louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02712736: Quality of Life in Patients With Primary Sclerosing Cholangitis
Official title: Quality of Life in Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Sclerosing Cholangitis
Keywords: Primary Sclerosing Cholangitis
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the healthcare-related quality of life (HRQOL), the impact of risk of liver transplant and risk of malignancy on HRQOL, and the complementary and alternative medicine use in patients with PSC.

Detailed description: A cohort of adult (age ≥ 18) patients with a diagnosis of PSC will be identified. The patients will be approached about participating in the study while at their appointment, either by the investigators or someone else known to the patient. If the patient agrees, the investigators or other key personnel will then provide information about the study and obtain their informed consent to participate.

The patients who consent to participate will be sent home from the clinic with a survey to complete and return via mail in a provided addressed, stamped envelope. The survey consists of the Short Form-36 (SF-36), the Chronic Liver Disease Questionnaire (CLDQ), questions from the PROMIS SexFs v2.0, questions regarding perceived risk for liver transplant, cholangiocarcinoma, and colorectal carcinoma, as well as perceived overall life expectancy, and questions regarding complementary and alternative medicine use.

Demographic information and clinical data will also be obtained from the patient's electronic medical record. The study will be cross-sectional in nature, and there will be no follow-up with the subjects after the survey is completed.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥ 18) patients with PSC, confirmed by laboratory tests, imaging, and/or liver biopsy

Exclusion Criteria:

* Patients \<18
* Patients who have undergone liver transplant, patients with frank hepatic encephalopathy
* Patients with active inflammatory bowel disease (IBD) flares
* Patients with malignancies
* Patients unable to understand English
* Patients refusing to participate or provide informed consent

Primary outcomes:
measure: Impaired quality of life as measured by questionnaire
timeFrame: Approximately 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew Muir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927536: Evaluating Color Perception Under LED Red/Green and Green Dominant Light
Official title: Evaluating Color Perception Under LED Red/Green and Green Dominant Light
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Color Blindness, Acquired
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-08-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal color vision status

Brief summary: The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA called the Tomahawk MC Tactical Light to determine the range of colors people are able to see with these flashlights at night. The flashlight has been designed to reduce visibility of the user and uses a combination of green and red LED lamps to achieve this. In this study investigators wish to determine how well a subject can differentiate colors at night in a quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which requires the user to put shades of red, green, blue and yellow into progressive color order which is scored according to the manufactures specifications.


Eligibility criteria: Inclusion Criteria:

* normal vision
* 18-65 years

Exclusion Criteria:

* blindness
* colorblind
* pregnant women
* prisoners
* decisionally challenged

Primary outcomes:
measure: Change in Normal Color vision
timeFrame: 1 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Dept of Opthalmology
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Mark Petrash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00497536: Pharmacokinetics of IAsp Following CSII in Patients With T1DM
Official title: Pharmacokinetics of Insulin Aspart (IAsp) Following Continuous Subcutaneous Insulin Infusion (CSII) in Patients With Type 1 Diabetes Mellitus (T1DM)- Basal Rate Resolution.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Continuous Subcutaneous Insulin Infusion (CSII)
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per hour compared with multiple boluses per hour.

The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion (CSII) versus continuous intravenous insulin infusion (CIII).

Detailed description: Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be administered as a basal rate with additional insulin administration from the pump related to mealtimes.

Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to enhance its action on metabolism.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus (T1DM)
* Insulin pump users' ≥ 48 hours, 24 h dose \< 80 U
* Insulin dose ≥ 0,4 IE/kg/24hours
* 18 years \< age \< 50 years
* Time since diagnosis of T1DM ≥ 5 years
* HbA1c ≤ 8,5 %
* Safe anticonceptive for fertile women
* Being able to understand and read Danish

Exclusion Criteria:

* Dysregulation of endocrine disorders other than type 1 diabetes mellitus
* Severe dysregulation of diabetes mellitus
* Other severe adverse disease
* Pregnancy, planning pregnancy, or nursing

Primary outcomes:
measure: CV SSPIasp
timeFrame: 6 hours
Secondary outcomes:
measure: • Δ SSPIAsp (S.C. /I.V.) • AUC IAsp • Tmax IAsp • Cmax IAsp - Bioequivalence of Iasp under SS (GIR, S-FFA, S-glycerol)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Medicinsk Endokrinologisk Afdeling M
state: Region Midtjylland
Study officials:
affiliation: University of Aarhus
name: Torsten Lauritzen, MD
role: STUDY_DIRECTOR
affiliation: University of Aarhus
name: Torben Laursen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06001736: Utility of CC7 Transfer in Stroke Subtypes
Official title: Seventh Cervical Nerve Transfer for Spastic Arm Paresis: a Prospective Analysis of Efficacy in Ischemic Vs. Hemorrhagic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Spastic Hemiparesis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 limb functional improvement after contralateral C7 root transfer in stroke patients.

Detailed description: Spastic limb paresis after stroke is a cause of long-term disability and reduction is quality of life, with loss of hand dexterity being especially prohibitive. In the recovery phase after initial injury, neural reorganization occurs and has been observed in both ipsilateral and contralateral hemispheres. Previous studies have identified contralesional (opposite to the side of the injury), in other words, ipsilateral, activation in the recovery of paretic hand function. However, this pathway of recovery is limited due to sparse connections between the ipsilateral hemisphere and the affected arm/hand. By establishing an anatomic connection between the ipsilateral hemisphere and the paretic arm with contralateral nerve transfer, compensatory capacity of the ipsilateral hemisphere is facilitated. This cross neck C7-C7 root transfer is an established procedure for the treatment of brachial plexus injuries and recently, for the treatment of spastic arm paresis in those with cerebral injury.

Eligibility criteria: Inclusion Criteria:

* History of ischemic or hemorrhagic stroke with resultant arm paresis that has ceased to improve within 1-5 years of rehabilitation.

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Change from baseline in arm function, as measured by the Fugl-Meyer upper-extremity scale.
timeFrame: 12 months with visits at baseline and months 2, 4, 8, and 12 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Health
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Jennifer Hong, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01572636: Laronidase (Aldurazyme TM) Enzyme Replacement Therapy With Hematopoietic Stem Cell Transplant for Hurler Syndrome
Official title: MT2011-21C Laronidase (Aldurazyme TM) Enzyme Replacement Therapy (ERT) With Hematopoietic Stem Cell Transplantation (HSCT) for Hurler Syndrome (MPS IH).
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mucopolysaccharidosis Type IH
MPS I
Hurler Syndrome
Keywords: Hurler Syndrome
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome) and being considered as a candidate for first transplant according to a University of Minnesota myeloablative hematopoietic stem cell transplant (HSCT) protocol

Brief summary: This is a standard of care treatment guideline for patients with the diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome) who are being considered as candidates for first hematopoietic stem cell transplantation (HSCT) according to a University of Minnesota myeloablative HSCT protocol.

Detailed description: Laronidase Enzyme Replacement Therapy will be performed using laronidase once a week for 12 weeks prior to hematopoietic stem cell transplantation and for 8 weeks post-transplant to reduce pulmonary complications.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome) and being considered as a candidate for first transplant according to a University of Minnesota myeloablative hematopoietic stem cell transplant (HSCT) protocol

Exclusion Criteria:

* No prior therapy with laronidase enzyme replacement therapy (ERT)

Primary outcomes:
measure: Overall Survival
timeFrame: At 1 Year
Secondary outcomes:
measure: Incidence of Engraftment
timeFrame: 1 Year Post Transplant
measure: Incidence of Grade III-IV Acute Graft Versus Host Disease
timeFrame: Day 100
measure: Proportion of patients in need of ventilator support
timeFrame: 1 Year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Paul Orchard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05081336: Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry
Official title: Low-density Lipoprotein Cholesterol Reduction With State-of-the-art Therapy in Secondary Prevention and Major Cardiovascular Adverse Events: Republic of Srpska Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Dyslipidemias
Lead sponsor: University Clinical Centre of Republic of Srpska
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients presented with acute coronary syndrome in one of hospitals in Republic of Srpska

Brief summary: Recent trials have demonstrated that a reduction in low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular adverse events following acute coronary syndrome (ACS). However, the data coming from the real-world setting are limited. Therefore, the aim of the study is to assess the association between LDL-C changes with prognosis in patients who survive ACS.

Patients with ACS will be followed for mortality and major events for at least 1 year. Changes in LDL-C between the ACS and a 6- to 10-week follow-up visit will be analysed. The associations between quartiles of LDL-C change and therapy intensity with outcomes will be investigated using adjusted Cox regression analyses.


Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: Major Cardiovascular Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: LDL reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
state: Republic Of Srpska
Study officials:
affiliation: University Clinical Centre of the Republic of Srpska
name: Bojan M Stanetic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05906836: A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants
Official title: Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single Dose Selpercatinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug Drug Interaction Trial
Selpercatinib (Retevmo®)
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine the effect of selpercatinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with selpercatinib in healthy participants. This study will last up to approximately 26 days excluding screening period.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Participant must be Caucasian
* Body mass index (BMI) within the range of 19.0 to 32.0 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have known allergies to selpercatinib-related compounds or any components of the formulation of selpercatinib, or or rosuvastatin
* • Have a significant previous or current history or presence of cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product
* Have used or are intending to use over-the-counter or prescription medication, including dietary supplements and herbal medications, within 14 days prior to dosing

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
timeFrame: Pre-dose up to 72 hours post-dose
measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Rosuvastatin
timeFrame: Pre-dose up to 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Labcorp Clinical Research LP
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06142136: The Effect of Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3
Official title: A Randomised Comparative Study of the Effect of LYL Love Your Life ® sunD3 LYL Micro™ Vitamin D Sublingual Spray on Vitamin D3 Levels in the Blood Compared to Other Forms of Vitamin D3 - Oral Oil Droplets and Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D3 Deficiency
Lead sponsor: Pauls Stradins Clinical University Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The randomized comparative study was performed on 99 outpatients with below 30 ng/ml of vitamin D. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Each participant received vitamin D3 4000 IU daily for 30 days and the vitamin D levels were measured before and after the intervention.

Detailed description: This randomized comparative study was performed in Liepaja, Latvia, on 99 outpatients, with vitamin D levels below 30 ng/ml. Participants were randomized into three groups to receive vitamin D3 supplementation in three different forms - sublingual spray, oral oil droplets, and capsules. Before intervention blood samples were taken to determine vitamin D3 level, creatinine, and GFR, each participant received vitamin D3 4000 IU daily for 30 days. After that blood test was performed again, to measure changes in vitamin D3 levels in the blood. Participants answered the questionnaire to collect information about things that might affect vitamin D3 levels, such as dietary habits, physical activities, usage of sunscreen, compliance, etc.

Eligibility criteria: Inclusion Criteria:

* Vitamin D3 level in the blood below 30 ng/ml.

Exclusion Criteria:

* Celiac disease, Crohn's disease, ulcerative colitis, autoimmune gastritis.
* Patients with mental health problems.
* Vitamin D level ≥ 30 ng/ml.
* Pregnant women.
* Any other illness or condition that the researcher deemed may interfere with the results.
* Patients who refuse the studies.

Primary outcomes:
measure: Changes in vitamin D level in the blood depending on the received vitamin D form.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Pauls Stradins Clinical Univeristy Hospital
Study officials:
affiliation: Pauls Stradins Clinical University Hospital
name: Valdis Pirags, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00236236: The HF-HRV Registry
Official title: CONTAK RENEWAL® Heart Failure Heart Rate Variability Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Arrhythmia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients receiving their first CRT-D
* Patients who sign and date a Patient Informed Consent prior to device implant
* Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled

Exclusion Criteria:

* Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
* Patients who are younger than 18 years of age
* Patients whose life expectancy is less than six-months due to other medical conditions
* Patients with or who are likely to receive a tricuspid or other valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
* Women who are pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Guidant Corporation
name: Kellie Chase
role: STUDY_CHAIR
References: