louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04334421: APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
Official title: APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Abdominoperineal Resection
Wound Heal
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All study patients who have abdominoperineal resection

Brief summary: Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.

Previous studies on synthetic mesh repair on perineum are almost lacking.

Detailed description: The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.

30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.

Eligibility criteria: Inclusion Criteria:

* Abdominoperineal resection and permanent colostoma

Exclusion Criteria:

* Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
* Potentially curable resection not possible
* Patient undergoing emergency procedure
* Metastatic disease
* Pregnant or suspected pregnancy

Primary outcomes:
measure: Comprehensive Complication index
timeFrame: 30 days
Secondary outcomes:
measure: Surgical site infection
timeFrame: 30 days
measure: Reoperation rate
timeFrame: 30 days
measure: Operative time
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Costs
timeFrame: 30 days
measure: Total perineal healing time
timeFrame: 30 days
measure: Perineal sinus
timeFrame: 30 days
measure: Perineal hernia
timeFrame: 12 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Elisa Mäkäräinen-Uhlbäck, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00282321: High-protein and High-carbohydrate Diets' Effect on Urinary Concentrating Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We wanted to test urinary concentrating ability and AQP-2 expression in kidney during high-protein and high-carbohydrate diet.


Eligibility criteria: Inclusion Criteria:

* (1) Genders; both mal and female
* (2) Age; 18- 65 years old
* (3) BMI; below 30
* (4) Females had to bee in oral contraceptive treatment

Exclusion Criteria:

* (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
* (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
* (3) Albuminuria or glucosuria
* (4) Cancer
* (5) Arterial hypertension
* (6) Alcohol abuse
* (7) Use of tobacco
* (8) Medical treatment, except oral contraceptives
* (9) Pregnancy or breast feeding
* (10) Medicine abuse
* (11) Donation of blood less than 1 month before the study.

Primary outcomes:
measure: u-AQP-2
measure: FeNa+
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
Study officials:
affiliation: Holstebro Hospital, 7500 Holstebro Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
affiliation: Holstebro Hospital, 7500 Holstebro, Denmark
name: Thomas G Knudsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03085121: Femoral Extramedullary Versus Intramedullary Alignment Systems in Total Knee Arthroplasty
Official title: A Comparative Study of Femoral Extramedullary and Intramedullary Alignment Systems in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: extramedullary
intramedullary
total knee arthroplasty (TKA)
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study will be performed to compare the clinical outcome after total knee arthroplasty (TKA) using two different alignment systems: an extramedullary system versus an intramedullary system. The extramedullary femoral alignment system is newly designed. These two systems are used to make the distal femoral resection in 100 patients in a random order.


Eligibility criteria: Inclusion Criteria:

* Varus knee; degrees of extra articular deformity \< 15°; Knee Osteoarthritis; Straight limited \< 30°; range of knee flexion \> 90°; No hip abnormalities

Exclusion Criteria:

* Valgus knee; degrees of extra articular deformity \> 15°; Knee infection; Rheumatic arthritis; Ankylosing Spondylitis; Prior femoral surgery

Primary outcomes:
measure: Imaging tests
timeFrame: pre surgery and 3, 12 months post surgery
measure: Assess the changes of KSS scores
timeFrame: pre surgery and 3, 12 months post surgery
measure: Assess the changes of SF-36 scores
timeFrame: pre surgery and 3, 12 months post surgery
measure: Assess the changes of WOMAC scores
timeFrame: pre surgery and 3, 12 months post surgery
Secondary outcomes:
measure: deep vein thrombosis (DVT)
timeFrame: pre surgery and 3, 12 months post surgery
measure: Range of knee motion
timeFrame: pre surgery and 3, 12 months post surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhihong Xu
state: Jiangsu
Study officials:
References:
citation: Meding JB, Berend ME, Ritter MA, Galley MR, Malinzak RA. Intramedullary vs extramedullary femoral alignment guides: a 15-year follow-up of survivorship. J Arthroplasty. 2011 Jun;26(4):591-5. doi: 10.1016/j.arth.2010.05.008.
citation: Nakahara H, Matsuda S, Okazaki K, Tashiro Y, Iwamoto Y. Sagittal cutting error changes femoral anteroposterior sizing in total knee arthroplasty. Clin Orthop Relat Res. 2012 Dec;470(12):3560-5. doi: 10.1007/s11999-012-2397-1. Epub 2012 May 19.
citation: Kim CW, Seo SS, Kim JH, Lee HJ, Lee CR. Factors affecting the osteolysis around the components after posterior-stabilized total knee replacement arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1863-9. doi: 10.1007/s00167-014-3088-0. Epub 2014 Jun 11.
Clinical trial NCT06307821: the Role of Probiotic in Protein Metabolism
Official title: Assessing the Impact of Weizmannella Coagulans BC99 on Protein Digestion and Metabolism: A Randomized, Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Probiotic; Protein digestion
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the functional effects of probiotics on athletes by administering Weizmannella coagulans BC99 for six weeks. It aims to assess the probiotic's influence on skeletal muscle content, athletic performance, and protein digestion and metabolism. This is achieved by monitoring changes in digestive enzymes, amino acids, body composition, and hormone levels. The research seeks to offer a theoretical foundation for optimizing athletes' training and nutrition strategies and suggests the potential of probiotics in enhancing nutrient absorption and utilization, particularly in individuals with compromised digestive capabilities.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
2. Agree to abide by the protocol and study restrictions;
3. The subject is not allergic to protein products;
4. Male or female subjects aged 18 to 35 years old (including 18 and 35 years old);
5. Male subjects should weigh no less than 50 kilograms. Female subjects must weigh no less than 45 kg. Body mass index (BMI) = weight (kg)/height (m)2, body mass index is in the range of 19.0 to 24.0 kg/m2;
6. No history of hidden risks of cardiovascular and cerebrovascular diseases, hypertension, diabetes, liver/kidney function, etc. and metabolic abnormalities.

Exclusion Criteria:

1. Patients with allergies and immune deficiency;
2. Donated blood or lost a large amount of blood (≥200 mL) within 3 months before taking the trial drug;
3. Other systemic diseases, including cardiovascular disease, lung disease, liver disease, kidney disease and other serious lesions of important organs, severe metabolic diseases (diabetes, thyroid disease), severe immune system diseases; no cardiovascular and cerebrovascular diseases, hypertension , diabetes, liver/kidney function and other hidden dangers and metabolic abnormalities.
4. Drugs that affect intestinal flora (including antibacterial drugs, microecological preparations, intestinal mucosal protective agents, Chinese patent medicines, etc.) have been used continuously for more than 1 week within 1 month before screening;
5. Subjects judged by other researchers to be unfit to participate.

Primary outcomes:
measure: Digestibility and absorption of dietary protein
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Henan University of Science and Technology
state: Henan
Study officials:
References:
Clinical trial NCT03934021: Gut Microbiota in Acute Stroke Patients
Official title: Gut Microbiota in Acute Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Microbiome
Atherosclerosis Cerebral
Keywords: Stroke
Ischemic stroke
microbiome
atherosclerotic
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 200
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: Consecutive patients diagnosed with acute ischaemic stroke during hospitalization in PWH will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria. Control group will be recruited from medical out patient clinic

Brief summary: This study is to find out the significance of gut-microbiota in acute stroke patients, including their neurological, radiological outcomes as well as their stroke mechanisms.

Detailed description: Patients who suffered from acute stroke and in hospitalization in Prince of Wales Hospital will be recruited in the study.

After the informed consent, their first bowel opening will be collected for storage. They will also receive assessment by the stroke team at 3 and 6 months to determine their outcomes (NIHSS and mRS). Clinically and radiologically parameters including their degree of disability, imaging findings will also be collected to determine whether there are any correlations with the stool microbiota composition against matched individuals.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed as acute ischaemic stroke
2. Aged 18 or above Chinese
3. Radiological evidence of acute ischaemic stroke by Computed tomography (CT) or magnetic resonance imaging (MRI) brain.

Exclusion Criteria:

1. Patient with symptoms and signs suggestive of alternative diagnoses,
2. Evidence of intracerebral haemorrhage,
3. Absence of DWI evidence of acute ischaemic infarct,
4. Pregnancy,
5. Evidence of gastrointestinal infection/ inflammation/ obstruction
6. History of partial or total resection of small or large bowel, as well as gut re-anastomosis,
7. Use of antibiotics within 2 weeks prior to symptoms onset,
8. Gastrointestinal malignancy
9. Any hospitalization within 3 months before recruitment
10. Institutionalized patients

Primary outcomes:
measure: The composition of gut-microbiota contributing neurological outcome between groups
timeFrame: 31 Dec, 2020
Secondary outcomes:
measure: The composition of gut-mircobiota contributing radiological finding between groups
timeFrame: 31 Dec, 2020
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Yiu Ming Bonaventure IP, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04347421: Effect of Krill Oil on Cognitive Function in Adults
Official title: Effect of Krill Oil on Cognitive Function in Adults With Subjective Memory Impairment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Memory Impairment
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Krill oil on cognitive function in adults with subjective memory impairment for 12 weeks.

Detailed description: Previous animal studies have indicated that Krill oil may have the ability to improve cognitive function. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Krill oil on cognitive function in adults with subjective memory impairment for 12 weeks; the safety of the compound are also evaluate. The Investigators examine chemical and metabolic parameters, and cognitive function at baseline, as well as after 6 and 12 weeks of intervention. One hundred adults were administered either 500 mg of Krill oil or a placebo each day for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Global Deterioration Scale (GDS) 2 or 3

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of viral hepatitis or cancer
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks

Primary outcomes:
measure: Mini-Mental State Examination total score
timeFrame: Change from Baseline Mini-Mental State Examination total score at 3 months
Secondary outcomes:
measure: Korean instrumental activity of daily living total score
timeFrame: Change in Korean instrumental activity of daily living total score during 3 months
measure: Computerized NeuroCognitive Function test total score
timeFrame: Change in Computerized NeuroCognitive Function test total score during 3 months
measure: brain derived neurotrophic factor
timeFrame: Change in brain derived neurotrophic factor level during 3 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666821: A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population
Official title: A Population-based Study of Macular Choroidal Neovascularization Using Optical Coherence Tomography in a Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geographic Atrophy
Wet Macular Degeneration
Retinal Drusen
Keywords: macular degeneration; choroidal neovascularization
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 59
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: recruited 1813 adults citizens aged above 45 years by probability sampling from the Youyi Street, Baoshan District, Shanghai, China for an epidemiologic survey. All participants gave written informed consent, and this study was approved by the local Ethics Committee in accordance with the Helsinki Declaration.

Brief summary: To investigate pathomorphological and functional variations of choroidal neovascularization (CNV) in age-related macular degeneration (AMD) in a Chinese population using optical coherence tomography (OCT) to find which kinds of Fundus characteristics indicated exudative AMD.

Detailed description: This population-based study enrolled 59 patients (\>45 years old; 70 eyes) with early and intermediate-stage AMD from Youyi Street, Baoshan District, Shanghai, China. Comprehensive standardized ophthalmic examinations included visual acuity, anterior segment analysis by slit lamp, dilated fundus evaluation by direct ophthalmoscopy, 90D handheld lens, fundus photography, fluorescein angiography (FFA), and fast optic disk scans using OCT. The macular CNV characteristic profiles in early and intermediate-stage AMD were determined by OCT. Data were obtained at first visit and 6 to 24 months follow-up, and FFA and OCT outcomes of early and intermediate-stage AMD patients were analyzed.

Eligibility criteria: Inclusion Criteria:

* adults citizens aged above 45 years

Exclusion Criteria:

* lost samples

Primary outcomes:
measure: change of the early and intermediate-stage AMD
timeFrame: May 2004-September 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Youyi Street
state: Baoshan District
Study officials:
affiliation: Director of ophthalmology
name: zhao jie, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01721421: Effects of Extended Haemodialysis Treatment Duration in Patients With End-stage Renal Disease
Official title: Feasibility and Physiological and Nutritional Effects of Extended Treatment Duration in Patients With End-stage Renal Disease on Haemodialysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: End Stage Renal Disease
Keywords: haemodialysis
Crossover
Treatment time
nutritional status
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-11-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Design: Prospective randomised cross-over study. Fifty-two eligible patients will be randomised to a treatment time of either 6 hours or 4 hours for a period of 24 weeks and following a washout period of 4 weeks, switch to the alternative treatment time for an additional 24 weeks.

Aims: To examine the feasibility and effect of extended dialysis treatment time, 6 hours thrice weekly, versus the standard, 4 hours thrice weekly, comparing the differences from baseline in outcome measures over a total 12-month period.

Primary outcome measure

1\]Serum albumin

Secondary outcome measures Nutritional status

1. Malnutrition-inflammation score
2. Dietary intake
3. Hand-Grip strength
4. Energy expenditure

Quality of life

1. Patient reported quality of life and
2. time to recovery from dialysis

Serum biomarkers

1. BNP
2. Troponin
3. MCP-1

Others 24- hour Ambulatory blood pressure 24-hour accelerometer

Population: Local haemodialysis population of 1200 patients Eligibility: Minimum 90days on haemodialysis treatment Duration: Fifty-six weeks


Eligibility criteria: Inclusion Criteria:

* Dialysis dependant for over 90 days

Exclusion Criteria:

1. Haemodialysis for less than 90 days
2. Patients with anticipated life expectancy less than 6 months secondary to significant morbidity e.g. metastatic malignancy, advanced human immunodeficiency virus
3. Patients with acute liver disease; History of underlying haematological condition;
4. Elective planned change of renal replacement modality within the 12 months.

Primary outcomes:
measure: Serum albumin
timeFrame: baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Peter Choi, MBcHB PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03196921: Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection
Official title: A Prospective Cohort to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB/MAT2203) for the Treatment of Cryptococcal Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Cryptococcal Infections
Keywords: amphotericin B
cryptococcal
Lead sponsor: Matinas BioPharma Nanotechnologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Minnesota
First posted: 2017-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients with symptomatic cryptococcal meningitis will be enrolled in treatment arm Patients that are CRAG positive will be enrolled the in prevention arm
Primary purpose: TREATMENT

Brief summary: This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.


Eligibility criteria: Inclusion Criteria:

* HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG

Exclusion Criteria:

* Presence of jaundice or known liver cirrhosis, \>72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits

Primary outcomes:
measure: Tolerability of drug over 14 days of dosing
timeFrame: 14-days
measure: Microbiologic clearance of Cryptococcus from the CSF
timeFrame: 14-days
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 14-days
measure: Survival from cryptococcal infection
timeFrame: 10-weeks
measure: Pharmacokinetics
timeFrame: 24-hours
measure: Pharmacokinetics
timeFrame: 24-hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: David R Boulware, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Asella Teaching Hospital, Arsi University
name: Tafese Beyene Tufa
role: PRINCIPAL_INVESTIGATOR
References: