louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05996146: Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
Official title: Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hoarseness
Keywords: hoarseness
spine surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 427
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age range is 20 to 80 years old. Patients who require surgical treatment for degenerative spine conditions and visit at Seoul National University Hospital. Patients who voluntarily consent to participate in the study

Brief summary: Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.

Detailed description: The primary outcome of this study is the incidence of hoarseness on the day of surgery.

The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.

Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Age range is 20 to 80 years old
* degenerative spine conditions
* visit at Seoul National University Hospital only
* Patients who voluntarily consent to participate in the study

Exclusion Criteria:

* History of surgery around the airway or mediastinum
* patients with vocal cord-related disorders
* Patients with fractures, bleeding, or other trauma
* Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
* Patients who cannot be extubated or who are transferred to the ICU after surgery
* Pregnant women
* Patients who do not wish to participate in the study

Primary outcomes:
measure: the primary outcome was to measure the incidence of hoarseness
timeFrame: voice recordings six hours after the end of anesthesia
Secondary outcomes:
measure: The secondary outcome involved measuring the incidence of hoarseness one month after the surgery
timeFrame: one month after the surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Neurosurgery, Seoul National University Hospital, Republic of Korea.
name: SUM KIM, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01542346: Subcutaneous Adaption and Cosmetic Outcome Following Caesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Delivery
Keywords: Wound closure
cosmetic outcome
Lead sponsor: Klinikum Klagenfurt am Wörthersee
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double blinded randomized study investigating if subcutaneous adaption has an impact on cosmetic outcome after Caesarean delivery.


Eligibility criteria: Inclusion Criteria:

* women undergoing cesarean section for any indication
* literate in german language

Exclusion Criteria:

* history of keloids
* previous transversal suprapubic scars
* known patient hypersensitivity to any of the suture materials used in the protocol
* a medical disorder that could affect wound healing (eg, diabetes mellitus, chronic corticosteroid use)

Primary outcomes:
measure: Objective and subjective cosmetic appearance
timeFrame: after 6 months
Secondary outcomes:
measure: Surgical site infection and wound breakdown
timeFrame: within 30 days after surgery
measure: Haematoma
timeFrame: within 5 days after surgery
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Woerthersee
state: Carinthia
Study officials:
affiliation: Klinikum Klagenfurt am Woerthersee and Medical University Vienna
name: Heinrich Husslein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Husslein H, Gutschi M, Leipold H, Herbst C, Franz M, Worda C. Suture Closure versus Non-Closure of Subcutaneous Fat and Cosmetic Outcome after Cesarean Section: A Randomized Controlled Trial. PLoS One. 2014 Dec 10;9(12):e114730. doi: 10.1371/journal.pone.0114730. eCollection 2014.
Clinical trial NCT03467646: Long-term Follow up After SG vs RYGB vs OAGB
Official title: Long-term Follow up After Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: A Comparative Study of Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Weight Loss
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

Detailed description: A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) \>40 Kg/m2
* BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
* age older than 18 years
* Patients willing to participate in the study and giving their written consent

Exclusion Criteria:

* patients undergoing other bariatric techniques than SG, RYGB and OAGB
* Patients undergoing any other surgical procedure added to the bariatric surgery
* patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
* inability to understand the nature and purpose of the study and / or to accept written participation in the study
* impossibility to comply with pre-established clinical follow-up.

Primary outcomes:
measure: Weight loss
timeFrame: 1 , 2 and 5 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centro de Tratamiento de la Obesidad
name: Miguel Angel Carbajo
role: STUDY_DIRECTOR
References:
citation: Ruiz-Tovar J, Carbajo MA, Jimenez JM, Castro MJ, Gonzalez G, Ortiz-de-Solorzano J, Zubiaga L. Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities. Surg Endosc. 2019 Feb;33(2):401-410. doi: 10.1007/s00464-018-6307-9. Epub 2018 Jun 25.
Clinical trial NCT05712746: Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.
Official title: Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 1600
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 in Japan with volume overload in heart failure who are planned to be newly started on Samtasu therapy

Brief summary: To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* patients with a known hypersensitivity to Tolvaptan sodium phosphate or Tolvaptan

Primary outcomes:
measure: Safety information (Adverse Event)
timeFrame: 14 days from the initiation of tolvaptan sodium phosphate treatment
measure: Number of Special Situations
timeFrame: 14 days from the initiation of tolvaptan sodium phosphate treatment
measure: Number of off-Label Use
timeFrame: 14 days from the initiation of tolvaptan sodium phosphate treatment
measure: Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
timeFrame: 14 days from the initiation of tolvaptan sodium phosphate treatment
measure: Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
timeFrame: 14 days from the initiation of tolvaptan sodium phosphate treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Pharmacovigilance Department
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yasuhiko Fukuta, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03523546: Oncology Episode Payment Model in Hawaii
Official title: Oncology Episode Payment Model in Hawaii
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colon Cancer
Lung Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Hawaii Medical Service Association
First posted: 2018-05-14
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The HMSA Cancer Episode Payment Model (CEM) is a payment model designed to test the effects of better care coordination on health outcomes and costs of care for Hawaii Medical Services Association (HMSA) members with cancer who receive chemotherapy.

Detailed description: The CEM is designed to improve community health, to improve care coordination, quality, and appropriateness of care, to improve patient experience, and to implement a value-based incentive structure that appropriately rewards oncologists for cost-savings and sustained of improved quality of care.

Eligibility criteria: Inclusion Criteria:

* Any oncologist who practices with Hawaii Oncology and is a participating provider.

Exclusion Criteria:

* Any provider who does not practice with Hawaii Oncology.

Primary outcomes:
measure: Composite quality score
timeFrame: 1 year
measure: Episode cost
timeFrame: 6 months
measure: Utilization of acute and specialty care
timeFrame: 6 months
Secondary outcomes:
measure: Quality of care at end of life
timeFrame: 6 months
measure: Survival
timeFrame: one year
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Hawaii Oncology
state: Hawaii
Study officials:
References:
Clinical trial NCT04499846: Educational Intervention Targeting Statin Therapy and Compliance in Diabetic Patients
Official title: Can Educational Intervention Targeting Statin Therapy Improve Compliance in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type II Diabetes
Keywords: Diabetes
Compliance
Statin
Education
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients hospitalized in the diabetes day hospitals of the Saint Philibert or Saint-Vincent hospitals (Lille, France)

Brief summary: The objective of the study is to measure changes in compliance to statin therapy in patients with type 2 diabetes after an educational intervention. This intervention is part of the therapeutic education of the diabetic patient, carried out throughout the follow-up of his/her diabetes.


Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* Type 2 diabetes
* Following treatment with statins
* Hospitalization in the diabetes day hospitals of the Saint Philibert or Saint Vincent Hospitals (Lille, France).
* Ability to answer the Girerd test in both interviews (in the individual interview and by phone)
* Patient informed to participate in the study
* Signed patient's consent.

Exclusion Criteria:

* Patients under guardianship

Primary outcomes:
measure: Compliance rate to the statin treatment
timeFrame: 3 months
Secondary outcomes:
measure: Compliance rate to the statin treatment according to schedule of drug intake
timeFrame: 3 months
measure: Compliance rate to the statin treatment according to treatment duration.
timeFrame: 3 months
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hôpital Saint-philibert
state: Nord Pas De Calais
Study officials:
affiliation: GHICL
name: François Delecourt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01717846: Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis
Official title: In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Apoptotic DNA Damage
Rheumatoid Arthritis
T-cell Lymphocytosis
Keywords: Apoptosos
Rheumatoid Arthritis
T cells, B cells
DAS28
Clinical Disease activity Index
CDAI
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2012-10-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.

Detailed description: Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis (RA) patient's cells. To date, no studies have been performed to evaluate the effect of Orencia on apoptosis in RA patients.

Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.

Secondary: To evaluate the association between the changes in apoptosis to changes in disease activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of abatacept.

Eligibility criteria: Inclusion Criteria:

1. Over age 18
2. Meeting ACR Criteria 1987 for RA diagnosis
3. Naïve to treatment with abatacept
4. Must be able to understand information in the Informed Consent

Exclusion Criteria:

1. Pregnancy or breast feeding
2. Previous exposure to abatacept.
3. History of a concomitant autoimmune disease (eg. SLE, PsA etc.)
4. Patients with history of cancer

Primary outcomes:
measure: To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points
timeFrame: Base line, 3 and 6 months
Secondary outcomes:
measure: To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points
timeFrame: Baseline, 3 and 6 months
Other outcomes:
measure: To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.
timeFrame: Baseline, 3 and 6 months
Locations:
city: Los Angeles
country: United States
facility: Univerity of California at Los Angeles
state: California
Study officials:
affiliation: University of California at Los Angeles, UCLA
name: Ram P Singh, MS, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at Los Angeles (UCLA)
name: Mihaela Taylor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02301546: Cognitive Training and Practice Effects in Mild Cognitive Impairment
Official title: Cognitive Training and Practice Effects in Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-11-26
Enrollment: 197
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study will test the effectiveness of a computerized cognitive training program on auditory memory and attention in patients with mild cognitive impairment. Practice effects will also be examined as a moderator of treatment response.

Detailed description: The current study will test the effectiveness of a computerized cognitive (thinking) training program on improving thinking and memory in patients with mild cognitive impairment. The investigators will also examine how short term changes in thinking abilities (i.e., practice effects) can be related to improvement in thinking abilities after the cognitive training program.

Eligibility criteria: Inclusion Criteria:

* Mild Cognitive Impairment, amnestic subtype

  * 65 years of age or older
  * Availability of a knowledgeable informant
* Access to internet 3 hours per week
* Adequate vision, hearing, and motor responding to participate in training

Exclusion Criteria:

* History of major stroke, head injury with loss of consciousness of \>30 minutes, or other neurological disorder or systemic illness that are thought to be affecting cognition (e.g., seizure disorder, demyelinating disorder, etc.)
* Current or past major psychiatric illness (e.g., schizophrenia, bipolar affective disorder)
* History of substance abuse
* Current use of antipsychotics or anticonvulsant medications
* Currently residing in a nursing home or other skilled nursing facility

Primary outcomes:
measure: Auditory Memory Attention Index
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Center for Alzheimer's Care, Imaging and Research
state: Utah
Study officials:
affiliation: University of Utah
name: Kevin Duff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duff K, Ying J, Suhrie KR, Dalley BCA, Atkinson TJ, Porter SM, Dixon AM, Hammers DB, Wolinsky FD. Computerized Cognitive Training in Amnestic Mild Cognitive Impairment: A Randomized Clinical Trial. J Geriatr Psychiatry Neurol. 2022 May;35(3):400-409. doi: 10.1177/08919887211006472. Epub 2021 Mar 30.
Clinical trial NCT01356446: Checklist Application and Mortality
Official title: Impact of the Surgical Checklist on 30-day and 90-day Mortality in Elective Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mortality
Outcome
Keywords: safety
team
team performance
surgery
outcome
Lead sponsor: Regional Hospital of Bolzano
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study investigates the impact of the implementation of a surgical checklist on the mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is performed in a single tertiary care center. The study is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").


Eligibility criteria: Inclusion Criteria:

* elective surgery in general or regional anesthesia lasting \> 15 min

Exclusion Criteria:

* urgent / emergent surgery

Primary outcomes:
measure: Change in over all mortality
timeFrame: within 90 days
Secondary outcomes:
measure: change in over all mortality
timeFrame: within 30 days
Other outcomes:
Locations:
city: Bolzano
country: Italy
facility: Bolzano Central Hospital
Study officials:
affiliation: Central Hospital Bolzano, Italy
name: Matthias Bock, MD
role: PRINCIPAL_INVESTIGATOR
References: