louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02538250: Acceptability Study on Oral Nutrition Supplement (ONS)
Official title: Acceptability Study on Nutricomp Drink Plus in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Nutritional Supplementation
Keywords: Oral nutritional supplement
supplementation
adult patients
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.


Eligibility criteria: Inclusion:

* Male and female patients
* ≥ 18 years of age
* Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
* Patient is able and willing to provide written informed consent

Exclusion:

* Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
* Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
* Patients who express general dislike to two or more of the four flavours
* Severely impaired gastrointestinal function or complete failure
* Severe metabolic or circulatory disorders
* Acute disease
* Unstable vital functions
* Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy
* Simultaneous participation in another interventional study
* Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
* Pregnancy
* Emergencies

Primary outcomes:
measure: Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)
timeFrame: 7 days
Secondary outcomes:
measure: Occurrence of further adverse effects
timeFrame: 7 days
measure: Evaluation of palatability by questionnaire
timeFrame: 1 day
measure: Evaluation of compliance.
timeFrame: 7 days
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit
Study officials:
affiliation: The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK
name: David Sanders, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04095650: A New Model to Reach Vulnerable Older Adults With Pain Self-management Support
Official title: A New Model to Reach Vulnerable Older Adults With Pain Self-management Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: American Pain Society
First posted: 2019-09-19
Enrollment: 38
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: Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.


Eligibility criteria: Inclusion Criteria:

* English-proficient
* Age \>= 60 years
* Ambulatory with or without assistive device
* Community-living
* Have a cell or landline phone
* Have Internet access (home or elsewhere)
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities
* Ability to attend a one-time study orientation session

Exclusion Criteria:

* Serious acute illness or hospitalization in last month
* Planned surgery in next three months
* Significant cognitive impairment as indicated by affirmative response to question: "Do you have significant difficulties with your memory that get in the way of your usual daily activities?"
* Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.

Primary outcomes:
measure: Change in pain interference
timeFrame: baseline and 8 weeks
measure: Participant engagement
timeFrame: 8 weeks
Secondary outcomes:
measure: Participant Global Impression of Change
timeFrame: 8 weeks
measure: Participant satisfaction: Likert-scale questions
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan School of Public Health
name: Mary Janevic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02353650: The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Keywords: Q10
ubiquinol
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2015-02-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.


Eligibility criteria: Inclusion Criteria:

* chronic non-pulsatile tinnitus \> 3 months
* tinnitus has a clear otological cause
* age \> 18 years

Exclusion Criteria:

* pulsatile tinnitus
* persons who take already Q10
* pregnancy
* cervical tinnitus
* holocranial tinnitus
* depression
* mental of neurological disorders
* history of chemotherapy
* middle ear diseases

Primary outcomes:
measure: Tinnitus Functional Index
timeFrame: 2 months
Secondary outcomes:
measure: Audiometric tresholds test
timeFrame: 2 months
measure: Tinnitus Analysis _ loudness matches
timeFrame: 2 months
measure: Tinnitus Analysis_Minimal masking level
timeFrame: 2 months
measure: Visual Analogue Scale of loudness
timeFrame: 2 months
measure: Hospital Anxiety and Depression Scale
timeFrame: 2 months
measure: Hyperacusis Questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University hospital of Antwerp
state: Antwerp
Study officials:
References:
Clinical trial NCT06305650: Probiotic Influence on Obesity-Related Lipidemia
Official title: The Efficacy and Safety of a Probiotic in Reducing Body Fat and Blood Lipids Among Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Keywords: Probiotic
Obesity
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-12
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of Bifidobacterium breve BBr60 on key health indicators in overweight and obese adults. Specifically, it will assess the probiotic's impact on body composition metrics such as BMI, body fat percentage, WHR, and BMR. The inclusion criteria for participants are a BMI of ≥28 kg/m\^2, targeting individuals who stand to benefit significantly from metabolic and body composition improvements.


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ≥ 28 kg/m2;
2. Voluntarily, in writing, and signing the informed consent form, agreeing to participate in this study;
3. Those who agree to abide by the protocol and study restrictions and are able to comply with a low-carbohydrate, energy-restricted diet plan.
4. Subjects (including male subjects) have no plans to have children from 14 days before screening to 6 months after the end of the trial and voluntarily take effective contraceptive measures;

Exclusion Criteria:

1. Taking items with similar functions to those tested in a short period of time will affect the judgment of the results;
2. Patients with severe allergies and immune deficiency;
3. Women who are pregnant, breastfeeding or planning to become pregnant;
4. Severe diseases of cardiovascular, lungs, liver, kidneys and other important organs, diabetes, thyroid disease, severe metabolic diseases, malignant tumors, and severe immune system diseases;
5. People who have used antibiotics in the past two weeks;
6. Those who failed to consume the test samples as required or failed to follow up on time, resulting in uncertainty in determining the efficacy;
7. Have used laxatives or fiber supplements in the past 6 weeks;
8. Subjects judged by other researchers to be unfit to participate. Those who meet any of the above conditions will not be selected.

Primary outcomes:
measure: Effect on body mass index (BMI) values.
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 NCT06509750: The Postprandial Effects of a Carob-containing Meal
Official title: The Postprandial Effects of a Carob-containing Meal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In an era where malnutrition and unhealthy eating patterns are salient contributors to global health deterioration, the urge for better access to nutritious alimentation is striking. Native to the Mediterranean region, the carob tree holds significant promise in this regard. With its rich nutritional profile, containing high levels of dietary fiber, polyphenols, and essential minerals, carob has been increasingly exploited by the food industry. Carob flour, derived from the pod after seed removal, is widely used as a cocoa substitute. The carob tree's fruit comprises 10% seeds and 90% pulp, containing numerous bioactive components such as dietary fiber, cyclitols, phenolic compounds, amino acids, and minerals. These components have been associated with beneficial effects on the gastrointestinal system and glucose absorption, with small-scale clinical studies indicating a hypolipidemic effect in patients with hypolipidemia. Nevertheless, comprehensive data from randomized controlled trials on the biological actions of carob remain restricted. This study explores the postprandial effects of incorporating carob into a Western-style meal, focusing on regulating glucose, insulin, and appetite hormones. The hypothesis is that a carob-enriched breakfast meal could positively influence satiety and appetite regulation, potentially offering a nutritious and sustainable dietary option for improving metabolic health. The high fiber and polyphenol content in carob are expected to modulate these postprandial responses, contributing to a better understanding of carob's role in dietary interventions. This study supports international initiatives to combat malnutrition and encourage a healthy diet, especially in light of the growing world population and the requirement for sustainable food supplies. By investigating the impact of carob on postprandial metabolic responses, this study seeks to contribute valuable insights into its potential benefits as part of a healthy diet.


Eligibility criteria: Inclusion Criteria:

* healthy male adults
* normal weight

Exclusion Criteria:

high body fat mass Type 1 Diabetes, cardiovascular diseases, hypertension thyroid disorder, liver disease, kidney disease gastrointestinal disease mental illness use of nutraceutical supplements or natural products for weight loss dietitians/nutritionists

Primary outcomes:
measure: Plasma ghrelin levels
timeFrame: 3 hours
measure: Changes in visual analogue scale
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
References:
Clinical trial NCT02380950: Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery
Alcohol Consumption
Cognitive Function
Lead sponsor: eSwiss Medical & Surgical Center
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol effects after gastric bypass we suggest that also general cognitive function is stronger impaired.

Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8 normal weight subjects) in the study. Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".


Eligibility criteria: Inclusion Criteria:

Gastric bypass group:

* women
* preOP BMI \>35 kg/m²
* time since bariatric surgery \> 1 year
* age 18-60 years
* moderate drinking habits

obese group:

* women
* BMI \>35 kg/m²
* age 18-60 years
* moderate drinking habits

normal weight group:

* women
* BMI 18.5 - 25 kg/m²
* age 18-60 years
* moderate drinking habits

Exclusion Criteria:

* men
* patient does not drink wine
* usage of psychotropic drugs
* alcoholic
* pregnancy

Primary outcomes:
measure: Change in reaction time after alcohol consumption
timeFrame: Change measures (baseline, 10 min, 45 min)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00732550: Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Official title: Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Keywords: cholelithiasis
cholecystitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Age 18-60
* symptomatic cholelithiasis
* ASA 1-2

Exclusion Criteria:

* pregnancy
* morbid obesity with BMI\>35
* other gallbladder pathology like polyps or tumor
* history of upper abdomen laparotomy
* suspected choledocholithiasis

Primary outcomes:
measure: To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.
timeFrame: Continuous
Secondary outcomes:
measure: To assess pain associated with the single trocar approach
timeFrame: Continuous
measure: To assess scar formation associated with single trocar approach
timeFrame: Continuous
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization Ein-Kerem campus
Study officials:
affiliation: Hadassah Medical Organization
name: Yoav Mintz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Avraham Rivkind, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05148923: Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
Official title: Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: DCCV
atrial fibrillation
Lead sponsor: Nemocnice AGEL Trinec-Podlesi a.s.
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Direct current cardioversion (DCCV) is a widespread method to restore sinus rhythm in patients with atrial fibrillation. It is a safe and effective method of treating atrial fibrillation. In this study, the investigators want to compare two algorithms. The rational one, with lower initial energy and the second one with the maximum possible shock energy.


Eligibility criteria: Inclusion Criteria:

1. Patients must have atrial fibrillation or atrial tachycardia.
2. Patients must be on therapeutic anticoagulation at least three weeks prior to DCCV or undergo esophageal echocardiography to rule out intracardiac thrombus.
3. Patients come on an empty stomach.
4. Patients must be over 18 years of age.
5. Patients must provide verbal and written informed consent to participate in the study.

Exclusion Criteria:

1. Omitting oral anticoagulant treatment in the last three weeks.
2. Unclear time of onset of palpitations in acute patients without anticoagulation therapy.
3. A different type of arrhythmia than atrial fibrillation or atrial tachycardia.

Primary outcomes:
measure: Heart rhythm after DCCV
timeFrame: one minute after DCCV
measure: Incidence of Neurological Adverse Events
timeFrame: two hours after DCCV
Secondary outcomes:
measure: Incidence of skin changes
timeFrame: two hours after DCCV
measure: Chest pain
timeFrame: one day after DCCV
Other outcomes:
Locations:
city: Trinec
country: Czechia
facility: Nemocnice AGEL Trinec-Podlesi
state: Česká Republika (Česko)
Study officials:
affiliation: Nemocnice AGEL Trinec-Podlesi
name: Lucjan Rucki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942123: Study On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis
Official title: On the Role of Mitochondrial Dysfunction in the Pathogenesis of Metformin-associated Lactic Acidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactic Acidosis
Metformin
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 10
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: Patients with lactic acidosis and metformin intoxication (as documented by drug serum measurement)

Brief summary: Metformin is the first line drug of choice for the treatment of type II diabetes. Lactic acidosis can develop as a side effect, especially when renal failure leads to drug accumulation. Lactic acidosis is usually attributed to an abnormal inhibition of hepatic lactate clearance.

Growing evidence suggest that metformin can dose-dependently inhibit hepatocyte mitochondrial function. Whether a similar effect occurs in extra-hepatic human tissues remains unknown.

The investigators hypothesize that mitochondrial dysfunction occurs during metformin intoxication even in tissues other than the liver, thus contributing to the development of lactic acidosis. The aim of this study is to investigate mitochondrial integrity in circulating platelets of patients with lactic acidosis due to metformin intoxication.


Eligibility criteria: Inclusion Criteria:

1. Lactic acidosis (pH \< 7.35 or base deficit \> 5 mmol/L and lactate \> 5 mmol/L)
2. Metformin intoxication (serum drug level \> 4 mcg/mL)
3. Absence of evidence of any other condition that could primarily explain the lactic acidosis

Exclusion Criteria:

1. Less than 18 years of age
2. Hemoglobin \< 8 g/dL (10 g/dL if ischemic cardiac disease)

Primary outcomes:
measure: Platelet mitochondrial respiratory chain enzyme activity
timeFrame: Within 48 hours from admission to ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico
state: MI
Study officials:
References:
citation: Protti A, Lecchi A, Fortunato F, Artoni A, Greppi N, Vecchio S, Fagiolari G, Moggio M, Comi GP, Mistraletti G, Lanticina B, Faraldi L, Gattinoni L. Metformin overdose causes platelet mitochondrial dysfunction in humans. Crit Care. 2012 Oct 3;16(5):R180. doi: 10.1186/cc11663.