louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01687855: Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep
Official title: Observation of the Change in Soft Tissue in OSAH
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnoea
Keywords: Obstructive Sleep
Apnoea
tongue
alteration
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 41
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited prospectively from the Tenth Hospital Affiliated to Tongji University of Shanghai,with varying degrees of symptoms of OSAHS (daytime sleepiness, snoring and/or nocturnal apneas).

Brief summary: The aim of this study was to evaluate the dynamic changes of the tongue in patients with obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using Ultrafast Magnetic Resonance Imaging (UMRI)

Detailed description: UMRI was undertaken on the upper airway in 21 OSAHS patients and 20 normal people after being deprived of sleep for one night. A series of midline sagittal images of the upper airway were obtained. The dynamic alterations of the tongue size and the distance from the tongue to X axis (an extended line from the anterior nasal spine to posterior nasal spine) and Y axis (a perpendicular line from the center of the pituitary to the X axis) were measured.Statistical comparisons between pairs of means were performed via t-tests using Spss10 software. A probability level of p\<0.05 was considered to be statistically significant.

Eligibility criteria: Inclusion Criteria:

1. patients who are male
2. patients were diagnosed as OSAHS
3. patients underwent a thorough history (including the Epworth somnolence questionnaire) and physical examination
4. patients did not undergo any treatment
5. each subject gave written informed consent before entering the study.

Exclusion Criteria:

1. patients didn't sign written informed consent
2. Any situation or condition that will interfere with adherence to study activities

Primary outcomes:
measure: the distance from the tongue to X axis and Y axis
timeFrame: one night
Secondary outcomes:
measure: the tongue size
timeFrame: one night
Other outcomes:
Locations:
city: Shanghai
country: China
facility: The Tenth Hospital Affiliated to Tongji University
state: Shanghai
Study officials:
affiliation: Wenzhou Medical University
name: Rong D Hu, Ph.D
role: STUDY_CHAIR
References:
citation: Horner RL, Innes JA, Morrell MJ, Shea SA, Guz A. The effect of sleep on reflex genioglossus muscle activation by stimuli of negative airway pressure in humans. J Physiol. 1994 Apr 1;476(1):141-51.
citation: Wang Y, Mcdonald JP, Liu Y, Pan K, Zhang X, Hu R. Dynamic alterations of the tongue in obstructive sleep apnea-hypopnea syndrome during sleep: analysis using ultrafast MRI. Genet Mol Res. 2014 Jun 17;13(2):4552-63. doi: 10.4238/2014.June.17.7.
Clinical trial NCT00005455: Chagas Disease as an Undiagnosed Type of Cardiomyopathy in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Myocardial Diseases
Chagas Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in the United States.

Detailed description: BACKGROUND:

In Latin America, 16 to 18 million individuals are thought to have Chagas' disease and 90 million are considered to be at risk of infection. In the United States, the occurrence of Chagas' disease is virtually limited to individuals who have resided in Latin America where they acquired the infection, and then migrated to this country.

DESIGN NARRATIVE:

Data on the prevalence of positive serologic reactions for Trypanosoma cruzi (a protozoan causing Chagas cardiomyopathy) serve for calculating that a total of up to 74,000 Latin Americans residing in the United States have the chronic form of chagasic cardiomyopathy. The vast majority of these individuals are either undiagnosed, or misdiagnosed as having idiopathic dilated cardiomyopathy or coronary artery disease. Vector transmission of T. cruzi infection is very unlikely to occur in the United States because of variations in biological behavior of local species of insect vectors and because of changes in human living conditions. Transfusion of blood from infected but asymptomatic individuals is considered the most important mechanism of transmission of this disorder in the United States.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02804555: Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section
Official title: Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstetrical Complication of Anesthesia
Keywords: reactive oxygen species
elective cesarean section
oxygen therapy
newborn
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 107
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.

Detailed description: Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.

Eligibility criteria: Inclusion Criteria:

* Elective cesarean section.
* Signed informed consent form.

Exclusion Criteria:

* Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.

Primary outcomes:
measure: Hyperoxia Newborns
timeFrame: through study completion up to two years
Secondary outcomes:
measure: Maternal hyperoxia
timeFrame: through study completion up to two years
measure: Alterations in newborns' enzyme functions due to maternal hyperoxia
timeFrame: through study completion up to two years
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
Study officials:
affiliation: Szeged University
name: Zsolt Molnar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04217655: Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
Official title: Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lung; Node
Lead sponsor: Xuzhou Central Hospital
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.

Detailed description: At present, low-dose scanning protocol is widely used in computed tomography-guided interventions because these procedures usually require repeat scans, which causes more radiation exposure to the patients. Computed tomography-guided core needle biopsy is widely used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. Compared with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules might require more scanning to adjust the position of needle tip. Therefore, it might expose the patients to more radiation. However, studies regarding computed tomography-guided core needle biopsy for lung nodules are still lacking.

In this study, investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose and standard-dose computed tomography-guided core needle biopsy for lung nodules.

Eligibility criteria: Inclusion Criteria:

1. Non-diagnostic lung lesions (no definitive pathological diagnosis);
2. Lesion size between 5 and 30 mm;
3. Solid lung lesions.

Exclusion Criteria:

1. The lesion which has been punctured previously;
2. A lesion that had shrunk in size or a lesion with a stable size for 1 year;
3. Severe dysfunction in heart, lung and coagulation function;
4. Patients who refused to provide informed consent.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: From the date of randomization until the date of first documented final diagnosis, assessed up to 12 months
Secondary outcomes:
measure: Radiation dose
timeFrame: From the date of randomization until the date of first documented biopsy procedures, assessed up to 1 day.
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Central Hospital
name: Xian-Chi Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fu YF, Li GC, Xu QS, Shi YB, Wang C, Wang T. Computed tomography-guided lung biopsy: a randomized controlled trial of low-dose versus standard-dose protocol. Eur Radiol. 2020 Mar;30(3):1584-1592. doi: 10.1007/s00330-019-06464-6. Epub 2019 Nov 27.
Clinical trial NCT04482855: Low-Level Laser in Head and Neck Chronic Lymphedema
Official title: Low-level Laser in Treatment of Head and Neck Chronic Lymphedema: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Lymphedema
Fibrosis
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, wait-list control
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of low-level laser treatment (LLLT) on the severity of lymphedema, symptom burden, functional status, and quality of life in HNC survivors.

Detailed description: Primary aim: To determine the impact of LLLT, as compared to wait-list control, on changes in severity of lymphedema.

Secondary aim: To determine the impact of LLLT, as compared to a wait-list control, on lymphedema-related symptom burden (e.g., tightness), functional impairments (e.g., range of motion in jaw and neck), and quality of life.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* \>6 months post HNC treatment
* No evidence of cancer confirmed with imaging tests
* Having head and neck lymphedema with or without fibrosis
* Completion of initial lymphedema therapy
* Lymphedema duration between 3-24 months
* Ability to speak and read English
* Ability to provide informed consent

Exclusion Criteria:

Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of LLLT:

* Pregnancy
* Acute infection
* Photosensitivity
* Chronic inflammatory diseases
* Venous thrombosis
* Carotid artery stenosis
* History of severe trauma
* Medication that affects body fluid and electrolyte balance
* Use of high doses of non-steroidal anti-inflammatory drugs
* Pre-existing skin rash, ulceration, open wound in the treatment area
* Active lymphedema therapy or physical therapy
* Allergic and other systemic skin diseases

Primary outcomes:
measure: Total Severity of External Lymphedema and Fibrosis (LEF)
timeFrame: Baseline, 8-week post-intervention visit
Secondary outcomes:
measure: Symptom Burden Score: Soft Tissues and Neurologic Toxicity Subscale
timeFrame: Baseline, 8-week post-intervention visit
measure: Neck Range of Motion Degree: Right Lateral Rotation
timeFrame: Baseline, 8-week post-intervention visit
measure: Quality of Life Score: Feeding Tube
timeFrame: Baseline, 8-week post-intervention visit
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00325455: MK0859 Dose-Ranging Study (0859-003)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy, Safety, and Tolerability of MK-0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypercholesterolemia
Mixed Hyperlipemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the cholesterol changing effects of MK0859 in patients with primary hypercholesterolemia or mixed dyslipidemia.


Eligibility criteria: Inclusion Criteria:

* Eligible patients will be men and women of non-child bearing potential, 18 through 75 years of age diagnosed with high cholesterol

Exclusion Criteria:

* Patients with CHD or CHD-equivalent disease (except diabetes)
* Diabetics on statins

Primary outcomes:
measure: To assess the cholesterol changing effects of MK0859
Secondary outcomes:
measure: Acceptable safety profile
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Dansky HM, Bloomfield D, Gibbons P, Liu S, Sisk CM, Tribble D, McKenney JM, Littlejohn TW 3rd, Mitchel Y. Efficacy and safety after cessation of treatment with the cholesteryl ester transfer protein inhibitor anacetrapib (MK-0859) in patients with primary hypercholesterolemia or mixed hyperlipidemia. Am Heart J. 2011 Oct;162(4):708-16. doi: 10.1016/j.ahj.2011.07.010. Epub 2011 Sep 1.
citation: Krauss RM, Pinto CA, Liu Y, Johnson-Levonas AO, Dansky HM. Changes in LDL particle concentrations after treatment with the cholesteryl ester transfer protein inhibitor anacetrapib alone or in combination with atorvastatin. J Clin Lipidol. 2015 Jan-Feb;9(1):93-102. doi: 10.1016/j.jacl.2014.09.013. Epub 2014 Oct 13.
Clinical trial NCT01219855: Safety/Efficacy Study of CTAP101 in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism (SHPT)
Official title: A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease
Secondary Hyperparathyroidism
Vitamin D Insufficiency
Keywords: Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
Hyperparathyroidism
Kidney Diseases
Kidney Failure
Renal Insufficiency, Chronic
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).


Eligibility criteria: Inclusion Criteria:

1. Urinary albumin excretion of ≤3000 μg of creatinine
2. Stage 3 CKD
3. Plasma iPTH: \> 70 pg/mL and \< 500 pg/mL
4. Serum Ca: ≥ 8.4 mg/dL and \< 10.0 mg/dL
5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL
6. Serum 25-hydroxyvitamin D: \> 10 ng/mL and \< 29 ng/mL.
7. Discontinue vitamin D use for duration of study

Exclusion Criteria:

1. History of kidney transplant or parathyroidectomy
2. Spot urine calcium:creatinine ratio \> 0.2
3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
4. Currently on dialysis

Primary outcomes:
measure: Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP).
timeFrame: 6 weeks
measure: Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change From Baseline in Serum 25-hydroxyvitamin D at Week 6
timeFrame: Baseline to End of Treatment (6 weeks)
measure: Percent Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment (EOT, Week 6) in the Per Protocol Population
timeFrame: Baseline to End of Treatment (6 weeks)
measure: Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 30% at Week 6
timeFrame: Baseline to End of Treatment (6 weeks)
measure: Proportion of Subjects With Reduction of Intact Parathyroid Hormone (iPTH) of at Least 20% at Week 6
timeFrame: Baseline to End of Treatment (6 weeks)
Other outcomes:
Locations:
city: Bannockburn
country: United States
facility: OPKO Health, Inc
state: Illinois
Study officials:
affiliation: OPKO Health, Inc.
name: Joel Melnick, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03346655: Brain Metastases in Norway - A Prospective Cohort Study
Official title: Brain Metastases in Norway - Improved Classification and Treatment. A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Metastases
Keywords: Treatment
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Cancer Society
name: South-Eastern Norway Regional Health Authority
First posted: 2017-11-17
Enrollment: 3000
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: Patients With previously or newly diagnosed cancer With radiologically proven brain metastases

Brief summary: The overall aim and primary outcome of this study will be a descriptive analysis of the current treatment practice of BM in Norway. Specifically, it may give answers to the following research questions:

* What is the true incidence of BM in Norway?
* How are patients with BM treated at present?
* Do treatments differ between hospitals?
* How do treatments impact quality of life of the patients?
* Which factors (treatment, tumor and host variables) can explain disease control, survival, symptom relief, and general functions?
* How can BM staging be improved?


Eligibility criteria: Inclusion Criteria:

* Verified cancer diagnosis of solid tumors (based on radiological, histological/cytological or operative evidence).
* Brain metastases verified by computer tomography (CT), contrast-enhanced magnetic resonance imaging (MRI), or surgical biopsies
* Age ≥ 18 years
* Able to comply with study procedures
* Able to provide written informed consent after information in Norwegian

Exclusion Criteria:

* Primary brain tumors
* Primary hematological malignancies (lymphomas, leukemias)
* Previous diagnosis and/or treatment of BM
* Unable to produce written informed consent after information in Norwegian

Primary outcomes:
measure: Overall survival after diagnosis of brain metastases
timeFrame: Time from diagnosis of brain metastases till death of any cause, assessed up to 12 months
Secondary outcomes:
measure: Treatment offered to patients diagnosed with brain metastases
timeFrame: 3 years
measure: Changes in patient reported symptoms and quality of life items through EORTC questionnaire QLQ PAL15 and submodule BN20
timeFrame: Monthly up to 12 months after inclusion
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Post-doc
name: Olav E Yri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02554955: A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants
Official title: Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult participants greater than 18 years of age
* Single organ (heart) transplant recipients
* At risk for post-transplant renal dysfunction

Exclusion Criteria:

* Previous organ transplant
* Previous treatment with mycophenolate mofetil, daclizumab or sirolimus
* Positive for human immunodeficiency virus (HIV) infection
* History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse

Primary outcomes:
measure: Percentage of participants with reported biopsy proven acute rejection episodes
timeFrame: up to 6 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: up to 6 months
measure: Incidence of Opportunistic Infections
timeFrame: Up to 5 years post transplant
measure: Patient and graft survival
timeFrame: up to 6 months
measure: Number of participants with malignancies
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: El Palmar Murcia
country: Spain
city: Hospitalet de Llobregat
country: Spain
city: La Coruna
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Pamplona
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: