louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01670253: Reduction of Starvation Time Prior to Gastroscopy
Official title: Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Habile Adult Patients Referred to the Elective Gastroscopy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective is to investigate whether intake of approximately 200 ml of sugary fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of fasting period for patients without reducing the quality of the study.

Current standard for fasting and fluid intake before gastroscopy is completely fasting 6 hours before the study. Studies in patients in general anesthesia has been found that it does not increase the risk of aspiration of stomach content during the operation by allowing the patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have examined the quality gastroscopy using this fasting procedure. Some studies show that intake of sugary liquids do not have significant effect on gastric emptying.

There are not deemed to be ethical problems with this study, as it seeks to show that a more lenient standard procedure in endoscopy is as safe as the established. The study is considered safe.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Sufficient knowledge of Danish to understand the written information
* legally competent patients

Exclusion Criteria:

* Patients with a history of pyloric stenosis (narrowing of the transition from stomach to the duodenum)
* Incapacitated patients
* Patients with daily vomiting.

Primary outcomes:
measure: Number of uncomplicated examinations
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 hour
Secondary outcomes:
measure: Reduction of discomfort for the patients according to the survey.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Odense University Hospital
name: Anton Bilenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01923753: A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Official title: A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Neural respiratory drive
Airway clearance technique
Expectoration
Positive expiratory pressure device
Lead sponsor: Actegy Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-16
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of CF (established by genotype or sweat sodium \>70mmol/l or sweat chloride of \>60 mmol/l
* Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics

Exclusion Criteria:

* Acute respiratory failure
* Haemodynamic instability (including severe right heart failure with hypotension)
* Current severe haemoptysis
* Ineffective cough
* Rib fractures
* Pregnancy
* Current or recent pneumothorax
* Epilepsy
* Current pulmonary embolism
* Oesophageal varices
* Recent thoracic upper gastro-intestinal tract or facial surgery
* Active tuberculosis
* Recent brain, eye, ear, ENT surgery
* Myocardial infarction
* Ascending aortic aneurysm
* Acute diarrhoea
* Pulmonary embolism
* Angina
* Severe hypertension (systolic \>200 mm Hg, diastolic \>120 mm Hg)
* Confusion/dementia
* Inability to give consent

Primary outcomes:
measure: Wet weight of sputum expectorated during treatment session
timeFrame: up to 30 minutes after treatment
Secondary outcomes:
measure: Change in FEV1
timeFrame: immediately before and up to 30 minutes after treatment
measure: Change in VC
timeFrame: immediately before and up to 30 minutes after treatment
measure: Change in oxygen saturation
timeFrame: continuously from 3 minutes prior to treatment and until 3 minutes after treatment
measure: Change in ventilation
timeFrame: 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
measure: Change in neural respiratory drive
timeFrame: 5 minutes prior to treatment and 30 minutes after treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital, Bessemer Road, Denmark Hill
Study officials:
affiliation: King's College Hospital NHS Trust
name: John Moxham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05735353: Sleep, Diet, Exercise and Older Persons
Official title: High-Speed Circuit Resistance Training vs. High-Speed Multidirectional Yoga on Changes in Cognition in Healthy Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Cognitive Decline
Keywords: Circuit Resistance Training
Yoga
Cognition
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the impacts of a cognitive yoga program and circuit resistance training on cognitive and physical performance with nutrition and sleep as modulating factors in healthy, older adults.


Eligibility criteria: Inclusion Criteria:

* Montreal Cognitive Assessment \> 23
* No memory loss complaints

Exclusion Criteria:

* Uncontrolled cardiovascular or neuromuscular disease that prevents participation in a training program
* Musculoskeletal impairments or injury that may impact exercise participation
* Visual or hearing impairments
* Neurological disease
* Stroke

Primary outcomes:
measure: Changes in Executive Function
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Changes in Nutritional Status
timeFrame: Baseline, 16 weeks.
measure: Changes in Sleep Quality as measured by the Pittsburg Sleep Quality Index
timeFrame: Baseline, 16 weeks.
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Laboratory of Neruomuscular Research and Active Aging
state: Florida
Study officials:
affiliation: University of Miami
name: Joseph Signorile, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04792853: Tablet-based Cognitive Behavioral Intervention for Older Adults With Arthritis Fatigue
Official title: Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Fatigue
Keywords: arthritis
fatigue
cognitive behavioral therapy
group education
older adults
tablet
simple walking
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study uses an experimental pre- and post-test repeated measures design. Those satisfying the inclusion and exclusion criteria are randomly assigned to the intervention (Tab-G, n=20) or comparison group (n=20).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this project is to pilot test a long-term effect of Tab-G (tablet-based cognitive behavioral group education intervention). The investigators will evaluate the effect of Tab-G, relative to usual care group, on (a) daily steps, (b) fatigue level, (c) self-efficacy and (d) quality of life.

Tab-G participants will receive 4 weekly CBT-based group education focusing on shared goal setting and mutual reinforcement in a group with 5 members. The outcomes will be measured baseline, week 4 (intervention completion) and week 8 (follow-up). The investigators hypothesize that older adults receiving Tab-G will have greater improvements on outcomes compared to those receiving usual care at week 4, the intervention completion and at week 8 follow-up.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of osteoarthritis or rheumatoid arthritis;
2. presence of greater than minimal fatigue scoring ≥13 (T-score\>55) on the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0-Fatigue 6a; and
3. having Wi-Fi at home

Exclusion Criteria:

1. currently engaging in regular exercise;
2. non-ambulatory or presence of a condition that would limit the ability to walk (e.g., foot deformity, lower extremity joint surgery in past 6 months, stroke, severe chronic obstructive pulmonary disease, etc.); and
3. delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog.

Primary outcomes:
measure: daily steps
timeFrame: 24 hours
measure: BRICS NINR PROMIS Fatigue Short Form 6a
timeFrame: past 1 week
measure: Self-Efficacy for Managing Chronic Disease 6-Item Scale
timeFrame: 24 hours
measure: Quality of Life-Rheumatoid Arthritis Scale
timeFrame: past 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Jeungok Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762653: Morphological Pancreatic Features in Diabetes Mellitus Type 2
Official title: Morphological Features of the Pancreas in Patients With Type 2 Diabetes Mellitus: Correlation With Clinical Features of the Disease.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Keywords: pancreatic fibrosis
endoscopic ultrasound
elastography
fecal elastase
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult diabetic (patients) and nondiabetic (controls) undergoing endoscopic ultrasound for indications other than evaluation of the pancreas due to suspected or known pancreatic disease.

Brief summary: Hypothesis: Type 2 diabetes mellitus is associated with pancreatic fibrosis that can be evaluated by minimally invasive imaging techniques. That fibrosis is associated with alteration of exocrine pancreatic function, defined as a reduced secretion of pancreatic enzymes and the development of nutritional deficiencies.

To test that hypothesis, a prospective, observational, cross-sectional, comparative, case-control study has been designed.

Pancreatic fibrosis will be evaluated by endoscopic ultrasound and quantitative elastography in cases (type-2 diabetes) and age-gender-matched controls without diabetes.

Pancreatic function will be explored by fecal elastase test and nutritional evaluation.

Calculated sample size is 94 patients (47 cases and 47 controls). Study period is 2 years.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years.
* Undergoing an upper endoscopic ultrasound for any indication other than pancreatic disease.
* Signed informed consent-
* Patients: Previous diagnosis of type-2 diabetes mellitus.
* Controls: Nondiabetic subjects, matched by age, gender, alcohol consumption, and smoking with patients.

Exclusion Criteria:

* History of pancreatic disease or surgery.
* History of upper gastrointestinal surgery.
* Diabetes type other than type-2.
* Severe cardiovascular or respiratory disease.
* Lack of informed consent.

Primary outcomes:
measure: Degree of pancreatic fibrosis
timeFrame: Day 1
measure: Degree of impairment of exocrine pancreatic function
timeFrame: Up to 7 days
Secondary outcomes:
measure: Prevalence of pancreatic atrophy
timeFrame: Day 1
measure: Factors associated with pancreatic fibrosis
timeFrame: Day 1
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: A Coruña
Study officials:
affiliation: University Hospital of Santiago de Compostela, Spain
name: J. Enrique Dominguez-Munoz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01249053: Expression of Optic Atrophy Type 1 (OPA1) Protein in Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Keywords: OPA1
lung adenocarcinomas
Prognosis
Expression of optic atrophy type 1 (OPA1) protein in lung adenocarcinoma
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between January 2006 and December 2008, we will retrospectively enroll 100 consecutive LADC patients who were admitted to the Department of Thoracic Surgery of China Medical University Hospital.

Brief summary: Optic atrophy type 1(OPA1) is a nuclear dynamin-related GTPase, targeted to the inner mitochondrial membrane, which plays a role in mitochondrial fusion. Mitochondria fusion is associated with process of apoptosis. . OPA1 plays an important role in the mitochondrial bioenergetics and mitochondrial networks. The changes in mitochondrial shape and mitochondrial bioenergetics may be cause of the disease. In this study, we investigate the expression of OPA1 in lung adenocarcinoma (LADC) cells and tissue.


Eligibility criteria: Inclusion Criteria:

* We will collect paraffin blocked resected lung tissue samples from stage I\~IIIa non-small cell lung cancer patients (age, 40\~80 years old) who received lobectomy of the affected lung.

Exclusion Criteria:

* History of uremia, other malignant disease, and liver cirrhosis
* History of pneumonia and pulmonary tuberculosis
* History of long period of medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Fang Hsin Yuan
Study officials:
References:
Clinical trial NCT04192253: Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Official title: Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced, Squamous Cell Carcinoma of the Vulva
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
Primary purpose: TREATMENT

Brief summary: Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive thereby diminishing the chance for morbidity.

Detailed description: Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but frequently causes invalidating and chronic postoperative morbidity, especially in patients with high stage disease. Theoretically, downstaging with neoadjuvant chemotherapy could shrink the tumour, making surgical treatment less extensive, thereby diminishing the chance for morbidity.

Eligibility criteria: Inclusion Criteria:

* Woman k 18 years
* Signed and written informed consent.
* Histologically confirmed squamous cell vulvar carcinoma
* World Health Organization performance status of 0-2
* Adequate hematological function
* Adequate hepatic function
* Adequate renal function
* Negative pregnancy test for woman of childbearing potential
* measurable disease by physical examination
* TNM stage T2, any N, MO

Exclusion Criteria:

* Vulvar cancer other than squamous cell carcinoma at biopsy
* Previous radiotherapy of the vulva, groins or pelvis
* Patients with metastasis limited to the pelvic lymph nodes, who can be primarily operated with curative intent
* Other diagnosis of malignancy or evidence of other malignancy for 5 years before screening for this study

Primary outcomes:
measure: tumour size change by neoadjuvant chemotherapy
timeFrame: 18 weeks
Secondary outcomes:
measure: avoidance of exenterative or invalidating surgery
timeFrame: 21 weeks
measure: Chemotherapy related morbidity
timeFrame: 21 weeks
measure: overall survival
timeFrame: 5 years after treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI-AVL
Study officials:
affiliation: NKI-AvL
name: Frederic Amant, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289453: Phacoemulsification in Acute Congestive Glaucoma
Official title: Phacoemulsification in Acute Congestive Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute primary angle closure (APAC) is usually caused by an abrupt closure of the trabecular meshwork in the anterior chamber angle that leads to a sudden rise in intraocular pressure (IOP). APAC is a subgroup of angle closure disease characterised by a sudden onset of headache, blurred vision, seeing halos around lights, corneal oedema, mid-dilated pupil, eye pain and redness. Asian also has a much higher incident rate of APAC compare to the Caucasian population - with the crude incidence rate of 12.2 and 10.4 per 100,000 people per year in the above 30-year-old population of Singapore and Hong Kong, respectively . This is higher than the average incidence rate of 3.9-4.1 cases per 100,000 people per year in the European regions .

In APAC, both LPI and primary lens extraction by phacoemulsification and intraocular lens implant (phaco/IOL) were demonstrated to be effective to control IOP elevation. The latter has been shown to be the more effective treatment than LPI for IOP reduction at the early and mid-term IOP control. Together with the advancement of phaco/IOL technique, primary lens extraction is the more popular choice of treatment nowadays. However, operating on an eye with early aborted APAC is technically challenging and may increase the risk of complications because of the presence of corneal oedema, inflammation, shallow anterior chamber, floppy iris and unstable lens. Furthermore, "the best time window" for performing lens extraction after an APAC attack remains uncertain. The long-term results (e.g. more than 5 years) of early lens extraction compared to the conventional LPI are also unknown. In this study, we summarise the approach of treating APAC at the initial acute stage and review the studies that consider IOP control in the mid and long term. We would also touch on the role of goniosynechialysis, trabeculectomy and endoscopic cyclophotocoagulation in treating APAC, as well as considering the economic aspect of treatment.

Aim of the study: to evaluate the safety and efficacy of phacoemulsificatiojn in cases of acute congestive glaucoma


Eligibility criteria: Inclusion Criteria:

* patients with acute congestive glaucoma

Exclusion Criteria:

* people under 18 years

Primary outcomes:
measure: iop control
timeFrame: 3 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Hany Mahmoud
Study officials:
References:
Clinical trial NCT06675253: Perioperative Fluid Therapy from the Perspective of an Anesthesiologist
Official title: Perioperative Fluid Therapy from the Perspective of an Anesthesiologist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Care
Keywords: Fluid therapy
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 913
Sex: ALL
Minimum age (years): 26
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: survey study conducted among doctors

Brief summary: A survey conducted in 2022 in ,,Medycyna Praktyczna'' magazine, publishing house regarding fluid therapy in hospital wards showed that many recommendations regarding proper fluid therapy have become common practice, but there are still a significant number of practices established over the years that differ significantly from the principles of good clinical practice

Detailed description: In the period August 28, 2021- April 15, 2022, two online surveys were conducted among anesthesiologists in the ,,Practical Medicine'' magazine, asking about the principles they follow when conducting PFT(Perioperative Fluid Therapy).

Eligibility criteria: Inclusion Criteria:

* medical physician

Exclusion Criteria:

* no medical physician

Primary outcomes:
measure: evaluation of clinical practice
timeFrame: 8 months from the publication of the survey
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: University Clinical Center
Study officials:
References: