louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06013072: Pre-probiotic Supplementation for Post-covid Fatigue Syndrome
Official title: The Effects of 3-month Supplementation With a Pre-probiotic on Patient- and Clinician-reported Outcomes, and Brain Tissue Metabolism in Patients With Post-covid Fatigue Syndrome: a Placebo-controlled Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Keywords: Prebiotic
Probiotic
Metabolism
Fatigue
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 32
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: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled double-blind parallel-group interventional trial is to evaluate the effects of of dietary supplementation with a pre-probiotic on patient- and clinician-reported outcomes, and brain tissue metabolism in patients with post-covid fatigue syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 65 years
* Covid-19 positive test within last 3 months (as documented byvalid PCR or antigentest
* Moderate-to-severe fatigue (20-MFI test total score \> 43.5)
* At least one of additional covid-19 related symptoms (anosmia,ageusia,breathingdifficulties,lungpain, body aches, headaches, difficulties concentrating etc.)

Exclusion Criteria:

* Other pulmonary and cardiovascular conditions
* History of dietary supplement use during the past 4 weeks
* Organic gastrointestinal (GI) disorders such as inflammatory bowel disease, coeliac disease, eosinophilic disorders, or current infection of the GI tract.
* Bowel surgery or short bowel syndrome.
* Medication or supplement which can impact the gut microbiome, including: antibiotics, antimicrobials, or antifungals in the two months
* Probiotic or prebiotic supplements in the last 4 weeks

Primary outcomes:
measure: Fatigue
timeFrame: Change from baseline fatigue at 3 months
Secondary outcomes:
measure: Brain creatine
timeFrame: Change from baseline brain creatine concentrations at 3 months
measure: Patient-reported symptoms
timeFrame: Change from baseline fatigue at 3 months
measure: Time to exhaustion
timeFrame: Change from baseline time to exhaustion at 3 months
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
References:
Clinical trial NCT03697772: Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients
Official title: Continuity of Care and Use of Urgent Healthcare in Multimorbid Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multimorbidity
Continuity of Care
Keywords: continuity of care
primary care
multimorbidity
quality of life
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multimorbid primary care patients

Brief summary: Chronic disease management is a public health problem that faces monitoring difficulties related to complex care pathways. This study will analyze the use of unscheduled or urgent care according to the continuity of care in multimorbid patients

Detailed description: The prevalence of chronic diseases in the population is increasing significantly. It represents a new challenge for doctors and health authorities. However, patients often have at least two chronic diseases. These are referred to as "multimorbid" patients, whose continuity of care has not been well studied to date.

This observational study evaluates the association between the continuity of care in multimorbid patients seen in general practice and their use of urgent healthcare, their quality of life and their burden of treatment.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age, seen in consultation in the office by an investigating doctor, with a follow-up for more than 12 months in the office, presenting at least two chronic disease , having given their written consent to participate in the study

Exclusion Criteria:

* seen at home
* unable to respond (cognitive problems or language barrier)

Primary outcomes:
measure: Continuity of care
timeFrame: over the past 1year
measure: care pathway
timeFrame: over the past 1 year
Secondary outcomes:
measure: global quality of life
timeFrame: over the past 1 year
measure: burden of traitement
timeFrame: over the past 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Université Paris Cité
Study officials:
References:
Clinical trial NCT00213772: Risk Factors of Porphyria Cutanea Tarda (PCT)
Official title: "Factors Associated With Porphyria Cutanea Tarda in Patients Infected With Hepatitis C Virus"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Porphyria Cutanea Tarda
Keywords: Porphyria cutanea tarda
hepatitis C
hemochromatosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Comparison of patients with documented PCT and HCV infection, documented PCT without HCV, HCV infection without PCT and controls without HCV or PCT.

Single blood + urine sample uptake to investigate : mutations in HFE gene, uroporphyrinogen decarboxylase activity, HCV genotye, history of disease.


Eligibility criteria: Inclusion Criteria:

* Porphyria cutanea tarda /HCV negative Porphyria cutanea tarda/ HCV positive HCV positive HCV negative controls

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Bernard Cribier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Pitié-Salpétrière / Paris
name: O. Chosidow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Henri Mondor / CHU Créteil
name: M. Bagot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de l'Archet / CHU Nice
name: J.P Lacour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01997372: Different Doses of Anti-thymocyte Globin to Treat Child Severe Aplastic Anemia
Official title: Different Doses of Anti-thymocyte Globin With 2.5 or 3.75mg/kg to Treat Child Severe Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Severe Aplastic Anemia
Keywords: ATG
SAA
immunosuppressive treatment
cyclosporine
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-11-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe acquired aplastic anaemia (SAA) is a life-threatening disease characterized by pancytopenia and hypoplastic bone marrow. Immunosuppressive treatment with antithymocyte globulin (ATG)and cyclosporine remain the standard regimen with response rates of 70% or more and excellent overall survival. However ,there are no clinical trials to illustrate the response and complete remission rate with different doses of ATG.And there are no data reported on children with SAA so far.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of childhood acquired severe aplastic anemia(SAA)

Exclusion Criteria:

* clinical diagnosis of no childhood acquired severe aplastic anemia(SAA)

Primary outcomes:
measure: the response and complete remission rate with different doses of ATG to treat child severe aplastic anemia
timeFrame: 1 years
Secondary outcomes:
measure: the relapse rate with different doses of ATG to treat child severe aplastic anemia
timeFrame: 4-10 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of Pediatrics, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References:
citation: Camitta BM, Rappeport JM, Parkman R, Nathan DG. Selection of patients for bone marrow transplantation in severe aplastic anemia. Blood. 1975 Mar;45(3):355-63.
Clinical trial NCT01499472: Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers
Official title: ESWT Treatment of Diabetic Foot VS. Standard Care Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.


Eligibility criteria: Inclusion Criteria:

1. Signed Informed Consent.
2. Diagnosed with Diabetes.
3. An Active Diabetic Ulcer larger than 5 cm2
4. Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)\>=0.5

Exclusion Criteria:

1. Pregnancy.
2. The patient is under another research protocol.
3. One of the following:

   A. ABI\<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
4. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
5. Sufficient Noncompliant.
6. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids

Primary outcomes:
measure: healed ulcer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00875472: Social Influences on Adolescents' Snack Purchases
Official title: Social Influences on Adolescents' Snack Purchases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Influences
Food Consumption
Keywords: social influences
food purchases
childhood obesity
amount of energy dense food and beverage items purchased
amount of nutrient dense food and beverage items purchased
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2009-04-03
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to assess the effects of peer influences on snack purchases in adolescents. During the session teens will be given a certain amount of money to use to purchase foods and beverages in a hypothetical convenience store setting.

The investigators hypothesize that overweight youth will be less responsive to own-price elasticity for high calorie foods and less likely to show cross price elasticity for low calorie foods when the price of the high calorie for nutrient foods increases. The investigators also predict that overweight youth will show more cross price elasticity for low calorie foods when in the presence of peers; whereas lean youth's food purchases and price sensitivity will not be affected by the presence of peers.


Eligibility criteria: Inclusion Criteria:

* Boys and girls ages 12-14
* Youth must have at least a moderate liking of study foods used
* Youth must be at or above the 15th BMI percentile

Exclusion Criteria:

* Youth should have no dietary restrictions
* Youth should have no food allergies
* Youth should have no medical conditions that alter the body's ability to absorb nutrients or that can otherwise influence the participants' response to food

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, Division of Behavioral Medicine
state: New York
Study officials:
affiliation: University at Buffalo
name: Sarah J Salvy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01632072: The Undernourished Patient: Prevention and Treatment
Official title: The Undernourished Patient: Prevention and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Weight Loss
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Godthaab rehabilitation centre
First posted: 2012-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a nutrition intervention during a rehabilitation stay followed by nutritional advice after discharge, can improve the nutritional status of the patients after 3 months.


Eligibility criteria: Inclusion Criteria:

1. In risk of undernutrition or undernourished according to the screening tool NRS-2002, score 3 or above.
2. Living in Oslo, Bærum or Asker municipality.
3. Must be able to cooperate.

Exclusion Criteria:

1. Unwilling to participate
2. Less than 12 months life expectancy

Primary outcomes:
measure: Body weight change
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bekkestua
country: Norway
facility: Godthaab rehabilitation center
Study officials:
affiliation: University of Oslo
name: Per O Iversen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson J, Hulander E, Rothenberg E, Iversen PO. Effect on Body Weight, Quality of Life and Appetite Following Individualized, Nutritional Counselling to Home-Living Elderly after Rehabilitation - An Open Randomized Trial. J Nutr Health Aging. 2017;21(7):811-818. doi: 10.1007/s12603-016-0825-8.
Clinical trial NCT06585072: Pancreatic Cancer and Diabetes Mellitus
Official title: Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cancer
Surgery
Diabetes Mellitus
Keywords: Pancreatic Cancer
Surgery
Diabetes Mellitus
Risk factor
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 150
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 with pancreatic cancer after pancreatic surgery

Brief summary: The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:

1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
2. Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.

The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.

Detailed description: Investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.

Eligibility criteria: Inclusion Criteria:

1. male or female Chinese subjects; 2. Age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital.

-

Exclusion Criteria:

1. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. Cognitive impairment or other reasons for failing to sign the informed consent form.

-

Primary outcomes:
measure: Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)
timeFrame: From enrollment to five years after the end of the surgery
Secondary outcomes:
measure: Overall Survival
timeFrame: From enrollment to five years after the end of the surgery
measure: Disease-Free Survival
timeFrame: From enrollment to five years after the end of the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Changzheng Hospital
name: tuo Li, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03814772: To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM
Official title: To Establish a Prediction Model of Massive Blood Transfusion for Liver Transplantation Patients Based on Patient Blood Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Transfusion Complication
Keywords: liver transplantation
blood transfusion
Patient blood management
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Second Xiangya Hospital of Central South University
name: RenJi Hospital
name: Qilu Hospital of Shandong University
First posted: 2019-01-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Allogeneic liver transplantation surgery

Brief summary: Based on the principle of patient blood management, this study aims to reduce the risk of blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood transfusion, and to provide new methods and basis for restrictive blood transfusion.

Detailed description: 1. Preoperative variables and statistical analysis of a large number of intraoperative blood transfusions in allogeneic liver transplantation patients were performed to screen preoperative variables.
2. Models were established by machine learning algorithms to predict a large number of blood transfusions during surgery, providing a reference for preoperative blood preparation and postoperative outcome.

Eligibility criteria: Inclusion Criteria:

* 48h preoperative biochemical indicators, blood general indicators, coagulation test complete

Exclusion Criteria:

* 1. Inspection information is not detailed 2. Blood transfusion information is not detailed 3.Postoperative medical record information is not detailed

Primary outcomes:
measure: one year mortality
timeFrame: 2019-2021
Secondary outcomes:
measure: Intraoperative blood transfusion
timeFrame: 2019-2021
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT06334172: The Role of Oxytocin in Regulating Blood Glucose
Official title: The Role of Oxytocin in Regulating Blood Glucose
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Keywords: oxytocin
blood glucose
glucose stabilization
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blinded, single-arm study. Each participant goes through three experimental days in a randomized order - acting as their own controls
Primary purpose: BASIC_SCIENCE

Brief summary: Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.

Detailed description: Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) \< 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI 19-25 kg/m2

Exclusion Criteria:

* Diabetes
* Heart-, liver or kidney disease
* More than 14 units of alcohol weekly, or drug abuse
* Smoking or any kind of nicotine products
* Alanin aminotransferase (ALAT) ≥ 2 × normal range
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1,73m2 or creatinine above normal range
* Blood pressure \> 140/90
* Hemoglobin \< normal range
* Corrected QT Interval (Qtc) \>0,45 sec. at electrocardiogram (ECG) at screening
* Known disease in the pituitary gland or previous pituitary surgery
* Any other disease/condition which the trial managers believe may affect participation in the trial

Primary outcomes:
measure: Insulin secretion - c-peptide
timeFrame: From time 0 to time 180 min
Secondary outcomes:
measure: Glucose
timeFrame: From time 0 minutes to time 180 minutes
measure: Insulin
timeFrame: From time 0 minutes to time 180 minutes
measure: Glucagon
timeFrame: From time 0 minutes to time 180 minutes
measure: GIP
timeFrame: From time 0 minutes to time 180 minutes
measure: GLP-1
timeFrame: From time 0 minutes to time 180 minutes
measure: Lipids
timeFrame: From time 0 minutes to time 180 minutes
measure: Cross-linked C-telopeptide of type I collagen( CTX)
timeFrame: From time 0 minutes to time 180 minutes
measure: Procollagen type I N-terminal propeptide (P1NP)
timeFrame: From time 0 minutes to time 180 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Gentofte Hospital
state: Capital Region
Study officials:
References:
Clinical trial NCT05467072: PMCFU of an Annular Closure System
Official title: Post-Marketing Clinical Follow-up of an Annular Closure System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Disc Herniation
Lead sponsor: Intrinsic Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 250
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: Patient previously treated with lumbar discectomy and annular closure, with 3 month post op follow up data available

Brief summary: The purpose of this retrospective chart review study is to collect the data that will be used to provide clinical evidence to support the post-market surveillance program.

Detailed description: Retrospective chart review of patients treated with lumbar discectomy and annular closure. Review of patient charts through 3 month post op, for analysis of symptomatic lumbar reherniation at the index level.

Eligibility criteria: Inclusion Criteria:

* Records for any subject treated with a Barricaid annular closure device will be considered for inclusion into the study

Exclusion Criteria:

* Records for any subject treated without a Barricaid annular closure device will be considered for exclusion

Primary outcomes:
measure: Symptomatic reherniation
timeFrame: 3 months post op
Secondary outcomes:
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Orthopedic Institute of Western Kentucy
state: Kentucky
Study officials:
affiliation: New England Baptist Hospital
name: David H Kim, MD
role: STUDY_CHAIR
References: