louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01152879: Home Parenteral Nutrition in Cancer Patients
Official title: An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Parenteral Nutrition
Quality of Life
Lead sponsor: Southwestern Regional Medical Center
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 100
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: Patient who are candidates for HPN will be identified by the Nutrition and Metabolic Support Team. Patients will be appropriate for HPN as indicated by a safe home environment, readiness for discharge, and reimbursement for the therapy at home. Candidates for HPN include: Patients will a nonfunctioning gastrointestinal tract. Patients that are moderately or severely malnourished (SGA B or C) with aniticipated deterioration in nutritional status due to aggressive treatment. Patients who have failured enteral feedings for nutrition support. Patients with life expectancy of greater than 3 months.

Brief summary: This study is being done to examine the effect of Parenteral (intravenous) nutrition support in the home setting on quality of life in cancer patients. In addition, this study is being done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea medication.

Detailed description: This is a prospective descriptive non-randomized clinical study to examine quality of life outcomes and use of pain and anti-emetic therapy for patients receiving HPN support. The EORTC QLQ-C30 will be used to evaluate quality of life. All subjects will be monitored monthly throughout the course of treatment for a minimum of 3 months and a maximum of 1 year.

Eligibility criteria: Inclusion Criteria:

* Patients with a cancer diagnosis who have been receiving parenteral nutrition in the hospital or have started on HPN while at Cancer Treatment Centers of America and meet the criteria for home parenteral nutrition.
* Patient expected to have a life expectancy of greater than 90 days post discharge.

Exclusion Criteria:

* Patients less than 18 years of age
* HPN patients who do not receive nutrition assessment and follow-up by the Coram Healthcare nutrition support team
* Refuse to participate

Primary outcomes:
measure: Quality of Life
timeFrame: Monthly for a minimum of 3 months to a maximum of 12 months
Secondary outcomes:
measure: Pain and nausea medication usage
timeFrame: Monthly for a minumum of 3 months to a maximum of 12 months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America at Southwestern Regional Medical Center
state: Oklahoma
Study officials:
affiliation: Cancer Treatment Centers of America at Southwestern Regional Medical Center
name: Ross Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04219579: Antithrombin III Concentrate After Liver Transplantation
Official title: Continuous Versus Intermittent Infusion of Human Antithrombin III Concentrate in the Immediate Postoperative Period After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant; Complications
Keywords: antithrombin III
liver transplantation
administration method
dosage
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to demonstrate more effective administration method of AT-III in immediate post-liver transplantation period.

Detailed description: Antithrombin III(AT-III) concentrates have been used to prevent critical thrombosis in the immediate post-liver transplantation period without clear evidence regarding the optimal dose or administration scheme.

The investigators retrospectively analyzed the clinical data from the patients who received liver transplantation and developed pharmacokinetic model of AT-III in the previous research. According to this study, optimal AT-III activity level will be well-maintained with smaller dose with continuous infusion than with intermittent infusion which is widely accepted way of administration currently.

A prospective study was planned to show the more effective manner of AT-III concentrate administration after liver transplantation.

Eligibility criteria: Inclusion Criteria:

* Scheduled operation
* Living donor liver transplantation
* Adult patients (\>=18 years old)

Exclusion Criteria:

* Patients under 18 years old
* Emergency operation
* Deceased donor liver transplantation

Primary outcomes:
measure: Proportion of patients within target range at postoperative 72 hours
timeFrame: 72 hours after liver transplantation
Secondary outcomes:
measure: Proportion of patients within target range at postoperative 12/24/48/84 hours
timeFrame: 12/24/48/84 hours after liver transplantation
measure: Proportion of AT-III level values within target range
timeFrame: 12/24/48/72/84 hours after liver transplantation
measure: Time required for AT-III level value to fall within target range
timeFrame: operation day ~ postoperative day 7
measure: Duration for cessation of AT-III concentrate administration
timeFrame: operation day ~ postoperative day 7
measure: Bleeding requiring intervention
timeFrame: operation day ~ postoperative day 7
measure: Thrombosis event
timeFrame: operation day ~ postoperative day 7
measure: Postoperative hospital stay
timeFrame: through the hospital day, an average of 14 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ho Geol Ryu, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01811979: Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination for Retinopathy of Prematurity
Official title: Efficacy of Oral Sucrose and Topical Anesthetics to Reduce Pain During Eye Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Investigate the Efficacy of Sucrose During Eye Examination
Keywords: eye examination, oral sucrose, premature infant pain scale
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Detailed description: Oral sucrose reduces pain during heel sticks and venipunctures in preterm infants. Administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates.The purpose of this study was to determine the effectiveness of local anesthetic eye drops and a pacifier, plus repeated doses of 24% sucrose, to relieve pain associated with eye examinations for retinopathy of prematurity.

Eligibility criteria: Inclusion Criteria:

-VLBW infants \<32 weeks of gestational age

Exclusion Criteria:

* infants \>32 weeks of gestational age
* neuromuscular abnormality
* major abnormality

Primary outcomes:
measure: Premature Infant Pain Profile
timeFrame: two hours
Secondary outcomes:
measure: Crying time
timeFrame: two hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr Sami Ulus Children Hospital
Study officials:
affiliation: MD
name: Eda Ç İlarslan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD001069. doi: 10.1002/14651858.CD001069.pub4.
citation: Dilli D, Ilarslan NE, Kabatas EU, Zenciroglu A, Simsek Y, Okumus N. Oral sucrose and non-nutritive sucking goes some way to reducing pain during retinopathy of prematurity eye examinations. Acta Paediatr. 2014 Feb;103(2):e76-9. doi: 10.1111/apa.12454. Epub 2013 Nov 11.
Clinical trial NCT06246279: Disease Management in Adolescents With Type 1 Diabetes
Official title: The Effect of the Education Program Prepared in Line With Transition Theory on Adaptation to Adolescence and Disease Management in Adolescents With Type 1 Diabetes: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: type1diabetes
Adolescent Behavior
Self Efficacy
Keywords: Type 1 Diabetes
Transition Theory
Diabetes Management
Pediatric Nurse
Randomized Controlled Trial
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adolescence period; It is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. Adolescence is a predictable developmental transition period for the individual. They also encounter unpredictable situations (such as childhood illnesses). One of these conditions is Type 1 Diabetes Mellitus, which is the most common metabolic endocrine system disease in adolescents. Type 1 diabetes is an important health/disease transition in the life of a child and adolescent. Therefore, this study aimed to determine the effect of the "Adaptation to Adolescence and Type 1 Diabetes Management Training Programme", prepared in line with Meleis's Transition Theory, on the adolescent's developmental transition adaptation, self-efficacy for diabetes management and glycemic control.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with type 1 diabetes in the last 6 months
* HbA1c level \>7.5

Exclusion Criteria:

* presence of a diagnosis of intellectual disability, autism spectrum disorder and psychotic disorder

Primary outcomes:
measure: Reynolds Adjustment Screening Inventory for Adolescents
timeFrame: This scale was administered three times at beginning, 3rd and 6th months.
Secondary outcomes:
measure: Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
timeFrame: This scale was administered three times at beginning, 3rd and 6th months.
measure: Glycemic Control - Hemoglobin A1C
timeFrame: This scale was administered three times at beginning, 3rd and 6th months.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz Univercity
Study officials:
affiliation: Akdeniz Univercity
name: Ceren Calik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03358979: Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)
Official title: Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Conjunctival Diseases
Dry Eye Syndromes
Keywords: Conjunctival Diseases
Dry Eye Syndromes
Antigens
CD147
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe eye dryness will be compared with persons without eye dryness.

Brief summary: Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.


Eligibility criteria: Patients:

Inclusion criteria

* 18 years and over
* Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop (2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, Tear Break Up Time ≤ 5 seconds (fluorescein test) Schirmer's test score without anesthesia ≤ 5mm at 5 minutes

Exclusion criteria

* Treatment with topical ciclosporin
* Autologous serum treatment
* Wearer of scleral lenses
* Known pregnancy or breastfeeding

Control subjects:

Inclusion criteria

* 18 years and over
* Tear Break Up Time \> 5 seconds (fluorescein test)

Exclusion criteria

* Wearer of contact lenses
* Functional ocular signs
* Anomalies of the ocular surface observed during examination with the slit lamp
* Fluorescein staining of the ocular surface (cornea, conjunctiva)
* Topical ocular treatment
* Known pregnancy or breastfeeding

Primary outcomes:
measure: comparison of surface area of cell markers measured on conjunctival epithelial cells, in persons with and without severe eye dryness.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Eric GABISON
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03794479: Intestinal Microbiota and Antimicrobial Resistance in Hong Kong Residents After Travel
Official title: Changes in Intestinal Microbiota and Acquisition of Antimicrobial Resistance in Hong Kong Residents After Travel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antimicrobial Resistance
Keywords: Intestinal microbiota
Antimicrobial resistance
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 125
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: Adults planning for travel

Brief summary: International travel is well reported to be associated with acquisition of multidrug-resistant organisms, however, the impact of colonization of these multidrug-resistant organisms is currently uncertain. As colonization of multidrug-resistant organisms had been demonstrated to be associated with distinct intestinal microbiota composition and travellers constitute a generally healthy population with minimal antibiotics exposure; by evaluating serial stool samples before and after travel, the investigators can delineate a potential causal relationship between host intestinal microbiota and subsequent risk of acquisition of multidrug-resistant organisms.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or above
* Chinese ethnicity
* Planning to visit any places outside of Hong Kong within the next three months
* Able to provide informed consent

Exclusion Criteria:

* Use of antibiotics within 4 weeks prior to the time of recruitment (Except for antimalarial prophylaxis)
* Hospitalization within 3 months
* Underlying gastrointestinal diseases, including gastrointestinal malignancy, inflammatory bowel disease, resection of small or large bowel
* Pregnancy

Primary outcomes:
measure: Proportion of patients acquiring intestinal colonization of ESBL-producing Enterobacteriaceae
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients acquiring intestinal colonization of carbapenem-resistant Enterobacteriaceae
timeFrame: 1 year
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT04688879: Thrombolysis With Intra-arterial Urokinase
Official title: Thrombolysis With Intra-arterial Urokinase for Acute Superior Mesenteric Artery Occlusion: Outcome Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Occlusion Mesenteric Artery Superior
Keywords: intra-arterial urokinase
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 13
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: 13

Brief summary: Patients with acute superior mesenteric artery (SMA) occlusion were included in this study. The clinical presentation and effect of the recanalization of the SMA was analyzed on follow-up angiography.

Detailed description: Thirteen patients with acute SMA occlusion who underwent intra-arterial urokinase thrombolysis between 2008 and 2020 were retrospectively evaluated.

Clinically, the abdominal pain and the effect of the SMA on angiography will be compared in response and non-response groups.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of SMA occlusion

Exclusion Criteria:

* shock in the triage screening
* peritonitis
* 3. intramural gas, mesenteric or portal venous gas on contrast-enhanced abdominal CT

Primary outcomes:
measure: Thrombolysis with intra-arterial urokinase for acute superior mesenteric artery occlusion: Outcome analysis
timeFrame: Daily series follow-up angiography in the next 72 hours after thrombolysis with intra-arterial urokinase.
Secondary outcomes:
Other outcomes:
Locations:
city: TaoYuan City
country: Taiwan
facility: Chang Gung memorial Hospital
Study officials:
affiliation: Chang Gung Hospital
name: Being-Chuan Lin
role: STUDY_DIRECTOR
References:
citation: Bala M, Kashuk J, Moore EE, Kluger Y, Biffl W, Gomes CA, Ben-Ishay O, Rubinstein C, Balogh ZJ, Civil I, Coccolini F, Leppaniemi A, Peitzman A, Ansaloni L, Sugrue M, Sartelli M, Di Saverio S, Fraga GP, Catena F. Acute mesenteric ischemia: guidelines of the World Society of Emergency Surgery. World J Emerg Surg. 2017 Aug 7;12:38. doi: 10.1186/s13017-017-0150-5. eCollection 2017.
citation: Bjornsson S, Bjorck M, Block T, Resch T, Acosta S. Thrombolysis for acute occlusion of the superior mesenteric artery. J Vasc Surg. 2011 Dec;54(6):1734-42. doi: 10.1016/j.jvs.2011.07.054. Epub 2011 Sep 1.
citation: Tilsed JV, Casamassima A, Kurihara H, Mariani D, Martinez I, Pereira J, Ponchietti L, Shamiyeh A, Al-Ayoubi F, Barco LA, Ceolin M, D'Almeida AJ, Hilario S, Olavarria AL, Ozmen MM, Pinheiro LF, Poeze M, Triantos G, Fuentes FT, Sierra SU, Soreide K, Yanar H. ESTES guidelines: acute mesenteric ischaemia. Eur J Trauma Emerg Surg. 2016 Apr;42(2):253-70. doi: 10.1007/s00068-016-0634-0.
Clinical trial NCT04653779: A Clinical Trial to Evaluate the Preference Regarding Convenience of Medication and Efficacy/Safety of SUGAMET®XR Tablet 5/1000mg
Official title: A Multi-center, Open-label, Single-arm, Phase IV Clinical Trial to Evaluate the Preference Regarding Convenience of Medication, Efficacy and Safety After Switching to SUGAMET®XR Tablet 5/1000mg in Patients With Type 2 Diabetes and Renal Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Renal Disease
Diabetes Mellitus
Metabolic Disease
Endocrine System Diseases
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-04
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases


Eligibility criteria: Inclusion Criteria:

* Aged ≥60 years
* Subjects with type 2 diabetes mellitus
* Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
* Subjects with HbA1c≤7.5% at screening
* Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
* Subjects with fasting glucose≤200 at screening
* Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening

Exclusion Criteria:

* Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
* ESRD or Patients who have kidney dialysis
* Subjects with ALT and AST 3 times or higher than upper normal range

Primary outcomes:
measure: The preference regarding convenience of medication
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in HbA1c (%) After 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in HbA1C response rate(%) After 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in Glycated albumin After 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in e-GFR After 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in UACR After 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in HbA1c (%) After 12 weeks NAG
timeFrame: 12 weeks
measure: Change from baseline in Nephrin After 12 weeks
timeFrame: 12 weeks
measure: Change from baseline in Cystatin-C After 12 weeks
timeFrame: 12 weeks
measure: TSQM-9 scores
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Suncheonhyang Bucheon Hospital
state: Gyeonggi
city: Bucheon
country: Korea, Republic of
facility: Se-jong hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT00591279: Cancer Control Following Polypectomy
Official title: Cancer Control Following Polypectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: large bowel cancer
polyps
colorectal cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Mount Sinai Hospital, New York
name: Minneapolis Veterans Affairs Medical Center
name: Medical College of Wisconsin
name: St. Lukes hospital in Racine, Wiscousin
name: Massachusetts General Hospital
name: Cedars-Sinai Medical Center
name: Valley Presbyterian Hospital
First posted: 2008-01-11
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing colorectal cancer screening

Brief summary: This study evaluates strategies for the surveillance of post-polypectomy patients for the control of bladder cancer


Eligibility criteria: Inclusion Criteria:

* referral for colonoscopy or
* referral for proctoscopy or for a complete colonoscopy after a proctoscopy or flexible sigmoidoscopy

Exclusion Criteria:

* prior history of colon cancer, unrelated polypectomy, inflammatory bowel disease, family history of familial polyposis

Primary outcomes:
measure: evaluate strategies for the surveillance of post-polypectomy patients
timeFrame: 6 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: Sidney Winawer, MD
role: PRINCIPAL_INVESTIGATOR
References: