louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02740569: Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
Official title: Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scleroderma, Systemic
Sleep Apnea, Obstructive
Pulmonary Disease
Keywords: scleroderma
sleep apnea
pulmonary disease
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with known Scleroderma

Brief summary: Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.

Detailed description: Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement.

The investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated.

The investigators plan to include 60 patients.

Eligibility criteria: Inclusion Criteria:

* Known scleroderma diagnosis
* Must be able to give informed consent

Exclusion Criteria:

* Serious neurological and/or psychiatric disease

Primary outcomes:
measure: Occurrence of OSA defined by apnea-hypopnea index (AHI) of at least 15/h on the overnight sleep study
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of pulmonary involvement based on computer tomography findings
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Pendik
Study officials:
affiliation: Marmara University Medical School
name: Yuksel Peker, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yakut T, Balcan B, Karakurt S, Direskeneli H, Yalcinkaya Y, Peker Y. Impact of concomitant obstructive sleep apnea on pulmonary involvement and main pulmonary artery diameter in adults with scleroderma. Sleep Breath. 2021 Mar;25(1):135-143. doi: 10.1007/s11325-020-02059-4. Epub 2020 Apr 13.
Clinical trial NCT04867369: Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Official title: Pecs II Block Versus Surgeon Infiltration for Open Subpectoral Biceps Tenodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tendonitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 160
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: A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.


Eligibility criteria: Inclusion Criteria:

1. Patients between 18 and 75 years of age
2. Patients undergoing shoulder arthroscopy with open subpectoral biceps tenodesis

Exclusion Criteria:

1. Patients younger than 18 and older than 75;
2. Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
3. Patients who are allergic to oxycodone;
4. Patients with diagnosed or self-reported cognitive dysfunction;
5. Patients with a history of neurologic disorder that can interfere with pain sensation;
6. Patients with a history of drug or recorded alcohol abuse;
7. Patients who are unable to understand or follow instructions;
8. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
9. Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
10. Patients with a BMI over 45;
11. Any patient that the investigators feel cannot comply with all study related procedures;
12. NYU Langone Health students, residents, faculty or staff members.

Primary outcomes:
measure: Opioid Utilization for the First 24 Hours After Surgery
timeFrame: Up to 24-Hours Post-Operation
Secondary outcomes:
measure: Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU)
timeFrame: Typically 1-3 Hours Post-Operation
measure: Patient-reported Numerical Rating Scale (NRS) Score
timeFrame: 24 Hours Post-Operation
measure: Patient-reported Numerical Rating Scale (NRS) Score
timeFrame: Day 3 Post-Operation
measure: Number of Patients With Reactions to Surgical Subpectoral Incision - Movement
timeFrame: Intraoperative
measure: Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia
timeFrame: Intraoperative
measure: Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep
timeFrame: Intraoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Arthur Hertling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01002469: Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
Official title: Pilot Feasibility Study in Healthy Subjects and Healthy Asymptomatic Subjects Genetically Disposed to Urea Cycle Disorders to Evaluate the Use of 13 C Isotope Ratio Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urea Cycle Disorders
Keywords: isotope ratio measurement
urea cycle
13C acetate
Healthy adults
Lead sponsor: Cytonet GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required.

Urea synthesis will be evaluated by administering sodium \[1-13C\]-acetate and measuring subsequent incorporation of \[13C\] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.


Eligibility criteria: Inclusion Criteria:

* Group 1 + 2: Healthy subjects
* Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders
* All: age 18 to 50 years (adult)
* Written informed consent

Exclusion Criteria:

* Presence of acute infection
* Participation in other clinical trials within 30 days prior to inclusion
* Severe coagulopathy
* Severe systemic or chronic disease
* Pregnancy or lactation

Primary outcomes:
measure: Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline
Secondary outcomes:
measure: Cmax of absolute [13C]urea in plasma
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
facility: CRS Clinical Research Services Mönchengladbach GmbH
Study officials:
affiliation: CRS Clinical Research Services Mönchengladbach GmbH
name: Doris Neuenhofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00630669: Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe
Official title: Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Keywords: Internal hemorrhoids
Rubber band ligation
Bipolar coagulation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
First posted: 2008-03-07
Enrollment: 45
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 purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids.


Eligibility criteria: Inclusion Criteria:

1. Grade II or III internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy.
2. Age over 18 years
3. A life expectancy of at least 24 months
4. A signed written informed consent

Exclusion Criteria:

1. The patient was uncooperative or could not return for routine outpatient follow-up
2. Severe or end-stage co-morbid illness
3. Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months
4. Ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents
5. Presence of severe rectal pain
6. Recently thrombosed internal or external hemorrhoids
7. Anal stricture,fissure, fistula,or abscess
8. Rectal carcinoma or bleeding distal colonic polyp
9. Rectal varices
10. Acute or chronic colitis
11. Rectal prolapse
12. Radiation telangiectasia of the rectum
13. Prothrombin time \>3 seconds over control
14. Platelet count \<75,000

Primary outcomes:
measure: treatment success rate
timeFrame: one year
Secondary outcomes:
measure: treatment complication rate
timeFrame: one year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Rome Jutabha,MD
state: California
Study officials:
References:
Clinical trial NCT00672269: Study Investigating MEN1 and SDHD in Familial Carcinoid Tumors
Official title: A Pilot Study to Investigate Germ-Line MEN1 and SDHD Gene Mutation in Familial Cases of Carcinoid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoid Neuroendocrine Cancer
Keywords: carcinoid
family members
familial
tumors
cancer
Lead sponsor: Rutgers University
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with carcinoid cancer that report to have a first-degree family member also with carcinoid tumor

Brief summary: There is a high incidence among the first degree relatives of the carcinoid patients, indicating the involvement of genetic components in its initiation and pathogenesis.

Detailed description: This proposed pilot study will conduct detailed interviews into the medical, environmental, and family histories and to collect blood specimen to obtain DNA. The Blood specimen and DNA will be processed by the Rutgers University Cell and DNA Repository (RUCDR) to rule out Familial Multiple Endocrine Neoplasia (MEN 1), and succinate dehydrogenase complex, subunit D (SDHD), gene inactivation thought to be associated with different types of carcinoid cancer.

Eligibility criteria: Inclusion Criteria:

1. Over the age of 18 years
2. More than one ,member of a family with a history of biopsy confirmed carcinoid tumor
3. English speaking
4. Mentally and emotionally capable of answering questions
5. Willing and available for study participation
6. At least one other family member with carcinoid tumor

Exclusion Criteria:

1. If you are under the age of 18 years,
2. If you are unable to understand or unable to provide informed consent,
3. If you have a psychological condition (i.e. depression, anxiety disorder, substance abuse, etc.) which might cause you significant problems in dealing with test results.

Primary outcomes:
measure: Mutations in MEN1 and SDHD genes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Busch Campus of Rutgers University, Human Genetics Institute
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Nancy Gardner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Changshun Shao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00806169: Combined Triple Therapy in Diabetic Retinopathy (DRP)
Official title: Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Diabetic Retinopathy
Keywords: combined therapy
DRP
efficacy
safety
sustainability
macular edema due to DRP
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.

Detailed description: This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of diabetic retinopathy

  * macular edema more than 200 micron
  * vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS

Exclusion Criteria:

* Prior intraocular injection within 4 months
* Core or complete vitrectomy
* History of glaucoma or ocular hypertension
* Presence of iris neovascularization
* Significant media opacity
* Monocularity and pregnancy

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: Day of exam
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt / Main
country: Germany
facility: Department of Vitreoretinal Surgery
state: Hessen
Study officials:
References:
Clinical trial NCT01313169: Electronic Medical Record Reminders and Panel Management to Improve Primary Care of Elderly Patients
Official title: Electronic Medical Record Reminders and Panel Management to Improve Primary Care of Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EMR Reminders to Improve Rates of Recommended Care
Keywords: Electronic medical record reminders, Panel management
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Donald W. Reynolds Foundation
First posted: 2011-03-11
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators conducted a controlled trial to assess the effectiveness of electronic medical record (EMR) reminders, with or without a panel manager, on completion of health care proxy, osteoporosis screening, and influenza and pneumococcal vaccinations for patients age 65 or older. The investigators hypothesized that EMR reminders would improve adherence to practice guidelines and that benefits would be enhanced with the support of a panel manager.


Eligibility criteria: Inclusion Criteria:

* All practicing faculty primary care physicians at Beth Israel Deaconess Medical Center General Medicine \& primary care ambulatory clinic

Exclusion Criteria:

Primary outcomes:
measure: a designated health care proxy
timeFrame: 12 months after intervention made available
measure: initial bone density scan
timeFrame: 12 months after intervention made available
measure: administration of annual influenza vaccine
timeFrame: 12 months after intervention started
measure: administration of pneumococcal vaccine
timeFrame: 12 months after the start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Timothy S Loo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loo TS, Davis RB, Lipsitz LA, Irish J, Bates CK, Agarwal K, Markson L, Hamel MB. Electronic medical record reminders and panel management to improve primary care of elderly patients. Arch Intern Med. 2011 Sep 26;171(17):1552-8. doi: 10.1001/archinternmed.2011.394.
Clinical trial NCT04037969: Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
Official title: Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaporative Dry Eye
Lead sponsor: University of Waterloo
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.


Eligibility criteria: Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Has worn soft contact lenses for a minimum of 6 months;
5. Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
6. Has an acceptable fit and comfort with both study contact lenses in the powers available;
7. Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;
8. Is willing to be awake for at least 2 hours before visit 2;
9. Is willing to not wear eye makeup on the day of visit 2 and 3;
10. Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;
11. Has a wearable pair of spectacles.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to sodium fluorescein dye;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has a known sensitivity to petroleum jelly (Vaseline);
10. Has epilepsy and/or a sensitivity to flashing lights;
11. Wears toric contact lenses;
12. Has any physical impairment that would interfere with holding the evaporimeter;
13. Has taken part in another research study within the last 14 days.

Primary outcomes:
measure: Tear Evaporation Rate With Nesofilcon A
timeFrame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
measure: Tear Evaporation Rate With Delefilcon A
timeFrame: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
References:
Clinical trial NCT03805269: Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration
Official title: Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 94
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: There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy.

The purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.

Detailed description: Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.

Eligibility criteria: Inclusion Criteria:

* ASA class I-II
* Age: \>18

Exclusion Criteria:

* patients of severe kidney \& liver dysfunction
* allergy of local anesthetics

Primary outcomes:
measure: post operative pain score
timeFrame: 4 hours after end of surgery
Secondary outcomes:
measure: post operative opioid consumption
timeFrame: 4 hours after end of surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Universuty, Bundang Hospital
state: Gyonggido
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung-hi Ryu, Dr.
role: STUDY_CHAIR
References: