louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02295202: Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome
Official title: Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea
Metabolic Syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fleury
First posted: 2014-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Metabolic Syndrome (ATP III)
* Moderate to severe OSA

Exclusion Criteria:

* Smokers
* Patients under chronic use of medications
* Neurological diseases
* Coronary artery disease
* Acute heart failure
* Chronic renal failure (GFR \< 30 ml/min)
* Chronic obstructive pulmonary disease
* Mild OSA and patients with BMI over 40 kg/m2.

Primary outcomes:
measure: Reversibility of Metabolic Syndrome criteria
timeFrame: 6 months
Secondary outcomes:
measure: Abdominal fat
timeFrame: 6 months
measure: Hepatic steatosis
timeFrame: 6 months
measure: carotid intima-media thickness
timeFrame: 6 months
measure: endothelial function
timeFrame: 6 months
measure: coronary atherosclerosis
timeFrame: 6 months
measure: Inflammatory markers
timeFrame: 6 months
measure: Metabolomics
timeFrame: 6 months
measure: MicroRNAs
timeFrame: 6 months
measure: Epicardic fat
timeFrame: 6 months
measure: Heart remodeling
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Luciano Drager
Study officials:
affiliation: Heart Institute (InCor), University of Sao Paulo Medical School
name: Luciano F Drager, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giampa SQC, Furlan SF, Freitas LS, Macedo TA, Lebkuchen A, Cardozo KHM, Carvalho VM, Martins FC, Azam IFB, Costa-Hong V, Lopes HF, Baptista ML, Rochitte CE, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of CPAP on Metabolic Syndrome in Patients With OSA: A Randomized Trial. Chest. 2022 May;161(5):1370-1381. doi: 10.1016/j.chest.2021.12.669. Epub 2022 Jan 19.
Clinical trial NCT02826902: Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
Official title: Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Stature
Osteoarthritis
Keywords: Total intravenous anesthesia
desflurane
QoR-40
correctional tibial osteotomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The effect of total intravenous anesthesia (TIVA) versus inhalational anesthesia on the quality of recovery from surgery has been reported in several different types of operations. The Quality of Recovery 40 (QoR-40) questionnaire is designed multi-dimensionally to assess the degree of recovery after anesthesia and surgery, and has been validated in previous studies. The present study aims to compare the quality of recovery with the QoR-40 questionnaire, in patients undergoing correctional tibial osteotomy under general anesthesia with either TIVA with propofol or inhalational anesthesia with desflurane.


Eligibility criteria: Inclusion Criteria:

1. Adult patients over the age of 19 scheduled for cosmetic lower limg lengthening for short stature, or correctional tibial osteotomy for osteoarthritis

Exclusion Criteria:

1. Patient refusal
2. Patients with altered mental status
3. Ejection fraction under 55%
4. Recent MI, CVA, or major cardiovascular surgery
5. 3rd degree AV block, 2nd degree AV block with P:QRS ration greater than 3:1
6. Hemodynamically unstable patients requiring vasopressors or oxygen therapy
7. Febrile patients
8. Patients with decreased renal function (serum Cr \> 0.1 mg/dL)
9. Patients with known allergies to propofol
10. Pregnant patients

Primary outcomes:
measure: QoR-40 score
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: QoR-40 score
timeFrame: preoperative period to 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT02286102: A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Official title: A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains for Adults Undergoing Multilevel Spine Surgery for Deformity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Deformity
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.

Detailed description: The purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adult patients undergoing multilevel spine surgery for deformity. In addition, the ability of these drains to decrease the complications that are associated with allogenic blood exposure (postoperative infection, volume overload and transfusion reactions) will also be evaluated.

Eligibility criteria: Inclusion Criteria:

The patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent

Exclusion Criteria:

The patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.

The patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.

Primary outcomes:
measure: Volume of Allogenic Blood Transfused Postoperatively
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: Hemoglobin Levels, Post-Op Day 3
timeFrame: 3 days postop
measure: Hemoglobin Levels, Post-Op Day 2
timeFrame: 2 days postop
Other outcomes:
Locations:
city: New York
country: United States
facility: The Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Tom Ross, RN
role: STUDY_DIRECTOR
affiliation: Hospital for Special Surgery, New York
name: Han Jo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02578784: DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis
Official title: Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency
Keywords: Dialysis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% \[2-4\].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis.

The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown.

Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.


Eligibility criteria: Inclusion Criteria:

* dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion Criteria:

* missing informed consent or unable to consent
* age \< 18 years
* pregnancy

Primary outcomes:
measure: Time to worsening of dialysis fistula function [days]
timeFrame: one year
Secondary outcomes:
measure: Change in lumen 12 months after PTA [mm]
timeFrame: one year
measure: Change in dialysis flow [ml/min.]
timeFrame: one year
measure: Change in dialysis fistula flow [ml/min.]
timeFrame: one year
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Radiology and Nuclear Medicine
Study officials:
References:
Clinical trial NCT01013584: The Effect of Weight on Vitamin D Dose Response
Official title: The Effect of Weight on Vitamin D Dose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Vitamin D Deficiency
Keywords: vitamin D
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 67
Sex: MALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D3 is a vitamin that is an essential component of biological regulating systems in humans. Sun exposure is the predominant source of vitamin D3. Previous research has shown that vitamin D3 deficiency is common worldwide. It is especially common in northern countries with long winters due to inadequate sun exposure during winter. In the US, an estimated 36% to 57% of healthy middle-aged to elderly adults have vitamin D3 deficiency. Current research indicates that obesity is associated with a low vitamin D3 level.

Detailed description: Obesity is a known risk factor for vitamin D deficiency. Adequate levels of vitamin D are important, not only for bone health, but appear to be important for prevention of certain autoimmune diseases, infections and cancers. Current FDA recommendations for vitamin D intake do not differentiate between lean and obese people. There are no published studies indicating if the 25(OH)D response to a given daily dose of vitamin D is any less in an obese person than a normal weight person. The purpose of this study is to characterize the quantitative relationship between steady state cholecalciferol input and the resulting serum 25 (OH)D concentration in obese subjects. Data obtained in this study will be compared to published normative data for non-obese subjects. Recommendations will be provided for optimal treatment of vitamin D deficiency in obese men and women.

Eligibility criteria: Inclusion Criteria:

* men aged 19 to 60 with BMI \> 30.0.
* They will have low (\<1,000 IU) usual intake of vitamin D (from milk, multivitamins, supplements, and fortified foods)

Exclusion Criteria:

* Subjects will not have history of hepatic or renal disease.
* Subjects will not be taking medications known to affect vitamin D metabolism such as anti-seizure medications and/or corticosteroids.
* They will not be on hydrochlorothiazide medications which could cause hypercalcemia.
* They will not have diseases causing malabsorption of vitamin D, such as celiac sprue or small bowel surgeries.
* Pregnancy is also an exclusion criterion.

Primary outcomes:
measure: To characterize the dose response of 25(OH)D to 1,000, 5,000 or 10,000 IU/day of vitamin D3 for 21 weeks in a group of obese men and women.
timeFrame: 21 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Andjela Drincic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02728284: Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
Official title: Evaluation of Cardiac Function With Cardio-respiratory Synchronized MRI
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Heart Disease
Keywords: Magnetic Resonance Imaging (MRI)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this investigation is to evaluate newer methods of performing cardiovascular MRI (CMR) that will provide new kinds of information related to the interplay between the cardiac and the respiratory cycles, such as the interaction between the left ventricle and the right ventricle during respiration . The primary statistical objective is to provide preliminary indications of the relative utility of the investigational imaging software in terms of image quality and suitability for routine clinical use. Image quality will be expressed in terms of signal-to-noise ratios (SNR), contrast-to-noise ratios (CNR) and subjective Likert-type qualitative assessments independently provided by each of multiple blinded readers for each image. Suitability for routine use will be assessed in terms of imaging time and a binary indicator of whether, in the opinion of the investigator, adverse procedural complications (not expected) were encountered during a given imaging session.


Eligibility criteria: Inclusion Criteria:

* Subjects will be selected as they are scheduled for clinical MR examinations.
* Subjects will be selected on the basis of their willingness and ability to participate, on their comprehension of the informed consent document, on their likelihood of completing the study, and on the clinical appropriateness of the investigational technique for a given patient.

Exclusion Criteria:

* electrical implants such as cardiac pacemakers or perfusion pumps
* ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
* ferromagnetic objects such as jewelry or metal clips in clothing
* pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.

Primary outcomes:
measure: Image Quality measured by resolution
timeFrame: 10 Minutes
measure: Image Quality measured by signal to noise
timeFrame: 10 Minutes
measure: Suitability for routine use measured by imaging time and ease of use
timeFrame: 10 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Leon Axel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929784: tDCS to Treat Hemiplegic Shoulder Pain
Official title: Assesing Hemiplegic Shoulder Pain and the Use of tDCS to Treat This Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Hemiplegic Shoulder Pain
transcranial Direct Current Stimulation
Stroke
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
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 investigate the possibility of treating Hemiplegic Shoulder Pain (HSP) using transcranial direct current stimulation (tDCS) in patients following stroke.

The secondary aims are to see if this treatment affects motor function of the upper limb, to asses the different types of HSP and whether there is any correlation to the location and extent of the stroke.

Detailed description: Hemiplegic Shoulder Pain (HSP) is a common entity following stroke. It's prevalence varies between studies, probably because it includes many etiologies and there is no one way of diagnosis.

HSP delays rehabilitation, elongates hospitalization time and reduces quality of life.

Currently there is no one reccomended treatment for HSP. Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes in the human motor cortex. this effect depends on the stimulation polarity and is specific to the site of stimulation. Interacting with cortical activity, by means of cortical stimulation, can improve the rehabilitation potential of neurologic patients. In this respect, preliminary evidence suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect, and chronic pain disorders.

In this tDCS study the investigator uses one anode and one cathode electrode placed over the scalp to modulate a particular area of the central nervous system (CNS). The stimulation is administered via the neuroConn DC.Stimulator. The DC-STIMULATOR is a micro-processor-controlled constant current source. The DCSTIMULATOR is a CE-certified medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on people.Electrode positioning is determined according to the International EEG 10-20 System.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in the department of neurologic rehabilitation of Loewenstein Rehabilitation Center after first clinical stroke.
* Able to understand and comply with basic instructions
* Signed an informed consent form
* Hebrew speaking

Exclusion Criteria:

* Shoulder pain predating the stroke
* Epilepsy

Primary outcomes:
measure: Change in VAS (Visual Ananlof Scale) for pain assessment
timeFrame: 1 month
Secondary outcomes:
measure: Change in Fugl-Meyer assessment
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Loewenstein Rehabilition Center
name: Motti Ratmansky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00890084: Telmisartan Tab Hypertension
Official title: RESPECT: Observational, Prospective, Open-label, Multi-center Study Evaluating the Antihypertensive Effect of Treatment With Telmisartan (Alone or in Fixed Combination With HCTZ) in General Practitioner and Specialist Practice in Hypertensive Patients With High and Very High Cardiovascular Risk According to the ESH/ESC Guidelines 2007 Who Are Uncontrolled Under Current Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-04-29
Enrollment: 2913
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk

Detailed description: Study Design:

Eligibility criteria: Inclusion criteria:

Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria

Exclusion criteria:

Contra-indications as in the Summary of Product Characteristics

Primary outcomes:
measure: Percentage of Patients With Blood Pressure < 140/90 mm Hg
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Patients With Blood Pressure < 130/80 mm Hg
timeFrame: 12 weeks
measure: Absolute Blood Pressure Decrease
timeFrame: baseline and 12 weeks
measure: BP Response Rate (Drop of Systolic BP of 10mmHg or More)
timeFrame: 12 weeks
measure: Treatment Patterns
timeFrame: 12 weeks
measure: Change in Concomitant Antihypertensive Drugs Given at Study Entry
timeFrame: baseline and 12 weeks
measure: Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg
timeFrame: 12 weeks
measure: Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: