louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05842811: An Observational Study of Patients With Metabolic Syndrome and Related Conditions
Official title: An Observational Study of Patients With Metabolic Syndrome and Related Conditions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metabolic Syndrome
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 2000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adults with metabolic syndrome and related conditions.

Brief summary: TARGET-METABOLIC is an observational research study to conduct a comprehensive review of outcomes for patients with metabolic syndrome and related conditions.


Eligibility criteria: Disease Cohort

Inclusion Criteria:

- Adult patients at the time of enrollment with a diagnosis of metabolic syndrome or related conditions by ICD-10 code or with clinically calculated BMI ≥ 30 in the EHR/health system interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Engaged Cohort

Inclusion Criteria:

* Adult patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Primary outcomes:
measure: To characterize the natural history of disease in patients with metabolic syndrome and related conditions
timeFrame: 15 Years
measure: To assess safety and effectiveness of treatments for metabolic syndrome and related conditions.
timeFrame: 15 Years
Secondary outcomes:
measure: To evaluate provider management practices in the treatment of patients with metabolic syndrome and related conditions
timeFrame: 15 Years
measure: To evaluate longitudinal and patient reported outcomes in patients with metabolic syndrome and related conditions
timeFrame: 15 Years
measure: To select and evaluate quality of care measures for patients with metabolic syndrome and related conditions
timeFrame: 15 Years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01382511: Simvastatin Treatment of Pachyonychia Congenita
Official title: Simvastatin Treatment of Pachyonychia Congenita
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pachyonychia Congenita
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-06-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Simvastatin and related statins, such as compactin, are able to inhibit the constitutive expression of inducible/repressible keratin genes such as K6a and K17. This effect is due to the reported ability of statins to inhibit STAT1 expression (Lee et al., 2007). The constitutive K6a promoter activity is dependent on STAT1 and blocked by simvastatin or siRNA against STAT1. This STAT1-dependent constitutive expression of K6a, is independent of JAK (Janus family of kinases).

Thus simvastatin is capable of down-regulating both the constitutive and interferon-inducible expression of PC-related keratins such as K6a and K17. Therefore, this class of molecule has potential for the treatment of PC or related inherited disorders where the causative mutation resides in an inducible/repressible keratin gene such as K6a or K17.

Simvastatin or other statins approved for human use might be delivered either orally, as is currently the case for cholesterol-lowering treatment or, if higher therapeutic doses are required in skin for reduction of hyperkeratosis in PC or in related keratinizing disorders, this might be achieved by topical formulations.


Eligibility criteria: Inclusion Criteria:

* Patients with pachyonychia congenita with known mutations in keratin 6a. -

Exclusion Criteria:

* The use of concomitant medications known to interact with simvastatin.
* This would include itraconazole, ketoconazole, fluconazole, gemfibrozil, verapamil, diltiazem, mibefradil, erythromycin, clarithromycin, telithromycin, cyclosporine, ritonavir, nefazodone, danazol, amiodarone, Rifampin, and carbamazepine.
* During the study subjects must agree to avoid grapefruit juice.
* Also excluded are patients with a past history of myopathy, or impaired liver function.

Primary outcomes:
measure: Assessment of decreased hyperkeratosis
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00180011: Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Official title: Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Keywords: omalizumab
severe asthma
moderate asthma
injectable asthma medication
Xolair
Lead sponsor: DiMango, Emily, M.D.
Sponsor class: INDIV
Collaborators: name: Genentech, Inc.
name: Novartis
First posted: 2005-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with moderate to severe asthma who are not adequately controlled with use of inhaled or oral steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over the 12 week treatment period.


Eligibility criteria: Inclusion Criteria:

* Age 18-30
* Minority Patients
* Moderate or Severe allergic asthma (as defined by the National Asthma Education and Prevention Guidelines(7)\]. Allergic asthma will be defined as elevated IgE level (\> 100 IU/ml) and skin test sensitivity to at least one common aeroallergen
* asthma control score greater than 1.5 (5) at randomization visit with use of equivalent of at least 1000 mcg fluticasone daily or systemic steroid use
* FEV1 50-90% predicted at screening and randomization visit

Exclusion Criteria:

* Active smoking within one year and/or greater than 10-pack year history of smoking
* Women of childbearing age must be using effective contraception
* Malignancy diagnosed within the past 5 years
* Underlying lung disease other than asthma
* Inability to comply with study protocol

Primary outcomes:
measure: Asthma symptom utility index
timeFrame: 6 months
Secondary outcomes:
measure: Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Emily DiMango, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06765811: Rapid Kidney Function Decline in Older Adults
Official title: Identification of Rapid Kidney Function Decline in Older Adults with Different Types of Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Function Decline
Glomerular Filtration Rate
Urine Albumin-creatinine Ratio
Healthy Aging
Comorbidity
Chronic Kidney Disease
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 1539
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: kidney disease patient

Brief summary: This observational study investigates whether a single set of GFR and urine albumin-to-creatinine ratio (ACR) thresholds can accurately screen for rapid kidney function decline in different elderly groups.


Eligibility criteria: Inclusion Criteria:

1. Age greater than 70 years;
2. GFR data measured at least twice (two years apart) and ACR data measured once (at baseline);
3. A clear record of the cause of the previous visit; from this, people diagnosed with kidney disease were selected, and kidney disease was defined as various primary nephritis, secondary nephropathy, acute kidney injury (AKI), chronic kidney disease, kidney tumors, or a diagnosis of proteinuria alone.
4. Signed informed consent form.

Exclusion Criteria:

1. People with missing baseline biochemical data;
2. Outliers in the population indicators, i.e., data deviating from the mean ± three times the standard deviation;
3. Data with significantly abnormal baseline renal function follow-up (abnormally elevated GFR by more than 10% within 2 years or abnormal ACR value as determined by consultation with a senior nephrologist).

Primary outcomes:
measure: A ≥30% decline in glomerular filtration rate (GFR) within 2 years, i.e. a rapid decline in renal function
timeFrame: The risk of rapid decline in kidney function in the elderly was assessed during a 2-year follow-up period
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital, Fudan university
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jing Chen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00048711: Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI
Official title: Open-Label Study of Efficacy and Safety of Recombinant Human N-acetylgalactosamine 4-sulfatase in Patients With MPS VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucopolysaccharidosis VI
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2002-11-08
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is evaluate the efficacy, safety, and pharmacokinetics of weekly intravenous infusions of 1 mg/kg recombinant human N-acetylgalactosamine 4-sulfatase (rhASB) in patients diagnosed with Mucopolysaccharidosis VI (MPS VI)


Eligibility criteria: Inclusion Criteria:

* Patient consent
* Patient must be five years of age or older
* Patient must have documented biochemical or genetic proof of MPS VI
* Patient must walk at least 1 meter, but less than 250 meters, in the first 6 minutes of the baseline 12-minute walk test
* If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria:

* Patient is under consideration for or has undergone a successful bone marrow transplant (BMT).
* Pregnant or lactating patient
* Patient has received an investigational drug within 30 days prior to study enrollment
* Patient has been previously treated with rhASB
* Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance
* Patient has a known hypersensitivity to rhASB or to components of the study drug
* History of cancer (except low grade and fully resolved skin malignancy)

Primary outcomes:
measure: 12-minute walk test
timeFrame: weeks 6, 12, 24, 48, 96 and 144
measure: urinary glycoaminoglycan(uGAG)levels
timeFrame: weeks 1, 4, 6, 8, 12
Secondary outcomes:
Other outcomes:
Locations:
city: Novato
country: United States
facility: BioMarin Pharmaceutical Inc.
state: California
Study officials:
affiliation: BioMarin Pharmaceutical
name: Stuart J Sweidler, MD, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06833411: Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone
Official title: Treatment for Giant Cell Arteritis With Tocilizumab and 8 as Compared to 26 Weeks of Prednisone: a Randomized, Multicenter, Adaptive, Blinded, Phase III Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Giant Cell Arteritis (GCA)
Keywords: Tocilizumab
Glucocorticoid
Prednisone
Giant cell arteritis
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 178
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The GISCO study plans to determine whether 8-week therapy is just as effective as 26-week cortisone therapy for treating giant cell arteritis

* with tocilizumab,
* while using less cortisone.

Detailed description: The aim of this randomized clinical trial investigates whether 1) a shortened GC 8-week regimen is as effective as the current 26-week regimen and 2) associated with less GC exposure when introducing a GC-sparing agent in the treatment of GCA.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with giant cell arteritis
* Start of tocilizumab treatment at baseline as part of routine clinical practice
* Receive ≥ 20 mg/day prednisone (or equivalent) at baseline
* Written informed consent

Exclusion Criteria:

* Treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of tocilizumab.

Primary outcomes:
measure: Absence of a major relapse from randomization to 52 weeks
timeFrame: 52 weeks
measure: Cumulative glucocorticoid exposure from randomization to 52 weeks
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Rheumatology and Immunology, Inselspital, University of Bern
Study officials:
affiliation: Department of Rheumatology and Immunology, Inselspital, University of Bern, Bern, Switzerland
name: Lisa Christ, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04763811: Acceptability Study of Sensor in Elderly People's House Living Alone (Fragility Box)
Official title: Acceptability Study of Sensor in Elderly People's House Living Alone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: sensors
acceptability
qualitative study
autonomous
elderly people
prevention
Autonomy loss
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Saint Etienne School of Mine
name: Eovi Mcd Mutuelle
name: Gerontopole Auvergne Rhone-Alpes (AURA)
First posted: 2021-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older 65 people who live alone in their own house

Brief summary: The Fragility box is a project lead by Mines de Saint-Etienne, Gérontopôle Auvergne-Rhône-Alpes (AURA) and Eovi Mcd Mutually to prevent autonomy loss in the elderly dwelling population. With non-intrusive sensors installed in their residence, it is possible to monitor and forecast the frail state of elderly people living alone. The current study focuses on the technical feasibility of the project and the acceptability of these types of devices within the elderly's home. About ten participants have volunteered to be a part of this study. Therefore, they had the sensors installed at their home for a 12 months duration. A qualitative study with focus groups and individual interviews are carried out to evaluate the project: user satisfaction, expectations, and fears.

Detailed description: This research tend to study the acceptability of captors which can measure the evolution of autonomy of older 65 people.

Eligibility criteria: Inclusion Criteria:

* People living alone
* Autonomous person

Exclusion Criteria:

* Person with a neurological disease
* Person under guardianship or curatorship

Primary outcomes:
measure: Analysis representations of health/fragility and new technologies
timeFrame: Months:6
Secondary outcomes:
measure: Analysis Representations of health and frailties ; and new technologies Acceptability of sensors
timeFrame: Months:6
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Gérontopole AURA
Study officials:
affiliation: augusto@emse.fr
name: Vincent Augusto
role: STUDY_DIRECTOR
References:
Clinical trial NCT00601211: Bioequivalency Study of 5 mg Piolocarpine Tablets Under Fed Conditions
Official title: A Single Dose, Two-Treatment, Two-Period, Two Sequence Crossover Bioequivalency Study of 5 mg Pilocarpine Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Mouth
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine Tablets, 5 mg, to SALAGEN® Tablets, 5 mg (MGI Pharma) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Pilocarpine or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02106611: Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors
Official title: Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hodgkin Lymphoma Survivor
Keywords: MRI
stress echo
Clinical Assessment
14-017
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2014-04-08
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC

Brief summary: This study will test whether cardiac MRI can improve early detection of Hodgkin lymphoma associated heart disease compared to a stress echocardiogram. By doing both stress echocardiography and cardiac MRI, we will compare the ability of the two tests to detect heart disease.


Eligibility criteria: Inclusion Criteria:

* Classical or nodular lymphocyte predominant HL treated at Memorial Sloan-Kettering Cancer Center.
* Age ≥ 18 years
* Treatment for HL that included mediastinal RT at initial diagnosis or relapse.
* ≥ 5 years from last HL treatment.

Exclusion Criteria:

* Primary HL diagnosis prior to 1980.
* Additional mediastinal RT or subsequent cardiotoxic systemic therapy for secondary malignant neoplasm.
* Known CAD/CHF (defined as documented myocardial infarction, cardiac revascularization, angiographic obstructive CAD, or decreased LV function \[EF \< 55%\] during prior clinical care).
* Contraindication to MRI (i.e. pacemakers, defibrillators, or aneurysm clips, or other implanted ferromagnetic objects), gadolinium (i.e. known hypersensitivity to gadolinium, advanced renal insufficiency as defined by glomerular filtration rate \<30 ml/min/1.73m\^2).
* Contraindication to exercise stress testing other than the above (i.e. unstable angina or severe valvular stenosis).

Primary outcomes:
measure: compare the prevalence of cardiac injury
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alison Moskowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04273711: Can Thyroidectomy be Considered Safe in Obese Patients?
Official title: Can Thyroidectomy be Considered Safe in Obese Patients? Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Thyroid
Surgery--Complications
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 813
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to thyroidectomy

Brief summary: Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. This study showed that obesity, in the field of thyroid surgery, is not associated with any increase of postoperative complications. Thus, it is possible to conclude that thyroidectomy can be performed safely in obese patients.

Detailed description: Background: Obesity is a growing public health concern in most western countries. More and more patients with high body mass index (BMI) are undergoing surgical procedures of all kinds and, in this context, obese patients are undergoing thyroid surgery more than ever before. The aim of the present study was to evaluate whether thyroidectomy can be considered safe in obese patients.

Methods: Patients undergoing thyroidectomy in our Unit between January 2014 and December 2018 were retrospectively analysed. Patients were divided into 2 groups: those with BMI \< 30 kg/m2 were included in Group A, while those with BMI ≥ 30 kg/m2 in Group B.

Eligibility criteria: Inclusion Criteria:

* Patients submitted to thyroidectomy in our Unit

Exclusion Criteria:

-

Primary outcomes:
measure: Postoperative complications
timeFrame: 1 year
Secondary outcomes:
measure: Operative time
timeFrame: 1 day
Other outcomes:
measure: Postoperative stay
timeFrame: up to 2 weeks
Locations:
city: Monserrato
country: Italy
facility: Policlinico di Monserrato
state: CA
Study officials:
affiliation: University of Cagliari
name: Pietro Giorgio Calò
role: STUDY_DIRECTOR
References: