and after cataract surgery improved formulas are tried be developed.


Eligibility criteria: Inclusion Criteria:

* older 18
* clear cornea
* cataract

Primary outcomes:
measure: postoperative refraction (Diopters)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Augenzentrum Bahnhof Basel
state: Basel-Stadt
Study officials:
affiliation: University Basel
name: David Goldblum, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00205257: Prediction of Acute Rejection in Renal Transplant
Official title: Prediction of Acute Graft Rejection by Examining Urine Chemokines in Patients With Kidney Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Acute rejection is still a major risk factor affecting the prognosis of kidney transplant patients. Alloreactive cells of the recipient infiltrate the kidney graft and cause inflammatory reaction which damages the graft structure and function. Conventional diagnosis of acute rejection is based on clinical symptoms and kidney biopsy examination. The clinical symptoms are a result of the kidney damage, which occurs days after the initiation of the rejection reaction. Kidney biopsy is an invasive and expensive procedure. It has been wished to have new parameters that can replace/supplement the conventional procedures. Chemokines are small molecules that attract inflammatory cells. Changes of chemokine levels in the urine may correlate with the immune status in the kidney. A systematic study to evaluate the chemokine levels in urine and correlation with the kidney biopsy pathology will answer the question whether monitoring of urinary chemokines would be useful in predicting graft rejection/damage.


Eligibility criteria: Inclusion Criteria:

* One hundred subjects undergoing kidney biopsy for suspected rejection
* Forty subjects that have stable graft function with normal level of blood creatinine (No biopsy is needed at the time of sample collection).

Exclusion Criteria:

* Subjects under the age of 18
* Gender of potential subjects male or female
* Age Limits greater than 18 years of age

Primary outcomes:
measure: kidney biopsy pathology
timeFrame: 1 year
Secondary outcomes:
measure: urinary chemokines
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin Medical School
name: Thomas Chin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917226: A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2016-09-28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. For validating the CDSMS for diabetes patients, randomized controlled trial will be conducted.A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p\<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.


Eligibility criteria: Inclusion Criteria:

* Being over age 40
* Volunteer
* Computer and Internet literacy
* DM diagnosed or having at least one of diagnostic criteria.

These criteria;

* HbA1c ≥ 6.5
* FPG ≥ 126 mg / dl
* 2-hour postprandial glucose ≥ 200 mg / dl
* Any time postprandial glucose ≥ 200 mg / dl
* Diabetes symptoms

Exclusion Criteria:

* Having a communication problem
* Type 1 diabetes
* MODY type DM
* Level of psychiatric disorders in psychosis
* Dementia ones

Primary outcomes:
measure: fasting blood glucose
timeFrame: Change from baseline fasting blood glucose at 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kart O, Mevsim V, Kut A, Yurek I, Altin AO, Yilmaz O. A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial. BMC Med Inform Decis Mak. 2017 Nov 29;17(1):154. doi: 10.1186/s12911-017-0558-6.